XPOVIO is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.

This indication is approved under accelerated approval based on response rate [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Combination with Bortezomib and Dexamethasone (XVd)

The recommended dosage of XPOVIO is 100 mg taken orally once weekly on Day 1 of each week until disease progression or unacceptable toxicity in combination with:

Refer to Clinical Studies (14.1) and the prescribing information of bortezomib and dexamethasone for additional dosing information.

In Combination with Dexamethasone (Xd)

The recommended dosage of XPOVIO is 80 mg taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity in combination with dexamethasone 20 mg taken orally with each dose of XPOVIO on Days 1 and 3 of each week.

For additional information regarding the administration of dexamethasone, refer to its prescribing information.

The recommended dosage of XPOVIO is 60 mg taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity.

Monitor complete blood count (CBC) with differential, standard blood chemistries, body weight, nutritional status, and volume status at baseline and during treatment as clinically indicated. Monitor more frequently during the first three months of treatment [see Warning and Precautions (5.1, 5.2, 5.3, and 5.4)]. Assess the need for dosage modifications of XPOVIO for adverse reactions [see Dosage and Administration (2.5)].

Advise patients to maintain adequate fluid and caloric intake throughout treatment. Consider intravenous hydration for patients at risk of dehydration [see Warnings and Precautions (5.3, 5.4)].

Provide prophylactic antiemetics. Administer a 5-HT3 receptor antagonist and other anti-nausea agents prior to and during treatment with XPOVIO [see Warnings and Precautions (5.3)].

Recommended XPOVIO dosage reduction steps are presented in Table 1.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 1: XPOVIO Dosage Reduction Steps for Adverse Reactions </span> </caption> <col align="left" width="20.005%"/> <col align="left" width="26.657%"/> <col align="left" width="26.657%"/> <col align="left" width="26.682%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" rowspan="2" valign="bottom"><span class="Bold">Recommended</span> <br/> <span class="Bold">Starting Dosage</span></td><td align="center" class="Botrule Rrule Toprule" valign="bottom"><span class="Bold">Multiple Myeloma</span> <br/> <span class="Bold">In Combination with</span> <br/> <span class="Bold">Bortezomib and</span> <br/> <span class="Bold">Dexamethasone (XVd)</span></td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Multiple Myeloma</span> <br/> <span class="Bold">In Combination with</span> <br/> <span class="Bold">Dexamethasone (Xd)</span></td><td align="left" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Diffuse Large B-Cell Lymphoma</span></td> </tr> <tr> <td align="center" class="Botrule Rrule" valign="bottom">100 mg once weekly </td><td align="center" class="Botrule Rrule" valign="bottom">80 mg Days 1 and 3 of each week<br/>(160 mg total per week) </td><td align="center" class="Botrule Rrule" valign="bottom">60 mg Days 1 and 3 of each week<br/>(120 mg total per week) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="bottom"><span class="Bold">First Reduction</span></td><td align="center" class="Botrule Rrule" valign="bottom">80 mg once weekly </td><td align="center" class="Botrule Rrule" valign="bottom">100 mg once weekly </td><td align="center" class="Botrule Rrule" valign="bottom">40 mg Days 1 and 3 of each week<br/>(80 mg total per week) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="bottom"><span class="Bold">Second Reduction</span></td><td align="center" class="Botrule Rrule" valign="bottom">60 mg once weekly </td><td align="center" class="Botrule Rrule" valign="bottom">80 mg once weekly </td><td align="center" class="Botrule Rrule" valign="bottom">60 mg once weekly </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="bottom"><span class="Bold">Third Reduction</span></td><td align="center" class="Botrule Rrule" valign="bottom">40 mg once weekly </td><td align="center" class="Botrule Rrule" valign="bottom">60 mg once weekly </td><td align="center" class="Botrule Rrule" valign="bottom">40 mg once weekly </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="bottom"><span class="Bold">Fourth Reduction</span></td><td align="center" class="Botrule Rrule" valign="bottom">Permanently discontinue </td><td align="center" class="Botrule Rrule" valign="bottom">Permanently discontinue </td><td align="center" class="Botrule Rrule" valign="bottom">Permanently discontinue </td> </tr> </tbody> </table></div>

Recommended dosage modifications for hematologic adverse reactions in patients with multiple myeloma and DLBCL are presented in Table 2 and Table 3, respectively. Recommended dosage modifications for nonhematologic adverse reactions are presented in Table 4.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 2: XPOVIO Dosage Modification Guidelines for Hematologic Adverse Reactions in Patients with Multiple Myeloma </span> </caption> <col align="left" width="24.308%"/> <col align="left" width="12.571%"/> <col align="left" width="63.121%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Adverse Reaction</span></td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Occurrence</span></td><td align="left" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Action</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">Thrombocytopenia </span><span class="Italics">[see Warning and Precautions (<a href="#s15">5.1</a>)]</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Platelet count 25,000 to less than 75,000/mcL </td><td align="center" class="Botrule Rrule" valign="top">Any </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Reduce XPOVIO by 1 dose level (see <a href="#t1">Table 1</a>). </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Platelet count 25,000 to less than 75,000/mcL <span class="Italics">with</span> concurrent bleeding </td><td align="center" class="Botrule Rrule" valign="top">Any </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Interrupt XPOVIO. </li> <li>Restart XPOVIO at 1 dose level lower (see <a href="#t1">Table 1</a>) after bleeding has resolved. </li> <li>Administer platelet transfusions per clinical guidelines. </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Platelet count less than 25,000/mcL </td><td align="center" class="Botrule Rrule" valign="top">Any<br/> </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Interrupt XPOVIO. </li> <li>Monitor until platelet count returns to at least 50,000/mcL. </li> <li>Restart XPOVIO at 1 dose level lower (see <a href="#t1">Table 1</a>). </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Adverse Reaction</span></td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Occurrence</span></td><td align="left" class="Botrule Rrule" valign="top"><span class="Bold">Action</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">Neutropenia </span><span class="Italics">[see Warning and Precautions (<a href="#s16">5.2</a>)]</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Absolute neutrophil count of 0.5 to 1 x 10<span class="Sup">9</span>/L without fever </td><td align="center" class="Botrule Rrule" valign="top">Any </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Reduce XPOVIO by 1 dose level (see <a href="#t1">Table 1</a>). </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Absolute neutrophil count less than 0.5 x 10<span class="Sup">9</span>/L <span class="Italics">OR</span> <br/>febrile neutropenia </td><td align="center" class="Botrule Rrule" valign="top">Any<br/> </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Interrupt XPOVIO. </li> <li>Monitor until neutrophil counts return to 1 x 10<span class="Sup">9</span>/L or higher. </li> <li>Restart XPOVIO at 1 dose level lower (see <a href="#t1">Table 1</a>). </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">Anemia</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Hemoglobin less than 8 g/dL </td><td align="center" class="Botrule Rrule" valign="top">Any </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Reduce XPOVIO by 1 dose level (see <a href="#t1">Table 1</a>). </li> <li>Administer blood transfusions per clinical guidelines. </li> </ul> </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">Life-threatening consequences<br/> </td><td align="center" class="Botrule Rrule" valign="top">Any </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Interrupt XPOVIO. </li> <li>Monitor hemoglobin until levels return to 8 g/dL or higher. </li> <li>Restart XPOVIO at 1 dose level lower (see <a href="#t1">Table 1</a>). </li> <li>Administer blood transfusions per clinical guidelines. </li> </ul> </td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 3: XPOVIO Dosage Modification Guidelines for Hematologic Adverse Reactions in Patients with Diffuse Large B-Cell Lymphoma </span> </caption> <col align="left" width="22.100%"/> <col align="left" width="15.400%"/> <col align="left" width="62.500%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Adverse Reaction</span></td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Occurrence</span></td><td align="left" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Action</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">Thrombocytopenia </span><span class="Italics">[see Warning and Precautions (<a href="#s15">5.1</a>)]</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Platelet count 50,000 to less than 75,000/mcL </td><td align="center" class="Botrule Rrule" valign="top">Any </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Interrupt one dose of XPOVIO. </li> <li>Restart XPOVIO at the same dose level. </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Platelet count 25,000 to less than 50,000/mcL <span class="Italics">without</span> bleeding </td><td align="center" class="Botrule Rrule" valign="top">1st </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Interrupt XPOVIO. </li> <li>Monitor until platelet count returns to at least 50,000/mcL. </li> <li>Reduce XPOVIO by 1 dose level (see <a href="#t1">Table 1</a>). </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Platelet count 25,000 to less than 50,000/mcL <span class="Italics">with</span> concurrent bleeding </td><td align="center" class="Botrule Rrule" valign="top">Any </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Interrupt XPOVIO. </li> <li>Monitor until platelet count returns to at least 50,000/mcL. </li> <li>Restart XPOVIO at 1 dose level lower (see <a href="#t1">Table 1</a>), after bleeding has resolved. </li> <li>Administer platelet transfusions per clinical guidelines. </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Platelet count less than 25,000/mcL </td><td align="center" class="Botrule Rrule" valign="top">Any </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Interrupt XPOVIO. </li> <li>Monitor until platelet count returns to at least 50,000/mcL. </li> <li>Restart XPOVIO at 1 dose level lower (see <a href="#t1">Table 1</a>). </li> <li>Administer platelet transfusions per clinical guidelines. </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">Neutropenia </span><span class="Italics">[see Warning and Precautions (<a href="#s16">5.2</a>)]</span></td> </tr> <tr> <td align="justify" class="Botrule Lrule Rrule" rowspan="2" valign="top">Absolute neutrophil count of 0.5 to less than 1 x 10<span class="Sup">9</span>/L without fever </td><td align="center" class="Botrule Rrule" valign="top">1st occurrence </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Interrupt XPOVIO. </li> <li>Monitor until neutrophil counts return to 1 x 10<span class="Sup">9</span>/L or higher. </li> <li>Restart XPOVIO at the same dose level. </li> </ul> </td> </tr> <tr> <td align="center" class="Botrule Rrule" valign="top">Recurrence </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Interrupt XPOVIO. </li> <li>Monitor until neutrophil counts return to 1 x 10<span class="Sup">9</span>/L or higher. </li> <li>Administer growth factors per clinical guidelines. </li> <li>Restart XPOVIO at 1 dose level lower (see <a href="#t1">Table 1</a>). </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Absolute neutrophil count less than 0.5 x 10<span class="Sup">9</span>/L<br/> <span class="Italics">OR</span> <br/>Febrile neutropenia </td><td align="center" class="Botrule Rrule" valign="top">Any </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Interrupt XPOVIO. </li> <li>Monitor until neutrophil counts return to 1 x 10<span class="Sup">9</span>/L or higher. </li> <li>Administer growth factors per clinical guidelines. </li> <li>Restart XPOVIO at 1 dose level lower (see <a href="#t1">Table 1</a>). </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">Anemia</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Hemoglobin less than 8 g/dL </td><td align="center" class="Botrule Rrule" valign="top">Any </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Reduce XPOVIO by 1 dose level (see <a href="#t1">Table 1</a>). </li> <li>Administer blood transfusions per clinical guidelines. </li> </ul> </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">Life-threatening consequences </td><td align="center" class="Botrule Rrule" valign="top">Any </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Interrupt XPOVIO. </li> <li>Monitor hemoglobin until levels return to 8 g/dL or higher. </li> <li>Restart XPOVIO at 1 dose level lower (see <a href="#t1">Table 1</a>). </li> <li>Administer blood transfusions per clinical guidelines. </li> </ul> </td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 4: XPOVIO Dosage Modification Guidelines for Non-Hematologic Adverse Reactions </span> </caption> <col align="left" width="25.533%"/> <col align="left" width="13.933%"/> <col align="left" width="60.533%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Adverse Reaction</span></td><td align="left" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Occurrence</span></td><td align="left" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Action</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">Nausea and Vomiting </span><span class="Italics">[see Warning and Precautions (<a href="#s17">5.3</a>)]</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Grade 1 or 2 nausea (oral intake decreased without significant weight loss,<br/>dehydration or malnutrition)<br/> <span class="Italics">OR</span> <br/>Grade 1 or 2 vomiting (5 or fewer episodes per day) </td><td align="center" class="Botrule Rrule" valign="top">Any </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Maintain XPOVIO and initiate additional anti-nausea medications. </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Grade 3 nausea (inadequate oral caloric or fluid intake)<br/> <span class="Italics">OR</span> <br/>Grade 3 or higher vomiting (6 or more episodes per day) </td><td align="center" class="Botrule Rrule" valign="top">Any </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Interrupt XPOVIO. </li> <li>Monitor until nausea or vomiting has resolved to Grade 2 or lower or baseline. </li> <li>Initiate additional anti-nausea medications. </li> <li>Restart XPOVIO at 1 dose level lower (see <a href="#t1">Table 1</a>). </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">Diarrhea </span><span class="Italics">[see Warning and Precautions (<a href="#s17">5.3</a>)]</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" rowspan="2" valign="top">Grade 2 (increase of 4 to 6 stools per day over baseline) </td><td align="center" class="Botrule Rrule" valign="top">1<span class="Sup">st</span></td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Maintain XPOVIO and institute supportive care. </li> </ul> </td> </tr> <tr> <td align="center" class="Botrule Rrule" valign="top">2<span class="Sup">nd</span> and subsequent </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Reduce XPOVIO by 1 dose level (see <a href="#t1">Table 1</a>). </li> <li>Institute supportive care. </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Grade 3 or higher (increase of 7 stools or more per day over baseline; hospitalization indicated) </td><td align="center" class="Botrule Rrule" valign="top">Any<br/> </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Interrupt XPOVIO and institute supportive care. </li> <li>Monitor until diarrhea resolves to Grade 2 or lower. </li> <li>Restart XPOVIO at 1 dose level lower (see <a href="#t1">Table 1</a>). </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">Weight Loss and Anorexia </span><span class="Italics">[see Warning and Precautions (<a href="#s17">5.3</a>)]</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Weight loss of 10% to less than 20%<br/> <span class="Italics">OR</span> <br/>Anorexia associated with significant weight loss or malnutrition </td><td align="center" class="Botrule Rrule" valign="top">Any </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Interrupt XPOVIO and institute supportive care. </li> <li>Monitor until weight returns to more than 90% of baseline weight. </li> <li>Restart XPOVIO at 1 dose level lower (see <a href="#t1">Table 1</a>). </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">Hyponatremia </span><span class="Italics">[see Warning and Precautions (<a href="#s21">5.4</a>)]</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Sodium level 130 mmol/L or less </td><td align="center" class="Botrule Rrule" valign="top">Any </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Interrupt XPOVIO, evaluate, and provide supportive care. </li> <li>Monitor until sodium levels return to greater than 130 mmol/L. </li> <li>Restart XPOVIO at 1 dose level lower (see <a href="#t1">Table 1</a>). </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">Fatigue</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Grade 2 lasting greater than 7 days<br/> <span class="Italics">OR</span> <br/>Grade 3 </td><td align="center" class="Botrule Rrule" valign="top">Any<br/> </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Interrupt XPOVIO. </li> <li>Monitor until fatigue resolves to Grade 1 or baseline. </li> <li>Restart XPOVIO at 1 dose level lower (see <a href="#t1">Table 1</a>). </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">Ocular Toxicity </span><span class="Italics">[see Warning and Precautions (<a href="#s25">5.8</a>)]</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Grade 2, excluding cataract </td><td align="center" class="Botrule Rrule" valign="top">Any </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Perform ophthalmologic evaluation. </li> <li>Interrupt XPOVIO and provide supportive care. </li> <li>Monitor until ocular symptoms resolve to Grade 1 or baseline. </li> <li>Restart XPOVIO at 1 dose level lower (see <a href="#t1">Table 1</a>). </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Grade ≥3, excluding cataract </td><td align="center" class="Botrule Rrule" valign="top">Any </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Permanently discontinue XPOVIO. </li> <li>Perform ophthalmologic evaluation. </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="3" valign="top"><span class="Bold">Other Non-Hematologic Adverse Reactions </span><span class="Italics">[see Warning and Precautions (<a href="#s23">5.6</a>)]</span></td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">Grade 3 or 4 </td><td align="center" class="Botrule Rrule" valign="top">Any </td><td align="left" class="Botrule Rrule" valign="top"> <ul class="Disc"> <li>Interrupt XPOVIO. </li> <li>Monitor until resolved to Grade 2 or lower; restart XPOVIO at 1 dose level lower (see <a href="#t1">Table 1</a>). </li> </ul> </td> </tr> </tbody> </table></div>

Each XPOVIO dose should be taken at approximately the same time of day and each tablet should be swallowed whole with water. Do not break, chew, crush, or divide the tablets.

If a dose of XPOVIO is missed or delayed, instruct patients to take their next dose at the next regularly scheduled time.

If a patient vomits a dose of XPOVIO, the patient should not repeat the dose and the patient should take the next dose on the next regularly scheduled day.

Tablets:

{ "type": "p", "children": [], "text": "Tablets:\n" }

10 mg, blue, round, bi-convex, film-coated tablets with “X10” debossed on one side and nothing on the other side.

{ "type": "p", "children": [], "text": "10 mg, blue, round, bi-convex, film-coated tablets with “X10” debossed on one side and nothing on the other side.\n" }

20 mg, blue, round, bi-convex, film-coated tablets with “K20” debossed on one side and nothing on the other side.

{ "type": "p", "children": [], "text": "20 mg, blue, round, bi-convex, film-coated tablets with “K20” debossed on one side and nothing on the other side.\n" }

40 mg tablets, blue, oval, film-coated, debossed on both sides with “X40”.

{ "type": "p", "children": [], "text": "40 mg tablets, blue, oval, film-coated, debossed on both sides with “X40”.\n" }

50 mg tablets, blue, oval, film-coated, debossed on both sides with “X50”.

{ "type": "p", "children": [], "text": "50 mg tablets, blue, oval, film-coated, debossed on both sides with “X50”.\n" }

60 mg tablets, blue, oval, film-coated, debossed on both sides with “X60”.

{ "type": "p", "children": [], "text": "60 mg tablets, blue, oval, film-coated, debossed on both sides with “X60”.\n" }

None.

{ "type": "p", "children": [], "text": "None.\n" }

XPOVIO can cause life-threatening thrombocytopenia, potentially leading to hemorrhage. Thrombocytopenia is the leading cause of dosage modifications [see Adverse Reactions (6.1)].

In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), thrombocytopenia was reported in 92% of patients and severe (Grade 3-4) thrombocytopenia was reported in 43% of patients. The median time to first onset was 22 days for any grade thrombocytopenia and 43 days for Grade 3 or 4 thrombocytopenia. Bleeding occurred in 16% of patients with thrombocytopenia, clinically significant bleeding (Grade ≥3 bleeding) occurred in 4% of patients with thrombocytopenia, and fatal hemorrhage occurred in 2% of patients with thrombocytopenia. Permanent discontinuations of XPOVIO due to thrombocytopenia occurred in 2% of patients.

In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), thrombocytopenia was reported as an adverse reaction in 74% of patients and severe (Grade 3-4) thrombocytopenia was reported in 61% of patients. The median time to onset of the first event was 22 days. Bleeding occurred in 23% of patients with thrombocytopenia, clinically significant bleeding occurred in 5% of patients with thrombocytopenia, and fatal hemorrhage occurred in <1% of patients.

In patients with DLBCL who received XPOVIO 60 mg twice weekly (SADAL, n=134), thrombocytopenia developed or worsened in 86% of patients, including Grade 3-4 thrombocytopenia in 49% of patients (Grade 4, 18%). The median time to first onset was 28 days for any grade thrombocytopenia and 33 days for Grade 3 or 4 thrombocytopenia.

Monitor platelet counts at baseline and throughout treatment. Monitor more frequently during the first three months of treatment. Institute platelet transfusion and/or other treatments as clinically indicated. Monitor patients for signs and symptoms of bleeding and evaluate promptly. Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction [see Dosage and Administration (2.5)].

XPOVIO can cause life-threatening neutropenia, potentially increasing the risk of infection [see Adverse Reactions (6.1)].

In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), neutropenia was reported in 48% of patients and severe neutropenia (Grade 3-4) was reported in 12% of patients. The median time to onset of the first event was 23 days for any grade neutropenia and 40 days for Grade 3-4 neutropenia. Febrile neutropenia was reported in <1% of patients.

In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), neutropenia was reported as an adverse reaction in 34% of patients and severe (Grade 3-4) neutropenia was reported in 21% of patients. The median time to onset of the first event was 25 days. Febrile neutropenia was reported in 3% of patients.

In patients with DLBCL (SADAL, n=134), Grade 3 neutropenia developed in 21% of patients and Grade 4 neutropenia developed in 9% of patients. The median time to first onset of Grade 3 or 4 neutropenia was 32 days. Febrile neutropenia was reported in 3% of patients.

Obtain white blood cell counts with differential at baseline and throughout treatment. Monitor more frequently during the first three months of treatment. Monitor patients for signs and symptoms of concomitant infection and evaluate promptly. Consider supportive measures, including antimicrobials and growth factors (e.g., G-CSF). Interrupt, reduce dose or permanently discontinue based on severity of adverse reaction [see Dosage and Administration (2.5)].

XPOVIO can cause severe gastrointestinal toxicities [see Adverse Reactions (6.1)]. In patients with DLBCL (n=134), gastrointestinal toxicity occurred in 80% of patients with Grade 3 or 4 in 13%.

Nausea/Vomiting

In patients with multiple myeloma who received XPOVIO once weekly (BOSTON, n=195) with use of antiemetic prophylaxis (88% of patients), nausea was reported in 50% of patients and Grade 3 nausea was reported in 8% of patients. The median time to onset of the first event was 6 days. Vomiting was reported in 21% of patients and Grade 3 vomiting was reported in 4.1% of patients. The median time to onset of the first event was 8 days. Permanent discontinuation due to nausea occurred in 3.1% of patients and due to vomiting occurred in 2.1% of patients.

In patients with multiple myeloma receiving XPOVIO 80 mg twice weekly (STORM, n=202) with use of antiemetic prophylaxis, nausea was reported as an adverse reaction in 72% of patients and Grade 3 nausea occurred in 9%. The median time to first onset of nausea was 3 days. Vomiting was reported in 41% of patients and Grade 3 vomiting occurred in 4% of patients. The median time to first onset of vomiting was 5 days.

In patients with DLBCL (SADAL, n=134) with use of antiemetic prophylaxis, nausea occurred in 57% of patients and Grade 3 nausea occurred in 6% of patients. Vomiting occurred in 28% of patients and Grade 3 vomiting occurred in 1.5% of patients. The median time to first onset was 3 days for nausea and 7 days for vomiting.

Provide prophylactic antiemetics. Administer 5-HT3 receptor antagonists and other anti-nausea agents prior to and during treatment with XPOVIO. Interrupt, reduce dose or permanently discontinue based on severity of adverse reaction [see Dosage and Administration (2.5)]. Administer intravenous fluids to prevent dehydration and replace electrolytes as clinically indicated.

Diarrhea

In patients with multiple myeloma who received XPOVIO once weekly (BOSTON, n=195), diarrhea was reported in 32% of patients and Grade 3 diarrhea was reported in 6% of patients. The median time to onset of the first event was 50 days. Permanent discontinuation due to diarrhea occurred in 1% of patients.

In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), diarrhea was reported as an adverse reaction in 44% of patients and Grade 3 diarrhea occurred in 6% of patients. The median time to onset of diarrhea was 15 days.

In patients with DLBCL (SADAL, n=134), diarrhea occurred in 37% of patients and Grade 3 diarrhea occurred in 3% of patients treated with XPOVIO. The median time to onset of the first event was 12 days.

Interrupt, reduce dose or permanently discontinue based on severity of adverse reaction [see Dosage and Administration (2.5)]. Provide standard anti-diarrheal agents, administer intravenous fluids to prevent dehydration and replace electrolytes as clinically indicated.

Anorexia/Weight Loss

In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), anorexia was reported in 35% of patients and Grade 3 anorexia was reported in 3.6% of patients. The median time to onset of the first event was 35 days. Permanent discontinuations due to anorexia occurred in 2.1% of patients. Weight loss was reported in 26% of patients and Grade 3 weight loss was reported in 2.1% of patients. The median time to onset of the first event was 58 days. Permanent discontinuation due to weight loss occurred in 1% of patients.

In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM n=202), anorexia was reported as an adverse reaction in 53% of patients and Grade 3 anorexia occurred in 5% of patients. The median time to onset of anorexia was 8 days. Weight loss was reported as an adverse reaction in 47% of patients and Grade 3 weight loss occurred in 1% of patients treated with XPOVIO. The median time to onset of weight loss was 15 days.

In patients with DLBCL (SADAL, n=134), anorexia was reported as an adverse reaction in 37% of patients and Grade 3 anorexia occurred in 3.7% of patients treated with XPOVIO. Weight loss (Grade 1-2) was reported as an adverse reaction in 30% of patients.

Monitor weight, nutritional status, and volume status at baseline and throughout treatment. Monitor more frequently during the first three months of treatment. Interrupt, reduce dose or permanently discontinue based on severity of adverse reaction [see Dosage and Administration (2.5)]. Provide nutritional support, fluids, and electrolyte repletion as clinically indicated.

XPOVIO can cause severe or life-threatening hyponatremia [see Adverse Reactions (6.1)].

In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), hyponatremia was reported in 58% of patients and Grade 3-4 hyponatremia was reported in 14% of patients. The median time to first onset was 21 days for any grade hyponatremia and the median time to first onset for Grade 3 or 4 hyponatremia was 22 days.

In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), hyponatremia was reported as an adverse reaction in 39% of patients and Grade 3 or 4 hyponatremia was reported in 22% of patients. The median time to onset of the first event was 8 days.

In patients with DLBCL (SADAL, n=134), hyponatremia developed in 62% of patients and Grade 3 hyponatremia developed in 16% of patients treated with XPOVIO. In approximately 63% of cases, hyponatremia occurred in the context of gastrointestinal toxicity such as nausea, vomiting, diarrhea, dehydration, and anorexia.

Monitor sodium level at baseline and throughout treatment. Monitor more frequently during the first two months of treatment. Correct sodium levels for concurrent hyperglycemia (serum glucose >150 mg/dL) and high serum paraprotein levels. Assess hydration status and manage hyponatremia per clinical guidelines, including intravenous saline and/or salt tablets as appropriate and dietary review. Interrupt, reduce dose or permanently discontinue based on severity of the adverse reaction [see Dosage and Administration (2.5)].

XPOVIO can cause serious and fatal infections. Most of these infections were not associated with Grade 3 or higher neutropenia [see Adverse Reactions (6.1)].

In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), 69% of patients experienced any grade of infection. Grade ≥3 infections were reported in 32% of patients, and deaths from infections occurred in 3.1% of patients. The most frequently reported Grade ≥3 infection was pneumonia in 14% of patients, followed by sepsis in 4.1% and upper respiratory tract infection in 3.6% of patients.

In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), 52% of patients experienced any grade of infection. Grade ≥3 infections were reported in 25% of patients, and deaths from infections occurred in 4% of patients within 30 days of last treatment. Upper respiratory tract infection of any grade occurred in 21%, pneumonia in 13%, and sepsis in 6% of patients. The most frequently reported Grade ≥3 infections were pneumonia in 9% of patients, followed by sepsis in 6%. The median time to onset was 54 days for pneumonia and 42 days for sepsis.

In patients with DLBCL (SADAL, n=134), 25% of patients experienced Grade 3 or higher infection and 21% had an infection-related serious adverse reaction; 49% developed an infection of any grade, most frequently involving the upper or lower respiratory tract. The most frequently reported Grade ≥3 infections were lower respiratory tract infections in 9% of patients (including pneumonia in 6%), followed by sepsis (6%). The median time to onset of Grade ≥3 infection was 42 days.

Atypical infections reported after XPOVIO include, but are not limited to, fungal pneumonia and herpes virus infection.

Monitor for signs and symptoms of infection, evaluate and treat promptly.

XPOVIO can cause life-threatening neurological toxicities [see Adverse Reactions (6.1)].

In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), neurological adverse reactions (excluding peripheral neuropathy) including dizziness, syncope, depressed level of consciousness, vertigo, amnesia, and mental status changes (including delirium and confusional state) occurred in 26% of patients and severe events (Grade 3-4) occurred in 3.6% of patients. The median time to the first event was 29 days. Permanent discontinuation due to neurological adverse reactions occurred in 2.1% of patients.

In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), neurological adverse reactions, including dizziness, syncope, depressed level of consciousness, and mental status changes (including delirium and confusional state) occurred in 30% of patients and severe events (Grade 3-4) occurred in 9% of patients. The median time to the first event was 15 days.

In patients with DLBCL (SADAL, n=134), neurological adverse reactions occurred in 25% of patients and severe events (Grade 3-4) occurred in 6% of patients treated with XPOVIO. The most frequent manifestations were dizziness (16%) and mental status changes (11%), including confusion, cognitive disorders, somnolence, hallucination, delirium, and depressed level of consciousness. Syncope occurred in 2.2% of patients. The median time to the first event was 28 days. Among patients with such neurological adverse reactions, 68% recovered with a median time to recovery of 14 days.

Coadministration of XPOVIO with other products that cause dizziness or mental status changes may increase the risk of neurological toxicity.

Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until the neurological toxicity fully resolves. Optimize hydration status, hemoglobin level, and concomitant medications to avoid exacerbating dizziness or mental status changes. Institute fall precautions as appropriate.

Based on data from animal studies and its mechanism of action, XPOVIO can cause fetal harm when administered to a pregnant woman. Selinexor administration to pregnant animals during organogenesis resulted in structural abnormalities and alterations to growth at exposures below those occurring clinically at the recommended dose.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with a female partner of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the last dose [see Use in Specific Populations (8.1, 8.3)].

New onset or exacerbation of cataract has occurred during treatment with XPOVIO [see Adverse Reactions (6.1)]. In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), the incidence of new onset or worsening cataracts requiring clinical intervention was reported in 22% of patients. The median time to new onset of cataract was 228 days and was 237 days for worsening of cataract in patients presenting with cataract at start of XPOVIO therapy. Treatment of cataracts usually requires surgical removal of the cataract.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Multiple Myeloma

XPOVIO in Combination with Bortezomib and Dexamethasone (XVd)

The safety of XPOVIO in combination with bortezomib and dexamethasone was evaluated in BOSTON [see Clinical Studies (14.1)]. Patients were randomized to receive XPOVIO 100 mg orally once weekly in combination with bortezomib and dexamethasone (XVd) (n=195) or bortezomib and dexamethasone (Vd) (n=204). Among patients who received XPOVIO, the median duration of XPOVIO treatment was 29 weeks (range: 1 to 120 weeks) and the median dose was 80 mg (range: 30 to 137 mg) per week.

Serious adverse reactions occurred in 52% of patients who received XPOVIO in combination with bortezomib and dexamethasone. Serious adverse reactions in >3% of patients included pneumonia (14%), sepsis, diarrhea and vomiting (4% each). Fatal adverse reactions occurred in 6% of patients within 30 days of last treatment, including pneumonia (n=3) and sepsis (n=3).

Grade ≥2 peripheral neuropathy, a pre-specified key secondary endpoint, was lower in the XVd arm (21%) compared to the Vd arm (34%); odds ratio 0.50 [95% CI: 0.32, 0.79]. The median treatment duration was 30 weeks (range: 1-120 weeks) in patients who received once weekly XVd as compared to 32 weeks (range: 1-122 weeks) in patients who received twice weekly Vd.

Permanent discontinuation of XPOVIO due to an adverse reaction occurred in 19% of patients. Adverse reactions which resulted in permanent discontinuation of XPOVIO in >2% of patients included fatigue (3.6%), nausea (3.1%), thrombocytopenia, decreased appetite, peripheral neuropathy, and vomiting (2.1% each).

Dosage interruptions of XPOVIO due to an adverse reaction occurred in 83% of patients. Adverse reactions which required dosage interruption in >5% of patients included thrombocytopenia (33%), fatigue (13%), asthenia (12%), pneumonia (11%), upper respiratory tract infection (10%), decreased appetite (9%), neutropenia (8%), pyrexia (8%), nausea (7%), bronchitis (7%), diarrhea (6%), weight decreased (6%), and anemia (5%).

Dose reductions of XPOVIO due to an adverse reaction occurred in 64% of patients. Adverse reactions which required dose reductions in >5% of patients included thrombocytopenia (31%), decreased appetite (8%), nausea, fatigue, weight decreased (7% each), and asthenia (6%).

The most common adverse reactions (≥20% with a difference between arms of >5% compared to Vd) were fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, weight decreased, cataract, and vomiting. Grade 3-4 laboratory abnormalities (≥10%) were thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia, and neutropenia.

Table 5 summarizes the adverse reactions in BOSTON.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 5: Adverse Reactions (≥10%) in Patients with Multiple Myeloma Who Received XPOVIO in Combination with Bortezomib and Dexamethasone (XVd) with a Difference Between Arms of &gt;5% Compared to Vd in BOSTON </span> </caption> <col align="left" width="37.287%"/> <col align="left" width="15.663%"/> <col align="left" width="15.683%"/> <col align="left" width="15.683%"/> <col align="left" width="15.683%"/> <tfoot> <tr class="First"> <td align="left" colspan="5" valign="top"> <p class="First Footnote">Key: X=XPOVIO, Vd=bortezomib-dexamethasone </p> </td> </tr> <tr> <td align="left" colspan="5" valign="top"> <p class="First Footnote">a. Fatigue includes fatigue and asthenia. </p> </td> </tr> <tr> <td align="left" colspan="5" valign="top"> <p class="First Footnote">b. Peripheral neuropathy includes neuropathy peripheral, peripheral sensory neuropathy, polyneuropathy, peripheral sensorimotor neuropathy, toxic neuropathy, and peripheral motor neuropathy. </p> </td> </tr> <tr> <td align="left" colspan="5" valign="top"> <p class="First Footnote">c. Upper respiratory tract infection includes upper respiratory infection, nasopharyngitis, pharyngitis, respiratory syncytial virus infection, respiratory tract infection, rhinitis, and viral upper respiratory tract infection. </p> </td> </tr> <tr class="Last"> <td align="left" colspan="5" valign="top"> <p class="First Footnote">d. Vision blurred includes blurred vision, visual acuity reduced, and visual impairment. </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" rowspan="2" valign="bottom"><span class="Bold">Adverse Reaction</span></td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="bottom"><span class="Bold">Weekly XVd (n=195)</span></td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="bottom"><span class="Bold">Twice Weekly Vd (n=204)</span></td> </tr> <tr> <td align="center" class="Botrule Rrule" valign="top"><span class="Bold">All Grades (%)</span></td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Grade 3 or 4 (%)</span></td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">All Grades (%)</span></td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Grade 3 or 4 (%)</span></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Gastrointestinal <br/> </span>     Nausea </td><td align="center" class="Rrule" valign="top"> <br/>50 </td><td align="center" class="Rrule" valign="top"> <br/>8 </td><td align="center" class="Rrule" valign="top"> <br/>10 </td><td align="center" class="Rrule" valign="top"> <br/>0 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Diarrhea </td><td align="center" class="Rrule" valign="top">32 </td><td align="center" class="Rrule" valign="top">6 </td><td align="center" class="Rrule" valign="top">25 </td><td align="center" class="Rrule" valign="top">&lt;1 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Vomiting </td><td align="center" class="Botrule Rrule" valign="top">21 </td><td align="center" class="Botrule Rrule" valign="top">4.1 </td><td align="center" class="Botrule Rrule" valign="top">4.4 </td><td align="center" class="Botrule Rrule" valign="top">0 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">General Conditions</span> <br/>      Fatigue<span class="Sup">a</span></td><td align="center" class="Rrule" valign="top"> <br/>59 </td><td align="center" class="Rrule" valign="top"> <br/>21 </td><td align="center" class="Rrule" valign="top"> <br/>28 </td><td align="center" class="Rrule" valign="top"> <br/>5 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Pyrexia </td><td align="center" class="Botrule Rrule" valign="top">15 </td><td align="center" class="Botrule Rrule" valign="top">1.5 </td><td align="center" class="Botrule Rrule" valign="top">11 </td><td align="center" class="Botrule Rrule" valign="top">1 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Metabolism and Nutrition</span> <br/>      Decreased appetite </td><td align="center" class="Rrule" valign="top"> <br/>35 </td><td align="center" class="Rrule" valign="top"> <br/>3.6 </td><td align="center" class="Rrule" valign="top"> <br/>5 </td><td align="center" class="Rrule" valign="top"> <br/>0 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Weight decreased </td><td align="center" class="Botrule Rrule" valign="top">26 </td><td align="center" class="Botrule Rrule" valign="top">2.1 </td><td align="center" class="Botrule Rrule" valign="top">12 </td><td align="center" class="Botrule Rrule" valign="top">1 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Nervous System</span> <br/>     Peripheral neuropathy<span class="Sup">b</span></td><td align="center" class="Rrule" valign="top"> <br/>32 </td><td align="center" class="Rrule" valign="top"> <br/>4.6 </td><td align="center" class="Rrule" valign="top"> <br/>47 </td><td align="center" class="Rrule" valign="top"> <br/>9 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Dizziness </td><td align="center" class="Botrule Rrule" valign="top">12 </td><td align="center" class="Botrule Rrule" valign="top">&lt;1 </td><td align="center" class="Botrule Rrule" valign="top">3.9 </td><td align="center" class="Botrule Rrule" valign="top">0 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Infections</span> <br/>     Upper respiratory tract infection<span class="Sup">c</span></td><td align="center" class="Botrule Rrule" valign="top"> <br/>29 </td><td align="center" class="Botrule Rrule" valign="top"> <br/>3.6 </td><td align="center" class="Botrule Rrule" valign="top"> <br/>22 </td><td align="center" class="Botrule Rrule" valign="top"> <br/>1.5 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Eye Disorders</span> <br/>      Cataract </td><td align="center" class="Rrule" valign="top"> <br/>22 </td><td align="center" class="Rrule" valign="top"> <br/>9 </td><td align="center" class="Rrule" valign="top"> <br/>6 </td><td align="center" class="Rrule" valign="top"> <br/>1.5 </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">     Vision blurred<span class="Sup">d</span></td><td align="center" class="Botrule Rrule" valign="top">13 </td><td align="center" class="Botrule Rrule" valign="top">&lt;1 </td><td align="center" class="Botrule Rrule" valign="top">6 </td><td align="center" class="Botrule Rrule" valign="top">0 </td> </tr> </tbody> </table></div>

Clinically relevant adverse reactions in <10% of patients who received XPOVIO in combination with bortezomib and dexamethasone included:

Table 6 summarizes selected laboratory abnormalities in BOSTON.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 6: Select Laboratory Abnormalities (≥15%) That Worsened from Baseline in Patients with Multiple Myeloma Who Received XPOVIO in Combination with Bortezomib and Dexamethasone (XVd) in BOSTON </span> </caption> <col align="left" width="31.440%"/> <col align="left" width="17.140%"/> <col align="left" width="17.140%"/> <col align="left" width="17.140%"/> <col align="left" width="17.140%"/> <tfoot> <tr class="First"> <td align="left" colspan="5" valign="top"> <p class="First Footnote">The denominator used to calculate the rate varied from 91 to 201 based on the number of patients with at least one post-treatment value. </p> </td> </tr> <tr class="Last"> <td align="left" colspan="5" valign="top"> <p class="First Footnote">a. Includes one fatal anemia. </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" rowspan="2" valign="bottom"><span class="Bold">Laboratory Abnormality</span></td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="bottom"><span class="Bold">Weekly XVd</span></td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">Twice Weekly Vd</span></td> </tr> <tr> <td align="center" class="Botrule Rrule" valign="top"><span class="Bold">All Grades <br/>(%)</span></td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Grade 3 or 4 <br/>(%)</span></td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">All Grades <br/>(%)</span></td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Grade 3 or 4 <br/>(%)</span></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Hematologic</span> <br/>     Platelet count decrease </td><td align="center" class="Rrule" valign="top"> <br/>92 </td><td align="center" class="Rrule" valign="top"> <br/>43 </td><td align="center" class="Rrule" valign="top"> <br/>51 </td><td align="center" class="Rrule" valign="top"> <br/>19 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Lymphocyte count decrease </td><td align="center" class="Rrule" valign="top">77 </td><td align="center" class="Rrule" valign="top">38 </td><td align="center" class="Rrule" valign="top">70 </td><td align="center" class="Rrule" valign="top">27 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Hemoglobin decrease </td><td align="center" class="Rrule" valign="top">71 </td><td align="center" class="Rrule" valign="top">17 </td><td align="center" class="Rrule" valign="top">51<span class="Sup">a</span></td><td align="center" class="Rrule" valign="top">12 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Neutrophil count decrease </td><td align="center" class="Botrule Rrule" valign="top">48 </td><td align="center" class="Botrule Rrule" valign="top">12 </td><td align="center" class="Botrule Rrule" valign="top">19 </td><td align="center" class="Botrule Rrule" valign="top">7 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Chemistry</span> <br/>     Glucose increase </td><td align="center" class="Rrule" valign="top"> <br/>62 </td><td align="center" class="Rrule" valign="top"> <br/>3.8 </td><td align="center" class="Rrule" valign="top"> <br/>47 </td><td align="center" class="Rrule" valign="top"> <br/>4.1 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Phosphate decrease </td><td align="center" class="Rrule" valign="top">61 </td><td align="center" class="Rrule" valign="top">23 </td><td align="center" class="Rrule" valign="top">42 </td><td align="center" class="Rrule" valign="top">11 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Sodium decrease </td><td align="center" class="Rrule" valign="top">58 </td><td align="center" class="Rrule" valign="top">14 </td><td align="center" class="Rrule" valign="top">25 </td><td align="center" class="Rrule" valign="top">3 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Calcium decrease </td><td align="center" class="Rrule" valign="top">55 </td><td align="center" class="Rrule" valign="top">2.1 </td><td align="center" class="Rrule" valign="top">47 </td><td align="center" class="Rrule" valign="top">1 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Blood urea nitrogen increase </td><td align="center" class="Rrule" valign="top">41 </td><td align="center" class="Rrule" valign="top">5 </td><td align="center" class="Rrule" valign="top">40 </td><td align="center" class="Rrule" valign="top">5 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Creatinine increase </td><td align="center" class="Rrule" valign="top">28 </td><td align="center" class="Rrule" valign="top">3.6 </td><td align="center" class="Rrule" valign="top">24 </td><td align="center" class="Rrule" valign="top">1.5 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Potassium decrease </td><td align="center" class="Rrule" valign="top">27 </td><td align="center" class="Rrule" valign="top">6 </td><td align="center" class="Rrule" valign="top">22 </td><td align="center" class="Rrule" valign="top">3.5 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Magnesium decrease </td><td align="center" class="Rrule" valign="top">27 </td><td align="center" class="Rrule" valign="top">&lt;1 </td><td align="center" class="Rrule" valign="top">23 </td><td align="center" class="Rrule" valign="top">1.5 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Potassium increase </td><td align="center" class="Botrule Rrule" valign="top">18 </td><td align="center" class="Botrule Rrule" valign="top">4.1 </td><td align="center" class="Botrule Rrule" valign="top">21 </td><td align="center" class="Botrule Rrule" valign="top">2.5 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Hepatic</span> <br/>     ALT increase </td><td align="center" class="Rrule" valign="top"> <br/>33 </td><td align="center" class="Rrule" valign="top"> <br/>3.1 </td><td align="center" class="Rrule" valign="top"> <br/>30 </td><td align="center" class="Rrule" valign="top"> <br/>&lt;1 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Albumin decrease </td><td align="center" class="Rrule" valign="top">27 </td><td align="center" class="Rrule" valign="top">&lt;1 </td><td align="center" class="Rrule" valign="top">35 </td><td align="center" class="Rrule" valign="top">&lt;1 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     AST increase </td><td align="center" class="Rrule" valign="top">24 </td><td align="center" class="Rrule" valign="top">1.5 </td><td align="center" class="Rrule" valign="top">19 </td><td align="center" class="Rrule" valign="top">&lt;1 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Bilirubin increase </td><td align="center" class="Rrule" valign="top">16 </td><td align="center" class="Rrule" valign="top">1 </td><td align="center" class="Rrule" valign="top">13 </td><td align="center" class="Rrule" valign="top">2 </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">     ALP increase </td><td align="center" class="Botrule Rrule" valign="top">12 </td><td align="center" class="Botrule Rrule" valign="top">0 </td><td align="center" class="Botrule Rrule" valign="top">16 </td><td align="center" class="Botrule Rrule" valign="top">&lt;1 </td> </tr> </tbody> </table></div>

XPOVIO in Combination with Dexamethasone (Xd)

The safety of XPOVIO in combination with dexamethasone was evaluated in STORM [see Clinical Studies (14.1)]. Patients received XPOVIO 80 mg orally with dexamethasone 20 mg on Days 1 and 3 of every week (n=202). The median duration of XPOVIO treatment was 8 weeks (range: 1 to 60 weeks). The median dose was 115 mg (range: 36 to 200 mg) per week.

Fatal adverse reactions occurred in 9% of XPOVIO treated patients. Serious adverse reactions occurred in 58% of patients.

The treatment discontinuation rate due to adverse reactions was 27%; 53% of patients had a reduction in the XPOVIO dose, and 65% had the dose of XPOVIO interrupted. Thrombocytopenia was the leading cause of dose modification, resulting in dose reduction and/or interruption in >25% of patients. The most frequent adverse reactions requiring permanent discontinuation in 4% or greater of patients who received XPOVIO included fatigue, nausea, and thrombocytopenia.

Table 7 summarizes the adverse reactions in STORM.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 7: Adverse Reactions (≥10%) in Patients Who Received XPOVIO in STORM </span> </caption> <col align="left" width="48.167%"/> <col align="left" width="25.900%"/> <col align="left" width="25.933%"/> <tfoot> <tr class="First"> <td align="left" colspan="3" valign="top"> <p class="First Footnote">a. Thrombocytopenia includes thrombocytopenia and platelet count decreased. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">b. Fatigue includes fatigue and asthenia. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">c. Anemia includes anemia and hematocrit decreased. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">d. Neutropenia includes neutropenia and neutrophil count decreased. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">e. Dyspnea includes dyspnea, dyspnea exertional, and dyspnea at rest. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">f. Upper respiratory tract infection includes upper respiratory tract infection, respiratory tract infection, pharyngitis, nasopharyngitis, bronchitis, bronchiolitis, respiratory syncytial virus infection, parainfluenza virus infection, rhinitis, rhinovirus infection, and adenovirus infection. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">g. Cough includes cough, productive cough, and upper-airway cough syndrome. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">h. Mental status changes includes mental status changes, confusional state, and delirium. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">i. Hypercreatininemia includes hypercreatininemia and hypercreatinemia. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">j. Pneumonia includes pneumonia, atypical pneumonia, lung infection, lower respiratory tract infection, pneumocystis jirovecii pneumonia, pneumonia aspiration, pneumonia influenzal, and pneumonia viral. </p> </td> </tr> <tr class="Last"> <td align="left" colspan="3" valign="top"> <p class="First Footnote">k. Includes fatal event. </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" rowspan="2" valign="bottom"><span class="Bold">Adverse Reaction</span></td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">XPOVIO 80 mg twice weekly +</span> <br/> <span class="Bold">Dexamethasone (n=202)</span></td> </tr> <tr> <td align="center" class="Botrule Rrule" valign="top"><span class="Bold">All Grades <br/>(%)</span></td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Grades ≥3 <br/>(%)</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Thrombocytopenia<span class="Sup">a</span></td><td align="center" class="Botrule Rrule" valign="top">74 </td><td align="center" class="Botrule Rrule" valign="top">61 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Fatigue<span class="Sup">b</span></td><td align="center" class="Botrule Rrule" valign="top">73 </td><td align="center" class="Botrule Rrule" valign="top">22 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Nausea </td><td align="center" class="Botrule Rrule" valign="top">72 </td><td align="center" class="Botrule Rrule" valign="top">9 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Anemia<span class="Sup">c</span></td><td align="center" class="Botrule Rrule" valign="top">59 </td><td align="center" class="Botrule Rrule" valign="top">40 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Decreased appetite </td><td align="center" class="Botrule Rrule" valign="top">53 </td><td align="center" class="Botrule Rrule" valign="top">4.5 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Weight decreased </td><td align="center" class="Botrule Rrule" valign="top">47 </td><td align="center" class="Botrule Rrule" valign="top">0.5 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Diarrhea </td><td align="center" class="Botrule Rrule" valign="top">44 </td><td align="center" class="Botrule Rrule" valign="top">6 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Vomiting </td><td align="center" class="Botrule Rrule" valign="top">41 </td><td align="center" class="Botrule Rrule" valign="top">3.5 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Hyponatremia </td><td align="center" class="Botrule Rrule" valign="top">39 </td><td align="center" class="Botrule Rrule" valign="top">22 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Neutropenia<span class="Sup">d</span></td><td align="center" class="Botrule Rrule" valign="top">34 </td><td align="center" class="Botrule Rrule" valign="top">21 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Leukopenia </td><td align="center" class="Botrule Rrule" valign="top">28 </td><td align="center" class="Botrule Rrule" valign="top">11 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Constipation </td><td align="center" class="Botrule Rrule" valign="top">25 </td><td align="center" class="Botrule Rrule" valign="top">1.5 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Dyspnea<span class="Sup">e</span></td><td align="center" class="Botrule Rrule" valign="top">24 </td><td align="center" class="Botrule Rrule" valign="top">3.5<span class="Sup">k</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Upper respiratory tract infection<span class="Sup">f</span></td><td align="center" class="Botrule Rrule" valign="top">21 </td><td align="center" class="Botrule Rrule" valign="top">3 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Cough<span class="Sup">g</span></td><td align="center" class="Botrule Rrule" valign="top">16 </td><td align="center" class="Botrule Rrule" valign="top">0 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Mental status changes<span class="Sup">h</span></td><td align="center" class="Botrule Rrule" valign="top">16 </td><td align="center" class="Botrule Rrule" valign="top">7 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Pyrexia </td><td align="center" class="Botrule Rrule" valign="top">16 </td><td align="center" class="Botrule Rrule" valign="top">0.5 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Hyperglycemia </td><td align="center" class="Botrule Rrule" valign="top">15 </td><td align="center" class="Botrule Rrule" valign="top">7 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Dizziness </td><td align="center" class="Botrule Rrule" valign="top">15 </td><td align="center" class="Botrule Rrule" valign="top">0 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Insomnia </td><td align="center" class="Botrule Rrule" valign="top">15 </td><td align="center" class="Botrule Rrule" valign="top">2 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Lymphopenia </td><td align="center" class="Botrule Rrule" valign="top">15 </td><td align="center" class="Botrule Rrule" valign="top">10 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Dehydration </td><td align="center" class="Botrule Rrule" valign="top">14 </td><td align="center" class="Botrule Rrule" valign="top">3.5 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Hypercreatininemia<span class="Sup">i</span></td><td align="center" class="Botrule Rrule" valign="top">14 </td><td align="center" class="Botrule Rrule" valign="top">2 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Pneumonia<span class="Sup">j</span></td><td align="center" class="Botrule Rrule" valign="top">13 </td><td align="center" class="Botrule Rrule" valign="top">9<span class="Sup">k</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Epistaxis </td><td align="center" class="Botrule Rrule" valign="top">12 </td><td align="center" class="Botrule Rrule" valign="top">0.5 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Hypokalemia </td><td align="center" class="Botrule Rrule" valign="top">12 </td><td align="center" class="Botrule Rrule" valign="top">3.5 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Dysgeusia </td><td align="center" class="Botrule Rrule" valign="top">11 </td><td align="center" class="Botrule Rrule" valign="top">0 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Vision blurred </td><td align="center" class="Botrule Rrule" valign="top">10 </td><td align="center" class="Botrule Rrule" valign="top">0.5 </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">Headache </td><td align="center" class="Botrule Rrule" valign="top">10 </td><td align="center" class="Botrule Rrule" valign="top">0 </td> </tr> </tbody> </table></div>

Diffuse Large B-Cell Lymphoma

The safety of XPOVIO was evaluated in SADAL [see Clinical Studies (14.2)]. Patients received XPOVIO 60 mg orally on Days 1 and 3 of every week (n=134). The study required an absolute neutrophil count ≥1000/μL, platelet count ≥75,000/μL, hepatic transaminases ≤2.5 times upper limit of normal (ULN) unless abnormal from lymphoma, and bilirubin ≤2 times ULN. The study permitted a maximum of 5 prior systemic regimens for DLBCL. Antiemetic prophylaxis with a 5HT-3 receptor antagonist was required. The median duration of XPOVIO treatment was 2.1 months (range: 1 week to 3.7 years) with 38% receiving at least 3 months and 22% receiving at least 6 months of treatment. The median exposure was 100 mg per week.

Fatal adverse reactions occurred in 3.7% of patients within 30 days and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reaction was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients who received XPOVIO; the most frequent serious adverse reaction was infection (21% of patients).

Discontinuation due to adverse reactions occurred in 17% of patients who received XPOVIO. Adverse reactions which results in discontinuation in ≥2% of patients included: infection, fatigue, thrombocytopenia, and nausea.

Adverse reactions led to XPOVIO dose interruption in 61% of patients and dose reduction in 49%, with 17% of all patients having 2 or more dose reductions. The median time to first dose modification (reduction or interruption) was 4 weeks, with the leading causes being thrombocytopenia (40% of all patients), neutropenia (16%), fatigue (16%), nausea (10%), and anemia (10%). The median time to first dose reduction was 6 weeks, with 83% of first dose reductions occurring within the first 3 months.

The most common adverse reactions, excluding laboratory abnormalities, in ≥20% of patients were fatigue, nausea, diarrhea, decreased appetite, weight decreased, constipation, vomiting, and pyrexia. Table 8 summarizes selected adverse reactions in SADAL.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 8: Adverse Reactions (≥10%), Excluding Laboratory Terms, in Patients with DLBCL Who Received XPOVIO in SADAL </span> </caption> <col align="left" width="55.415%"/> <col align="left" width="22.959%"/> <col align="left" width="21.626%"/> <tfoot> <tr class="First"> <td align="left" colspan="3" valign="top"> <p class="First Footnote">a. Fatigue includes fatigue and asthenia. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">b. Edema includes edema, swelling, swelling face, edema peripheral, peripheral swelling, acute pulmonary edema. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">c. Diarrhea includes diarrhea, post-procedural diarrhea, gastroenteritis. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">d. Abdominal pain includes abdominal pain, abdominal pain upper, abdominal discomfort, epigastric discomfort. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">e. Decreased appetite includes decreased appetite and hypophagia. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">f. Cough includes cough and productive cough. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">g. Dyspnea includes dyspnea and dyspnea exertional. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">h. Upper respiratory tract infection includes upper respiratory tract infection, sinusitis, nasopharyngitis, pharyngitis, rhinitis, viral upper respiratory infection. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">i. Urinary tract infection includes urinary tract infection and specific types of urinary tract infection. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">j. Dizziness includes dizziness and vertigo. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">k. Taste disorder includes taste disorder, dysgeusia, ageusia. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">l. Mental status changes include confusional state, amnesia, cognitive disorder, hallucination, delirium, somnolence, depressed level of consciousness, memory impairment. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">m. Peripheral neuropathy includes peripheral neuropathy, peripheral sensory neuropathy, sensory disturbance, paresthesia, neuralgia. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">n. Musculoskeletal pain includes musculoskeletal pain, back pain, musculoskeletal chest pain, neck pain, pain in extremity, bone pain. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">o. Hemorrhage includes hemorrhage, hematoma, hematuria, epistaxis, rectal hemorrhage, injection site hematoma, subdural hematoma, upper gastrointestinal hemorrhage, corneal bleeding. </p> </td> </tr> <tr class="Last"> <td align="left" colspan="3" valign="top"> <p class="First Footnote">p. Vision blurred includes vision blurred, visual acuity reduced, visual impairment. </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" rowspan="2" valign="bottom"><span class="Bold">Adverse Reaction</span></td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">XPOVIO 60 mg twice weekly</span> <br/> <span class="Bold">(n=134)</span></td> </tr> <tr> <td align="center" class="Botrule Rrule" valign="top"><span class="Bold">All Grades <br/>(%)</span></td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Grade 3 or 4 <br/>(%)</span></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">General Conditions </span> <br/>     Fatigue<span class="Sup">a</span></td><td align="center" class="Rrule" valign="top"> <br/>63 </td><td align="center" class="Rrule" valign="top"> <br/>15 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Pyrexia </td><td align="center" class="Rrule" valign="top">22 </td><td align="center" class="Rrule" valign="top">4.5 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Edema<span class="Sup">b</span></td><td align="center" class="Botrule Rrule" valign="top">17 </td><td align="center" class="Botrule Rrule" valign="top">2.2 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Gastrointestinal</span> <br/>     Nausea </td><td align="center" class="Rrule" valign="top"> <br/>57 </td><td align="center" class="Rrule" valign="top"> <br/>6 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Diarrhea<span class="Sup">c</span></td><td align="center" class="Rrule" valign="top">37 </td><td align="center" class="Rrule" valign="top">3.0 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Constipation </td><td align="center" class="Rrule" valign="top">29 </td><td align="center" class="Rrule" valign="top">0 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Vomiting </td><td align="center" class="Rrule" valign="top">28 </td><td align="center" class="Rrule" valign="top">1.5 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Abdominal pain<span class="Sup">d</span></td><td align="center" class="Botrule Rrule" valign="top">10 </td><td align="center" class="Botrule Rrule" valign="top">0 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" rowspan="2" valign="bottom"><span class="Bold">Adverse Reaction</span></td><td align="center" class="Botrule Rrule" colspan="2" valign="top"><span class="Bold">XPOVIO 60 mg twice weekly</span> <br/> <span class="Bold">(n=134)</span></td> </tr> <tr> <td align="center" class="Botrule Rrule" valign="top"><span class="Bold">All Grades (%)</span></td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Grade 3 or 4 (%)</span></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Metabolism and Nutrition <br/> </span>     Decreased appetite<span class="Sup">e</span></td><td align="center" class="Rrule" valign="top"> <br/>37 </td><td align="center" class="Rrule" valign="top"> <br/>3.7 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Weight decreased </td><td align="center" class="Botrule Rrule" valign="top">30 </td><td align="center" class="Botrule Rrule" valign="top">0 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Respiratory </span> <br/>     Cough<span class="Sup">f</span></td><td align="center" class="Rrule" valign="top"> <br/>18 </td><td align="center" class="Rrule" valign="top"> <br/>0 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Dyspnea<span class="Sup">g</span></td><td align="center" class="Botrule Rrule" valign="top">10 </td><td align="center" class="Botrule Rrule" valign="top">1.5 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Infections</span> <br/>     Upper respiratory tract infection<span class="Sup">h</span></td><td align="center" class="Rrule" valign="top"> <br/>17 </td><td align="center" class="Rrule" valign="top"> <br/>1.5 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Pneumonia </td><td align="center" class="Rrule" valign="top">10 </td><td align="center" class="Rrule" valign="top">6 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Urinary tract infection<span class="Sup">i</span></td><td align="center" class="Botrule Rrule" valign="top">10 </td><td align="center" class="Botrule Rrule" valign="top">3 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Nervous System <br/> </span>     Dizziness<span class="Sup">j</span></td><td align="center" class="Rrule" valign="top"> <br/>16 </td><td align="center" class="Rrule" valign="top"> <br/>0.7 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Taste disorder<span class="Sup">k</span></td><td align="center" class="Rrule" valign="top">13 </td><td align="center" class="Rrule" valign="top">0 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Mental status changes<span class="Sup">l</span></td><td align="center" class="Rrule" valign="top">11 </td><td align="center" class="Rrule" valign="top">3.7 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Peripheral neuropathy, sensory<span class="Sup">m</span></td><td align="center" class="Botrule Rrule" valign="top">10 </td><td align="center" class="Botrule Rrule" valign="top">0 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Musculoskeletal</span> <br/>     Musculoskeletal pain<span class="Sup">n</span></td><td align="center" class="Botrule Rrule" valign="top"> <br/>15 </td><td align="center" class="Botrule Rrule" valign="top"> <br/>2.2 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Vascular</span> <br/>     Hypotension </td><td align="center" class="Rrule" valign="top"> <br/>13 </td><td align="center" class="Rrule" valign="top"> <br/>3.0 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Hemorrhage<span class="Sup">o</span></td><td align="center" class="Botrule Rrule" valign="top">10 </td><td align="center" class="Botrule Rrule" valign="top">0.7 </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Eye Disorders</span> <br/>      Vision blurred<span class="Sup">p</span></td><td align="center" class="Botrule Rrule" valign="top"> <br/>11 </td><td align="center" class="Botrule Rrule" valign="top"> <br/>0.7 </td> </tr> </tbody> </table></div>

Clinically relevant adverse reactions in <10% of patients who received XPOVIO included:

Table 9 summarizes selected new or worsening laboratory abnormalities in SADAL. Grade 3-4 laboratory abnormalities in ≥15% included thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. Grade 4 laboratory abnormalities in ≥5% were thrombocytopenia (18%), lymphopenia (5%), and neutropenia (9%).

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 9: Select Laboratory Abnormalities (≥15%) Worsening from Baseline in Patients with DLBCL Who Received XPOVIO in SADAL </span> </caption> <col align="left" width="40.800%"/> <col align="left" width="28.833%"/> <col align="left" width="30.367%"/> <tfoot> <tr class="First"> <td align="left" colspan="3" valign="top"> <p class="First Footnote">The denominator used to calculate the rate varied from 107 to 128 based on the number of patients with at least one post-treatment value. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">a. Not fasting. </p> </td> </tr> <tr class="Last"> <td align="left" colspan="3" valign="top"> <p class="First Footnote">b. CK increase was not associated with reports of myopathy or myalgia. </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" rowspan="2" valign="bottom"><span class="Bold">Laboratory Abnormality</span></td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">XPOVIO 60 mg twice weekly</span></td> </tr> <tr> <td align="center" class="Botrule Rrule" valign="top"><span class="Bold">All Grades <br/>(%)</span></td><td align="center" class="Botrule Rrule" valign="top"><span class="Bold">Grade 3 or 4 <br/>(%)</span></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Hematologic</span> <br/>     Platelet count decrease </td><td align="center" class="Rrule" valign="top"> <br/>86 </td><td align="center" class="Rrule" valign="top"> <br/>49 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Hemoglobin decrease </td><td align="center" class="Rrule" valign="top">82 </td><td align="center" class="Rrule" valign="top">25 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Lymphocyte count decrease </td><td align="center" class="Rrule" valign="top">63 </td><td align="center" class="Rrule" valign="top">37 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Neutrophil count decrease </td><td align="center" class="Botrule Rrule" valign="top">58 </td><td align="center" class="Botrule Rrule" valign="top">31 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Chemistry</span> <br/>     Sodium decrease </td><td align="center" class="Rrule" valign="top"> <br/>62 </td><td align="center" class="Rrule" valign="top"> <br/>16 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Glucose increase </td><td align="center" class="Rrule" valign="top">57<span class="Sup">a</span></td><td align="center" class="Rrule" valign="top">5 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Creatinine increase </td><td align="center" class="Rrule" valign="top">47 </td><td align="center" class="Rrule" valign="top">3.9 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Phosphate decrease </td><td align="center" class="Rrule" valign="top">34 </td><td align="center" class="Rrule" valign="top">11 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Magnesium decrease </td><td align="center" class="Rrule" valign="top">30 </td><td align="center" class="Rrule" valign="top">2.6 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Calcium decrease </td><td align="center" class="Rrule" valign="top">30 </td><td align="center" class="Rrule" valign="top">0.9 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Potassium increase </td><td align="center" class="Rrule" valign="top">26 </td><td align="center" class="Rrule" valign="top">3.9 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Potassium decrease </td><td align="center" class="Rrule" valign="top">23 </td><td align="center" class="Rrule" valign="top">7 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     CK increase<span class="Bold"><span class="Sup">b</span></span></td><td align="center" class="Botrule Rrule" valign="top">21 </td><td align="center" class="Botrule Rrule" valign="top">1.9 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Hepatic</span> <br/>     ALT increase </td><td align="center" class="Rrule" valign="top"> <br/>29 </td><td align="center" class="Rrule" valign="top"> <br/>0.8 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Albumin decrease </td><td align="center" class="Rrule" valign="top">25 </td><td align="center" class="Rrule" valign="top">0 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     AST increase </td><td align="center" class="Rrule" valign="top">24 </td><td align="center" class="Rrule" valign="top">3.1 </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">     Bilirubin increase </td><td align="center" class="Botrule Rrule" valign="top">16 </td><td align="center" class="Botrule Rrule" valign="top">1.6 </td> </tr> </tbody> </table></div>

Risk Summary

Based on findings in animal studies and its mechanism of action [see Clinical Pharmacology (12.1)], XPOVIO can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of selinexor to pregnant rats during organogenesis resulted in structural abnormalities and alterations to growth at exposures that were below those occurring clinically at the recommended dose (see Data). Advise pregnant women of the risks to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Animal data

In an embryo-fetal development study in pregnant rats, daily oral administration of selinexor at 0, 0.25, 0.75, or 2 mg/kg throughout organogenesis caused incomplete or delayed ossification, skeletal variations, and reduced fetal weight compared with controls at a dose of 0.75 mg/kg (approximately 0.08-fold of human area under the curve [AUC] at the recommended dose). Malformations were observed at 2 mg/kg, including microphthalmia, fetal edema, malpositioned kidney, and persistent truncus arteriosus.

Risk Summary

There is no information regarding the presence of selinexor or its metabolites in human milk, or their effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with XPOVIO and for 1 week after the last dose.

XPOVIO can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].

Pregnancy Testing

Verify the pregnancy status of females of reproductive potential prior to initiating XPOVIO [see Use in Specific Populations (8.1)].

Contraception

Females

Advise females of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the last dose.

Males

Advise males with a female partner of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the last dose.

Infertility

Females and Males

Based on findings in animals, XPOVIO may impair fertility in females and males of reproductive potential [see Nonclinical Toxicology (13.1)].

The safety and effectiveness of XPOVIO have not been established in pediatric patients.

In BOSTON, of the 195 patients with multiple myeloma who received XPOVIO in combination with bortezomib and dexamethasone, 56% were 65 years of age and older, while 17% were 75 years of age and older. No overall differences in effectiveness were observed between these patients and younger patients. When comparing patients 65 years of age and older to younger patients, older patients had a higher incidence of discontinuation due to an adverse reaction (28% vs 13%) and a higher incidence of serious adverse reactions (56% vs 47%).

In STORM, of the 202 patients with multiple myeloma who received XPOVIO, 49% were 65 years of age and older, while 11% were 75 years of age and older. No overall difference in effectiveness was observed in patients over 65 years of age, including patients over 75 years of age, when compared with younger patients. When comparing patients 75 years of age and older to younger patients, older patients had a higher incidence of discontinuation due to an adverse reaction (44% vs 27%), higher incidence of serious adverse reactions (70% vs 58%), and higher incidence of fatal adverse reactions (17% vs 9%).

Among 134 patients with DLBCL who received XPOVIO in SADAL, 61% were 65 years of age and older, while 25% were 75 years of age and older. Clinical studies of XPOVIO in patients with relapsed or refractory DLBCL did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:

{ "type": "p", "children": [], "text": "Selinexor is a nuclear export inhibitor. Selinexor is (2Z)-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1yl}-N'-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C17H11F6N7O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:\n" }

XPOVIO tablets for oral dosing are supplied in five strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, or 60 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.

{ "type": "p", "children": [], "text": "XPOVIO tablets for oral dosing are supplied in five strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, or 60 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.\n" }

In nonclinical studies, selinexor reversibly inhibits nuclear export of tumor suppressor proteins (TSPs), growth regulators, and mRNAs of oncogenic proteins by blocking exportin 1 (XPO1). XPO1 inhibition by selinexor leads to accumulation of TSPs in the nucleus and reductions in several oncoproteins, such as c-myc and cyclin D1, cell cycle arrest, and apoptosis of cancer cells. Selinexor demonstrated pro-apoptotic activity in vitro in multiple myeloma cells and showed anti-tumor activity in murine xenograft models of multiple myeloma and diffuse large B cell lymphoma. The combination of selinexor and dexamethasone or bortezomib demonstrated synergistic cytotoxic effects in multiple myeloma in vitro and increased anti-tumor activity in murine xenograft multiple myeloma models in vivo, including those resistant to proteasome inhibitors.

An increase in selinexor exposure was associated with an increase in the probability of dose modification and some adverse reactions.

Cardiac Electrophysiology

The effect of multiple doses of XPOVIO, up to 175 mg per dose (1.75 times the maximum approved recommended dose), on the QTc interval was evaluated in patients with heavily pretreated hematologic malignancies. XPOVIO had no large effect (i.e. no greater than 20 ms) on QTc interval at the therapeutic dose level.

Selinexor Cmax and AUC increased proportionally over a dose range from 3 mg/m2 to 85 mg/m2 (0.05 to 1.44) times the maximum approved recommended dose, based on 1.7 m2 body surface area. No clinically relevant accumulation at steady state was observed. Selinexor Cmax and AUC0-INF after administration of a single dose of XPOVIO in patients with hematologic malignancies are presented in Table 10.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 10: Selinexor C<span class="Sub">max</span> and AUC After Administration of a Single Dose of XPOVIO </span> </caption> <col align="left" width="20.375%"/> <col align="left" width="26.525%"/> <col align="left" width="26.550%"/> <col align="left" width="26.550%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" rowspan="2" valign="bottom">Mean (XD) </td><td align="left" class="Botrule Toprule" valign="top"></td><td align="center" class="Botrule Toprule" valign="top">XPOVIO Dose </td><td align="left" class="Botrule Rrule Toprule" valign="top"></td> </tr> <tr> <td align="center" class="Botrule Rrule" valign="top">60 mg </td><td align="center" class="Botrule Rrule" valign="top">80 mg </td><td align="center" class="Botrule Rrule" valign="top">100 mg </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">C<span class="Sub">max</span> (ng/mL) </td><td align="center" class="Botrule Rrule" valign="top">442 (188) </td><td align="center" class="Botrule Rrule" valign="top">680 (124) </td><td align="center" class="Botrule Rrule" valign="top">693 (201) </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">AUC<span class="Sub">0-INF</span> (ng·h/mL) </td><td align="center" class="Botrule Rrule" valign="top">4,096 (1,185) </td><td align="center" class="Botrule Rrule" valign="top">5,386 (1,116) </td><td align="center" class="Botrule Rrule" valign="top">6,998 (818) </td> </tr> </tbody> </table></div>

Absorption

The Cmax is reached within 4 hours following oral administration of XPOVIO.

Effect of Food

Concomitant administration of a high-fat meal (800 to 1,000 calories with approximately 50% of total caloric content of the meal from fat) did not affect the pharmacokinetics of selinexor to a clinically significant extent.

Distribution

The apparent volume of distribution of selinexor is 133 L in patients with cancer. The protein binding of selinexor is 95%.

Elimination

Following a single dose of XPOVIO, the mean half-life is 6 to 8 hours. The apparent total clearance of selinexor is 18.6 L/h in patients with cancer.

Metabolism

Selinexor is metabolized by CYP3A4, multiple UDP-glucuronosyltransferases (UGTs) and glutathione Stransferases (GSTs).

Specific Populations

No clinically significant differences in the pharmacokinetics of selinexor were observed based on age (18 to 94 years old), sex, body weight (36 to 168 kg), ethnicity, mild to severe renal impairment (CLCR: 15 to 89 mL/min, estimated by the Cockcroft-Gault equation), and disease type (hematological non-DLBCL, solid tumor, DLBCL). The effect of end-stage renal disease (CLCR <15 mL/min) or hemodialysis on selinexor pharmacokinetics is unknown. Mild hepatic impairment had no clinically significant effect on the pharmacokinetics of selinexor. The effect of moderate and severe hepatic impairment on selinexor pharmacokinetics is unknown.

Drug Interaction Studies

Clinical Studies

Acetaminophen: No clinically significant differences in selinexor pharmacokinetics were observed when coadministered with acetaminophen (up to 1,000 mg daily dose of acetaminophen).

Clarithromycin (a strong CYP3A4 inhibitor): No clinically significant differences in selinexor pharmacokinetics were observed when co-administered with clarithromycin (up to 1,000 mg daily dose of clarithromycin).

In vitro Studies

CYP Enzymes: Selinexor does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP3A4/5. Selinexor is not a CYP3A4, CYP1A2, or CYP2B6 inducer.

Non-CYP Enzyme Systems: Selinexor is a substrate of UGTs and GSTs.

Transporter Systems: Selinexor inhibits OATP1B3 but does not inhibit other solute carrier (SLC) transporters.

Selinexor is not a substrate of P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1, or MATE2-K.

Carcinogenicity studies have not been conducted with selinexor.

Selinexor was not mutagenic in vitro in a bacterial reverse mutation (Ames) assay and was not clastogenic in either the in vitro cytogenetic assay in human lymphocytes or in the in vivo rat micronucleus assay.

Fertility studies in animals have not been conducted with selinexor. In repeat-dose oral toxicity studies, selinexor was administered for up to 13 weeks in rats and monkeys. Reduced sperm, spermatids, and germ cells in epididymides and testes were observed in rats at ≥1 mg/kg, decreased ovarian follicles were observed in rats at ≥2 mg/kg, and single cell necrosis of testes was observed in monkeys at ≥1.5 mg/kg. These dose levels resulted in systemic exposures approximately 0.11, 0.28, and 0.53 times, respectively, the exposure (AUClast) in humans at the recommended human dose of 80 mg.

XPOVIO Combination with Bortezomib and Dexamethasone (XVd)

The efficacy of XPOVIO in combination with bortezomib and dexamethasone was evaluated in BOSTON (NCT03110562). BOSTON was a global, randomized, open label, active-controlled trial in adult patients who had received 1 to 3 prior anti-MM regimens. Prior treatment with bortezomib or other PI was allowed.

Patients with Grade 2 or higher peripheral neuropathy at study entry were excluded.

Patients were randomized to receive one of the following:

Treatment continued in both arms until disease progression or unacceptable toxicity. Randomization was stratified based on prior proteasome inhibitor therapies exposure (yes versus no), number of prior regimens (1 versus >1), Stage (III versus I or II) according to the Revised-International Staging System (RISS) and region. Upon confirmed progressive disease (PD), patients in the Vd arm could receive XPOVIO in combination with bortezomib and dexamethasone (XVd) or XPOVIO 100 mg taken orally on Days 1, 8, 15, 22, 29 with dexamethasone 20 mg taken orally on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle.

A total of 402 patients were randomized: 195 to XVd arm and 207 to Vd arm. Baseline patient demographics and disease characteristics are summarized in Table 11 and Table 12, respectively.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 11: Baseline Demographics (BOSTON) </span> </caption> <col align="left" width="54.251%"/> <col align="left" width="22.874%"/> <col align="left" width="22.874%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="bottom"><span class="Bold">Characteristic</span></td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">XVd <br/>(n=195)</span></td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Vd <br/>(n=207)</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Median age, years (range) </td><td align="center" class="Botrule Rrule" valign="top">66 (40, 87) </td><td align="center" class="Botrule Rrule" valign="top">67 (38, 90) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Age distribution, n (%)<br/>     &lt;65 years </td><td align="center" class="Rrule" valign="top"> <br/>86 (44) </td><td align="center" class="Rrule" valign="top"> <br/>75 (36) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     65 – 74 years </td><td align="center" class="Rrule" valign="top">75 (38) </td><td align="center" class="Rrule" valign="top">85 (41) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     ≥75 years </td><td align="center" class="Botrule Rrule" valign="top">34 (17) </td><td align="center" class="Botrule Rrule" valign="top">47 (23) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Sex, n (%)<br/>     Male </td><td align="center" class="Rrule" valign="top"> <br/>115 (59) </td><td align="center" class="Rrule" valign="top"> <br/>115 (56) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Female </td><td align="center" class="Botrule Rrule" valign="top">80 (41) </td><td align="center" class="Botrule Rrule" valign="top">92 (44) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Race, n (%) <br/>     White </td><td align="center" class="Rrule" valign="top"> <br/>161 (83) </td><td align="center" class="Rrule" valign="top"> <br/>165 (80) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Black or African American </td><td align="center" class="Rrule" valign="top">4 (2) </td><td align="center" class="Rrule" valign="top">7 (3) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Asian </td><td align="center" class="Rrule" valign="top">25 (13) </td><td align="center" class="Rrule" valign="top">25 (12) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Other </td><td align="center" class="Rrule" valign="top">0 </td><td align="center" class="Rrule" valign="top">1 (0.5) </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">     Missing </td><td align="center" class="Botrule Rrule" valign="top">5 (3) </td><td align="center" class="Botrule Rrule" valign="top">9 (4) </td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 12: Disease Characteristics (BOSTON) </span> </caption> <col align="left" width="64.367%"/> <col align="left" width="17.633%"/> <col align="left" width="18.000%"/> <tfoot> <tr class="First Last"> <td align="left" colspan="3" valign="top"> <p class="First Footnote">a. Includes any of del (17p)/p53, t (14;16), t (4;14), 1q21. </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="bottom"><span class="Bold">Parameter</span></td><td align="left" class="Botrule Rrule Toprule" valign="top"><span class="Bold">XVd (n=195)</span></td><td align="left" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Vd (n=207)</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Median years from diagnosis to randomization (range) </td><td align="center" class="Botrule Rrule" valign="top">3.81 (0.4,23.0) </td><td align="center" class="Botrule Rrule" valign="top">3.59 (0.4, 22.0) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">ECOG performance status score, n (%)<br/>     0-1 </td><td align="center" class="Rrule" valign="top"> <br/>175 (90) </td><td align="center" class="Rrule" valign="top"> <br/>191 (92) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     ≥2 </td><td align="center" class="Botrule Rrule" valign="top">20 (10) </td><td align="center" class="Botrule Rrule" valign="top">16 (8) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Creatinine Clearance, n (%), mL per minute<br/>     &lt;30 </td><td align="center" class="Rrule" valign="top"> <br/>3 (1.5) </td><td align="center" class="Rrule" valign="top"> <br/>10 (5) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     30 to 59 </td><td align="center" class="Rrule" valign="top">53 (27) </td><td align="center" class="Rrule" valign="top">60 (29) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     ≥60 </td><td align="center" class="Botrule Rrule" valign="top">139 (71) </td><td align="center" class="Botrule Rrule" valign="top">137 (66) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Revised International Staging System at Baseline, n (%)<br/>     I </td><td align="center" class="Rrule" valign="top"> <br/>56 (29) </td><td align="center" class="Rrule" valign="top"> <br/>52 (25) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     II </td><td align="center" class="Rrule" valign="top">117 (60) </td><td align="center" class="Rrule" valign="top">125 (60) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     III </td><td align="center" class="Rrule" valign="top">12 (6) </td><td align="center" class="Rrule" valign="top">16 (8) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Unknown </td><td align="center" class="Botrule Rrule" valign="top">10 (5) </td><td align="center" class="Botrule Rrule" valign="top">14 (7) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Number of Prior Therapies, n (%)<br/>     1<br/>     2<br/>     3 </td><td align="center" class="Botrule Rrule" valign="top"> <br/>99 (51)<br/>65 (33) 31 (16) </td><td align="center" class="Botrule Rrule" valign="top"> <br/>99 (48)<br/>64 (31) 44 (21) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Type of known prior therapy, n (%) Stem<br/>     Cell transplantation </td><td align="center" class="Rrule" valign="top"> <br/>76 (39) </td><td align="center" class="Rrule" valign="top"> <br/>63 (30) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Lenalidomide </td><td align="center" class="Rrule" valign="top">77 (39) </td><td align="center" class="Rrule" valign="top">77 (37) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Pomalidomide </td><td align="center" class="Rrule" valign="top">11 (6) </td><td align="center" class="Rrule" valign="top">7 (3) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Bortezomib </td><td align="center" class="Rrule" valign="top">134 (69) </td><td align="center" class="Rrule" valign="top">145 (70) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Carfilzomib </td><td align="center" class="Rrule" valign="top">20 (10) </td><td align="center" class="Rrule" valign="top">21 (10) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Daratumumab </td><td align="center" class="Botrule Rrule" valign="top">11 (6) </td><td align="center" class="Botrule Rrule" valign="top">6 (3) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Median weeks since end of last prior therapy, (range) </td><td align="center" class="Botrule Rrule" valign="top">48 (1, 1088) </td><td align="center" class="Botrule Rrule" valign="top">42 (2, 405) </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">Known high-risk cytogenetics<span class="Sup">a</span>, n (%) </td><td align="center" class="Botrule Rrule" valign="top">97 (50) </td><td align="center" class="Botrule Rrule" valign="top">95 (46) </td> </tr> </tbody> </table></div>

Efficacy was based on progression free survival (PFS) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma, as assessed by an Independent Review Committee (IRC). Efficacy results based on a preplanned PFS interim analysis, are shown in Table 13 and Figure 1.

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 13: Efficacy Results per IRC in Multiple Myeloma (BOSTON) </span> </caption> <col align="left" width="33.333%"/> <col align="left" width="33.333%"/> <col align="left" width="33.333%"/> <tfoot> <tr class="First"> <td align="left" colspan="3" valign="top"> <p class="First Footnote">a. Hazard ratio is based on stratified Cox's proportional hazard regression modeling, p-value based on stratified log-rank test. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">Median follow up of 15.1 months at the time of the analysis. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">b. The pre-planned PFS interim analysis boundary of statistical significance was defined as a p-value &lt;0.0103. </p> </td> </tr> <tr> <td align="left" colspan="3" valign="top"> <p class="First Footnote">c. Includes sCR + CR + VGPR + PR, p value based on Cochran-Mantel-Haenszel test. </p> </td> </tr> <tr class="Last"> <td align="left" colspan="3" valign="top"> <p class="First Footnote">d. Includes sCR + CR + VGPR, p value based on Cochran-Mantel-Haenszel test. </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="bottom"></td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">XVd <br/>(n=195)</span></td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Vd <br/>(n=207)</span></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Progression Free Survival (PFS)</span><span class="Bold"><span class="Sup">a</span></span> <br/>     Hazard Ratio [95% CI] </td><td align="center" class="Rrule" colspan="2" valign="top"> <br/>0.70 [0.53, 0.93] </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">           One-sided p-value<span class="Sup">b</span></td><td align="center" class="Rrule" colspan="2" valign="top">0.0075 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> <br/>     Median PFS in months [95% CI] </td><td align="center" class="Botrule" valign="bottom">13.9 (11.7, Not Reached) </td><td align="center" class="Botrule Rrule" valign="bottom">9.5 (7.6, 10.8) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Overall Response Rate (ORR)</span><span class="Bold"><span class="Sup">c</span></span><span class="Bold">, n (%)</span></td><td align="center" class="Rrule" valign="top">149 (76.4) </td><td align="center" class="Rrule" valign="top">129 (62.3) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">           95% CI </td><td align="center" class="Rrule" valign="top">(69.8, 82.2) </td><td align="center" class="Rrule" valign="top">(55.3, 68.9) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">           One-sided p-value </td><td align="center" class="Rrule" colspan="2" valign="top">0.0012 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     <br/>     Stringent Complete Response (sCR) </td><td align="center" class="Rrule" valign="bottom">19 (10) </td><td align="center" class="Rrule" valign="bottom">13 (6) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Complete Response (CR) </td><td align="center" class="Rrule" valign="top">14 (7) </td><td align="center" class="Rrule" valign="top">9 (4) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Very Good Partial Response (VGPR) </td><td align="center" class="Rrule" valign="top">54 (28) </td><td align="center" class="Rrule" valign="top">45 (22) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Partial Response (PR) </td><td align="center" class="Botrule Rrule" valign="top">62 (32) </td><td align="center" class="Botrule Rrule" valign="top">62 (30) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">≥ VGPR Response Rate</span><span class="Bold"><span class="Sup">d</span></span><span class="Bold">, n (%)</span></td><td align="center" class="Rrule" valign="top">87 (44.6) </td><td align="center" class="Rrule" valign="top">67 (32.4) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">           95% CI </td><td align="center" class="Rrule" valign="top">(37.5, 51.9) </td><td align="center" class="Rrule" valign="top">(26.0, 39.2) </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">           One-sided p-value </td><td align="center" class="Botrule Rrule" colspan="2" valign="top">0.0082 </td> </tr> </tbody> </table></div>

Figure 1: Kaplan-Meier Curve of PFS (BOSTON)

The median time to response was 1.4 months in the XVd arm and 1.6 months in the Vd arm. The median duration of response, among responding patients, was 20.3 months and 12.9 months in the XVd and Vd arms, respectively.

XPOVIO Combination with Dexamethasone (Xd)

The efficacy of XPOVIO plus dexamethasone was evaluated in STORM (KCP-330-012; NCT02336815). STORM was a multicenter, single-arm, open-label study of adults with relapsed or refractory multiple myeloma (RRMM). STORM Part 2 included 122 patients with RRMM who had previously received three or more antimyeloma treatment regimens including an alkylating agent, glucocorticoids, bortezomib, carfilzomib, lenalidomide, pomalidomide, and an anti-CD38 monoclonal antibody; and whose myeloma was documented to be refractory to glucocorticoids, a proteasome inhibitor, an immunomodulatory agent, an anti-CD38 monoclonal antibody, and to the last line of therapy.

In STORM Part 2, a total of 122 patients received XPOVIO 80 mg orally in combination with dexamethasone 20 mg orally on Days 1 and 3 of every week. Treatment continued until disease progression or unacceptable toxicity. Eighty-three patients had RRMM that was refractory to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab. Baseline patient demographics and disease characteristics of these 83 patients are summarized in Table 14 and Table 15, respectively.

Efficacy was based on overall response rate (ORR), as assessed by an Independent Review Committee (IRC) based on the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple

Myeloma. The approval of XPOVIO was based upon the efficacy and safety in a prespecified subgroup analysis of the 83 patients whose disease was refractory to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab, as the benefit-risk ratio appeared to be greater in this more heavily pretreated population than in the overall trial population. Overall response rate results are presented in Table 16. The median time to first response was 4 weeks (range: 1 to 10 weeks). The median duration of response was 3.8 months (95% CI: 2.3, not estimable).

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 14: Baseline Demographics (STORM) </span> </caption> <col align="left" width="66.600%"/> <col align="left" width="33.400%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="bottom"><span class="Bold">Demographic</span></td><td align="center" class="Botrule Rrule Toprule" valign="bottom"><span class="Bold">STORM</span> <br/> <span class="Bold">(n=83)</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="middle">Median age, years (range) </td><td align="center" class="Botrule Rrule" valign="middle">65 (40, 86) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="middle"><span class="Bold">Age category, n (%)</span></td><td align="left" class="Botrule Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     &lt;65 years </td><td align="center" class="Botrule Rrule" valign="top">40 (48) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     65 – 74 years </td><td align="center" class="Botrule Rrule" valign="top">31 (37) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     ≥75 years </td><td align="center" class="Botrule Rrule" valign="top">12 (15) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="middle"><span class="Bold">Sex, n (%)</span></td><td align="left" class="Botrule Rrule" valign="top"></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Male </td><td align="center" class="Botrule Rrule" valign="top">51 (61) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Female </td><td align="center" class="Botrule Rrule" valign="top">32 (39) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="middle"><span class="Bold">Race, n (%)</span></td><td align="left" class="Botrule Rrule" valign="middle"></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     White </td><td align="center" class="Botrule Rrule" valign="top">58 (70) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Black or African American </td><td align="center" class="Botrule Rrule" valign="top">13 (16) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Asian </td><td align="center" class="Botrule Rrule" valign="top">2 (2) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Native Hawaiian or other Pacific Islander </td><td align="center" class="Botrule Rrule" valign="top">1 (1) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Other </td><td align="center" class="Botrule Rrule" valign="top">6 (7) </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">     Missing </td><td align="center" class="Botrule Rrule" valign="top">3 (4) </td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 15: Disease Characteristics (STORM) </span> </caption> <col align="left" width="75.200%"/> <col align="left" width="24.800%"/> <tfoot> <tr class="First Last"> <td align="left" colspan="2" valign="top"> <p class="First Footnote">a. Includes any of del(17p)/p53, t(14; 16), t(4; 14), 1q21. </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="bottom"><span class="Bold">Parameter</span></td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">STORM</span> <br/> <span class="Bold">(n=83)</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Median years from diagnosis to start of study treatment (range) </td><td align="center" class="Botrule Rrule" valign="top">7 (1, 23) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Prior treatment regimens, median (range) </td><td align="center" class="Botrule Rrule" valign="top">8 (4, 18) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Documented refractory status, n (%)<br/>     Lenalidomide </td><td align="center" class="Rrule" valign="top"> <br/>83 (100) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Pomalidomide </td><td align="center" class="Rrule" valign="top">83 (100) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Bortezomib </td><td align="center" class="Rrule" valign="top">83 (100) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Carfilzomib </td><td align="center" class="Rrule" valign="top">83 (100) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Daratumumab </td><td align="center" class="Botrule Rrule" valign="top">83 (100) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Documented refractory status to specific combinations, n (%)<br/>     Bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab </td><td align="center" class="Rrule" valign="top"> <br/>83 (100) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Daratumumab in any combination </td><td align="center" class="Rrule" valign="top">57 (69) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Daratumumab as single agent (+/- dexamethasone) </td><td align="center" class="Botrule Rrule" valign="top">26 (31) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">Previous stem cell transplant, n (%) </td><td align="center" class="Botrule Rrule" valign="top">67 (81) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">Revised International Staging System at Baseline, n (%)<br/>     I </td><td align="center" class="Rrule" valign="top"> <br/>10 (12) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     II </td><td align="center" class="Rrule" valign="top">56 (68) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     III </td><td align="center" class="Rrule" valign="top">17 (21) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Unknown </td><td align="center" class="Botrule Rrule" valign="top">0 </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">High-risk cytogenetics<span class="Sup">a</span>, n (%) </td><td align="center" class="Botrule Rrule" valign="top">47 (57) </td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 16: Efficacy Results per IRC in Relapsed or Refractory Multiple Myeloma (STORM) </span> </caption> <col align="left" width="56.150%"/> <col align="left" width="43.850%"/> <tfoot> <tr class="First Last"> <td align="left" colspan="2" valign="top"> <p class="First Footnote">a. Includes sCR + CR + VGPR + PR. </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="bottom"><span class="Bold">Response</span></td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">STORM</span> <br/> <span class="Bold">(n=83)</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"><span class="Bold">Overall Response Rate (ORR)</span><span class="Bold"><span class="Sup">a</span></span><span class="Bold">, n (%)</span></td><td align="center" class="Botrule Rrule" valign="top">21 (25.3) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     95% CI </td><td align="center" class="Botrule Rrule" valign="top">16.4, 36 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Stringent Complete Response (sCR) </td><td align="center" class="Botrule Rrule" valign="top">1 (1) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Complete Response (CR) </td><td align="center" class="Botrule Rrule" valign="top">0 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Very Good Partial Response (VGPR) </td><td align="center" class="Botrule Rrule" valign="top">4 (5) </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">     Partial Response (PR) </td><td align="center" class="Botrule Rrule" valign="top">16 (19) </td> </tr> </tbody> </table></div>

The efficacy of XPOVIO monotherapy was evaluated in SADAL (KCP-330-009; NCT02227251). SADAL was a multicenter, single-arm, open-label study of adults with relapsed or refractory DLBCL, not otherwise specified (NOS), after 2 to 5 systemic regimens. Eligible patients were not candidates for autologous hematopoietic stem cell transplantation (HSCT). The study required a minimum of 60 days since last systemic therapy, with a minimum of 98 days in patients with refractory disease (defined as less than partial response) to last systemic therapy.

Patients received XPOVIO 60 mg orally on Days 1 and 3 of each week. Treatment continued until disease progression or unacceptable toxicity. Of 134 patients evaluated, the median age was 67 years (range: 35-91), 59% were male, 79% were White, and 7% were Asian. Most patients (88%) had an ECOG performance status of 0 or 1. The diagnosis was de novo DLBCL not otherwise specified (NOS) in 75% and transformed DLBCL in 23%. The median number of prior systemic therapies was 2 (range: 1-5), with 63% of patients receiving 2 prior systemic therapies, 24% receiving 3 prior therapies, and 10% receiving 4 or 5 prior therapies. Twenty-eight percent had documented refractory disease to the most recent therapy; 30% had prior autologous HSCT. The median time from last systemic therapy to the start of XPOVIO was 5.4 months overall and 3.6 months in the patients with refractory disease.

Efficacy was based on overall response rate (ORR) and duration of response as assessed by an Independent Review Committee (IRC) using Lugano 2014 criteria (Table 17). The median time to first response was 8.1 weeks (range: 6.7-16.4 weeks).

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 17: Efficacy Results per IRC in Relapsed or Refractory DLBCL (SADAL) </span> </caption> <col align="left" width="65.500%"/> <col align="left" width="34.500%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="top"> <br/> <span class="Bold">Parameter</span></td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold">XPOVIO 60 mg twice weekly</span> <br/> <span class="Bold">(n=134)</span></td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">ORR per Lugano criteria, n (%)</span> <br/>     95% CI, % </td><td align="center" class="Rrule" valign="top">39 (29)<br/>22, 38 </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Complete Response </td><td align="center" class="Rrule" valign="top">18 (13) </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">     Partial Response </td><td align="center" class="Botrule Rrule" valign="top">21 (16) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top"><span class="Bold">Duration of Response</span> <br/>     Patients maintaining response at 3 months, n/N (%) </td><td align="center" class="Rrule" valign="top"> <br/>22/39 (56) </td> </tr> <tr> <td align="left" class="Lrule Rrule" valign="top">     Patients maintaining response at 6 months, n/N (%) </td><td align="center" class="Rrule" valign="top">15/39 (38) </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">     Patients maintaining response at 12 months, n/N (%) </td><td align="center" class="Botrule Rrule" valign="top">6/39 (15) </td> </tr> </tbody> </table></div>

XPOVIO 10 mg tablets are blue, round, bi-convex, film-coated debossed with “X10” on one side and nothing on the other side.

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XPOVIO 20 mg tablets are blue, round, bi-convex, film-coated debossed with “K20” on one side and nothing on the other side.

{ "type": "p", "children": [], "text": "XPOVIO 20 mg tablets are blue, round, bi-convex, film-coated debossed with “K20” on one side and nothing on the other side.\n" }

XPOVIO 40 mg tablets are blue, oval, film-coated, debossed on both sides with “X40”.

{ "type": "p", "children": [], "text": "XPOVIO 40 mg tablets are blue, oval, film-coated, debossed on both sides with “X40”.\n" }

XPOVIO 50 mg tablets are blue, oval, film-coated, debossed on both sides with “X50”.

{ "type": "p", "children": [], "text": "XPOVIO 50 mg tablets are blue, oval, film-coated, debossed on both sides with “X50”.\n" }

XPOVIO 60 mg tablets are blue, oval, film-coated, debossed on both sides with “X60”.

{ "type": "p", "children": [], "text": "XPOVIO 60 mg tablets are blue, oval, film-coated, debossed on both sides with “X60”.\n" }

Tablets are packaged in a child-resistant blister pack. Four blister packs are supplied per carton. The following thirteen dose presentations are available:

{ "type": "p", "children": [], "text": "Tablets are packaged in a child-resistant blister pack. Four blister packs are supplied per carton. The following thirteen dose presentations are available:\n" }

<div class="scrollingtable"><table width="100%"> <col align="left" width="19.996%"/> <col align="left" width="19.996%"/> <col align="left" width="20.016%"/> <col align="left" width="19.996%"/> <col align="left" width="19.996%"/> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule" valign="bottom"><span class="Bold">Weekly dose</span></td><td align="center" class="Botrule Rrule Toprule" valign="bottom"><span class="Bold">Strength per tablet</span></td><td align="left" class="Botrule Rrule Toprule" valign="bottom"><span class="Bold">Carton (28 day supply)</span></td><td align="left" class="Botrule Rrule Toprule" valign="bottom"><span class="Bold">Blister Pack</span></td><td align="left" class="Botrule Rrule Toprule" valign="bottom"><span class="Bold">NDC</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">80 mg twice weekly </td><td align="center" class="Botrule Rrule" valign="top">20 mg </td><td align="left" class="Botrule Rrule" valign="top">4 blister packs<br/>(32 tablets total in the<br/>carton) </td><td align="left" class="Botrule Rrule" valign="top">Each blister has eight 20 mg tablets </td><td align="left" class="Botrule Rrule" valign="top">Outer carton NDC<br/>72237-101-04<br/> <br/>Blister pack NDC<br/>72237-101-14 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">60 mg twice weekly </td><td align="center" class="Botrule Rrule" valign="top">20 mg </td><td align="left" class="Botrule Rrule" valign="top">4 blister packs<br/>(24 tablets total in the<br/>carton) </td><td align="left" class="Botrule Rrule" valign="top">Each blister has six 20 mg tablets </td><td align="left" class="Botrule Rrule" valign="top">Outer carton NDC<br/>72237-101-03<br/> <br/>Blister pack NDC<br/>72237-101-13 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">100 mg once weekly </td><td align="center" class="Botrule Rrule" valign="top">20 mg </td><td align="left" class="Botrule Rrule" valign="top">4 blister packs<br/>(20 tablets total in the<br/>carton) </td><td align="left" class="Botrule Rrule" valign="top">Each blister has five 20 mg tablets </td><td align="left" class="Botrule Rrule" valign="top">Outer carton NDC<br/>72237-101-05<br/> <br/>Blister pack NDC<br/>72237-101-15 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">80 mg once weekly </td><td align="center" class="Botrule Rrule" valign="top">20 mg </td><td align="left" class="Botrule Rrule" valign="top">4 blister packs<br/>(16 tablets total in the<br/>carton) </td><td align="left" class="Botrule Rrule" valign="top">Each blister has four 20 mg tablets </td><td align="left" class="Botrule Rrule" valign="top">Outer carton NDC<br/>72237-101-02<br/> <br/>Blister pack NDC<br/>72237-101-12 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">40 mg twice weekly </td><td align="center" class="Botrule Rrule" valign="top">20 mg </td><td align="left" class="Botrule Rrule" valign="top">4 blister packs<br/>(16 tablets total in the<br/>carton) </td><td align="left" class="Botrule Rrule" valign="top">Each blister has four 20 mg tablets </td><td align="left" class="Botrule Rrule" valign="top">Outer carton NDC<br/>72237-101-06<br/> <br/>Blister pack NDC<br/>72237-101-16 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">60 mg once weekly </td><td align="center" class="Botrule Rrule" valign="top">20 mg </td><td align="left" class="Botrule Rrule" valign="top">4 blister packs<br/>(12 tablets total in the<br/>carton) </td><td align="left" class="Botrule Rrule" valign="top">Each blister has three 20 mg tablets </td><td align="left" class="Botrule Rrule" valign="top">Outer carton NDC<br/>72237-101-01<br/> <br/>Blister pack NDC<br/>72237-101-11 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">40 mg once weekly </td><td align="center" class="Botrule Rrule" valign="top">20 mg </td><td align="left" class="Botrule Rrule" valign="top">4 blister packs<br/>(8 tablets total in the carton) </td><td align="left" class="Botrule Rrule" valign="top">Each blister has two 20 mg tablets </td><td align="left" class="Botrule Rrule" valign="top">Outer carton NDC<br/>72237-101-07<br/> <br/>Blister pack NDC<br/>72237-101-17 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">100 mg once weekly </td><td align="center" class="Botrule Rrule" valign="top">50 mg </td><td align="left" class="Botrule Rrule" valign="top">4 blister packs<br/>(8 tablets total in the carton) </td><td align="left" class="Botrule Rrule" valign="top">Each blister has two 50 mg tablets </td><td align="left" class="Botrule Rrule" valign="top">Outer carton NDC <br/>72237-103-05<br/> <br/>Blister pack NDC<br/>72237-103-15 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">80 mg once weekly </td><td align="center" class="Botrule Rrule" valign="top">40 mg </td><td align="left" class="Botrule Rrule" valign="top">4 blister packs<br/>(8 tablets total in the carton) </td><td align="left" class="Botrule Rrule" valign="top">Each blister has two 40 mg tablets </td><td align="left" class="Botrule Rrule" valign="top">Outer carton NDC <br/>72237-102-02<br/> <br/>Blister pack NDC<br/>72237-102-12 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">40 mg twice weekly </td><td align="center" class="Botrule Rrule" valign="top">40 mg </td><td align="left" class="Botrule Rrule" valign="top">4 blister packs<br/>(8 tablets total in the carton) </td><td align="left" class="Botrule Rrule" valign="top">Each blister has two 40 mg tablets </td><td align="left" class="Botrule Rrule" valign="top">Outer carton NDC<br/>72237-102-06<br/> <br/>Blister pack NDC<br/>72237-102-16 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">60 mg once weekly </td><td align="center" class="Botrule Rrule" valign="top">60 mg </td><td align="left" class="Botrule Rrule" valign="top">4 blister packs<br/>(4 tablets total in the carton) </td><td align="left" class="Botrule Rrule" valign="top">Each blister has one 60 mg tablet </td><td align="left" class="Botrule Rrule" valign="top">Outer carton NDC<br/>72237-104-01<br/> <br/>Blister pack NDC<br/>72237-104-11 </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top">40 mg once weekly </td><td align="center" class="Botrule Rrule" valign="top">40 mg </td><td align="left" class="Botrule Rrule" valign="top">4 blister packs<br/>(4 tablets total in the carton) </td><td align="left" class="Botrule Rrule" valign="top">Each blister has one 40 mg tablet </td><td align="left" class="Botrule Rrule" valign="top">Outer carton NDC<br/>72237-102-07<br/> <br/>Blister pack NDC<br/>72237-102-17 </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" valign="top">40 mg once weekly </td><td align="center" class="Botrule Rrule" valign="top">10 mg </td><td align="left" class="Botrule Rrule" valign="top">4 blister packs<br/>(16 tablets total in the carton) </td><td align="left" class="Botrule Rrule" valign="top">Each blister has four 10 mg tablets </td><td align="left" class="Botrule Rrule" valign="top">Outer carton NDC<br/>72237-106-01<br/> <br/>Blister pack NDC<br/>72237-106-11 </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" width=\"19.996%\"/>\n<col align=\"left\" width=\"19.996%\"/>\n<col align=\"left\" width=\"20.016%\"/>\n<col align=\"left\" width=\"19.996%\"/>\n<col align=\"left\" width=\"19.996%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" valign=\"bottom\"><span class=\"Bold\">Weekly dose</span></td><td align=\"center\" class=\"Botrule Rrule Toprule\" valign=\"bottom\"><span class=\"Bold\">Strength per tablet</span></td><td align=\"left\" class=\"Botrule Rrule Toprule\" valign=\"bottom\"><span class=\"Bold\">Carton (28 day supply)</span></td><td align=\"left\" class=\"Botrule Rrule Toprule\" valign=\"bottom\"><span class=\"Bold\">Blister Pack</span></td><td align=\"left\" class=\"Botrule Rrule Toprule\" valign=\"bottom\"><span class=\"Bold\">NDC</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">80 mg twice weekly\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">20 mg\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">4 blister packs<br/>(32 tablets total in the<br/>carton)\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Each blister has eight 20 mg tablets\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Outer carton NDC<br/>72237-101-04<br/>\n<br/>Blister pack NDC<br/>72237-101-14\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">60 mg twice weekly\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">20 mg\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">4 blister packs<br/>(24 tablets total in the<br/>carton)\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Each blister has six 20 mg tablets\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Outer carton NDC<br/>72237-101-03<br/>\n<br/>Blister pack NDC<br/>72237-101-13\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">100 mg once weekly\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">20 mg\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">4 blister packs<br/>(20 tablets total in the<br/>carton)\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Each blister has five 20 mg tablets\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Outer carton NDC<br/>72237-101-05<br/>\n<br/>Blister pack NDC<br/>72237-101-15\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">80 mg once weekly\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">20 mg\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">4 blister packs<br/>(16 tablets total in the<br/>carton)\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Each blister has four 20 mg tablets\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Outer carton NDC<br/>72237-101-02<br/>\n<br/>Blister pack NDC<br/>72237-101-12\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">40 mg twice weekly\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">20 mg\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">4 blister packs<br/>(16 tablets total in the<br/>carton)\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Each blister has four 20 mg tablets\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Outer carton NDC<br/>72237-101-06<br/>\n<br/>Blister pack NDC<br/>72237-101-16\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">60 mg once weekly\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">20 mg\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">4 blister packs<br/>(12 tablets total in the<br/>carton)\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Each blister has three 20 mg tablets\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Outer carton NDC<br/>72237-101-01<br/>\n<br/>Blister pack NDC<br/>72237-101-11\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">40 mg once weekly\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">20 mg\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">4 blister packs<br/>(8 tablets total in the carton)\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Each blister has two 20 mg tablets\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Outer carton NDC<br/>72237-101-07<br/>\n<br/>Blister pack NDC<br/>72237-101-17\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">100 mg once weekly\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">50 mg\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">4 blister packs<br/>(8 tablets total in the carton)\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Each blister has two 50 mg tablets\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Outer carton NDC <br/>72237-103-05<br/>\n<br/>Blister pack NDC<br/>72237-103-15\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">80 mg once weekly\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">40 mg\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">4 blister packs<br/>(8 tablets total in the carton)\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Each blister has two 40 mg tablets\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Outer carton NDC <br/>72237-102-02<br/>\n<br/>Blister pack NDC<br/>72237-102-12\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">40 mg twice weekly\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">40 mg\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">4 blister packs<br/>(8 tablets total in the carton)\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Each blister has two 40 mg tablets\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Outer carton NDC<br/>72237-102-06<br/>\n<br/>Blister pack NDC<br/>72237-102-16\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">60 mg once weekly\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">60 mg\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">4 blister packs<br/>(4 tablets total in the carton)\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Each blister has one 60 mg tablet\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Outer carton NDC<br/>72237-104-01<br/>\n<br/>Blister pack NDC<br/>72237-104-11\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">40 mg once weekly\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">40 mg\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">4 blister packs<br/>(4 tablets total in the carton)\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Each blister has one 40 mg tablet\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Outer carton NDC<br/>72237-102-07<br/>\n<br/>Blister pack NDC<br/>72237-102-17\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\">40 mg once weekly\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">10 mg\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">4 blister packs<br/>(16 tablets total in the carton)\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Each blister has four 10 mg tablets\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\">Outer carton NDC<br/>72237-106-01<br/>\n<br/>Blister pack NDC<br/>72237-106-11\n</td>\n</tr>\n</tbody>\n</table></div>" }

Store at or below 30°C (86°F).

{ "type": "p", "children": [], "text": "Store at or below 30°C (86°F).\n" }

Dosing Instructions [see Dosage and Administration (2)]:

Hematologic Adverse Reactions

Thrombocytopenia

Advise patients that they may develop low platelet counts (thrombocytopenia). Symptoms of thrombocytopenia may include bleeding and easy bruising. Advise patients that platelet counts will be monitored at baseline, during treatment, and as clinically indicated, with more frequent monitoring during the first 3 months of treatment. Advise patients to report signs of bleeding right away [see Warnings and Precautions (5.1)].

Anemia

Advise patients that they may develop anemia. Symptoms of anemia may include fatigue and shortness of breath. Advise patients to report signs or symptoms of anemia [see Adverse Reactions (6.1)].

Neutropenia

Advise patients that they may develop low neutrophil counts which may increase their susceptibility to infection [see Warnings and Precautions (5.2)]. Advise patients that neutrophil counts will be monitored at baseline, during treatment, and as clinically indicated, with more frequent monitoring during the first 3 months of treatment.

Gastrointestinal Adverse Reactions

Advise patients they may experience nausea/vomiting or diarrhea and to contact their physician if these adverse reactions occur or persist [see Warnings and Precautions (5.3)].

Advise patients that they may experience weight loss or decreased appetite. Advise patients to report decreased appetite and weight loss [see Warnings and Precautions (5.3)].

Hyponatremia

Advise patients that they may develop low sodium levels (hyponatremia). Most cases of hyponatremia were not associated with specific symptoms. Advise patients that levels of sodium will be monitored at baseline and during treatment as clinically indicated, with more frequent monitoring during the first two months of treatment [see Warnings and Precautions (5.4)].

Serious Infection

Advise patients of the possibility of serious infections. Instruct patients to immediately report infection-related signs or symptoms (e.g., chills, fever) [see Warnings and Precautions (5.5)].

Neurotoxicity

Advise patients that they may experience confusion and dizziness. Advise patients to report symptoms of neurological toxicity right away. Advise patients not to drive or operate hazardous machinery until the neurological toxicity fully resolves. Advise patients to use fall prevention measures as warranted [see Warnings and Precautions (5.6)].

Embryo-Fetal Toxicity

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to contact their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.7) and Use in Specific Populations (8.1)].

Advise females of reproductive potential and males with a female partner of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the final dose [see Use in Specific Populations (8.3)].

Cataract

Advise patients of the potential risk of worsening or new onset of cataract, that may require surgery. Advise patients to readily inform their healthcare professionals of changes in vision (i.e. blurred vision) and that ophthalmologic evaluation may be performed as clinically indicated [see Warnings and Precautions (5.8)].

Fatigue

Advise patients that they may experience fatigue [see Adverse Reactions (6.1)].

Lactation

Advise women not to breastfeed during treatment with XPOVIO and for 1 week after the last dose [see Use in Specific Populations (8.2)].

Concomitant Medications

Advise patients to take 5-HT3 antagonist prophylactic treatment and other anti-nausea agents prior to and during treatment with XPOVIO [see Dosage and Administration (2.4)].

Advise patients to speak with their physician about other medications they are currently taking and before starting any new medication.

Manufactured for and marketed by: Karyopharm Therapeutics Inc., 85 Wells Avenue, Newton, MA, 02459.XPOVIO is a registered trademark of Karyopharm Therapeutics Inc. ©2025 Karyopharm Therapeutics Inc. For more information, call 1-888-209-9326 or go to www.XPOVIO.com.

<div class="scrollingtable"><table width="100%"> <col align="left" width="89.400%"/> <col align="left" width="10.600%"/> <tfoot> <tr class="First Last"> <td align="left" valign="top"> <p class="First Footnote">This Medication Guide has been approved by the U.S. Food and Drug Administration. </p> </td><td align="right" valign="top"> <p class="First Footnote"> <span class="Bold">Revised: 3/2022</span> </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"><span class="Bold">MEDICATION GUIDE</span> <br/>XPOVIO<span class="Sup">®</span> (x-PO-Vee-O)<br/>(selinexor) tablets </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="p02"></a><span class="Bold">What is the most important information I should know about XPOVIO?</span> <br/> <span class="Bold">XPOVIO can cause serious side effects, including:</span> <br/> </p> <ul class="Disc"> <li> <span class="Bold">Low platelet counts</span>. Low platelet counts are common with XPOVIO and can lead to bleeding which can be severe and can sometimes cause death. Your healthcare provider may prescribe platelet transfusions or other treatments for your low platelet counts. <br/> <span class="Bold">Tell your healthcare provider right away if you have any bleeding or easy bruising during treatment with XPOVIO.</span> </li> <li> <span class="Bold">Low white blood cell counts.</span> Low white blood cell counts are common with XPOVIO and can sometimes be severe. You may have an increased risk of getting bacterial infections during treatment with XPOVIO. Your healthcare provider may prescribe antibiotics if you have signs or symptoms of infection, or certain medicines to help increase your white blood cell count, if needed. </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top">Your healthcare provider will do blood tests before you start taking XPOVIO and often during the first 3 months of treatment and then as needed during treatment to monitor you for side effects.<br/>Your healthcare provider may change your dose of XPOVIO, stop your treatment for a period of time, or completely stop your treatment if you have certain side effects during treatment with XPOVIO.<br/> <span class="Bold">See “<a href="#p01">What are the possible side effects of XPOVIO?</a>” for more information about side effects.</span></td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2" valign="top"><span class="Bold">What is XPOVIO?</span> <br/>XPOVIO is a prescription medicine used:<br/> <ul class="Disc"> <li>in combination with the medicines VELCADE<span class="Sup">®</span> (bortezomib) and dexamethasone to treat adults with multiple myeloma (MM) who have received at least one prior treatment for their disease. </li> <li>in combination with dexamethasone to treat adults with multiple myeloma (MM) that has come back (relapsed) or that did not respond to previous treatment (refractory), and<ul class="Circle"> <li>who have received at least 4 prior therapies, <span class="Bold">and</span> </li> <li>whose disease did not respond to (refractory) to at least 2 proteasome inhibitor medicines, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody medicine. </li> </ul> </li> <li>to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory) and who have received at least 2 prior therapies<br/> </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top">It is not known if XPOVIO is safe and effective in children less than 18 years of age. </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2" valign="top"><span class="Bold">What should I tell my healthcare provider before taking XPOVIO?</span> <br/> <span class="Bold">Before taking XPOVIO, tell your healthcare provider about all of your medical conditions, including if you:</span> <br/> <ul class="Disc"> <li>have or have had a recent or active infection </li> <li>have or have had bleeding problems </li> <li>are pregnant or plan to become pregnant. XPOVIO can harm your unborn baby. <br/> <span class="Bold">Females who are able to become pregnant:</span> <ul class="Circle"> <li>Your healthcare provider will check to see if you are pregnant before you start taking XPOVIO. </li> <li>You should use effective birth control (contraception) during treatment with XPOVIO and for 1 week after your last dose. </li> <li>Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with XPOVIO. </li> </ul> <p class="First"> <span class="Bold">Males with female partners who are able to become pregnant:</span> </p> <ul class="Circle"> <li>You should use effective birth control during treatment with XPOVIO and for 1 week after your last dose. </li> </ul> </li> <li>are breastfeeding or plan to breastfeed. It is not known if XPOVIO passes into your breast milk.<ul class="Circle"> <li>Do not breastfeed during treatment with XPOVIO and for 1 week after your last dose of XPOVIO. </li> </ul> </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Tell your healthcare provider about all the medicines you take</span>, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Talk with your healthcare provider before taking any new medicines. </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="p03"></a><span class="Bold">How should I take XPOVIO?</span> <br/> </p> <ul class="Disc"> <li>Take XPOVIO exactly as prescribed by your healthcare provider. </li> <li>If you have multiple myeloma, your healthcare provider will prescribe dexamethasone with your XPOVIO treatment. Take dexamethasone exactly as prescribed. </li> <li>Your healthcare provider will tell you how much XPOVIO to take and when to take it. Do not change your dose or stop taking XPOVIO without talking to your healthcare provider first. </li> <li>Swallow XPOVIO tablets whole with water. <span class="Bold">Do not break, chew, crush, or divide the tablets.</span> </li> <li>Be sure to take any medicines prescribed by your healthcare provider before and during treatment with XPOVIO to help prevent nausea and vomiting. Tell your healthcare provider if the prescribed medicine does not control your nausea and vomiting. </li> <li>It is important for you to drink enough fluids to help prevent dehydration and to eat enough calories to help prevent weight loss during treatment with XPOVIO. Talk to your healthcare provider if this is a problem for you. <span class="Bold">See “<a href="#p01">What are the possible side effects of XPOVIO?</a>”</span> </li> <li>If you miss a dose of XPOVIO, take your next dose at your next regularly scheduled day and time. </li> <li>If you vomit after taking a dose of XPOVIO, do not take an extra dose. Take your next dose at your next regularly scheduled day and time. </li> <li>If you take too much XPOVIO, call your healthcare provider right away. </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">What should I avoid while taking XPOVIO?</span> <br/> <span class="Bold">XPOVIO can cause neurologic side effects.</span> <br/> <ul class="Disc"> <li> <span class="Bold">See “<a href="#p01">What are the possible side effects of XPOVIO?</a>” below.</span> </li> <li>If you have any neurologic side effects with XPOVIO, <span class="Bold">do not drive or operate heavy or dangerous machinery until your neurologic side effects go away.</span> </li> <li> <span class="Bold">Avoid falling.</span> Use care as needed to avoid falling due to neurologic side effects. </li> </ul> </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2" valign="top"> <p class="First"> <a name="p01"></a><span class="Bold">What are the possible side effects of XPOVIO?</span> <br/> <span class="Bold">XPOVIO can cause serious side effects, including:</span> <br/> </p> <ul class="Disc"> <li> <span class="Bold">See “<a href="#p02">What is the most important information I should know about XPOVIO?</a>”</span> </li> <li> <span class="Bold">Nausea and vomiting</span>. Nausea and vomiting are common with XPOVIO and can sometimes be severe. Nausea and vomiting may affect your ability to eat and drink well. You can lose too much body fluid and body salts (electrolytes) and may be at risk for becoming dehydrated. You may need to receive intravenous (IV) fluids or other treatments to help prevent dehydration. Your healthcare provider will prescribe anti-nausea medicines for you to take before you start and during treatment with XPOVIO. <span class="Bold">See “<a href="#p03">How should I take XPOVIO?</a>”</span> </li> <li> <span class="Bold">Diarrhea.</span> Diarrhea is common with XPOVIO and can sometimes be severe. You can lose too much body fluid and body salts (electrolytes) and may be at risk for becoming dehydrated. You may need to receive IV fluids or other treatments to help prevent dehydration. Your healthcare provider will prescribe anti-diarrhea medicine for you as needed. </li> <li> <span class="Bold">Loss of appetite and weight loss</span>. Loss of appetite and weight loss are common with XPOVIO and can sometimes be severe. Tell your healthcare provider if you have a decrease or loss of appetite and if you notice that you are losing weight at any time during treatment. Your healthcare provider may prescribe medicines that can help increase your appetite or prescribe other kinds of nutritional support. Your healthcare provider will monitor your appetite and weight before you start XPOVIO and often during the first 3 months, then as needed during treatment. </li> <li> <span class="Bold">Decreased sodium levels in your blood</span>. Decreased sodium levels in your blood is common with XPOVIO but can also sometimes be severe. Low sodium levels in your blood can happen if you have nausea, vomiting, or diarrhea, you become dehydrated, or if you have loss of appetite with XPOVIO. You may not have any symptoms of a low sodium level. Your healthcare provider may talk with you about your diet and prescribe IV fluids for you based on the sodium levels in your blood. Your healthcare provider will do blood tests before you start taking XPOVIO, and often during the first 2 months of treatment, and then as needed during treatment to monitor the sodium levels in your blood. </li> <li> <span class="Bold">Serious infections.</span> Infections are common with XPOVIO and can be serious and can sometimes cause death. XPOVIO can cause infections including upper or lower respiratory tract infections, such as pneumonia, and an infection throughout your body (sepsis). <span class="Bold">Tell your healthcare provider right away if you have any signs or symptoms of an infection such as cough, chills or fever, during treatment with XPOVIO.</span> </li> <li> <span class="Bold">Neurologic side effects.</span> XPOVIO can cause neurologic side effects that can sometimes be severe and life- threatening.<ul class="Circle"> <li>XPOVIO can cause dizziness, fainting, decreased alertness, and changes in your mental status including confusion and decreased awareness of things around you (delirium). </li> <li>In some people, XPOVIO may also cause problems with thinking (cognitive problems), seeing or hearing things that are not really there (hallucinations), and may become very sleepy or drowsy. </li> <li>Taking other medicines that can cause dizziness or mental status changes during treatment with XPOVIO may increase your risk of neurologic side effects. </li> </ul> <p class="First"> <span class="Bold">Tell your healthcare provider right away if you get any of these signs or symptoms.</span> </p> </li> <li> <span class="Bold">New or worsening cataract, a cloudy or loss of transparency of the lens in the eye</span>. New or worsening cataract are common with XPOVIO. If a cataract forms, your vision may decrease, and you may need eye surgery to remove the cataract and restore your vision. <span class="Bold">Tell your healthcare provider right away if you have symptoms of a cataract such as double vision, blurred vision, sensitivity to light or glare.</span> </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top">Your healthcare provider may change your dose of XPOVIO, stop your treatment for a period of time, or completely stop your treatment if you have certain side effects during treatment with XPOVIO. </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2" valign="top">Common side effects of XPOVIO include:<br/> <ul class="Disc"> <li>tiredness </li> <li>low red blood cell count (anemia). Symptoms may include tiredness and shortness of breath. </li> <li>constipation </li> <li>shortness of breath </li> <li>increased blood sugar </li> <li>changes in body salt and mineral levels in your blood </li> <li>changes in kidney and liver function blood tests </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top">XPOVIO may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.<br/>These are not all the possible side effects of XPOVIO.<br/>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. </td> </tr> <tr> <td align="left" class="Lrule Rrule" colspan="2" valign="top"><span class="Bold">How should I store XPOVIO?</span> <br/> <ul class="Disc"> <li>Store XPOVIO at or below 86°F (30°C). </li> <li>XPOVIO comes in a child-resistant blister pack. </li> </ul> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">Keep XPOVIO and all medicines out of the reach of children.</span></td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">General information about the safe and effective use of XPOVIO.</span> <br/>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use XPOVIO for a condition for which it was not prescribed. Do not give XPOVIO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about XPOVIO that is written for health professionals. </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Bold">What are the ingredients in XPOVIO?</span> <br/> <span class="Bold">Active ingredient</span>: selinexor<br/> <span class="Bold">Inactive ingredients</span>: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.<br/>Manufactured for and marketed by: Karyopharm Therapeutics Inc., 85 Wells Avenue, Newton, MA, 02459<br/>XPOVIO is a registered trademark of Karyopharm Therapeutics Inc. All other trademarks are the property of their respective owners.<br/>©2022 Karyopharm Therapeutics Inc.<br/>For more information, call 1-888-209-9326 or go to www.XPOVIO.com </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" width=\"89.400%\"/>\n<col align=\"left\" width=\"10.600%\"/>\n<tfoot>\n<tr class=\"First Last\">\n<td align=\"left\" valign=\"top\">\n<p class=\"First Footnote\">This Medication Guide has been approved by the U.S. Food and Drug Administration. \n</p>\n</td><td align=\"right\" valign=\"top\">\n<p class=\"First Footnote\">\n<span class=\"Bold\">Revised: 3/2022</span>\n</p>\n</td>\n</tr>\n</tfoot>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">MEDICATION GUIDE</span>\n<br/>XPOVIO<span class=\"Sup\">®</span> (x-PO-Vee-O)<br/>(selinexor) tablets\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"p02\"></a><span class=\"Bold\">What is the most important information I should know about XPOVIO?</span>\n<br/>\n<span class=\"Bold\">XPOVIO can cause serious side effects, including:</span>\n<br/>\n</p>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">Low platelet counts</span>. Low platelet counts are common with XPOVIO and can lead to bleeding which can be severe and can sometimes cause death. Your healthcare provider may prescribe platelet transfusions or other treatments for your low platelet counts. <br/>\n<span class=\"Bold\">Tell your healthcare provider right away if you have any bleeding or easy bruising during treatment with XPOVIO.</span>\n</li>\n<li>\n<span class=\"Bold\">Low white blood cell counts.</span> Low white blood cell counts are common with XPOVIO and can sometimes be severe. You may have an increased risk of getting bacterial infections during treatment with XPOVIO. Your healthcare provider may prescribe antibiotics if you have signs or symptoms of infection, or certain medicines to help increase your white blood cell count, if needed.\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">Your healthcare provider will do blood tests before you start taking XPOVIO and often during the first 3 months of treatment and then as needed during treatment to monitor you for side effects.<br/>Your healthcare provider may change your dose of XPOVIO, stop your treatment for a period of time, or completely stop your treatment if you have certain side effects during treatment with XPOVIO.<br/>\n<span class=\"Bold\">See “<a href=\"#p01\">What are the possible side effects of XPOVIO?</a>” for more information about side effects.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">What is XPOVIO?</span>\n<br/>XPOVIO is a prescription medicine used:<br/>\n<ul class=\"Disc\">\n<li>in combination with the medicines VELCADE<span class=\"Sup\">®</span> (bortezomib) and dexamethasone to treat adults with multiple myeloma (MM) who have received at least one prior treatment for their disease.\n</li>\n<li>in combination with dexamethasone to treat adults with multiple myeloma (MM) that has come back (relapsed) or that did not respond to previous treatment (refractory), and<ul class=\"Circle\">\n<li>who have received at least 4 prior therapies, <span class=\"Bold\">and</span>\n</li>\n<li>whose disease did not respond to (refractory) to at least 2 proteasome inhibitor medicines, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody medicine.\n</li>\n</ul>\n</li>\n<li>to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory) and who have received at least 2 prior therapies<br/>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">It is not known if XPOVIO is safe and effective in children less than 18 years of age.\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">What should I tell my healthcare provider before taking XPOVIO?</span>\n<br/>\n<span class=\"Bold\">Before taking XPOVIO, tell your healthcare provider about all of your medical conditions, including if you:</span>\n<br/>\n<ul class=\"Disc\">\n<li>have or have had a recent or active infection\n</li>\n<li>have or have had bleeding problems\n</li>\n<li>are pregnant or plan to become pregnant. XPOVIO can harm your unborn baby. <br/>\n<span class=\"Bold\">Females who are able to become pregnant:</span>\n<ul class=\"Circle\">\n<li>Your healthcare provider will check to see if you are pregnant before you start taking XPOVIO.\n</li>\n<li>You should use effective birth control (contraception) during treatment with XPOVIO and for 1 week after your last dose.\n</li>\n<li>Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with XPOVIO.\n</li>\n</ul>\n<p class=\"First\">\n<span class=\"Bold\">Males with female partners who are able to become pregnant:</span>\n</p>\n<ul class=\"Circle\">\n<li>You should use effective birth control during treatment with XPOVIO and for 1 week after your last dose.\n</li>\n</ul>\n</li>\n<li>are breastfeeding or plan to breastfeed. It is not known if XPOVIO passes into your breast milk.<ul class=\"Circle\">\n<li>Do not breastfeed during treatment with XPOVIO and for 1 week after your last dose of XPOVIO.\n</li>\n</ul>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Tell your healthcare provider about all the medicines you take</span>, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Talk with your healthcare provider before taking any new medicines.\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"p03\"></a><span class=\"Bold\">How should I take XPOVIO?</span>\n<br/>\n</p>\n<ul class=\"Disc\">\n<li>Take XPOVIO exactly as prescribed by your healthcare provider.\n</li>\n<li>If you have multiple myeloma, your healthcare provider will prescribe dexamethasone with your XPOVIO treatment. Take dexamethasone exactly as prescribed.\n</li>\n<li>Your healthcare provider will tell you how much XPOVIO to take and when to take it. Do not change your dose or stop taking XPOVIO without talking to your healthcare provider first.\n</li>\n<li>Swallow XPOVIO tablets whole with water. <span class=\"Bold\">Do not break, chew, crush, or divide the tablets.</span>\n</li>\n<li>Be sure to take any medicines prescribed by your healthcare provider before and during treatment with XPOVIO to help prevent nausea and vomiting. Tell your healthcare provider if the prescribed medicine does not control your nausea and vomiting.\n</li>\n<li>It is important for you to drink enough fluids to help prevent dehydration and to eat enough calories to help prevent weight loss during treatment with XPOVIO. Talk to your healthcare provider if this is a problem for you. <span class=\"Bold\">See “<a href=\"#p01\">What are the possible side effects of XPOVIO?</a>”</span>\n</li>\n<li>If you miss a dose of XPOVIO, take your next dose at your next regularly scheduled day and time.\n</li>\n<li>If you vomit after taking a dose of XPOVIO, do not take an extra dose. Take your next dose at your next regularly scheduled day and time.\n</li>\n<li>If you take too much XPOVIO, call your healthcare provider right away.\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">What should I avoid while taking XPOVIO?</span>\n<br/>\n<span class=\"Bold\">XPOVIO can cause neurologic side effects.</span>\n<br/>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">See “<a href=\"#p01\">What are the possible side effects of XPOVIO?</a>” below.</span>\n</li>\n<li>If you have any neurologic side effects with XPOVIO, <span class=\"Bold\">do not drive or operate heavy or dangerous machinery until your neurologic side effects go away.</span>\n</li>\n<li>\n<span class=\"Bold\">Avoid falling.</span> Use care as needed to avoid falling due to neurologic side effects.\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">\n<a name=\"p01\"></a><span class=\"Bold\">What are the possible side effects of XPOVIO?</span>\n<br/>\n<span class=\"Bold\">XPOVIO can cause serious side effects, including:</span>\n<br/>\n</p>\n<ul class=\"Disc\">\n<li>\n<span class=\"Bold\">See “<a href=\"#p02\">What is the most important information I should know about XPOVIO?</a>”</span>\n</li>\n<li>\n<span class=\"Bold\">Nausea and vomiting</span>. Nausea and vomiting are common with XPOVIO and can sometimes be severe. Nausea and vomiting may affect your ability to eat and drink well. You can lose too much body fluid and body salts (electrolytes) and may be at risk for becoming dehydrated. You may need to receive intravenous (IV) fluids or other treatments to help prevent dehydration. Your healthcare provider will prescribe anti-nausea medicines for you to take before you start and during treatment with XPOVIO. <span class=\"Bold\">See “<a href=\"#p03\">How should I take XPOVIO?</a>”</span>\n</li>\n<li>\n<span class=\"Bold\">Diarrhea.</span> Diarrhea is common with XPOVIO and can sometimes be severe. You can lose too much body fluid and body salts (electrolytes) and may be at risk for becoming dehydrated. You may need to receive IV fluids or other treatments to help prevent dehydration. Your healthcare provider will prescribe anti-diarrhea medicine for you as needed.\n</li>\n<li>\n<span class=\"Bold\">Loss of appetite and weight loss</span>. Loss of appetite and weight loss are common with XPOVIO and can sometimes be severe. Tell your healthcare provider if you have a decrease or loss of appetite and if you notice that you are losing weight at any time during treatment. Your healthcare provider may prescribe medicines that can help increase your appetite or prescribe other kinds of nutritional support. Your healthcare provider will monitor your appetite and weight before you start XPOVIO and often during the first 3 months, then as needed during treatment.\n</li>\n<li>\n<span class=\"Bold\">Decreased sodium levels in your blood</span>. Decreased sodium levels in your blood is common with XPOVIO but can also sometimes be severe. Low sodium levels in your blood can happen if you have nausea, vomiting, or diarrhea, you become dehydrated, or if you have loss of appetite with XPOVIO. You may not have any symptoms of a low sodium level. Your healthcare provider may talk with you about your diet and prescribe IV fluids for you based on the sodium levels in your blood. Your healthcare provider will do blood tests before you start taking XPOVIO, and often during the first 2 months of treatment, and then as needed during treatment to monitor the sodium levels in your blood.\n</li>\n<li>\n<span class=\"Bold\">Serious infections.</span> Infections are common with XPOVIO and can be serious and can sometimes cause death. XPOVIO can cause infections including upper or lower respiratory tract infections, such as pneumonia, and an infection throughout your body (sepsis). <span class=\"Bold\">Tell your healthcare provider right away if you have any signs or symptoms of an infection such as cough, chills or fever, during treatment with XPOVIO.</span>\n</li>\n<li>\n<span class=\"Bold\">Neurologic side effects.</span> XPOVIO can cause neurologic side effects that can sometimes be severe and life- threatening.<ul class=\"Circle\">\n<li>XPOVIO can cause dizziness, fainting, decreased alertness, and changes in your mental status including confusion and decreased awareness of things around you (delirium).\n</li>\n<li>In some people, XPOVIO may also cause problems with thinking (cognitive problems), seeing or hearing things that are not really there (hallucinations), and may become very sleepy or drowsy.\n</li>\n<li>Taking other medicines that can cause dizziness or mental status changes during treatment with XPOVIO may increase your risk of neurologic side effects.\n</li>\n</ul>\n<p class=\"First\">\n<span class=\"Bold\">Tell your healthcare provider right away if you get any of these signs or symptoms.</span>\n</p>\n</li>\n<li>\n<span class=\"Bold\">New or worsening cataract, a cloudy or loss of transparency of the lens in the eye</span>. New or worsening cataract are common with XPOVIO. If a cataract forms, your vision may decrease, and you may need eye surgery to remove the cataract and restore your vision. <span class=\"Bold\">Tell your healthcare provider right away if you have symptoms of a cataract such as double vision, blurred vision, sensitivity to light or glare.</span>\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">Your healthcare provider may change your dose of XPOVIO, stop your treatment for a period of time, or completely stop your treatment if you have certain side effects during treatment with XPOVIO.\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\">Common side effects of XPOVIO include:<br/>\n<ul class=\"Disc\">\n<li>tiredness\n</li>\n<li>low red blood cell count (anemia). Symptoms may include tiredness and shortness of breath.\n</li>\n<li>constipation\n</li>\n<li>shortness of breath\n</li>\n<li>increased blood sugar\n</li>\n<li>changes in body salt and mineral levels in your blood\n</li>\n<li>changes in kidney and liver function blood tests\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\">XPOVIO may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.<br/>These are not all the possible side effects of XPOVIO.<br/>Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">How should I store XPOVIO?</span>\n<br/>\n<ul class=\"Disc\">\n<li>Store XPOVIO at or below 86°F (30°C).\n</li>\n<li>XPOVIO comes in a child-resistant blister pack.\n</li>\n</ul>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">Keep XPOVIO and all medicines out of the reach of children.</span></td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">General information about the safe and effective use of XPOVIO.</span>\n<br/>Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use XPOVIO for a condition for which it was not prescribed. Do not give XPOVIO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about XPOVIO that is written for health professionals.\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Bold\">What are the ingredients in XPOVIO?</span>\n<br/>\n<span class=\"Bold\">Active ingredient</span>: selinexor<br/>\n<span class=\"Bold\">Inactive ingredients</span>: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.<br/>Manufactured for and marketed by: Karyopharm Therapeutics Inc., 85 Wells Avenue, Newton, MA, 02459<br/>XPOVIO is a registered trademark of Karyopharm Therapeutics Inc. All other trademarks are the property of their respective owners.<br/>©2022 Karyopharm Therapeutics Inc.<br/>For more information, call 1-888-209-9326 or go to www.XPOVIO.com\n</td>\n</tr>\n</tbody>\n</table></div>" }

NDC 72237-106-01

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Rx ONLY

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40 mgOnceWeeklyBlister Packs

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XPOVIO®

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(selinexor) tablets

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16 film-coated tablets

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Dispense enclosed Medication Guideto each patient.

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Karyopharm® Therapeutics

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NDC 72237-106-11

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Rx ONLY

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1 PRESS& HOLDHERE

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40 mgOnceWeeklyBlister Pack

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1. PRESS 2. PULL

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XPOVIO®

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(selinexor) tablets

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Step 2: Pull outmedication card.

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Blister pack contains4 tablets (10 mg per tablet).

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Refer to PrescribingInformation for dosinginstructions.

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Do not break, chew, crush,or divide the tablets.

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Dispense enclosed MedicationGuide to each patient.

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Karyopharm® Therapeutics

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XPOVIO®(selinexor) tablets

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40 mg Dose (entire pack)

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IMPORTANT: Take each dose as prescribedby your physician. Take onlyone 40 mg dose in a singleday per week. Refer toPrescribing Information fordosing instructions.

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Push tablets through foil.

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Swallow whole with water.

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NDC 72237-101-01

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Rx ONLY

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60 mgOnceWeeklyBlister Packs

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XPOVIO®

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(selinexor) tablets

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Contents: 4 individual weeklyblister packs. Each blister packcontains 3 tablets (20 mg per tablet).

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12 film-coated tablets

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Dispense enclosed Medication Guideto each patient.

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Karyopharm® Therapeutics

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NDC 72237-101-11

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Rx ONLY

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1 PRESS& HOLDHERE

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60 mgOnceWeeklyBlister Pack

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1. PRESS 2. PULL

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XPOVIO®

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(selinexor) tablets

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Blister pack contains3 tablets (20 mg per tablet).

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Refer to PrescribingInformation for dosinginstructions.

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Do not break, chew, crush,or divide the tablets.

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Dispense enclosed MedicationGuide to each patient.

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Karyopharm® Therapeutics

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XPOVIO®(selinexor) tablets

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60 mgDose (entire pack)

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Push tablets through foil.

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Swallow whole with water.

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IMPORTANT: Take each dose as prescribed by your physician.

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Take only one 60 mg dose in a single day per week.

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Refer to Prescribing Information for dosing instructions.

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NDC 72237-101-02

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Rx ONLY

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80 mgOnceWeeklyBlister Packs

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XPOVIO®

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(selinexor) tablets

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Contents: 4 individual weeklyblister packs. Each blister packcontains 4 tablets (20 mg per tablet).

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16 film-coated tablets

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Dispense enclosed Medication Guideto each patient.

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Karyopharm® Therapeutics

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NDC 72237-101-12

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Rx ONLY

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1 PRESS& HOLDHERE

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80 mgOnceWeeklyBlister Pack

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1. PRESS 2. PULL

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XPOVIO®

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(selinexor) tablets

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TO OPEN

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Step 1: Press andhold button gently.

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Blister pack contains4 tablets (20 mg per tablet).

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Refer to PrescribingInformation for dosinginstructions.

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Do not break, chew, crush,or divide the tablets.

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Dispense enclosed MedicationGuide to each patient.

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Karyopharm® Therapeutics

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XPOVIO®(selinexor) tablets

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80 mgDose (entire pack)

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Push tabletsthrough foil.

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Swallowwhole withwater.

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IMPORTANT: Take each dose as prescribed by your physician.

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Take only one 80 mg dose in a single day per week.

{ "type": "p", "children": [], "text": "\nTake only one 80 mg dose in a single day per week.\n" }

Refer to Prescribing Information for dosing instructions.

{ "type": "p", "children": [], "text": "Refer to Prescribing Information for dosing instructions.\n" }

NDC 72237-101-03

{ "type": "p", "children": [], "text": "\nNDC 72237-101-03\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

60 mgTwiceWeeklyBlister Packs

{ "type": "p", "children": [], "text": "\n60 mgTwiceWeeklyBlister Packs\n" }

(120 mg total weekly dose)

{ "type": "p", "children": [], "text": "\n(120 mg total weekly dose)\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

Contents: 4 individual weeklyblister packs. Each blister packcontains 6 tablets (20 mg per tablet).

{ "type": "p", "children": [], "text": "Contents: 4 individual weeklyblister packs. Each blister packcontains 6 tablets (20 mg per tablet).\n" }

24 film-coated tablets

{ "type": "p", "children": [], "text": "24 film-coated tablets\n" }

Dispense enclosed Medication Guideto each patient.

{ "type": "p", "children": [], "text": "Dispense enclosed Medication Guideto each patient.\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\n\nTherapeutics\n" }

NDC 72237-101-13

{ "type": "p", "children": [], "text": "\nNDC 72237-101-13\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

1 PRESS& HOLDHERE

{ "type": "p", "children": [], "text": "\n1 PRESS& HOLDHERE\n" }

60 mgTwiceWeeklyBlister Pack

{ "type": "p", "children": [], "text": "\n60 mgTwiceWeeklyBlister Pack\n" }

(120 mg total weekly dose)

{ "type": "p", "children": [], "text": "\n(120 mg total weekly dose)\n" }

1. PRESS 2. PULL

{ "type": "p", "children": [], "text": "\n1. PRESS 2. PULL\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

TO OPEN

{ "type": "p", "children": [], "text": "\nTO OPEN\n" }

Step 1: Press andhold button gently.

{ "type": "p", "children": [], "text": "\nStep 1: Press andhold button gently.\n" }

Step 2: Pull outmedication card.

{ "type": "p", "children": [], "text": "\nStep 2: Pull outmedication card.\n" }

Blister pack contains6 tablets (20 mg per tablet).

{ "type": "p", "children": [], "text": "Blister pack contains6 tablets (20 mg per tablet).\n" }

Refer to PrescribingInformation for dosinginstructions.

{ "type": "p", "children": [], "text": "Refer to PrescribingInformation for dosinginstructions.\n" }

Do not break, chew, crush,

{ "type": "p", "children": [], "text": "Do not break, chew, crush,\n" }

or divide the tablets.

{ "type": "p", "children": [], "text": "or divide the tablets.\n" }

Dispense enclosed MedicationGuide to each patient.

{ "type": "p", "children": [], "text": "Dispense enclosed MedicationGuide to each patient.\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\n\nTherapeutics\n" }

XPOVIO®(selinexor) tablets

{ "type": "p", "children": [], "text": "\nXPOVIO®(selinexor) tablets\n" }

60 mgDose (entire pack)

{ "type": "p", "children": [], "text": "\n60 mgDose\n(entire pack)\n" }

Push tabletsthrough foil.

{ "type": "p", "children": [], "text": "Push tabletsthrough foil.\n" }

Swallowwhole withwater.

{ "type": "p", "children": [], "text": "Swallowwhole withwater.\n" }

IMPORTANT: Take each dose as prescribed by your physician.

{ "type": "p", "children": [], "text": "IMPORTANT: Take each dose as prescribed by your physician.\n" }

Take only one 60 mg dose in a single day. Take one 60 mg dose on Day 1 and one 60 mg dose on Day 3 of the week.

{ "type": "p", "children": [], "text": "\nTake only one 60 mg dose in a single day. Take one 60 mg dose on Day 1 and one 60 mg dose on Day 3 of the week.\n" }

Refer to Prescribing Information for dosing instructions.

{ "type": "p", "children": [], "text": "Refer to Prescribing Information for dosing instructions.\n" }

NDC 72237-101-04

{ "type": "p", "children": [], "text": "\nNDC 72237-101-04\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

80 mgTwiceWeeklyBlister Packs

{ "type": "p", "children": [], "text": "\n80 mgTwiceWeeklyBlister Packs\n" }

(160 mg total weekly dose)

{ "type": "p", "children": [], "text": "\n(160 mg total weekly dose)\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

Contents: 4 individual weeklyblister packs. Each blister packcontains 8 tablets (20 mg per tablet).

{ "type": "p", "children": [], "text": "Contents: 4 individual weeklyblister packs. Each blister packcontains 8 tablets (20 mg per tablet).\n" }

32 film-coated tablets

{ "type": "p", "children": [], "text": "32 film-coated tablets\n" }

Dispense enclosed Medication Guideto each patient.

{ "type": "p", "children": [], "text": "Dispense enclosed Medication Guideto each patient.\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\n\nTherapeutics\n" }

NDC 72237-101-14

{ "type": "p", "children": [], "text": "\nNDC 72237-101-14\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

1 PRESS& HOLDHERE

{ "type": "p", "children": [], "text": "\n1 PRESS& HOLDHERE\n" }

80 mgTwiceWeeklyBlister Pack

{ "type": "p", "children": [], "text": "\n80 mgTwiceWeeklyBlister Pack\n" }

(160 mg total weekly dose)

{ "type": "p", "children": [], "text": "\n(160 mg total weekly dose)\n" }

1.PRESS 2. PULL

{ "type": "p", "children": [], "text": "\n1.PRESS 2. PULL\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

TO OPEN

{ "type": "p", "children": [], "text": "\nTO OPEN\n" }

Step 1: Press andhold button gently.

{ "type": "p", "children": [], "text": "\nStep 1: Press andhold button gently.\n" }

Step 2: Pull outmedication card.

{ "type": "p", "children": [], "text": "\nStep 2: Pull outmedication card.\n" }

Blister pack contains8 tablets (20 mg per tablet).

{ "type": "p", "children": [], "text": "Blister pack contains8 tablets (20 mg per tablet).\n" }

Refer to PrescribingInformation for dosinginstructions.

{ "type": "p", "children": [], "text": "Refer to PrescribingInformation for dosinginstructions.\n" }

Do not break, chew, crush,or divide the tablets.

{ "type": "p", "children": [], "text": "Do not break, chew, crush,or divide the tablets.\n" }

Dispense enclosed MedicationGuide to each patient.

{ "type": "p", "children": [], "text": "Dispense enclosed MedicationGuide to each patient.\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\n\nTherapeutics\n" }

XPOVIO®(selinexor) tablets

{ "type": "p", "children": [], "text": "\nXPOVIO®(selinexor) tablets\n" }

80 mgDose (entire pack)

{ "type": "p", "children": [], "text": "\n80 mgDose\n(entire pack)\n" }

Push tabletsthrough foil.

{ "type": "p", "children": [], "text": "Push tabletsthrough foil.\n" }

Swallowwhole withwater.

{ "type": "p", "children": [], "text": "Swallowwhole withwater.\n" }

IMPORTANT: Take each dose as prescribed by your physician.

{ "type": "p", "children": [], "text": "IMPORTANT: Take each dose as prescribed by your physician.\n" }

Take only one 80 mg dose in a single day. Take one 80 mg dose on Day 1 and one 80 mg dose on Day 3 of the week.

{ "type": "p", "children": [], "text": "\nTake only one 80 mg dose in a single day. Take one 80 mg dose on Day 1 and one 80 mg dose on Day 3 of the week.\n" }

Refer to Prescribing Information for dosing instructions.

{ "type": "p", "children": [], "text": "Refer to Prescribing Information for dosing instructions.\n" }

NDC 72237-101-05

{ "type": "p", "children": [], "text": "\nNDC 72237-101-05\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

100 mgOnceWeeklyBlister Packs

{ "type": "p", "children": [], "text": "\n100 mgOnceWeeklyBlister Packs\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

Contents: 4 individual weeklyblister packs. Each blister packcontains 5 tablets (20 mg per tablet).

{ "type": "p", "children": [], "text": "Contents: 4 individual weeklyblister packs. Each blister packcontains 5 tablets (20 mg per tablet).\n" }

20 film-coated tablets

{ "type": "p", "children": [], "text": "20 film-coated tablets\n" }

Dispense enclosed Medication Guideto each patient.

{ "type": "p", "children": [], "text": "Dispense enclosed Medication Guideto each patient.\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\n\nTherapeutics\n" }

NDC 72237-101-15

{ "type": "p", "children": [], "text": "\nNDC 72237-101-15\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

1 PRESS& HOLDHERE

{ "type": "p", "children": [], "text": "\n1 PRESS& HOLDHERE\n" }

100 mgOnceWeeklyBlister Pack

{ "type": "p", "children": [], "text": "\n100 mgOnceWeeklyBlister Pack\n" }

1.PRESS 2. PULL

{ "type": "p", "children": [], "text": "\n1.PRESS 2. PULL\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

TO OPEN

{ "type": "p", "children": [], "text": "\nTO OPEN\n" }

Step 1: Press andhold button gently.

{ "type": "p", "children": [], "text": "\nStep 1: Press andhold button gently.\n" }

Step 2: Pull outmedication card.

{ "type": "p", "children": [], "text": "\nStep 2: Pull outmedication card.\n" }

Blister pack contains5 tablets (20 mg per tablet).

{ "type": "p", "children": [], "text": "Blister pack contains5 tablets (20 mg per tablet).\n" }

Refer to PrescribingInformation for dosinginstructions.

{ "type": "p", "children": [], "text": "Refer to PrescribingInformation for dosinginstructions.\n" }

Do not break, chew, crush,

{ "type": "p", "children": [], "text": "Do not break, chew, crush,\n" }

or divide the tablets.

{ "type": "p", "children": [], "text": "or divide the tablets.\n" }

Dispense enclosed MedicationGuide to each patient.

{ "type": "p", "children": [], "text": "Dispense enclosed MedicationGuide to each patient.\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\n\nTherapeutics\n" }

XPOVIO®(selinexor) tablets

{ "type": "p", "children": [], "text": "\nXPOVIO®(selinexor) tablets\n" }

100 mgDose (entire pack)

{ "type": "p", "children": [], "text": "\n100 mgDose\n(entire pack)\n" }

Push tabletsthrough foil.

{ "type": "p", "children": [], "text": "Push tabletsthrough foil.\n" }

Swallowwhole withwater.

{ "type": "p", "children": [], "text": "Swallowwhole withwater.\n" }

IMPORTANT: Take each dose as prescribed by your physician.

{ "type": "p", "children": [], "text": "IMPORTANT: Take each dose as prescribed by your physician.\n" }

Take only one 100 mg dose in a single day per week.

{ "type": "p", "children": [], "text": "\nTake only one 100 mg dose in a single day per week.\n" }

Refer to Prescribing Information for dosing instructions.

{ "type": "p", "children": [], "text": "Refer to Prescribing Information for dosing instructions.\n" }

NDC 72237-101-06

{ "type": "p", "children": [], "text": "\nNDC 72237-101-06\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

40 mgTwiceWeeklyBlister Packs

{ "type": "p", "children": [], "text": "\n40 mgTwiceWeeklyBlister Packs\n" }

(80 mg total weekly dose)

{ "type": "p", "children": [], "text": "\n(80 mg total weekly dose)\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

Contents: 4 individual weeklyblister packs. Each blister packcontains 4 tablets (20 mg per tablet).

{ "type": "p", "children": [], "text": "Contents: 4 individual weeklyblister packs. Each blister packcontains 4 tablets (20 mg per tablet).\n" }

16 film-coated tablets

{ "type": "p", "children": [], "text": "16 film-coated tablets\n" }

Dispense enclosed Medication Guideto each patient.

{ "type": "p", "children": [], "text": "Dispense enclosed Medication Guideto each patient.\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\n\nTherapeutics\n" }

NDC 72237-101-16

{ "type": "p", "children": [], "text": "\nNDC 72237-101-16\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

1 PRESS& HOLDHERE

{ "type": "p", "children": [], "text": "\n1 PRESS& HOLDHERE\n" }

40 mgTwiceWeeklyBlister Pack

{ "type": "p", "children": [], "text": "\n40 mgTwiceWeeklyBlister Pack\n" }

(80 mg total weekly dose)

{ "type": "p", "children": [], "text": "\n(80 mg total weekly dose)\n" }

1. PRESS 2. PULL

{ "type": "p", "children": [], "text": "\n1. PRESS 2. PULL\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

TO OPEN

{ "type": "p", "children": [], "text": "\nTO OPEN\n" }

Step 1: Press andhold button gently.

{ "type": "p", "children": [], "text": "\nStep 1: Press andhold button gently.\n" }

Step 2: Pull outmedication card.

{ "type": "p", "children": [], "text": "\nStep 2: Pull outmedication card.\n" }

Blister pack contains4 tablets (20 mg per tablet).

{ "type": "p", "children": [], "text": "Blister pack contains4 tablets (20 mg per tablet).\n" }

Refer to PrescribingInformation for dosinginstructions.

{ "type": "p", "children": [], "text": "Refer to PrescribingInformation for dosinginstructions.\n" }

Do not break, chew, crush,or divide the tablets.

{ "type": "p", "children": [], "text": "Do not break, chew, crush,or divide the tablets.\n" }

Dispense enclosed MedicationGuide to each patient.

{ "type": "p", "children": [], "text": "Dispense enclosed MedicationGuide to each patient.\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\n\nTherapeutics\n" }

XPOVIO®(selinexor) tablets

{ "type": "p", "children": [], "text": "\nXPOVIO®(selinexor) tablets\n" }

40 mgDose

{ "type": "p", "children": [], "text": "\n40 mgDose\n" }

Push tabletsthrough foil.

{ "type": "p", "children": [], "text": "Push tabletsthrough foil.\n" }

Swallowwhole withwater.

{ "type": "p", "children": [], "text": "Swallowwhole withwater.\n" }

IMPORTANT: Take each dose as prescribed by your physician.

{ "type": "p", "children": [], "text": "IMPORTANT: Take each dose as prescribed by your physician.\n" }

Take only one 40 mg dose in a single day. Take one 40 mg dose on Day 1 and one 40 mg dose on Day 3 of the week.

{ "type": "p", "children": [], "text": "\nTake only one 40 mg dose in a single day. Take one 40 mg dose on Day 1 and one 40 mg dose on Day 3 of the week.\n" }

Refer to Prescribing Information for dosing instructions.

{ "type": "p", "children": [], "text": "Refer to Prescribing Information for dosing instructions.\n" }

NDC 72237-101-07

{ "type": "p", "children": [], "text": "\nNDC 72237-101-07\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

40 mgOnceWeeklyBlister Packs

{ "type": "p", "children": [], "text": "\n40 mgOnceWeeklyBlister Packs\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

Contents: 4 individual weeklyblister packs. Each blister packcontains 2 tablets (20 mg per tablet).

{ "type": "p", "children": [], "text": "Contents: 4 individual weeklyblister packs. Each blister packcontains 2 tablets (20 mg per tablet).\n" }

8 film-coated tablets

{ "type": "p", "children": [], "text": "8 film-coated tablets\n" }

Dispense enclosed Medication Guideto each patient.

{ "type": "p", "children": [], "text": "Dispense enclosed Medication Guideto each patient.\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\n\nTherapeutics\n" }

NDC 72237-101-17

{ "type": "p", "children": [], "text": "\nNDC 72237-101-17\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

1 PRESS& HOLDHERE

{ "type": "p", "children": [], "text": "\n1 PRESS& HOLDHERE\n" }

40 mgOnceWeeklyBlister Pack

{ "type": "p", "children": [], "text": "\n40 mgOnceWeeklyBlister Pack\n" }

1. PRESS 2. PULL

{ "type": "p", "children": [], "text": "\n1. PRESS 2. PULL\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

TO OPEN

{ "type": "p", "children": [], "text": "\nTO OPEN\n" }

Step 1: Press andhold button gently.

{ "type": "p", "children": [], "text": "\nStep 1: Press andhold button gently.\n" }

Step 2: Pull outmedication card.

{ "type": "p", "children": [], "text": "\nStep 2: Pull outmedication card.\n" }

Blister pack contains2 tablets (20 mg per tablet).

{ "type": "p", "children": [], "text": "Blister pack contains2 tablets (20 mg per tablet).\n" }

Refer to PrescribingInformation for dosinginstructions.

{ "type": "p", "children": [], "text": "Refer to PrescribingInformation for dosinginstructions.\n" }

Do not break, chew, crush,or divide the tablets.

{ "type": "p", "children": [], "text": "Do not break, chew, crush,or divide the tablets.\n" }

Dispense enclosed MedicationGuide to each patient.

{ "type": "p", "children": [], "text": "Dispense enclosed MedicationGuide to each patient.\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\n\nTherapeutics\n" }

XPOVIO®(selinexor) tablets

{ "type": "p", "children": [], "text": "\nXPOVIO®(selinexor) tablets\n" }

40 mgDose (entire pack)

{ "type": "p", "children": [], "text": "\n40 mgDose\n(entire pack)\n" }

Push tablets through foil.

{ "type": "p", "children": [], "text": "Push tablets through foil.\n" }

Swallow whole with water.

{ "type": "p", "children": [], "text": "Swallow whole with water.\n" }

IMPORTANT: Take each dose as prescribed by your physician.

{ "type": "p", "children": [], "text": "IMPORTANT: Take each dose as prescribed by your physician.\n" }

Take only one 40 mg dose in a single day per week.

{ "type": "p", "children": [], "text": "\nTake only one 40 mg dose in a single day per week.\n" }

Refer to Prescribing Information for dosing instructions.

{ "type": "p", "children": [], "text": "Refer to Prescribing Information for dosing instructions.\n" }

NDC 72237-102-07

{ "type": "p", "children": [], "text": "\nNDC 72237-102-07\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

40 mgOnceWeeklyBlister Packs

{ "type": "p", "children": [], "text": "40 mgOnceWeeklyBlister Packs\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

Contents: 4 individual weekly blister packs. Each blister pack contains 1 tablet (40 mg per tablet).

{ "type": "p", "children": [], "text": "Contents: 4 individual weekly blister packs. Each blister pack contains 1 tablet (40 mg per tablet).\n" }

4 film-coated tablets

{ "type": "p", "children": [], "text": "4 film-coated tablets\n" }

Dispense enclosed Medication Guide to each patient

{ "type": "p", "children": [], "text": "Dispense enclosed Medication Guide to each patient\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\nTherapeutics\n" }

NDC 72237-102-17

{ "type": "p", "children": [], "text": "\nNDC 72237-102-17\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

1 PRESS& HOLDHERE

{ "type": "p", "children": [], "text": "\n1 PRESS& HOLDHERE\n" }

40 mgOnceWeeklyBlister Pack

{ "type": "p", "children": [], "text": "\n40 mgOnceWeeklyBlister Pack\n" }

1. PRESS 2. PULL

{ "type": "p", "children": [], "text": "\n1. PRESS 2. PULL\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

TO OPEN

{ "type": "p", "children": [], "text": "\nTO OPEN\n" }

Step 1: Press andhold button gently.

{ "type": "p", "children": [], "text": "\nStep 1: Press andhold button gently.\n" }

Step 2: Pull outmedication card.

{ "type": "p", "children": [], "text": "\nStep 2: Pull outmedication card.\n" }

Blister pack contains1 tablet (40 mg per tablet).

{ "type": "p", "children": [], "text": "Blister pack contains1 tablet (40 mg per tablet).\n" }

Refer to PrescribingInformation for dosinginstructions.

{ "type": "p", "children": [], "text": "Refer to PrescribingInformation for dosinginstructions.\n" }

Do not break, chew, crush,or divide the tablets.

{ "type": "p", "children": [], "text": "Do not break, chew, crush,or divide the tablets.\n" }

Dispense enclosed MedicationGuide to each patient.

{ "type": "p", "children": [], "text": "Dispense enclosed MedicationGuide to each patient.\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\n\nTherapeutics\n" }

XPOVIO®(selinexor)tablets

{ "type": "p", "children": [], "text": "\nXPOVIO®(selinexor)tablets\n" }

40 mg Dose 40mg

{ "type": "p", "children": [], "text": "\n40 mg Dose\n40mg\n" }

IMPORTANT: Take each dose as prescribed by your physician.

{ "type": "p", "children": [], "text": "\nIMPORTANT: Take each dose as prescribed by your physician.\n" }

Take only one 40 mg dose in a single day per week.

{ "type": "p", "children": [], "text": "\nTake only one 40 mg dose in a single day per week.\n" }

Refer to Prescribing Information for dosing instructions.

{ "type": "p", "children": [], "text": "Refer to Prescribing Information for dosing instructions.\n" }

Push tablet through foil.

{ "type": "p", "children": [], "text": "Push tablet through foil.\n" }

Swallow whole with water.

{ "type": "p", "children": [], "text": "Swallow whole with water.\n" }

NDC 72237-102-06

{ "type": "p", "children": [], "text": "\nNDC 72237-102-06\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

40 mgTwiceWeeklyBlister Packs

{ "type": "p", "children": [], "text": "40 mgTwiceWeeklyBlister Packs\n" }

(80 mg totalweekly dose)

{ "type": "p", "children": [], "text": "(80 mg totalweekly dose)\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

Contents: 4 individual weekly blister packs. Each blister pack contains 2 tablets (40 mg per tablet).

{ "type": "p", "children": [], "text": "Contents: 4 individual weekly blister packs. Each blister pack contains 2 tablets (40 mg per tablet).\n" }

8 film-coated tablets

{ "type": "p", "children": [], "text": "8 film-coated tablets\n" }

Dispense enclosed Medication Guide to each patient

{ "type": "p", "children": [], "text": "Dispense enclosed Medication Guide to each patient\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\nTherapeutics\n" }

NDC 72237-102-16

{ "type": "p", "children": [], "text": "\nNDC 72237-102-16\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

1 PRESS& HOLDHERE

{ "type": "p", "children": [], "text": "\n1 PRESS& HOLDHERE\n" }

40 mgTwiceWeeklyBlister Pack

{ "type": "p", "children": [], "text": "\n40 mgTwiceWeeklyBlister Pack\n" }

(80 mg totalweekly dose)

{ "type": "p", "children": [], "text": "\n(80 mg totalweekly dose)\n" }

1. PRESS 2. PULL

{ "type": "p", "children": [], "text": "\n1. PRESS 2. PULL\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

TO OPEN

{ "type": "p", "children": [], "text": "\nTO OPEN\n" }

Step 1: Press andhold button gently.

{ "type": "p", "children": [], "text": "\nStep 1: Press andhold button gently.\n" }

Step 2: Pull outmedication card.

{ "type": "p", "children": [], "text": "\nStep 2: Pull outmedication card.\n" }

Blister pack contains2 tablets (40 mg per tablet).

{ "type": "p", "children": [], "text": "Blister pack contains2 tablets (40 mg per tablet).\n" }

Refer to PrescribingInformation for dosinginstructions.

{ "type": "p", "children": [], "text": "Refer to PrescribingInformation for dosinginstructions.\n" }

Do not break, chew, crush,or divide the tablets.

{ "type": "p", "children": [], "text": "Do not break, chew, crush,or divide the tablets.\n" }

Dispense enclosed MedicationGuide to each patient.

{ "type": "p", "children": [], "text": "Dispense enclosed MedicationGuide to each patient.\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\n\nTherapeutics\n" }

XPOVIO®(selinexor) tablets

{ "type": "p", "children": [], "text": "\nXPOVIO®(selinexor) tablets\n" }

40mg

{ "type": "p", "children": [], "text": "40mg\n" }

40 mgDose

{ "type": "p", "children": [], "text": "\n40 mgDose\n" }

IMPORTANT: Take each dose as prescribed by your physician.

{ "type": "p", "children": [], "text": "\nIMPORTANT: Take each dose as prescribed by your physician.\n" }

Take only one 40 mg dose in a single day.

{ "type": "p", "children": [], "text": "\nTake only one 40 mg dose in a single day.\n" }

Take one 40 mg dose on Day 1 and one 40 mg dose on Day 3 of the week.

{ "type": "p", "children": [], "text": "\nTake one 40 mg dose on Day 1 and one 40 mg dose on Day 3 of the week.\n" }

Refer to Prescribing Information for dosing instructions.

{ "type": "p", "children": [], "text": "Refer to Prescribing Information for dosing instructions.\n" }

Push tablet through foil.

{ "type": "p", "children": [], "text": "Push tablet through foil.\n" }

Swallow whole with water.

{ "type": "p", "children": [], "text": "Swallow whole with water.\n" }

NDC 72237-104-01

{ "type": "p", "children": [], "text": "\nNDC 72237-104-01\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

60 mgOnceWeeklyBlister Packs

{ "type": "p", "children": [], "text": "60 mgOnceWeeklyBlister Packs\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

Contents: 4 individual weekly blister packs. Each blister pack contains 1 tablet (60 mg per tablet).

{ "type": "p", "children": [], "text": "Contents: 4 individual weekly blister packs. Each blister pack contains 1 tablet (60 mg per tablet).\n" }

4 film-coated tablets

{ "type": "p", "children": [], "text": "4 film-coated tablets\n" }

Dispense enclosed Medication Guide to each patient

{ "type": "p", "children": [], "text": "Dispense enclosed Medication Guide to each patient\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\nTherapeutics\n" }

NDC 72237-104-11

{ "type": "p", "children": [], "text": "\nNDC 72237-104-11\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

1 PRESS& HOLDHERE

{ "type": "p", "children": [], "text": "\n1 PRESS& HOLDHERE\n" }

60 mgOnceWeeklyBlister Pack

{ "type": "p", "children": [], "text": "\n60 mgOnceWeeklyBlister Pack\n" }

1. PRESS 2. PULL

{ "type": "p", "children": [], "text": "\n1. PRESS 2. PULL\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

TO OPEN

{ "type": "p", "children": [], "text": "\nTO OPEN\n" }

Step 1: Press andhold button gently.

{ "type": "p", "children": [], "text": "\nStep 1: Press andhold button gently.\n" }

Step 2: Pull outmedication card.

{ "type": "p", "children": [], "text": "\nStep 2: Pull outmedication card.\n" }

Blister pack contains1 tablet (60 mg per tablet).

{ "type": "p", "children": [], "text": "Blister pack contains1 tablet (60 mg per tablet).\n" }

Refer to PrescribingInformation for dosinginstructions.

{ "type": "p", "children": [], "text": "Refer to PrescribingInformation for dosinginstructions.\n" }

Do not break, chew, crush,or divide the tablets.

{ "type": "p", "children": [], "text": "Do not break, chew, crush,or divide the tablets.\n" }

Dispense enclosed MedicationGuide to each patient.

{ "type": "p", "children": [], "text": "Dispense enclosed MedicationGuide to each patient.\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\n\nTherapeutics\n" }

XPOVIO®(selinexor) tablets

{ "type": "p", "children": [], "text": "\nXPOVIO®(selinexor) tablets\n" }

60 mg Dose 60mg

{ "type": "p", "children": [], "text": "\n60 mg Dose\n60mg\n" }

IMPORTANT: Take each dose as prescribed by your physician.

{ "type": "p", "children": [], "text": "\nIMPORTANT: Take each dose as prescribed by your physician.\n" }

Take only one 60 mg dose in a single day per week.

{ "type": "p", "children": [], "text": "\nTake only one 60 mg dose in a single day per week.\n" }

Refer to Prescribing Information for dosing instructions.

{ "type": "p", "children": [], "text": "Refer to Prescribing Information for dosing instructions.\n" }

Push tablet through foil.

{ "type": "p", "children": [], "text": "Push tablet through foil.\n" }

Swallow whole with water.

{ "type": "p", "children": [], "text": "Swallow whole with water.\n" }

NDC 72237-102-02

{ "type": "p", "children": [], "text": "\nNDC 72237-102-02\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

80 mgOnceWeeklyBlister Packs

{ "type": "p", "children": [], "text": "80 mgOnceWeeklyBlister Packs\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

Contents: 4 individual weekly blister packs. Each blister pack contains 2 tablets (40 mg per tablet).

{ "type": "p", "children": [], "text": "Contents: 4 individual weekly blister packs. Each blister pack contains 2 tablets (40 mg per tablet).\n" }

8 film-coated tablets

{ "type": "p", "children": [], "text": "8 film-coated tablets\n" }

Dispense enclosed Medication Guide to each patient

{ "type": "p", "children": [], "text": "Dispense enclosed Medication Guide to each patient\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\nTherapeutics\n" }

NDC 72237-102-12

{ "type": "p", "children": [], "text": "\nNDC 72237-102-12\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

1 PRESS& HOLDHERE

{ "type": "p", "children": [], "text": "\n1 PRESS& HOLDHERE\n" }

80 mgOnceWeeklyBlister Pack

{ "type": "p", "children": [], "text": "\n80 mgOnceWeeklyBlister Pack\n" }

1. PRESS 2. PULL

{ "type": "p", "children": [], "text": "\n1. PRESS 2. PULL\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

TO OPEN

{ "type": "p", "children": [], "text": "\nTO OPEN\n" }

Step 1: Press andhold button gently.

{ "type": "p", "children": [], "text": "\nStep 1: Press andhold button gently.\n" }

Step 2: Pull outmedication card.

{ "type": "p", "children": [], "text": "\nStep 2: Pull outmedication card.\n" }

Blister pack contains2 tablets (40 mg per tablet).

{ "type": "p", "children": [], "text": "Blister pack contains2 tablets (40 mg per tablet).\n" }

Refer to PrescribingInformation for dosinginstructions.

{ "type": "p", "children": [], "text": "Refer to PrescribingInformation for dosinginstructions.\n" }

Do not break, chew, crush,or divide the tablets.

{ "type": "p", "children": [], "text": "Do not break, chew, crush,or divide the tablets.\n" }

Dispense enclosed MedicationGuide to each patient.

{ "type": "p", "children": [], "text": "Dispense enclosed MedicationGuide to each patient.\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\n\nTherapeutics\n" }

XPOVIO®(selinexor) tablets

{ "type": "p", "children": [], "text": "\nXPOVIO®(selinexor) tablets\n" }

80 mg Dose(entire pack) 40mg

{ "type": "p", "children": [], "text": "\n80 mg Dose(entire pack)\n40mg\n" }

40mg

{ "type": "p", "children": [], "text": "40mg\n" }

IMPORTANT: Take each dose as prescribed by your physician.

{ "type": "p", "children": [], "text": "\nIMPORTANT: Take each dose as prescribed by your physician.\n" }

Take only one 80 mg dose in a single day per week.

{ "type": "p", "children": [], "text": "\nTake only one 80 mg dose in a single day per week.\n" }

Refer to Prescribing Information for dosing instructions.

{ "type": "p", "children": [], "text": "Refer to Prescribing Information for dosing instructions.\n" }

Push tablet through foil.

{ "type": "p", "children": [], "text": "Push tablet through foil.\n" }

Swallow whole with water.

{ "type": "p", "children": [], "text": "Swallow whole with water.\n" }

NDC 72237-103-05

{ "type": "p", "children": [], "text": "\nNDC 72237-103-05\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

100 mgOnceWeeklyBlister Packs

{ "type": "p", "children": [], "text": "100 mgOnceWeeklyBlister Packs\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

Contents: 4 individual weekly blister packs. Each blister pack contains 2 tablets (50 mg per tablet).

{ "type": "p", "children": [], "text": "Contents: 4 individual weekly blister packs. Each blister pack contains 2 tablets (50 mg per tablet).\n" }

8 film-coated tablets

{ "type": "p", "children": [], "text": "8 film-coated tablets\n" }

Dispense enclosed Medication Guide to each patient

{ "type": "p", "children": [], "text": "Dispense enclosed Medication Guide to each patient\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\nTherapeutics\n" }

NDC 72237-103-15

{ "type": "p", "children": [], "text": "\nNDC 72237-103-15\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "Rx ONLY\n" }

1 PRESS& HOLDHERE

{ "type": "p", "children": [], "text": "\n1 PRESS& HOLDHERE\n" }

100 mgOnceWeeklyBlister Pack

{ "type": "p", "children": [], "text": "\n100 mgOnceWeeklyBlister Pack\n" }

1. PRESS 2. PULL

{ "type": "p", "children": [], "text": "\n1. PRESS 2. PULL\n" }

XPOVIO®

{ "type": "p", "children": [], "text": "\nXPOVIO®\n" }

(selinexor) tablets

{ "type": "p", "children": [], "text": "(selinexor) tablets\n" }

TO OPEN

{ "type": "p", "children": [], "text": "\nTO OPEN\n" }

Step 1: Press andhold button gently.

{ "type": "p", "children": [], "text": "\nStep 1: Press andhold button gently.\n" }

Step 2: Pull outmedication card.

{ "type": "p", "children": [], "text": "\nStep 2: Pull outmedication card.\n" }

Blister pack contains2 tablets (50 mg per tablet).

{ "type": "p", "children": [], "text": "Blister pack contains2 tablets (50 mg per tablet).\n" }

Refer to PrescribingInformation for dosinginstructions.

{ "type": "p", "children": [], "text": "Refer to PrescribingInformation for dosinginstructions.\n" }

Do not break, chew, crush,or divide the tablets.

{ "type": "p", "children": [], "text": "Do not break, chew, crush,or divide the tablets.\n" }

Dispense enclosed MedicationGuide to each patient.

{ "type": "p", "children": [], "text": "Dispense enclosed MedicationGuide to each patient.\n" }

Karyopharm® Therapeutics

{ "type": "p", "children": [], "text": "\nKaryopharm®\n\nTherapeutics\n" }

XPOVIO®(selinexor) tablets

{ "type": "p", "children": [], "text": "\nXPOVIO®(selinexor) tablets\n" }

100 mg Dose(entire pack) 50mg

{ "type": "p", "children": [], "text": "\n100 mg Dose(entire pack)\n50mg\n" }

50mg

{ "type": "p", "children": [], "text": "50mg\n" }

IMPORTANT: Take each dose as prescribed by your physician.

{ "type": "p", "children": [], "text": "\nIMPORTANT: Take each dose as prescribed by your physician.\n" }

Take only one 100 mg dose in a single day per week.

{ "type": "p", "children": [], "text": "\nTake only one 100 mg dose in a single day per week.\n" }

Refer to Prescribing Information for dosing instructions.

{ "type": "p", "children": [], "text": "Refer to Prescribing Information for dosing instructions.\n" }

Push tablet through foil.

{ "type": "p", "children": [], "text": "Push tablet through foil.\n" }

Swallow whole with water.

{ "type": "p", "children": [], "text": "Swallow whole with water.\n" }