POMALYST, in combination with dexamethasone, is indicated for adult patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

POMALYST is indicated for the treatment of:

This indication is approved under accelerated approval based on overall 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).

Females of reproductive potential must have negative pregnancy testing and use contraception methods before initiating POMALYST [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1, 8.3)].

The recommended dosage of POMALYST is 4 mg once daily orally with or without food on Days 1 through 21 of each 28-day cycle until disease progression. Give POMALYST in combination with dexamethasone [see Clinical Studies (14.1)].

The recommended dosage of POMALYST is 5 mg once daily taken orally with or without food on Days 1 through 21 of each 28-day cycle until disease progression or unacceptable toxicity. Continue HAART as HIV treatment in patients with AIDS-related Kaposi sarcoma (KS) [see Clinical Studies (14.2)].

Multiple Myeloma: Dosage Modifications for Hematologic Adverse Reactions

Initiate a new cycle of POMALYST in patients with multiple myeloma (MM) when the neutrophil count is at least 500 per mcL and the platelet count is at least 50,000 per mcL.

Dosage modification for POMALYST for hematologic adverse reactions in patients with MM are summarized in Table 1.

<div class="scrollingtable"><table width="90%"> <caption> <span>Table 1: Dosage Modifications for POMALYST for Hematologic in MM</span> </caption> <col width="30%"/> <col width="30%"/> <col width="40%"/> <thead> <tr class="First Last"> <th align="left" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Adverse Reaction</span></th><th align="left" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Severity</span></th><th align="left" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Dosage Modification</span></th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" colspan="3" valign="top">* Permanently discontinue POMALYST if unable to tolerate 1 mg once daily.<br/>ANC= absolute neutrophil count</td> </tr> </tfoot> <tbody> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" rowspan="2" valign="top"> <p class="First">Neutropenia <span class="Italics">[see <a href="#S5.5">Warnings and Precautions (5.5)</a>]</span> </p> </td><td class="Botrule Rrule Toprule" valign="top"> <dl> <dt>•</dt> <dd>ANC less than 500 per mcL or febrile neutropenia (fever greater than or equal to 38.5°C and ANC less than 1,000 per mcL)</dd> </dl> </td><td class="Botrule Rrule Toprule" valign="top"> <dl> <dt>•</dt> <dd>Withhold POMALYST until ANC is greater than or equal to 500 per mcL; follow CBC weekly.</dd> <dt>•</dt> <dd>Resume POMALYST dose at 1 mg less than the previous dose.*</dd> </dl> </td> </tr> <tr> <td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>For each subsequent drop of ANC less than 500 per mcL</dd> </dl> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Withhold POMALYST until ANC is greater than or equal to 500 mcL.</dd> <dt>•</dt> <dd>Resume POMALYST dose at 1 mg less than the previous dose.*</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" rowspan="2" valign="top"> <p class="First">Thrombocytopenia <span class="Italics">[see <a href="#S5.5">Warnings and Precautions (5.5)</a>]</span> </p> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Platelets less than 25,000 per mcL</dd> </dl> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Withhold POMALYST until platelets are greater than or equal to 50,000 per mcL; follow CBC weekly.</dd> <dt>•</dt> <dd>Resume POMALYST dose at 1 mg less than the previous dose*</dd> </dl> </td> </tr> <tr class="Last"> <td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>For each subsequent drop of platelets less than 25,000 per mcL</dd> </dl> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Withhold POMALYST until platelets are greater than or equal to 50,000 per mcL.</dd> <dt>•</dt> <dd>Resume POMALYST at 1 mg less than the previous dose*</dd> </dl> </td> </tr> </tbody> </table></div>

Kaposi Sarcoma: Dosage Modifications for Hematologic Adverse Reactions

Initiate a new cycle of POMALYST in patients with KS when the neutrophil count is at least 1000 per mcL and the platelet count is at least 75,000 per mcL.

Dose modifications for POMALYST for hematologic adverse reactions in patients with KS are summarized in Table 2.

<div class="scrollingtable"><table width="90%"> <caption> <span>Table 2: Dosage Modifications for POMALYST for Hematologic Adverse Reactions in KS</span> </caption> <col width="30%"/> <col width="30%"/> <col width="40%"/> <thead> <tr class="First Last"> <th align="left" class="Botrule Lrule Rrule Toprule" valign="top"><span class="Bold">Adverse Reaction</span></th><th align="left" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Severity</span></th><th align="left" class="Botrule Rrule Toprule" valign="top"><span class="Bold">Dosage Modification</span></th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" colspan="3" valign="top">* Permanently discontinue POMALYST if unable to tolerate 1mg once daily.<br/>ANC= absolute neutrophil count</td> </tr> </tfoot> <tbody> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" rowspan="2" valign="top"> <p class="First">Neutropenia <span class="Italics">[see <a href="#S5.5">Warnings and Precautions (5.5)</a>]</span> </p> </td><td class="Botrule Rrule Toprule" valign="top"> <p class="First">ANC 500 to less than 1,000 per mcL</p> </td><td class="Botrule Rrule Toprule" valign="top"> <p class="First"> <span class="Underline">Day 1 of cycle</span> </p> <dl> <dt>•</dt> <dd>Withhold POMALYST until ANC is greater than or equal to 1,000 per mcL.</dd> <dt>•</dt> <dd>Resume POMALYST at the same dose.</dd> </dl> <p> <span class="Underline">During cycle</span> </p> <dl> <dt>•</dt> <dd>Continue POMALYST at the current dose.</dd> </dl> </td> </tr> <tr> <td class="Botrule Rrule" valign="top"> <p class="First">ANC less than 500 per mcL</p> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Withhold POMALYST until ANC is greater than or equal to 1,000 per mcL.</dd> <dt>•</dt> <dd>Resume POMALYST at the same dose.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Febrile Neutropenia <span class="Italics">[see <a href="#S5.5">Warnings and Precautions (5.5)</a>]</span> </p> </td><td class="Botrule Rrule" valign="top"> <p class="First">ANC less than 1,000 per mcL and single temperature greater than or equal to 38.3°C<br/> or<br/> ANC less than 1,000 per mcL and sustained temperature greater than or equal to 38°C for more than 1 hour</p> </td><td class="Botrule Rrule" valign="top"> <dl> <dt>•</dt> <dd>Withhold POMALYST until ANC is greater than or equal to 1,000 per mcL.</dd> <dt>•</dt> <dd>Resume POMALYST at dose 1 mg less than the previous dose.*</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" rowspan="2" valign="top"> <p class="First">Thrombocytopenia <span class="Italics">[see <a href="#S5.5">Warnings and Precautions (5.5)</a>]</span> </p> </td><td class="Botrule Rrule" valign="top"> <p class="First">Platelet count 25,000 to less than 50,000 per mcL</p> </td><td class="Botrule Rrule" valign="top"> <p class="First"> <span class="Underline">Day 1 of cycle</span> </p> <dl> <dt>•</dt> <dd>Withhold POMALYST until platelet count is greater than or equal to 50,000 per mcL.</dd> <dt>•</dt> <dd>Resume POMALYST at the same dose.</dd> </dl> <p> <span class="Underline">During cycle:</span> </p> <dl> <dt>•</dt> <dd>Continue POMALYST at the current dose.</dd> </dl> </td> </tr> <tr class="Last"> <td class="Botrule Rrule" valign="top"> <p class="First">Platelet count less than 25,000 per mcL</p> </td><td class="Botrule Rrule" valign="top"> <p class="First">Permanently discontinue POMALYST.</p> </td> </tr> </tbody> </table></div>

Permanently discontinue POMALYST for angioedema, anaphylaxis, Grade 4 rash, skin exfoliation, bullae, or any other severe dermatologic reaction [See Warnings and Precautions (5.7, 5.12)].

For other Grade 3 or 4 toxicities, hold treatment and restart treatment at 1 mg less than the previous dose when toxicity has resolved to less than or equal to Grade 2 at the physician's discretion.

Avoid concomitant use of POMALYST with strong CYP1A2 inhibitors. If concomitant use of a strong CYP1A2 inhibitor is unavoidable, reduce POMALYST dose to 2 mg [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

Take POMALYST after completion of dialysis procedure on hemodialysis days [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Multiple Myeloma

For patients with MM with mild or moderate hepatic impairment (Child-Pugh A or B), reduce the recommended dosage to 3 mg orally daily.

For patients with MM with severe hepatic impairment (Child-Pugh C), reduce the recommended dosage to 2 mg [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

Kaposi Sarcoma

For patients with KS with mild, moderate, or severe hepatic impairment (Child-Pugh A, B, or C), reduce the recommended dosage to 3 mg orally daily [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

Swallow capsules whole with water. Do not break, chew, or open the capsules.

POMALYST may be taken with or without food.

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POMALYST is contraindicated in females who are pregnant. POMALYST can cause fetal harm when administered to a pregnant female [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. Pomalidomide is a thalidomide analogue and is teratogenic in both rats and rabbits when administered during the period of organogenesis. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus.

POMALYST is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, anaphylaxis) to pomalidomide or any of the excipients [see Warnings and Precautions (5.7), Description (11)].

POMALYST is a thalidomide analogue and is contraindicated for use during pregnancy. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death [see Use in Specific Populations (8.1)]. POMALYST is only available through PS-Pomalidomide REMS [see Warnings and Precautions (5.2)].

Females of Reproductive Potential

Females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning POMALYST therapy, during therapy, during dose interruptions and for at least 4 weeks after completing therapy.

Females must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control, beginning 4 weeks prior to initiating treatment with POMALYST, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of POMALYST therapy.

Two negative pregnancy tests must be obtained prior to initiating therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing POMALYST therapy and then weekly during the first month, then monthly thereafter in females with regular menstrual cycles, or every 2 weeks in females with irregular menstrual cycles [see Use in Specific Populations (8.3)].

Males

Pomalidomide is present in the semen of patients receiving the drug. Therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking POMALYST and for up to 4 weeks after discontinuing POMALYST, even if they have undergone a successful vasectomy. Male patients taking POMALYST must not donate sperm [see Use in Specific Populations (8.3)].

Blood Donation

Patients must not donate blood during treatment with POMALYST and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to POMALYST.

Because of the embryo-fetal risk [see Warnings and Precautions (5.1)], POMALYST is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), "PS-Pomalidomide REMS".

Required components of PS-Pomalidomide REMS include the following:

Further information about PS-Pomalidomide REMS is available at www.PS-PomalidomideREMS.com or by telephone at 1-888-423-5436.

Venous thromboembolic events (deep venous thrombosis and pulmonary embolism) and arterial thromboembolic events (myocardial infarction and stroke) have been observed in patients treated with POMALYST. In Trial 2, where anticoagulant therapies were mandated, thromboembolic events occurred in 8.0% of patients treated with POMALYST and low dose-dexamethasone (Low-dose Dex), and 3.3% of patients treated with high-dose dexamethasone. Venous thromboembolic events (VTE) occurred in 4.7% of patients treated with POMALYST and Low-dose Dex, and 1.3% of patients treated with high-dose dexamethasone. Arterial thromboembolic events include terms for arterial thromboembolic events, ischemic cerebrovascular conditions, and ischemic heart disease. Arterial thromboembolic events occurred in 3.0% of patients treated with POMALYST and Low-dose Dex, and 1.3% of patients treated with high-dose dexamethasone.

Patients with known risk factors, including prior thrombosis, may be at greater risk, and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient's underlying risk factors.

In two randomized clinical trials in patients with MM, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone, a use for which no PD-1 or PD-L1 blocking antibody is indicated, resulted in increased mortality. Treatment of patients with MM with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Multiple Myeloma

In trials 1 and 2 in patients who received POMALYST + Low-dose Dex, neutropenia was the most frequently reported Grade 3 or 4 adverse reaction, followed by anemia and thrombocytopenia. Neutropenia of any grade was reported in 51% of patients in both trials. The rate of Grade 3 or 4 neutropenia was 46%. The rate of febrile neutropenia was 8%.

Monitor patients for hematologic toxicities, especially neutropenia. Monitor complete blood counts weekly for the first 8 weeks and monthly thereafter. Patients may require dose interruption and/or modification [see Dosage and Administration (2.4)].

Kaposi Sarcoma

In Trial 12-C-0047, hematologic toxicities were the most common (all grades and Grade 3 or 4) adverse reactions [see Adverse Reactions (6.1)]. Fifty percent of patients had Grade 3 or 4 neutropenia. Monitor patients for hematologic toxicities, especially decreased neutrophils. Monitor complete blood counts every 2 weeks for the first 12 weeks and monthly thereafter. Withhold, reduce the dose, or permanently discontinue POMALYST based on the severity of the reaction [see Dosage and Administration (2.4)].

Hepatic failure, including fatal cases, has occurred in patients treated with POMALYST. Elevated levels of alanine aminotransferase and bilirubin have also been observed in patients treated with POMALYST. Monitor liver function tests monthly. Stop POMALYST upon elevation of liver enzymes and evaluate. After return to baseline values, treatment at a lower dose may be considered.

Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. DRESS may present with a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. These reactions can be fatal. Consider POMALYST interruption or discontinuation for Grade 2 or 3 skin rash. Permanently discontinue POMALYST for Grade 4 rash, exfoliative or bullous rash, or for other severe cutaneous reactions such as SJS, TEN or DRESS [see Dosage and Administration (2.5)].

In trials 1 and 2 in patients who received POMALYST + Low-dose Dex, 14% of patients experienced dizziness and 7% of patients experienced a confusional state; 1% of patients experienced Grade 3 or 4 dizziness, and 3% of patients experienced Grade 3 or 4 confusional state. Instruct patients to avoid situations where dizziness or confusional state may be a problem and not to take other medications that may cause dizziness or confusional state without adequate medical advice.

In trials 1 and 2 in patients who received POMALYST + Low-dose Dex, 18% of patients experienced neuropathy, with approximately 12% of the patients experiencing peripheral neuropathy. Two percent of patients experienced Grade 3 neuropathy in trial 2. There were no cases of Grade 4 neuropathy adverse reactions reported in either trial.

Cases of acute myelogenous leukemia have been reported in patients receiving POMALYST as an investigational therapy outside of MM.

Tumor lysis syndrome (TLS) may occur in patients treated with POMALYST. Patients at risk for TLS are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken.

Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to POMALYST have been reported. Permanently discontinue POMALYST for angioedema or anaphylaxis [see Dosage and Administration (2.5)].

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 (MM)

In Trial 1, data were evaluated from 219 patients (safety population) who received treatment with POMALYST + Low-dose Dex (112 patients) or POMALYST alone (107 patients). Median number of treatment cycles was 5. Sixty-seven percent of patients in the study had a dose interruption of either drug due to adverse reactions. Forty-two percent of patients in the study had a dose reduction of either drug due to adverse reactions. The discontinuation rate due to adverse reactions was 11%.

In Trial 2, data were evaluated from 450 patients (safety population) who received treatment with POMALYST + Low-dose Dex (300 patients) or High-dose Dexamethasone (High-dose Dex) (150 patients). The median number of treatment cycles for the POMALYST + Low-dose Dex arm was 5. In the POMALYST + Low-dose Dex arm, 67% of patients had a dose interruption of POMALYST, the median time to the first dose interruption of POMALYST was 4.1 weeks. Twenty-seven percent of patients had a dose reduction of POMALYST, the median time to the first dose reduction of POMALYST was 4.5 weeks. Eight percent of patients discontinued POMALYST due to adverse reactions.

Tables 3 and 4 summarize the adverse reactions reported in Trials 1 and 2, respectively.

<div class="scrollingtable"><table width="90%"> <caption> <span>Table 3: Adverse Reactions in Any POMALYST Treatment Arm in Trial 1*</span> </caption> <col width="22%"/> <col width="19%"/> <col width="20%"/> <col width="19%"/> <col width="20%"/> <tfoot> <tr class="First Last"> <td align="left" colspan="5" valign="top">* Regardless of attribution of relatedness to POMALYST.<br/> <span class="Sup">a</span> POMALYST alone arm includes all patients randomized to the POMALYST alone arm who took study drug; 61 of the 107 patients had dexamethasone added during the treatment period.<br/> <span class="Sup">b</span> Serious adverse reactions were reported in at least 2 patients in any POMALYST treatment arm.<br/>Data cutoff: 01 March 2013</td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="bottom"> <p class="First"> <span class="Bold">All Adverse Reactions ≥10% in Either Arm</span> </p> </td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="bottom"> <p class="First"> <span class="Bold">Grade 3 or 4 ≥5% in Either Arm</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="bottom"> <p class="First"> <span class="Bold">Body System</span> <br/>Adverse Reaction</p> </td><td align="center" class="Botrule Rrule" valign="bottom"> <p class="First"> <span class="Bold">POMALYST</span><span class="Sup">a</span> <br/> <span class="Bold"> (N=107)</span> </p> </td><td align="center" class="Botrule Rrule" valign="bottom"> <p class="First"> <span class="Bold">POMALYST + Low-dose Dex</span> <br/> <span class="Bold">(N=112)</span> </p> </td><td align="center" class="Botrule Rrule" valign="bottom"> <p class="First"> <span class="Bold">POMALYST</span> <br/> <span class="Bold">(N=107)</span> </p> </td><td align="center" class="Botrule Rrule" valign="bottom"> <p class="First"> <span class="Bold">POMALYST + Low-dose Dex</span> <br/> <span class="Bold">(N=112)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Number (%) of patients with at least one adverse reaction</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">107 (100)</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">112 (100)</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">98 (92)</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">102 (91)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">  Blood and lymphatic system disorders</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Neutropenia <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">57 (53)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">55 (49)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">51 (48)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">46 (41)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Anemia <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">41 (38)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">47 (42)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">25 (23)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">24 (21)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Thrombocytopenia <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">28 (26)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">26 (23)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">24 (22)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">21 (19)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Leukopenia</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">14 (13)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">22 (20)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">7 (7)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">11 (10)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Febrile neutropenia <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;10%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;10%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">6 (6)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (3)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Lymphopenia</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">4 (4)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">17 (15)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">2 (2)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">8 (7)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">  General disorders and administration site conditions</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Fatigue and asthenia <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">62 (58)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">70 (63)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">13 (12)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">19 (17)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Edema peripheral</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">27 (25)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">19 (17)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Pyrexia <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">25 (23)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">36 (32)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Chills</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">11 (10)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">14 (13)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">  Gastrointestinal disorders</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Nausea <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">39 (36)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">27 (24)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Constipation <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">38 (36)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">41 (37)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Diarrhea</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">37 (35)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">40 (36)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Vomiting <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">15 (14)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">16 (14)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">  Musculoskeletal and connective tissue disorders</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Back pain <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">37 (35)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">36 (32)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">15 (14)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">11 (10)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Musculoskeletal chest pain</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">25 (23)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">22 (20)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Muscle spasms</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">23 (21)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">22 (20)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Arthralgia</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">18 (17)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">17 (15)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Muscular weakness</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">15 (14)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">15 (13)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">6 (6)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">4 (4)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Bone pain</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">13 (12)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">8 (7)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Musculoskeletal pain</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">13 (12)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">19 (17)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Pain in extremity</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">8 (7)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">16 (14)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">  Infections and infestations</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Upper respiratory tract infection</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">40 (37)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">32 (29)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Pneumonia <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">30 (28)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">38 (34)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">21 (20)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">32 (29)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Urinary tract infection <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">11 (10)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">19 (17)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">2 (2)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">10 (9)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Sepsis <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;10%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;10%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">6 (6)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5 (4)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">  Metabolism and nutrition disorders</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Decreased appetite</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">25 (23)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">21 (19)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Hypercalcemia <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">23 (21)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">13 (12)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">11 (10)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (&lt;1)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Hypokalemia</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">13 (12)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">13 (12)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Hyperglycemia</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">12 (11)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">17 (15)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Hyponatremia</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">12 (11)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">14 (13)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Dehydration <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;10%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;10%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5 (4.7)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">6 (5.4)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Hypocalcemia</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">6 (6)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">13 (12)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">  Respiratory, thoracic and mediastinal disorders</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Dyspnea <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">38 (36)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">50 (45)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">8 (7)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">14 (13)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Cough</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">18 (17)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">25 (22)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Epistaxis</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">18 (17)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">12 (11)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Productive cough</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">10 (9)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">14 (13)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Oropharyngeal pain</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">6 (6)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">12 (11)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">  Nervous system disorders</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Dizziness</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">24 (22)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">20 (18)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Peripheral neuropathy</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">23 (21)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">20 (18)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Headache</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">16 (15)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">15 (13)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Tremor</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">11 (10)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">15 (13)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">    Skin and subcutaneous tissue disorders</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Rash</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">22 (21)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">18 (16)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">&lt;5%</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Pruritus</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">16 (15)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">10 (9)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Dry skin</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">10 (9)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">12 (11)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Hyperhidrosis</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">8 (7)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">18 (16)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Night sweats</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5 (5)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">14 (13)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">  Investigations</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Blood creatinine increased <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">20 (19)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">11 (10)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">6 (6)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (3)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Weight decreased</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">16 (15)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">10 (9)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Weight increased</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (&lt;1)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">12 (11)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">  Psychiatric disorders</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Anxiety</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">14 (13)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">8 (7)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Confusional state <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">13 (12)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">15 (13)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">6 (6)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (3)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Insomnia</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">7 (7)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">18 (16)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">  Renal and urinary disorders</span> </p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Renal failure <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">16 (15)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">11 (10)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">9 (8)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">8 (7)</p> </td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table width="90%"> <caption> <span>Table 4: Adverse Reactions in Trial 2</span> </caption> <col width="22%"/> <col width="19%"/> <col width="20%"/> <col width="19%"/> <col width="20%"/> <tfoot> <tr class="First Last"> <td align="left" colspan="5" valign="top"><span class="Sup">a</span> Percentage did not meet the criteria to be considered as an adverse reaction for POMALYST for that category of event (i.e., all adverse events or Grade 3 or 4 adverse events).<br/> <span class="Sup">b</span> Serious adverse reactions were reported in at least 3 patients in the POM + Low-dose Dex arm, AND at least 1% higher than the High-dose-Dex arm percentage.<br/>Data cutoff: 01 March 2013</td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="bottom"> <p class="First"> <span class="Bold">All Adverse Reactions</span> <br/> <span class="Bold"> (≥5% in POMALYST + Low-dose Dex arm, and at least 2% higher than the High-dose-Dex arm)</span> </p> </td><td align="center" class="Botrule Rrule Toprule" colspan="2" valign="bottom"> <p class="First"> <span class="Bold">Grade 3 or 4</span> <br/> <span class="Bold">(≥1% in POMALYST + Low-dose Dex arm, and at least 1% higher than the High-dose-Dex arm)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="bottom"> <p class="First"> <span class="Bold">Body System</span> <br/>Adverse Reaction</p> </td><td align="center" class="Botrule Rrule" valign="bottom"> <p class="First"> <span class="Bold">POMALYST + Low-dose Dex</span> <br/> <span class="Bold">(N=300)</span> </p> </td><td align="center" class="Botrule Rrule" valign="bottom"> <p class="First"> <span class="Bold">High-dose Dex</span> <br/> <span class="Bold">(N=150)</span> </p> </td><td align="center" class="Botrule Rrule" valign="bottom"> <p class="First"> <span class="Bold">POMALYST + Low-dose Dex</span> <br/> <span class="Bold"> (N=300)</span> </p> </td><td align="center" class="Botrule Rrule" valign="bottom"> <p class="First"> <span class="Bold">High-dose Dex</span> <br/> <span class="Bold"> (N=150)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Number (%) of patients with at least one adverse reaction</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">297 (99)</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">149 (99)</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">259 (86)</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">127 (85)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First">  <span class="Bold">Blood and lymphatic system disorders</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Neutropenia <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">154 (51)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">31 (21)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">145 (48)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">24 (16)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Thrombocytopenia</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">89 (30) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">44 (29) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">66 (22) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">39 (26) <span class="Sup">a</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Leukopenia</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">38 (13)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">8 (5)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">27 (9)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5 (3)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Febrile neutropenia <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">28 (9)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">28 (9)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First">  <span class="Bold">General disorders and administration site conditions</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Fatigue and asthenia</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">140 (47)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">64 (43)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">26 (9) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">18 (12) <span class="Sup">a</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Pyrexia <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">80 (27)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">35 (23)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">9 (3) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">7 (5) <span class="Sup">a</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Edema peripheral</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">52 (17)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">17 (11)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">4 (1) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (2) <span class="Sup">a</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Pain</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">11 (4) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (2) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5 (2)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (&lt;1)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First">  <span class="Bold">Infections and infestations</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Upper respiratory tract infection <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">93 (31)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">19 (13)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">9 (3)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (&lt;1)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Pneumonia <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">58 (19)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">20 (13)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">47 (16)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">15 (10)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Neutropenic sepsis <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (1) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (1)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First">  <span class="Bold">Gastrointestinal disorders</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Diarrhea </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">66 (22)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">28 (19)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (1) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">2 (1) <span class="Sup">a</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Constipation</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">65 (22)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">22 (15)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">7 (2)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Nausea</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">45 (15)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">17 (11)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (1) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">2 (1) <span class="Sup">a</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Vomiting</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">23 (8)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">6 (4)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (1)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First">  <span class="Bold">Musculoskeletal and connective tissue disorders</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Back pain <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">59 (20)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">24 (16)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">15 (5)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">6 (4)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Bone pain <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">54 (18)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">21 (14)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">22 (7)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">7 (5)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Muscle spasms</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">46 (15)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">11 (7)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (&lt;1) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (&lt;1) <span class="Sup">a</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Arthralgia</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">26 (9)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">7 (5)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">2 (&lt;1) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (&lt;1) <span class="Sup">a</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Pain in extremity</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">20 (7) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">9 (6) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">6 (2)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First">  <span class="Bold">Respiratory, thoracic and mediastinal disorders</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Dyspnea <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">76 (25)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">25 (17)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">17 (6)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">7 (5)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Cough</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">60 (20)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">15 (10)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">2 (&lt;1) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (&lt;1) <span class="Sup">a</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Chronic obstructive pulmonary disease <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5 (2) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">4 (1)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First">  <span class="Bold">Nervous system disorders</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Peripheral neuropathy</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">52 (17)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">18 (12)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5 (2) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">2 (1) <span class="Sup">a</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Dizziness</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">37 (12)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">14 (9)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">4 (1) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">2 (1) <span class="Sup">a</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Headache</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">23 (8)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">8 (5)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (&lt;1) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0) <span class="Sup">a</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Tremor</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">17 (6)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">2 (1)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">2 (&lt;1) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0) <span class="Sup">a</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Depressed level of consciousness</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5 (2) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (1)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First">  <span class="Bold">Metabolism and nutrition disorders</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Decreased appetite</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">38 (13)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">12 (8)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (1) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">2 (1) <span class="Sup">a</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Hypokalemia</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">28 (9) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">12 (8) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">12 (4)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">4 (3)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Hypocalcemia</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">12 (4) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">9 (6) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5 (2)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (&lt;1)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First">    <span class="Bold">Skin and subcutaneous tissue disorders</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Rash</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">23 (8)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">2 (1)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (1)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Pruritus</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">22 (7)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5 (3)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0) <span class="Sup">a</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Hyperhidrosis</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">15 (5)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (&lt;1)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0) <span class="Sup">a</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First">  <span class="Bold">Investigations</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Neutrophil count decreased</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">15 (5)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (&lt;1)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">14 (5)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (&lt;1)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Platelet count decreased</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">10 (3) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (2) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">8 (3)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">2 (1)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    White blood cell count decreased</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">8 (3) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (&lt;1) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">8 (3)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Alanine aminotransferase increased</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">7 (2) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">2 (1) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5 (2)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Aspartate aminotransferase increased</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">4 (1) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">2 (1) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (1)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Lymphocyte count decreased</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (1) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (&lt;1) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (1)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First">    <span class="Bold">Renal and urinary disorders</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Renal failure</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">31 (10) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">18 (12) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">19 (6)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">8 (5)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First">    <span class="Bold">Injury, poisoning and procedural complications</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Femur fracture <span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5 (2) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (&lt;1) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5 (2)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (&lt;1)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First">    <span class="Bold">Reproductive system and breast disorders</span> </p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">    Pelvic pain</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">6 (2) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (2) <span class="Sup">a</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">4 (1)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td> </tr> </tbody> </table></div>

Other Adverse Reactions

Other adverse reactions of POMALYST in patients with MM, not described above, and considered important:

Cardiac Disorders: Myocardial infarction, Atrial fibrillation, Angina pectoris, Cardiac failure congestive

Ear and Labyrinth Disorders: Vertigo

Gastrointestinal disorders: Abdominal pain

General Disorders and Administration Site Conditions: General physical health deterioration, Non-cardiac chest pain, Multi-organ failure

Hepatobiliary Disorders: Hyperbilirubinemia

Infections and Infestations: Pneumocystis jiroveci pneumonia, Respiratory syncytial virus infection, Neutropenic sepsis, Bacteremia, Pneumonia respiratory syncytial viral, Cellulitis, Urosepsis, Septic shock, Clostridium difficile colitis, Pneumonia streptococcal, Lobar pneumonia, Viral infection, Lung infection

Investigations: Alanine aminotransferase increased, Hemoglobin decreased

Injury, poisoning and procedural complications: Fall, Compression fracture, Spinal compression fracture

Metabolism and nutritional disorders: Hyperkalemia, Failure to thrive

Nervous system disorders: Depressed level of consciousness, Syncope

Psychiatric disorders: Mental status change

Renal and urinary disorders: Urinary retention, Hyponatremia

Reproductive system and breast disorders: Pelvic pain

Respiratory, thoracic, and mediastinal disorders: Interstitial lung disease, Pulmonary embolism, Respiratory failure, Bronchospasm

Vascular disorders: Hypotension

Kaposi Sarcoma (KS)

The safety of POMALYST in patients with KS was evaluated in Trial 12-C-0047 [see Clinical Studies (14.2)]. Twenty-eight patients received POMALYST 5 mg taken orally once daily on Days 1 through 21 of repeated 28-day cycles. The study excluded patients with procoagulant disorders or a history of venous or arterial thromboembolism. Patients received DVT prophylaxis with daily low dose aspirin. Across all patients treated on Trial 12-C-0047, 75% were exposed to pomalidomide for 6 months or longer and 25% were exposed for greater than one year.

Serious adverse reactions occurred in 18% (5/28) of patients who received POMALYST. The following serious adverse reactions each occurred in 1 patient: anemia, decreased neutrophil count, and hematuria.

Permanent discontinuation due to an adverse reaction occurred in 11% (3/28) of patients who received POMALYST.

Dosage interruptions due to an adverse reaction occurred in 14% (4/28) of patients who received POMALYST. The most frequent adverse reaction requiring dosage interruption was decreased neutrophil count, which occurred in 3 patients.

The POMALYST dose was reduced due to an adverse reaction in 1 patient due to gout.

Tables 5 and 6 summarize the adverse reactions and select laboratory abnormalities reported in Trial 12-C-0047.

<div class="scrollingtable"><table width="70%"> <caption> <span>Table 5: Adverse Reactions (≥ 20%) in Patients Who Received POMALYST in Trial 12-C-0047</span> </caption> <col width="39%"/> <col width="20%"/> <col width="20%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Adverse Reaction</span> </p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Grades 1-4</span> <br/> <span class="Bold">N=28</span> <br/> <span class="Bold">%</span> </p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Grade 3 or 4</span> <br/> <span class="Bold">N=28</span> <br/> <span class="Bold">%</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Rash, maculo-papular</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">71</p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First">3.6</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Constipation</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">71</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Fatigue</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">68</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Nausea</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">36</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Diarrhea</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">32</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3.6</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Cough</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">29</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Dyspnea</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">29</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Peripheral Edema</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">29</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3.6</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Upper respiratory tract infection</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">29</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Muscle spasms</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">25</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Hypothyroidism</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">21</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Dry skin</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">21</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Chills</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">21</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table width="90%"> <caption> <span>Table 6: Frequency of Select Laboratory Abnormalities (≥ 10%) Worsening from Baseline in Patients Who Received POMALYST in Trial 12-C-0047</span> </caption> <col width="50%"/> <col width="20%"/> <col width="30%"/> <tfoot> <tr class="First Last"> <td align="left" colspan="3" valign="top">* Denominator is the number of patients for whom there is a baseline and at least one post baseline assessment for the laboratory parameter.</td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="bottom"> <p class="First"> <span class="Bold">Laboratory Abnormality</span> </p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Grades 1-4*</span> <br/> <span class="Bold">%</span> </p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Grades 3-4*</span> <br/> <span class="Bold">%</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Hematology</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Decreased Absolute Neutrophil Count</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">96</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">50</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Decreased White Blood Cells</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">79</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3.6</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Decreased Hemoglobin</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">54</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Decreased Platelets</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">54</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Chemistry</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Elevated Creatinine</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">86</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3.6</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Elevated Glucose</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">57</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">7</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Decreased Albumin</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">54</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Decreased Phosphate</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">54</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">25</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Decreased Calcium</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">50</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Increased Alanine Aminotransferase (ALT)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">32</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Increased Aspartate Aminotransferase (AST)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">25</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Elevated Creatine Kinase</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">25</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">7</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Decreased Magnesium</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">14</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Elevated Alkaline Phosphate</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">14</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3.6</p> </td> </tr> </tbody> </table></div>

The following adverse reactions have been identified during postapproval use of POMALYST. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: Pancytopenia

Endocrine Disorders: Hypothyroidism, hyperthyroidism

Gastrointestinal Disorders: Gastrointestinal hemorrhage

Hepatobiliary Disorders: Hepatic failure (including fatal cases), elevated liver enzymes

Immune system Disorders: Allergic reactions (e.g., angioedema, anaphylaxis, urticaria), solid organ transplant rejection

Infections and Infestations: Hepatitis B virus reactivation, Herpes zoster, progressive multifocal leukoencephalopathy (PML)

Neoplasms benign, malignant and unspecified (incl cysts and polyps): Tumor lysis syndrome, basal cell carcinoma, and squamous cell carcinoma of the skin

Skin and Subcutaneous Tissue Disorders: Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS)

CYP1A2 inhibitors:

In healthy subjects, co-administration of fluvoxamine, a strong CYP1A2 inhibitor, increased Cmax and AUC of pomalidomide by 24% and 125% respectively [see Clinical Pharmacology (12.3)]. Increased pomalidomide exposure may increase the risk of exposure related toxicities. Avoid co-administration of strong CYP1A2 inhibitors (e.g. ciprofloxacin and fluvoxamine). If co-administration is unavoidable, reduce the POMALYST dose [see Dosage and Administration (2.6)].

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to POMALYST during pregnancy as well as female partners of male patients who are exposed to POMALYST. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to POMALYST to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the REMS Call Center at 1-888-423-5436.

Risk Summary

Based on the mechanism of action [see Clinical Pharmacology (12.1)] and findings from animal studies, POMALYST can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy [see Contraindications (4), and Warnings and Precautions (5.1)].

POMALYST is a thalidomide analogue. Thalidomide is a human teratogen, inducing a high frequency of severe and life-threatening birth defects such as amelia (absence of limbs), phocomelia (short limbs), hypoplasticity of the bones, absence of bones, external ear abnormalities (including anotia, micropinna, small or absent external auditory canals), facial palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart defects. Alimentary tract, urinary tract, and genital malformations have also been documented, and mortality at or shortly after birth has been reported in about 40% of infants.

Pomalidomide was teratogenic in both rats and rabbits when administered during the period of organogenesis. Pomalidomide crossed the placenta after administration to pregnant rabbits (see Data). If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus.

If pregnancy does occur during treatment, immediately discontinue the drug. Under these conditions, refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. Report any suspected fetal exposure to POMALYST to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the REMS Call Center at 1-888-423-5436.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. The estimated background risk in the U.S. general population of major birth defects is 2%-4% and of miscarriage is 15%-20% of clinically recognized pregnancies.

Data

Animal Data

Pomalidomide was teratogenic in both rats and rabbits in the embryo-fetal developmental studies when administered during the period of organogenesis.

In rats, pomalidomide was administered orally to pregnant animals at doses of 25 to 1000 mg/kg/day. Malformations or absence of urinary bladder, absence of thyroid gland, and fusion and misalignment of lumbar and thoracic vertebral elements (vertebral, central, and/or neural arches) were observed at all dose levels. There was no maternal toxicity observed in this study. The lowest dose in rats resulted in an exposure (AUC) approximately 85-fold of the human exposure at the recommended dose of 4 mg/day. Other embryo-fetal toxicities included increased resorptions leading to decreased number of viable fetuses.

In rabbits, pomalidomide was administered orally to pregnant animals at doses of 10 to 250 mg/kg/day. Increased cardiac malformations such as interventricular septal defect were seen at all doses with significant increases at 250 mg/kg/day. Additional malformations observed at 250 mg/kg/day included anomalies in limbs (flexed and/or rotated fore- and/or hindlimbs, unattached or absent digit) and associated skeletal malformations (not ossified metacarpal, misaligned phalanx and metacarpal, absent digit, not ossified phalanx, and short not ossified or bent tibia), moderate dilation of the lateral ventricle in the brain, abnormal placement of the right subclavian artery, absent intermediate lobe in the lungs, low-set kidney, altered liver morphology, incompletely or not ossified pelvis, an increased average for supernumerary thoracic ribs, and a reduced average for ossified tarsals. No maternal toxicity was observed at the low dose (10 mg/kg/day) that resulted in cardiac anomalies in fetuses; this dose resulted in an exposure (AUC) approximately equal to that reported in humans at the recommended dose of 4 mg/day. Additional embryo-fetal toxicity included increased resorption.

Following daily oral administration of pomalidomide from Gestation Day 7 through Gestation Day 20 in pregnant rabbits, fetal plasma pomalidomide concentrations were approximately 50% of the maternal Cmax at all dosages (5 to 250 mg/kg/day), indicating that pomalidomide crossed the placenta.

Risk Summary

There is no information regarding the presence of pomalidomide in human milk, the effects of POMALYST on the breastfed child, or the effects of POMALYST on milk production. Pomalidomide was excreted in the milk of lactating rats (see Data). Because many drugs are excreted in human milk and because of the potential for adverse reactions in a breastfed child from POMALYST, advise women not to breastfeed during treatment with POMALYST.

Data

Animal Data

Following a single oral administration of pomalidomide to lactating rats approximately 14 days postpartum, pomalidomide was transferred into milk, with milk to plasma ratios of 0.63 to 1.46.

Pregnancy Testing

POMALYST can cause fetal harm when administered during pregnancy [see Use in Specific Populations (8.1)]. Verify the pregnancy status of females of reproductive potential prior to initiating POMALYST therapy and during therapy. Advise females of reproductive potential that they must avoid pregnancy 4 weeks before therapy, while taking POMALYST, during dose interruptions and for at least 4 weeks after completing therapy.

Females of reproductive potential must have 2 negative pregnancy tests before initiating POMALYST. The first test should be performed within 10-14 days, and the second test within 24 hours prior to prescribing POMALYST. Once treatment has started and during dose interruptions, pregnancy testing for females of reproductive potential should occur weekly during the first 4 weeks of use, then pregnancy testing should be repeated every 4 weeks in females with regular menstrual cycles. If menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks. Pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in her menstrual bleeding. POMALYST treatment must be discontinued during this evaluation.

Contraception

Females

Females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously: one highly effective form of contraception – tubal ligation, IUD, hormonal (birth control pills, injections, hormonal patches, vaginal rings, or implants), or partner's vasectomy, and 1 additional effective contraceptive method – male latex or synthetic condom, diaphragm, or cervical cap. Contraception must begin 4 weeks prior to initiating treatment with POMALYST, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of POMALYST therapy. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy. Females of reproductive potential should be referred to a qualified provider of contraceptive methods, if needed.

Males

Pomalidomide is present in the semen of males who take POMALYST. Therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking POMALYST and for up to 4 weeks after discontinuing POMALYST, even if they have undergone a successful vasectomy. Male patients taking POMALYST must not donate sperm.

Infertility

Based on findings in animals, female fertility may be compromised by treatment with POMALYST [see Nonclinical Toxicology (13.1)].

The safety and effectiveness of POMALYST have not been established in pediatric patients. The safety and effectiveness were assessed but not established in two open-label studies: a dose escalation study in 25 pediatric patients aged 5 to <17 with recurrent, progressive or refractory CNS tumors [NCT02415153] and a parallel-group study conducted in 47 pediatric patients aged 4 to <17 years with recurrent or progressive high-grade glioma, medulloblastoma, ependymoma, or diffuse intrinsic pontine glioma (DIPG) [NCT03257631]. No new safety signals were observed in pediatric patients across these studies.

At the same dose by body surface area, pomalidomide exposure in 55 pediatric patients aged 4 to < 17 years old was within the range observed in adult patients with MM but higher than the exposure observed in adult patients with KS [see Clinical Pharmacology (12.3)].

Multiple Myeloma

Of the total number of patients in clinical studies of POMALYST, 44% were aged older than 65 years, while 10% were aged older than 75 years. No overall differences in effectiveness were observed between these patients and younger patients. In these studies, patients older than 65 years were more likely than patients less than or equal to 65 years of age to experience pneumonia.

Kaposi Sarcoma

Of the 28 patients who received POMALYST, 11% were 65 years or older, and 3.6% were 75 years of age or older. The clinical study did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

In patients with severe renal impairment requiring dialysis, the AUC of pomalidomide increased by 38% and the rate of SAE increased by 64% relative to patients with normal renal function; therefore, starting dose adjustment is recommended. For patients with severe renal impairment requiring dialysis, administer POMALYST after the completion of hemodialysis on dialysis days because exposure of pomalidomide could be significantly decreased during dialysis [see Dosage and Administration (2.7) and Clinical Pharmacology (12.3)].

Pomalidomide is metabolized primarily by the liver. Following single dose administration, the AUC of pomalidomide increased 51%, 58%, and 72% in subjects with mild (Child-Pugh class A), moderate (Child-Pugh class B), and severe (Child-Pugh class C) hepatic impairment, respectively compared to subjects with normal liver function. Dose adjustment is recommended in patients with hepatic impairment [see Dosage and Administration (2.8) and Clinical Pharmacology (12.3)].

Cigarette smoking reduces pomalidomide AUC due to CYP1A2 induction. Advise patients that smoking may reduce the efficacy of pomalidomide [see Clinical Pharmacology (12.3)].

Hemodialysis can remove pomalidomide from circulation.

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Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure:

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The empirical formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.24.

{ "type": "p", "children": [], "text": "The empirical formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.24." }

Pomalidomide is a yellow solid powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers.

{ "type": "p", "children": [], "text": "Pomalidomide is a yellow solid powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers." }

POMALYST is available in 1-mg, 2-mg, 3-mg, and 4-mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: mannitol, pregelatinized starch, and sodium stearyl fumarate. The 1-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, white ink, and black ink. The 2-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, FD&C red 3, and white ink. The 3-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, and white ink. The 4-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 1, FD&C blue 2, and white ink.

{ "type": "p", "children": [], "text": "POMALYST is available in 1-mg, 2-mg, 3-mg, and 4-mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: mannitol, pregelatinized starch, and sodium stearyl fumarate. The 1-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, white ink, and black ink. The 2-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, FD&C red 3, and white ink. The 3-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, and white ink. The 4-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 1, FD&C blue 2, and white ink." }

Pomalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. Cellular activities of pomalidomide are mediated through its target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex. In vitro, in the presence of drug, substrate proteins (including Aiolos and Ikaros) are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects. In in vitro cellular assays, pomalidomide inhibited proliferation and induced apoptosis of hematopoietic tumor cells. Additionally, pomalidomide inhibited the proliferation of lenalidomide-resistant multiple myeloma (MM) cell lines and synergized with dexamethasone in both lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumor cell apoptosis. Pomalidomide enhanced T cell- and natural killer (NK) cell-mediated immunity and inhibited production of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes. Pomalidomide demonstrated anti-angiogenic activity in a mouse tumor model and in the in vitro umbilical cord model.

Pomalidomide exposure-response analyses showed that there was no relationship between systemic pomalidomide exposure level and efficacy or safety following pomalidomide dose of 4 mg.

Cardiac Electrophysiology

The QTc prolongation potential of pomalidomide was evaluated in a single center, randomized, double-blind crossover study (N=72) using 4 mg pomalidomide, 20 mg pomalidomide, placebo, and 400 mg moxifloxacin (positive control). No significant QTc prolongation effect of pomalidomide was observed following pomalidomide doses of 4 and 20 mg.

In patients with MM who received POMALYST 4 mg daily alone or in combination with dexamethasone, pomalidomide steady-state drug exposure was characterized by AUC (CV%) of 860 (37%) ng∙h/mL and Cmax (CV%) of 75 (32%) ng/mL. In patients with Kaposi sarcoma (KS) who received POMALYST 5 mg daily, pomalidomide steady-state drug exposure was characterized by AUC of 462.3 ng∙h/mL (82%) and Cmax of 53.1 ng/mL (50%).

Absorption

Following administration of single oral doses of POMALYST, the maximum plasma concentration (Cmax) for pomalidomide occurs at 2 to 3 hours postdose in patients with MM or KS.

Effect of Food

Co-administration of POMALYST with a high-fat meal (approximately 50% of the total caloric content) and high-calorie meal (approximately 800 to 1000 calories) (the meal contained approximately 150, 250, and 500 to 600 calories from protein, carbohydrates, and fat, respectively) delays the Tmax by 2.5 hours, decreased mean plasma Cmax and AUC in healthy subjects by about 27% and 8%, respectively.

Distribution

Pomalidomide has a mean apparent volume of distribution (Vd/F) between 62 and 138 L at steady state in patients with MM or KS.

Pomalidomide is distributed in semen of healthy subjects at a concentration of approximately 67% of plasma level at 4 hours postdose (~Tmax) after 4 days of 2 mg once-daily dosing.

Human plasma protein binding of pomalidomide ranges from 12% to 44% and is not concentration dependent. Pomalidomide is a substrate for P-gp.

Elimination

Pomalidomide has a mean total body clearance (CL/F) of 7-10 L/h in patients with MM or KS. Pomalidomide is eliminated with a median plasma half-life of 9.5 hours in healthy subjects and 7.5 hours in patients with MM or KS.

Metabolism

Pomalidomide is primarily metabolized in the liver by CYP1A2 and CYP3A4. Minor contributions from CYP2C19 and CYP2D6 were also observed in vitro.

Excretion

Following a single oral administration of [14C]-pomalidomide to healthy subjects, approximately 73% and 15% of the radioactive dose was eliminated in urine and feces, respectively, with approximately 2% and 8% of the radiolabeled dose eliminated unchanged as pomalidomide in urine and feces.

Specific Populations

Age (61 to 85 years old), sex and race have no clinically significant effect on the systemic exposure of pomalidomide.

Patients with Renal Impairment

Pomalidomide pharmacokinetic parameters were not significantly affected in patients with moderate (30 mL/min ≤ CLcr< 60 mL/min) or severe (15 mL/min ≤ CLcr< 30 mL/min) renal impairment relative to patients with normal renal function (CLcr ≥ 60 mL/min). Mean exposure (AUC) to pomalidomide increased by 38% in patients with severe renal impairment requiring dialysis (CLcr< 30 mL/min requiring dialysis) and 40% in patients with end stage renal disease (CLcr< 15 mL/min) on non-dialysis days. In patients with severe renal impairment requiring dialysis, the estimated dialysis clearance is approximately 12 L/h which is higher than pomalidomide total body clearance, indicating hemodialysis will remove pomalidomide from the blood circulation.

Patients with Hepatic Impairment

Mean exposure (AUC) of pomalidomide increased by 51%, 58% and 72% in subjects with mild, moderate or severe hepatic impairment as defined by Child-Pugh criteria, respectively.

Drug Interaction Studies

Clinical Studies

Co-administration of POMALYST with the following drugs did not increase pomalidomide exposure to a clinically significant extent: ketoconazole (a strong CYP3A4 and P-gp inhibitor), carbamazepine (a strong CYP3A4 inducer) and dexamethasone (a weak to moderate CYP3A4 inducer). Co-administration of POMALYST with drugs that are CYP1A2 inducers has not been studied.

CYP1A2 Inhibitors: Co-administration of fluvoxamine (a strong CYP1A2 inhibitor) with POMALYST increased mean [90% confidence interval] pomalidomide exposure by 125% [98% to 157%] compared to POMALYST alone in healthy subjects. Co-administration of fluvoxamine in the presence of ketoconazole (a strong CYP3A4 and P-gp inhibitor) with POMALYST increased mean pomalidomide exposure by 146% [126% to 167%] compared to POMALYST administered alone in healthy subjects, indicating the predominant effect of CYP1A2 inhibition in the increase of pomalidomide exposure [see Dosage and Administration (2.6) and Drug Interactions (7.1)].

Strong CYP3A4 and P-gp Inhibitors: Co-administration of ketoconazole (a strong CYP3A4 and P-gp inhibitor) in 16 healthy male subjects increased AUC of pomalidomide by 19% compared to POMALYST administered alone.

Strong CYP1A2 Inducers: Co-administration of POMALYST with drugs that are CYP1A2 inducers has not been studied and may reduce pomalidomide exposure.

Strong CYP3A4 Inducers: Co-administration of carbamazepine to 16 healthy male subjects decreased AUC of pomalidomide by 20% with a 90% confidence interval [13% to 27%] compared to when pomalidomide was administered alone.

Dexamethasone: Co-administration of multiple doses of 4 mg POMALYST with 20 mg to 40 mg dexamethasone (a weak to moderate inducer of CYP3A4) to patients with MM had no effect on the pharmacokinetics of pomalidomide compared to when pomalidomide was administered alone.

Smoking: In 14 healthy male subjects who smoked 25 cigarettes per day for a total of 10 days, after single oral dose of 4 mg POMALYST, Cmax of pomalidomide increased 14% while AUC of pomalidomide decreased 32%, compared to that in 13 healthy male subjects who were non-smokers.

In Vitro Studies

Pomalidomide does not inhibit or induce cytochrome p450 enzymes or transporters in vitro.

Studies examining the carcinogenic potential of pomalidomide have not been conducted. One of 12 monkeys dosed with 1 mg/kg of pomalidomide (an exposure approximately 15-fold of the exposure in patients at the recommended dose of 4 mg/day) developed acute myeloid leukemia in a 9-month repeat-dose toxicology study.

Pomalidomide was not mutagenic or clastogenic in a battery of tests, including the bacteria reverse mutation assay (Ames test), the in vitro assay using human peripheral blood lymphocytes, and the micronucleus test in orally treated rats administered doses up to 2000 mg/kg/day.

In a fertility and early embryonic development study in rats, drug-treated males were mated with untreated or treated females. Pomalidomide was administered to males and females at doses of 25 to 1000 mg/kg/day. When treated males were mated with treated females, there was an increase in post-implantation loss and a decrease in mean number of viable embryos at all dose levels. There were no other effects on reproductive functions or the number of pregnancies. The lowest dose tested in animals resulted in an exposure (AUC) approximately 100-fold of the exposure in patients at the recommended dose of 4 mg/day. When treated males in this study were mated with untreated females, all uterine parameters were comparable to the controls. Based on these results, the observed effects were attributed to the treatment of females.

Trial 1

Trial 1 was a phase 2, multicenter, randomized open-label study in patients with relapsed multiple myeloma (MM) who were refractory to their last myeloma therapy and had received lenalidomide and bortezomib. Patients were considered relapsed if they had achieved at least stable disease for at least 1 cycle of treatment to at least 1 prior regimen and then developed progressive disease. Patients were considered refractory if they experienced disease progression on or within 60 days of their last therapy. A total of 221 patients were randomized to receive POMALYST alone or POMALYST with Low-dose Dex. In Trial 1, the safety and efficacy of POMALYST 4 mg, once daily for 21 of 28 days, until disease progression, were evaluated alone and in combination with Low-dose Dex (40 mg/day given only on Days 1, 8, 15, and 22 of each 28-day cycle for patients aged 75 years or younger, or 20 mg/day given only on Days 1, 8, 15, and 22 of each 28-day cycle for patients aged greater than 75 years). Patients in the POMALYST alone arm were allowed to add Low-dose Dex upon disease progression.

Table 7 summarizes the baseline patient and disease characteristics in Trial 1. The baseline demographics and disease characteristics were balanced and comparable between the study arms.

<div class="scrollingtable"><table width="90%"> <caption> <span>Table 7: Baseline Demographic and Disease-Related Characteristics – Trial 1</span> </caption> <col width="40%"/> <col width="30%"/> <col width="30%"/> <thead> <tr class="First Last"> <th align="left" class="Botrule Lrule Rrule Toprule" valign="top"></th><th align="center" class="Botrule Rrule Toprule" valign="middle"><span class="Bold">POMALYST</span> <br/> <span class="Bold">(n=108)</span></th><th align="center" class="Botrule Rrule Toprule" valign="middle"><span class="Bold">POMALYST + Low-dose Dex</span> <br/> <span class="Bold">(n=113)</span></th> </tr> </thead> <tfoot> <tr class="First Last"> <td align="left" colspan="3" valign="top">Data cutoff: 01 April 2011</td> </tr> </tfoot> <tbody> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Patient Characteristics</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Median age, years (range)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">61 (37-88)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">64 (34-88)</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">Age distribution, n (%)</p> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">  &lt;65 years</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">65 (60.2)</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">60 (53.1)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">  ≥65 years</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">43 (39.8)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">53 (46.9)</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">Sex, n (%)</p> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">  Male</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">57 (52.8)</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">62 (54.9)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">  Female</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">51 (47.2)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">51 (45.1)</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">Race/ethnicity, n (%)</p> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">  White</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">86 (79.6)</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">92 (81.4)</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">  Black or African American</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">16 (14.8)</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">17 (15)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">  All other race</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">6 (5.6)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">4 (3.6)</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">ECOG Performance, n (%)</p> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Status 0-1</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">95 (87.9)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">100 (88.5)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Disease Characteristics</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">Number of prior therapies</p> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">  Median (min, max)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5 (2, 12)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5 (2, 13)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Prior transplant, n (%)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">82 (75.9)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">84 (74.3)</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Refractory to bortezomib and lenalidomide, n (%)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">64 (59.3)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">69 (61.1)</p> </td> </tr> </tbody> </table></div>

Table 8 summarizes the analysis results of overall response rate (ORR) and duration of response (DOR), based on assessments by the Independent Review Adjudication Committee for the treatment arms in Trial 1. ORR did not differ based on type of prior antimyeloma therapy.

<div class="scrollingtable"><table width="90%"> <caption> <span>Table 8: Trial 1 Results</span> </caption> <col width="40%"/> <col width="30%"/> <col width="30%"/> <tfoot> <tr class="First Last"> <td align="left" colspan="3" valign="top"><span class="Sup">a</span> Results are prior to the addition of dexamethasone.<br/> <span class="Sup">b</span> ORR = PR + CR per EBMT criteria.<br/>CI, confidence interval; NE, not established (the median has not yet been reached).<br/>Data cutoff: 01 April 2011</td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">POMALYST<span class="Sup">a</span></span> <br/> <span class="Bold">(n=108)</span> </p> </td><td align="center" class="Botrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">POMALYST + Low-dose Dex</span> <br/> <span class="Bold">(n=113)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Response</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Overall Response Rate (ORR),<span class="Sup">b</span> n (%)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">8 (7.4)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">33 (29.2)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">95% CI for ORR (%)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">(3.3, 14.1)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">(21.0, 38.5)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Complete Response (CR), n (%)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0 (0.0)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (0.9)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Partial Response (PR), n (%)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">8 (7.4)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">32 (28.3)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Duration of Response (DOR)</span> </p> </td><td class="Botrule Rrule" valign="top"></td><td class="Botrule Rrule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Median, months</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">NE</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">7.4</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">95% CI for DOR (months)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">NE</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">(5.1, 9.2)</p> </td> </tr> </tbody> </table></div>

Trial 2

Trial 2 was a Phase 3 multi-center, randomized, open-label study, where POMALYST + Low-dose Dex therapy was compared to High-dose Dex in adult patients with relapsed and refractory MM, who had received at least two prior treatment regimens, including lenalidomide and bortezomib, and demonstrated disease progression on or within 60 days of the last therapy. Patients with creatinine clearance ≥ 45mL/min qualified for the trial. A total of 455 patients were enrolled in the trial: 302 in the POMALYST + Low-dose Dex arm and 153 in the High-dose Dex arm. Patients in the POMALYST + Low-dose Dex arm were administered 4 mg POMALYST orally on Days 1 to 21 of each 28-day cycle. Dexamethasone (40 mg) was administered once per day on Days 1, 8, 15 and 22 of a 28-day cycle. Patients > 75 years of age started treatment with 20 mg dexamethasone using the same schedule. For the High-dose Dex arm, dexamethasone (40 mg) was administered once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle. Patients > 75 years of age started treatment with 20 mg dexamethasone using the same schedule. Treatment continued until patients had disease progression.

Baseline patient and disease characteristics were balanced and comparable between the study arms, as summarized in Table 9. Overall, 94% of patients had disease refractory to lenalidomide, 79% had disease refractory to bortezomib and 74% had disease refractory to both lenalidomide and bortezomib.

<div class="scrollingtable"><table width="90%"> <caption> <span>Table 9: Baseline Demographic and Disease-Related Characteristics – Trial 2</span> </caption> <col width="40%"/> <col width="30%"/> <col width="30%"/> <tfoot> <tr class="First Last"> <td align="left" colspan="3" valign="top">Data cutoff: 01March 2013</td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td class="Lrule Rrule Toprule" valign="top"></td><td align="center" class="Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">POMALYST + Low-dose Dex</span> </p> </td><td align="center" class="Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">High-dose Dex</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td align="center" class="Botrule Rrule" valign="top"> <p class="First"> <span class="Bold">(N=302)</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First"> <span class="Bold">(N=153)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Patient Characteristics</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Median Age, years (range)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">64 (35, 84)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">65 (35, 87)</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">Age Distribution n (%)</p> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">  &lt; 65 years</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">158 (52)</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">74 (48)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">  ≥ 65 years</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">144 (48)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">79 (52)</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">Sex n (%)</p> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">  Male</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">181 (60)</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">87 (57)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">  Female</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">121 (40)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">66 (43)</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">Race/Ethnicity n (%)</p> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">  White</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">244 (81)</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">113 (74)</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">  Black or African American</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">4 (1)</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">3 (2)</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">  Asian</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">4 (1)</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">0 (0)</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">  Other Race</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">2 (1)</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">2 (1)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">  Not Collected</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">48 (16)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">35 (23)</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">ECOG Performance n (%)</p> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">  Status 0</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">110 (36)</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">36 (24)</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">  Status 1</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">138 (46)</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">86 (56)</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">  Status 2</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">52 (17)</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">25 (16)</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">  Status 3</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">0 (0)</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">3 (2)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">  Missing</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">2 (1)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (2)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="3" valign="top"> <p class="First"> <span class="Bold">Disease Characteristics</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">Number of Prior Therapies</p> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">  Median, (Min, Max)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5 (2, 14)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5 (2, 17)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Prior stem cell transplant n (%)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">214 (71)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">105 (69)</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Refractory to bortezomib and lenalidomide n (%)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">225 (75)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">113 (74)</p> </td> </tr> </tbody> </table></div>

Table 10 summarizes the progression free survival (PFS) and overall response rate (ORR) based on the assessment by the Independent Review Adjudication Committee (IRAC) review at the final PFS analysis and overall survival (OS) at the OS analysis. PFS was significantly longer with POMALYST + Low-dose Dex than High-dose Dex: HR 0.45 (95% CI: 0.35-0.59 p < 0.001). OS was also significantly longer with POMALYST + Low-dose Dex than High-dose Dex: HR 0.70 (95% CI: 0.54-0.92 p = 0.009). The Kaplan-Meier curves for PFS and OS for the ITT population are provided in Figures 1 and 2, respectively.

<div class="scrollingtable"><table width="90%"> <caption> <span>Table 10: Trial 2 Results</span> </caption> <col width="50%"/> <col width="25%"/> <col width="25%"/> <tfoot> <tr class="First Last"> <td align="left" colspan="3" valign="top">Note: CI=Confidence interval; HD-Dex=High dose dexamethasone; IRAC=Independent Review Adjudication Committee; LD-Dex=Low dose dexamethasone.<br/> <span class="Sup">a</span> The median is based on Kaplan-Meier estimate.<br/> <span class="Sup">b</span> Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups, stratified by age (≤75 vs &gt;75), diseases population (refractory to both Lenalidomide and Bortezomib vs not refractory to both drugs), and prior number of antimyeloma therapy (=2 vs &gt;2), stratification factors for the trial.<br/> <span class="Sup">c</span> The p-value is based on a stratified log-rank test with the same stratification factors as the above Cox model.<br/> <span class="Sup">d</span> 53% of patients in the High-dose Dex arm subsequently received POMALYST.<br/> <span class="Sup">e</span> Based on Cox proportional hazards model (unstratified) comparing the hazard functions associated with treatment groups.<br/> <span class="Sup">f</span> The p-value is based on an unstratified log-rank test.<br/> <span class="Sup">g</span> Alpha control for PFS and OS.<br/>Data cutoff: 07 Sep 2012 for PFS<br/>Data cutoff: 01 Mar 2013 for OS and ORR</td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td class="Lrule Rrule Toprule" valign="top"></td><td align="center" class="Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">POMALYST + Low-dose Dex</span> </p> </td><td align="center" class="Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">High-dose Dex</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"></td><td align="center" class="Botrule Rrule" valign="top"> <p class="First"> <span class="Bold">(N=302)</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First"> <span class="Bold">(N=153)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Progression Free Survival Time</span> </p> </td><td class="Botrule Rrule Toprule" valign="top"></td><td class="Botrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Number (%) of events</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">164 (54.3)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">103 (67.3)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Median<span class="Sup">a</span> (2-sided 95% CI) (months)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3.6 [3.0, 4.6]</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1.8 [1.6, 2.1]</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Hazard Ratio (Pom+LD-Dex:HD-Dex) 2-Sided 95% CI<span class="Sup">b</span> </p> </td><td align="center" class="Botrule Rrule" colspan="2" valign="top"> <p class="First">0.45 [0.35, 0.59]</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Log-Rank Test 2-sided P-Value<span class="Sup">c</span> </p> </td><td align="center" class="Botrule Rrule" colspan="2" valign="top"> <p class="First">&lt;0.001</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Overall Survival Time</span><span class="Sup">d</span> </p> </td><td class="Botrule Rrule" colspan="2" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Number (%) of deaths</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">147 (48.7)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">86 (56.2)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Median<span class="Sup">a</span> (2-sided 95% CI) (months)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">12.4 [10.4, 15.3]</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">8.0 [6.9, 9.0]</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Hazard Ratio (Pom+LD-Dex:HD-Dex) 2-Sided 95% CI<span class="Sup">e</span> </p> </td><td align="center" class="Botrule Rrule" colspan="2" valign="top"> <p class="First">0.70 [0.54, 0.92]</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Log-Rank Test 2-sided P-Value <span class="Sup">f, g</span> </p> </td><td align="center" class="Botrule Rrule" colspan="2" valign="top"> <p class="First">0.009</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Overall Response Rate, n (%)</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">71 (23.5)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">6 (3.9)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">  Complete Response</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (0.3)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">  Very Good Partial Response</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">8 (2.6)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (0.7)</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">  Partial Response</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">62 (20.5)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">5 (3.3)</p> </td> </tr> </tbody> </table></div>

Figure 1: Progression Free Survival Based on IRAC Review of Response by IMWG Criteria (Stratified Log Rank Test) (ITT Population)

Data cut-off: 07 Sep 2012

Figure 2: Kaplan-Meier Curve of Overall Survival (ITT Population)

Data cutoff: 01 Mar 2013

The clinical trial 12-C-0047 (NCT01495598), was an open label, single center, single arm clinical study that evaluated the safety and efficacy of POMALYST in patients with Kaposi sarcoma (KS). A total of 28 patients (18 HIV-positive, 10 HIV-negative) received POMALYST 5 mg orally once daily on Days 1 through 21 of each 28-day cycle until disease progression or unacceptable toxicity. All HIV-positive patients continued highly active antiretroviral therapy (HAART). The trial excluded patients with symptomatic pulmonary or visceral KS, history of venous or arterial thromboembolism, or procoagulant disorders. Patients received thromboprophylaxis with aspirin 81 mg once daily throughout therapy.

The median age was 52.5 years, all were male, 75% were White, and 14% Black or African American. Seventy-five percent of patients had advanced disease (T1) at the time of enrollment, 11% had ≥ 50 lesions, and 75% had received prior chemotherapy.

The major efficacy outcome measure was overall response rate (ORR), which included complete response (CR), clinical complete response (cCR), and partial response (PR). Response was assessed by the investigator according to the AIDS Clinical Trial Group (ACTG) Oncology Committee response criteria for KS. The median time to first response was 1.8 months (0.9 to 7.6). Efficacy results are presented in Table 11.

<div class="scrollingtable"><table width="80%"> <caption> <span>Table 11: Trial 12-C-0047 Results</span> </caption> <col width="30%"/> <col width="20%"/> <col width="20%"/> <col width="20%"/> <tfoot> <tr class="First Last"> <td align="left" colspan="4" valign="top">CI: confidence interval, ORR: overall response rate, CR: complete response, PR: partial response<br/> <span class="Sup">1</span> CR includes one HIV-negative patient who achieved a cCR.<br/> <span class="Sup">2</span> Calculated as date of first documented response to date of first documented disease progression, receipt of new treatment or second course of treatment, or death due to any cause, whichever occurs first. Median estimate is from Kaplan-Meier analysis.<br/> <span class="Sup">3</span> From Kaplan-Meier analysis.</td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">All Patients</span> <br/> <span class="Bold">N=28</span> </p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">HIV-Positive</span> <br/> <span class="Bold">N=18</span> </p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">HIV-Negative</span> <br/> <span class="Bold">N=10</span> </p> </td> </tr> <tr> <td class="Lrule Rrule Toprule" valign="top"> <p class="First">ORR <span class="Sup">1</span>, n (%)</p> </td><td align="center" class="Rrule Toprule" valign="top"> <p class="First">20 (71)</p> </td><td align="center" class="Rrule Toprule" valign="top"> <p class="First">12 (67)</p> </td><td align="center" class="Rrule Toprule" valign="top"> <p class="First">8 (80)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">[95% CI]</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">[51, 87]</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">(41, 87)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">(44, 98)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">  CR <span class="Sup">1</span>, n (%)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">4 (14)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">3 (17)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">1 (10)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">  PR, n (%)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">16 (57)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">9 (50)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">7 (70)</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">Duration of Response, KS <span class="Sup">2</span>,</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">12.1</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">12.5</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">10.5</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Median in months [95% CI]<span class="Sup">3</span> </p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">[7.6, 16.8]</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">[6.5, 24.9]</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">[3.9, 24.2]</p> </td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">Duration of Response, KS (%)</p> </td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td><td class="Rrule" valign="top"></td> </tr> <tr> <td class="Lrule Rrule" valign="top"> <p class="First">Percent greater than 12 months</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">50</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">58</p> </td><td align="center" class="Rrule" valign="top"> <p class="First">38</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Percent greater than 24 months</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">20</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">17</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">25</p> </td> </tr> </tbody> </table></div>

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Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].

Care should be exercised in handling of POMALYST. Do not open or crush POMALYST capsules. If powder from POMALYST contacts the skin, wash the skin immediately and thoroughly with soap and water. If POMALYST contacts the mucous membranes, flush thoroughly with water.

Follow procedures for proper handling and disposal of hazardous drugs. 1

Embryo-Fetal Toxicity

Advise patients that POMALYST is contraindicated in pregnancy [see Contraindications (4)]. POMALYST is a thalidomide analogue and may cause serious birth defects or death to a developing baby [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

PS-Pomalidomide REMS

Because of the risk of embryo-fetal toxicity, POMALYST is only available through a restricted program called PS-Pomalidomide REMS [see Warnings and Precautions (5.2)].

Pregnancy Exposure Registry

Inform females that there is a Pregnancy Exposure Registry that monitors pregnancy outcomes in females exposed to POMALYST during pregnancy and that they can contact the Pregnancy Exposure Registry by calling 1-888-423-5436 [see Use in Specific Populations (8.1)].

Venous and Arterial Thromboembolism

Inform patients of the risk of developing DVT, PE, MI, and stroke and to report immediately any signs and symptoms suggestive of these events for evaluation [see Warnings and Precautions (5.3)].

Hematologic Toxicities

Inform patients on the risks of developing neutropenia, thrombocytopenia, and anemia and the need to report signs and symptoms associated with these events to their healthcare provider for further evaluation [see Warnings and Precautions (5.5)].

Hepatotoxicity

Inform patients on the risks of developing hepatotoxicity, including hepatic failure and death, and to report signs and symptoms associated with these events to their healthcare provider for evaluation [see Warnings and Precautions (5.6)].

Severe Cutaneous Reactions

Inform patients of the potential risk for severe skin reactions such as SJS, TEN and DRESS and to report any signs and symptoms associated with these reactions to their healthcare provider for evaluation [see Warnings and Precautions (5.7)].

Dizziness and Confusional State

Inform patients of the potential risk of dizziness and confusional state with the drug, to avoid situations where dizziness or confusional state may be a problem, and not to take other medications that may cause dizziness or confusional state without adequate medical advice [see Warnings and Precautions (5.8)].

Neuropathy

Inform patients of the risk of neuropathy and to report the signs and symptoms associated with these events to their healthcare provider for further evaluation [see Warnings and Precautions (5.9)].

Second Primary Malignancies

Inform the patient that the potential risk of developing acute myelogenous leukemia during treatment with POMALYST is unknown [see Warnings and Precautions (5.10)].

Tumor Lysis Syndrome

Inform patients of the potential risk of tumor lysis syndrome and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions (5.11)].

Hypersensitivity

Inform patients of the potential for severe hypersensitivity reactions such as angioedema and anaphylaxis to POMALYST. Instruct patients to contact their healthcare provider right away for any signs and symptoms of these reactions. Advise patients to seek emergency medical attention for signs or symptoms of severe hypersensitivity reactions [see Warnings and Precautions (5.12)].

Smoking Tobacco

Advise patients that smoking tobacco may reduce the efficacy of POMALYST [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)].

Dosing Instructions

Inform patients on how to take POMALYST [see Dosage and Administration (2.2, 2.3, 2.9)]

Marketed by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA

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POMALYST® is a trademark of Celgene Corporation, a Bristol-Myers Squibb company.POMPI.017/MG.015

{ "type": "p", "children": [], "text": "POMALYST® is a trademark of Celgene Corporation, a Bristol-Myers Squibb company.POMPI.017/MG.015" }

<div class="scrollingtable"><table width="100.1%"> <col width="3%"/> <col width="36%"/> <col width="23%"/> <col width="16%"/> <col width="23%"/> <tfoot> <tr class="First Last"> <td class="Toprule" colspan="4" valign="top"> <p class="First">This Medication Guide has been approved by the U.S. Food and Drug Administration.</p> </td><td align="right" class="Toprule" valign="top"> <p class="First">Revised: Feb 2025    </p> </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="5" valign="top"> <p class="First"> <span class="Bold">MEDICATION GUIDE</span> <br/>POMALYST<span class="Sup">®</span> (POM-uh-list)<br/>(pomalidomide)<br/>capsules</p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">What is the most important information I should know about POMALYST?</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First">Before you begin taking POMALYST, you must read and agree to all of the instructions in PS-Pomalidomide REMS. For more information, call 1-888-423-5436 or go to www.PS-PomalidomideREMS.com. Before prescribing POMALYST, your healthcare provider will explain PS-Pomalidomide REMS to you and have you sign the Patient-Physician Agreement Form.</p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First">POMALYST can cause serious side effects including:</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Possible birth defects (deformed babies) or death of an unborn baby.</span> Females who are pregnant or who plan to become pregnant must not take POMALYST.<p class="First"> <span class="Bold">POMALYST is similar to the medicine thalidomide (THALOMID).</span> We know thalidomide can cause severe life-threatening birth defects. POMALYST has not been tested in pregnant females. POMALYST has harmed unborn animals in animal testing.</p> </dd> </dl> <p class="First"> <span class="Bold">Females must not get pregnant:</span> </p> <dl> <dt> </dt> <dd> <dl> <dt>∘</dt> <dd>For at least 4 weeks before starting POMALYST</dd> <dt>∘</dt> <dd>While taking POMALYST</dd> <dt>∘</dt> <dd>During any breaks (interruptions) in your treatment with POMALYST</dd> <dt>∘</dt> <dd>For at least 4 weeks after stopping POMALYST</dd> </dl> </dd> </dl> <p> <span class="Bold">Females who can become pregnant:</span> </p> <dl> <dt> </dt> <dd> <dl> <dt>∘</dt> <dd>Will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular.<br/> If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.</dd> <dt>∘</dt> <dd>Must agree to use two acceptable forms of birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping POMALYST.</dd> <dt>∘</dt> <dd>Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy before, during, and after treatment with POMALYST.</dd> </dl> </dd> </dl> <p> <span class="Bold">If you become pregnant while taking POMALYST, stop taking it right away and call your healthcare provider.</span> If your healthcare provider is not available, you can call the REMS Call Center at 1-888-423-5436.<br/>Healthcare providers and patients should report all cases of pregnancy to:</p> <dl> <dt> </dt> <dd> <dl> <dt>∘</dt> <dd>FDA MedWatch at 1-800-FDA-1088, and</dd> <dt>∘</dt> <dd>REMS Call Center at 1-888-423-5436</dd> </dl> </dd> </dl> <p>There is a pregnancy exposure registry that monitors the outcomes of females who take POMALYST during pregnancy, or if their male partner takes POMALYST and they are exposed during pregnancy. You can enroll in this registry by calling the REMS Call Center at the phone number listed above.</p> <p> <span class="Bold">POMALYST can pass into human semen:</span> </p> <dl> <dt> </dt> <dd> <dl> <dt>∘</dt> <dd>Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking POMALYST, during any breaks (interruptions) in your treatment with POMALYST, and for 4 weeks after stopping POMALYST.</dd> <dt>∘</dt> <dd>Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant.</dd> <dt>∘</dt> <dd>Do not donate sperm while taking POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping POMALYST. If a female becomes pregnant with your sperm, the baby may be exposed to POMALYST and may be born with birth defects.</dd> </dl> </dd> </dl> <p> <span class="Bold">Men, if your female partner becomes pregnant, you should call your healthcare provider right away.</span> </p> <dl> <dt>•</dt> <dd> <span class="Bold">Blood clots in your arteries, veins, and lungs, heart attack, and stroke can happen if you take POMALYST.</span> Most people who take POMALYST will also take a blood thinner medicine to help prevent blood clots.<br/>Before taking POMALYST, tell your healthcare provider:<dl> <dt>∘</dt> <dd>If you have had a blood clot in the past</dd> <dt>∘</dt> <dd>If you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia)</dd> <dt>∘</dt> <dd>About all the medicines you take. Certain other medicines can also increase your risk for blood clots<br/>Call your healthcare provider or get medical help right away if you get any of the following during treatment with POMALYST:<dl> <dt>▪</dt> <dd> <span class="Bold">Signs or symptoms of a blood clot in the lung, arm, or leg may include:</span> shortness of breath, chest pain, or arm or leg swelling</dd> <dt>▪</dt> <dd> <span class="Bold">Signs or symptoms of a heart attack may include:</span> chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen), feeling sweaty, shortness of breath, feeling sick or vomiting</dd> <dt>▪</dt> <dd> <span class="Bold">Signs or symptoms of stroke may include:</span> sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance.</dd> </dl> </dd> </dl> </dd> </dl> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">What is POMALYST?</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First">POMALYST is a prescription medicine used to treat adults with:</p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Multiple myeloma.</span> POMALYST is taken along with the medicine dexamethasone, in people who:<dl> <dt>o</dt> <dd>have received at least 2 prior medicines to treat multiple myeloma, including a type of medicine known as a proteasome inhibitor and lenalidomide, and</dd> <dt>o</dt> <dd>their disease has become worse during treatment or within 60 days of finishing the last treatment.</dd> </dl> </dd> <dt>•</dt> <dd> <span class="Bold">AIDS-related Kaposi sarcoma (KS).</span> POMALYST is taken when highly active antiretroviral therapy (HAART) has not worked well enough or stopped working (failed).</dd> <dt>•</dt> <dd> <span class="Bold">KS who do not have HIV infection (HIV negative).</span> </dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First">It is not known if POMALYST is safe and effective in children.</p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">Who should not take POMALYST?</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First">Do not take POMALYST if you:</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <dl> <dt>•</dt> <dd>are pregnant, plan to become pregnant, or become pregnant during treatment with POMALYST. <span class="Bold">See "What is the most important information I should know about POMALYST?"</span> </dd> <dt>•</dt> <dd>are allergic to pomalidomide or any of the ingredients in POMALYST. <span class="Bold">See the end of this Medication Guide for a complete list of ingredients in POMALYST.</span> </dd> </dl> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">What should I tell my healthcare provider before taking POMALYST?</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First">Before you take POMALYST, tell your healthcare provider if you:</p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <dl> <dt>•</dt> <dd>smoke cigarettes. POMALYST may not work as well in people who smoke</dd> <dt>•</dt> <dd>have liver problems</dd> <dt>•</dt> <dd>have kidney problems and are receiving hemodialysis treatment</dd> <dt>•</dt> <dd>have any other medical conditions</dd> <dt>•</dt> <dd>are breastfeeding. <span class="Bold">You should not</span> breastfeed during treatment with POMALYST. It is not known if POMALYST passes into your breast milk and can harm your baby.</dd> </dl> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First"> <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. POMALYST and other medicines may affect each other, causing serious side effects. Talk with your healthcare provider before taking any new medicines.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First">Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">How should I take POMALYST?</span> </p> <dl> <dt>•</dt> <dd>Take POMALYST exactly as prescribed and follow all the instructions of PS-Pomalidomide REMS.</dd> <dt>•</dt> <dd>Swallow POMALYST capsules whole with water 1 time a day. <span class="Bold">Do not break, chew, or open your capsules</span>.</dd> <dt>•</dt> <dd> <span class="Bold">POMALYST may be taken with or without food.</span> </dd> <dt>•</dt> <dd>Take POMALYST at about the same time each day.</dd> <dt>•</dt> <dd>If you are on hemodialysis, take POMALYST after hemodialysis, on hemodialysis days.</dd> <dt>•</dt> <dd>Do not open the POMALYST capsules or handle them any more than needed. If you touch a broken POMALYST capsule or the medicine in the capsule, wash the area of your body right away with soap and water.</dd> <dt>•</dt> <dd>If you miss a dose of POMALYST and it has been less than 12 hours since your regular time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.</dd> <dt>•</dt> <dd>If you take too much POMALYST, call your healthcare provider right away.</dd> </dl> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">What should I avoid while taking POMALYST?</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <dl> <dt>•</dt> <dd>See "What is the most important information I should know about POMALYST?"</dd> <dt>•</dt> <dd> <span class="Bold">Females: Do not get pregnant and do not breastfeed while taking POMALYST</span>.</dd> <dt>•</dt> <dd> <span class="Bold">Males: Do not donate sperm.</span> </dd> <dt>•</dt> <dd> <span class="Bold">Do not share POMALYST with other people.</span> It may cause birth defects and other serious problems.</dd> <dt>•</dt> <dd> <span class="Bold">Do not donate blood</span> while you take POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping POMALYST. If someone who is pregnant gets your donated blood, her baby may be exposed to POMALYST and may be born with birth defects.</dd> <dt>•</dt> <dd>POMALYST can cause dizziness and confusion. Avoid taking other medicines that may cause dizziness and confusion during treatment with POMALYST. Avoid situations that require you to be alert until you know how POMALYST affects you.</dd> </dl> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">What are the possible side effects of POMALYST?</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">POMALYST can cause serious side effects, including:</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">See "What is the most important information I should know about POMALYST?"</span> </dd> <dt>•</dt> <dd> <span class="Bold">Low white blood cells (neutropenia), low platelets (thrombocytopenia), and low red blood cells (anemia) are common with POMALYST, but can also be serious.</span> You may need a blood transfusion or certain medicines if your blood counts drop too low. Your blood counts should be checked weekly for the first 8 weeks of treatment and monthly after that.</dd> <dt>•</dt> <dd> <span class="Bold">Severe liver problems, including liver failure and death.</span> Your healthcare provider should do blood tests to check your liver function during your treatment with POMALYST. Tell your healthcare provider right away if you develop any of the following symptoms of liver problems:</dd> </dl> </td> </tr> <tr> <td class="Lrule" valign="top"></td><td colspan="2" valign="top"> <dl> <dt>o</dt> <dd>Yellowing of your skin or the white part of your eyes (jaundice)</dd> <dt>o</dt> <dd>Dark or brown (tea-colored) urine</dd> </dl> </td><td class="Rrule" colspan="2" valign="top"> <dl> <dt>o</dt> <dd>Pain on the upper right side of your stomach area (abdomen)</dd> <dt>o</dt> <dd>Bleeding or bruising more easily than normal</dd> <dt>o</dt> <dd>Feeling very tired</dd> </dl> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Severe allergic reactions and severe skin reactions</span> can happen with POMALYST and may cause death.<br/> <span class="Bold">Call your healthcare provider if you develop any of the following signs or symptoms during treatment with POMALYST:</span> </dd> </dl> </td> </tr> <tr> <td class="Lrule" valign="top"></td><td valign="top"> <dl> <dt>o</dt> <dd>a red, itchy, skin rash</dd> </dl> </td><td valign="top"> <dl> <dt>o</dt> <dd>peeling of your skin or blisters</dd> </dl> </td><td class="Rrule" colspan="2" valign="top"> <dl> <dt>o</dt> <dd>severe itching</dd> <dt>o</dt> <dd>fever</dd> </dl> </td> </tr> <tr> <td class="Lrule" valign="top"></td><td class="Rrule" colspan="4" valign="top"> <p class="First"> <span class="Bold">Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with POMALYST:</span> </p> </td> </tr> <tr> <td class="Lrule" valign="top"></td><td colspan="2" valign="top"> <dl> <dt>o</dt> <dd>swelling of your lips, mouth, tongue, or throat</dd> <dt>o</dt> <dd>trouble breathing or swallowing</dd> <dt>o</dt> <dd>raised red areas on your skin (hives)</dd> </dl> </td><td class="Rrule" colspan="2" valign="top"> <dl> <dt>o</dt> <dd>a very fast heartbeat</dd> <dt>o</dt> <dd>you feel dizzy or faint</dd> </dl> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <dl> <dt>•</dt> <dd> <span class="Bold">Dizziness and confusion. See "What should I avoid while taking POMALYST?</span> </dd> <dt>•</dt> <dd> <span class="Bold">Nerve damage</span>. Stop taking POMALYST and call your healthcare provider if you develop symptoms of nerve damage including: numbness, tingling, pain, burning sensation in your hands, legs, or feet.</dd> <dt>•</dt> <dd> <span class="Bold">Risk of new cancers (malignancies).</span> New cancers, including certain blood cancers (acute myelogenous leukemia or AML) have been seen in people who received POMALYST. Talk with your healthcare provider about your risk of developing new cancers if you take POMALYST.</dd> <dt>•</dt> <dd> <span class="Bold">Tumor lysis syndrome (TLS).</span> TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.</dd> </dl> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First">Your healthcare provider may tell you to stop taking POMALYST if you develop certain serious side effects during treatment.</p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First">The most common side effects of POMALYST in people with Multiple Myeloma include:</p> </td> </tr> <tr> <td class="Lrule" valign="top"></td><td valign="top"> <dl> <dt>o</dt> <dd>tiredness and weakness</dd> <dt>o</dt> <dd>constipation</dd> <dt>o</dt> <dd>nausea</dd> </dl> </td><td valign="top"> <dl> <dt>o</dt> <dd>diarrhea</dd> <dt>o</dt> <dd>shortness of breath</dd> <dt>o</dt> <dd>upper respiratory tract infection</dd> </dl> </td><td class="Rrule" colspan="2" valign="top"> <dl> <dt>o</dt> <dd>back pain</dd> <dt>o</dt> <dd>fever</dd> </dl> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First">The most common side effects of POMALYST in people with KS include:</p> </td> </tr> <tr> <td class="Lrule" valign="top"></td><td colspan="2" valign="top"> <dl> <dt>o</dt> <dd>tiredness</dd> <dt>o</dt> <dd>diarrhea</dd> <dt>o</dt> <dd>abnormal kidney function tests</dd> <dt>o</dt> <dd>decreased phosphate and calcium in the blood</dd> <dt>o</dt> <dd>rash. See <span class="Bold">"Severe allergic reactions and severe skin reactions"</span> above.</dd> </dl> </td><td class="Rrule" colspan="2" valign="top"> <dl> <dt>o</dt> <dd>nausea</dd> <dt>o</dt> <dd>constipation</dd> <dt>o</dt> <dd>increased blood sugar</dd> <dt>o</dt> <dd>decreased albumin in the blood</dd> </dl> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First">These are not all the possible side effects of POMALYST.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First">Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">How should I store POMALYST?</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <dl> <dt>•</dt> <dd>Store POMALYST at room temperature between 68°F to 77°F (20°C to 25°C).</dd> <dt>•</dt> <dd>Return any unused POMALYST to PS-Pomalidomide REMS by calling 1-888-423-5346 or your healthcare provider.</dd> </dl> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">Keep POMALYST and all medicines out of the reach of children.</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">General information about the safe and effective use of POMALYST.</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First">Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take POMALYST for conditions for which it was not prescribed. Do not give POMALYST to other people, even if they have the same symptoms you have. It may harm them and may cause birth defects.</p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First">If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about POMALYST that is written for health professionals.</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First">For more information, call 1-888-423-5436 or go to www.PS-PomalidomideREMS.com.</p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">What are the ingredients in POMALYST?</span> </p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">Active ingredient</span>: pomalidomide</p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">Inactive ingredients:</span> mannitol, pregelatinized starch, and sodium stearyl fumarate.</p> </td> </tr> <tr> <td class="Lrule Rrule" colspan="5" valign="top"> <p class="First">The 1-mg capsule shell contains gelatin, titanium dioxide, FD&amp;C blue 2, yellow iron oxide, white ink, and black ink.<br/>The 2-mg capsule shell contains gelatin, titanium dioxide, FD&amp;C blue 2, yellow iron oxide, FD&amp;C red 3, and white ink. <br/>The 3-mg capsule shell contains gelatin, titanium dioxide, FD&amp;C blue 2, yellow iron oxide, and white ink. <br/>The 4-mg capsule shell contains gelatin, titanium dioxide, FD&amp;C blue 1, FD&amp;C blue 2, and white ink.</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" colspan="5" valign="top"> <p class="First">Marketed by: Bristol-Myers Squibb Company, Princeton, NJ 08543 USA<br/> POMALYST<span class="Sup">®</span> is a trademark of Celgene Corporation, a Bristol-Myers Squibb company.<br/> POMMG.015</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100.1%\">\n<col width=\"3%\"/>\n<col width=\"36%\"/>\n<col width=\"23%\"/>\n<col width=\"16%\"/>\n<col width=\"23%\"/>\n<tfoot>\n<tr class=\"First Last\">\n<td class=\"Toprule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">This Medication Guide has been approved by the U.S. Food and Drug Administration.</p>\n</td><td align=\"right\" class=\"Toprule\" valign=\"top\">\n<p class=\"First\">Revised: Feb 2025    </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=\"5\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">MEDICATION GUIDE</span>\n<br/>POMALYST<span class=\"Sup\">®</span> (POM-uh-list)<br/>(pomalidomide)<br/>capsules</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What is the most important information I should know about POMALYST?</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">Before you begin taking POMALYST, you must read and agree to all of the instructions in PS-Pomalidomide REMS. For more information, call 1-888-423-5436 or go to www.PS-PomalidomideREMS.com. Before prescribing POMALYST, your healthcare provider will explain PS-Pomalidomide REMS to you and have you sign the Patient-Physician Agreement Form.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">POMALYST can cause serious side effects including:</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Possible birth defects (deformed babies) or death of an unborn baby.</span> Females who are pregnant or who plan to become pregnant must not take POMALYST.<p class=\"First\">\n<span class=\"Bold\">POMALYST is similar to the medicine thalidomide (THALOMID).</span> We know thalidomide can cause severe life-threatening birth defects. POMALYST has not been tested in pregnant females. POMALYST has harmed unborn animals in animal testing.</p>\n</dd>\n</dl>\n<p class=\"First\">\n<span class=\"Bold\">Females must not get pregnant:</span>\n</p>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt>∘</dt>\n<dd>For at least 4 weeks before starting POMALYST</dd>\n<dt>∘</dt>\n<dd>While taking POMALYST</dd>\n<dt>∘</dt>\n<dd>During any breaks (interruptions) in your treatment with POMALYST</dd>\n<dt>∘</dt>\n<dd>For at least 4 weeks after stopping POMALYST</dd>\n</dl>\n</dd>\n</dl>\n<p>\n<span class=\"Bold\">Females who can become pregnant:</span>\n</p>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt>∘</dt>\n<dd>Will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular.<br/> If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.</dd>\n<dt>∘</dt>\n<dd>Must agree to use two acceptable forms of birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping POMALYST.</dd>\n<dt>∘</dt>\n<dd>Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy before, during, and after treatment with POMALYST.</dd>\n</dl>\n</dd>\n</dl>\n<p>\n<span class=\"Bold\">If you become pregnant while taking POMALYST, stop taking it right away and call your healthcare provider.</span> If your healthcare provider is not available, you can call the REMS Call Center at 1-888-423-5436.<br/>Healthcare providers and patients should report all cases of pregnancy to:</p>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt>∘</dt>\n<dd>FDA MedWatch at 1-800-FDA-1088, and</dd>\n<dt>∘</dt>\n<dd>REMS Call Center at 1-888-423-5436</dd>\n</dl>\n</dd>\n</dl>\n<p>There is a pregnancy exposure registry that monitors the outcomes of females who take POMALYST during pregnancy, or if their male partner takes POMALYST and they are exposed during pregnancy. You can enroll in this registry by calling the REMS Call Center at the phone number listed above.</p>\n<p>\n<span class=\"Bold\">POMALYST can pass into human semen:</span>\n</p>\n<dl>\n<dt> </dt>\n<dd>\n<dl>\n<dt>∘</dt>\n<dd>Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking POMALYST, during any breaks (interruptions) in your treatment with POMALYST, and for 4 weeks after stopping POMALYST.</dd>\n<dt>∘</dt>\n<dd>Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant.</dd>\n<dt>∘</dt>\n<dd>Do not donate sperm while taking POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping POMALYST. If a female becomes pregnant with your sperm, the baby may be exposed to POMALYST and may be born with birth defects.</dd>\n</dl>\n</dd>\n</dl>\n<p>\n<span class=\"Bold\">Men, if your female partner becomes pregnant, you should call your healthcare provider right away.</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Blood clots in your arteries, veins, and lungs, heart attack, and stroke can happen if you take POMALYST.</span> Most people who take POMALYST will also take a blood thinner medicine to help prevent blood clots.<br/>Before taking POMALYST, tell your healthcare provider:<dl>\n<dt>∘</dt>\n<dd>If you have had a blood clot in the past</dd>\n<dt>∘</dt>\n<dd>If you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia)</dd>\n<dt>∘</dt>\n<dd>About all the medicines you take. Certain other medicines can also increase your risk for blood clots<br/>Call your healthcare provider or get medical help right away if you get any of the following during treatment with POMALYST:<dl>\n<dt>▪</dt>\n<dd>\n<span class=\"Bold\">Signs or symptoms of a blood clot in the lung, arm, or leg may include:</span> shortness of breath, chest pain, or arm or leg swelling</dd>\n<dt>▪</dt>\n<dd>\n<span class=\"Bold\">Signs or symptoms of a heart attack may include:</span> chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen), feeling sweaty, shortness of breath, feeling sick or vomiting</dd>\n<dt>▪</dt>\n<dd>\n<span class=\"Bold\">Signs or symptoms of stroke may include:</span> sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance.</dd>\n</dl>\n</dd>\n</dl>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What is POMALYST?</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">POMALYST is a prescription medicine used to treat adults with:</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Multiple myeloma.</span> POMALYST is taken along with the medicine dexamethasone, in people who:<dl>\n<dt>o</dt>\n<dd>have received at least 2 prior medicines to treat multiple myeloma, including a type of medicine known as a proteasome inhibitor and lenalidomide, and</dd>\n<dt>o</dt>\n<dd>their disease has become worse during treatment or within 60 days of finishing the last treatment.</dd>\n</dl>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">AIDS-related Kaposi sarcoma (KS).</span> POMALYST is taken when highly active antiretroviral therapy (HAART) has not worked well enough or stopped working (failed).</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">KS who do not have HIV infection (HIV negative).</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">It is not known if POMALYST is safe and effective in children.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Who should not take POMALYST?</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">Do not take POMALYST if you:</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>are pregnant, plan to become pregnant, or become pregnant during treatment with POMALYST. <span class=\"Bold\">See \"What is the most important information I should know about POMALYST?\"</span>\n</dd>\n<dt>•</dt>\n<dd>are allergic to pomalidomide or any of the ingredients in POMALYST. <span class=\"Bold\">See the end of this Medication Guide for a complete list of ingredients in POMALYST.</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What should I tell my healthcare provider before taking POMALYST?</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">Before you take POMALYST, tell your healthcare provider if you:</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>smoke cigarettes. POMALYST may not work as well in people who smoke</dd>\n<dt>•</dt>\n<dd>have liver problems</dd>\n<dt>•</dt>\n<dd>have kidney problems and are receiving hemodialysis treatment</dd>\n<dt>•</dt>\n<dd>have any other medical conditions</dd>\n<dt>•</dt>\n<dd>are breastfeeding. <span class=\"Bold\">You should not</span> breastfeed during treatment with POMALYST. It is not known if POMALYST passes into your breast milk and can harm your baby.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">\n<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. POMALYST and other medicines may affect each other, causing serious side effects. Talk with your healthcare provider before taking any new medicines.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I take POMALYST?</span>\n</p>\n<dl>\n<dt>•</dt>\n<dd>Take POMALYST exactly as prescribed and follow all the instructions of PS-Pomalidomide REMS.</dd>\n<dt>•</dt>\n<dd>Swallow POMALYST capsules whole with water 1 time a day. <span class=\"Bold\">Do not break, chew, or open your capsules</span>.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">POMALYST may be taken with or without food.</span>\n</dd>\n<dt>•</dt>\n<dd>Take POMALYST at about the same time each day.</dd>\n<dt>•</dt>\n<dd>If you are on hemodialysis, take POMALYST after hemodialysis, on hemodialysis days.</dd>\n<dt>•</dt>\n<dd>Do not open the POMALYST capsules or handle them any more than needed. If you touch a broken POMALYST capsule or the medicine in the capsule, wash the area of your body right away with soap and water.</dd>\n<dt>•</dt>\n<dd>If you miss a dose of POMALYST and it has been less than 12 hours since your regular time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.</dd>\n<dt>•</dt>\n<dd>If you take too much POMALYST, call your healthcare provider right away.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What should I avoid while taking POMALYST?</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>See \"What is the most important information I should know about POMALYST?\"</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Females: Do not get pregnant and do not breastfeed while taking POMALYST</span>.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Males: Do not donate sperm.</span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not share POMALYST with other people.</span> It may cause birth defects and other serious problems.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Do not donate blood</span> while you take POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping POMALYST. If someone who is pregnant gets your donated blood, her baby may be exposed to POMALYST and may be born with birth defects.</dd>\n<dt>•</dt>\n<dd>POMALYST can cause dizziness and confusion. Avoid taking other medicines that may cause dizziness and confusion during treatment with POMALYST. Avoid situations that require you to be alert until you know how POMALYST affects you.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the possible side effects of POMALYST?</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">POMALYST can cause serious side effects, including:</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">See \"What is the most important information I should know about POMALYST?\"</span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Low white blood cells (neutropenia), low platelets (thrombocytopenia), and low red blood cells (anemia) are common with POMALYST, but can also be serious.</span> You may need a blood transfusion or certain medicines if your blood counts drop too low. Your blood counts should be checked weekly for the first 8 weeks of treatment and monthly after that.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Severe liver problems, including liver failure and death.</span> Your healthcare provider should do blood tests to check your liver function during your treatment with POMALYST. Tell your healthcare provider right away if you develop any of the following symptoms of liver problems:</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\"></td><td colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>Yellowing of your skin or the white part of your eyes (jaundice)</dd>\n<dt>o</dt>\n<dd>Dark or brown (tea-colored) urine</dd>\n</dl>\n</td><td class=\"Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>Pain on the upper right side of your stomach area (abdomen)</dd>\n<dt>o</dt>\n<dd>Bleeding or bruising more easily than normal</dd>\n<dt>o</dt>\n<dd>Feeling very tired</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Severe allergic reactions and severe skin reactions</span> can happen with POMALYST and may cause death.<br/>\n<span class=\"Bold\">Call your healthcare provider if you develop any of the following signs or symptoms during treatment with POMALYST:</span>\n</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\"></td><td valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>a red, itchy, skin rash</dd>\n</dl>\n</td><td valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>peeling of your skin or blisters</dd>\n</dl>\n</td><td class=\"Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>severe itching</dd>\n<dt>o</dt>\n<dd>fever</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\"></td><td class=\"Rrule\" colspan=\"4\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with POMALYST:</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\"></td><td colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>swelling of your lips, mouth, tongue, or throat</dd>\n<dt>o</dt>\n<dd>trouble breathing or swallowing</dd>\n<dt>o</dt>\n<dd>raised red areas on your skin (hives)</dd>\n</dl>\n</td><td class=\"Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>a very fast heartbeat</dd>\n<dt>o</dt>\n<dd>you feel dizzy or faint</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Dizziness and confusion. See \"What should I avoid while taking POMALYST?</span>\n</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Nerve damage</span>. Stop taking POMALYST and call your healthcare provider if you develop symptoms of nerve damage including: numbness, tingling, pain, burning sensation in your hands, legs, or feet.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Risk of new cancers (malignancies).</span> New cancers, including certain blood cancers (acute myelogenous leukemia or AML) have been seen in people who received POMALYST. Talk with your healthcare provider about your risk of developing new cancers if you take POMALYST.</dd>\n<dt>•</dt>\n<dd>\n<span class=\"Bold\">Tumor lysis syndrome (TLS).</span> TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">Your healthcare provider may tell you to stop taking POMALYST if you develop certain serious side effects during treatment.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">The most common side effects of POMALYST in people with Multiple Myeloma include:</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\"></td><td valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>tiredness and weakness</dd>\n<dt>o</dt>\n<dd>constipation</dd>\n<dt>o</dt>\n<dd>nausea</dd>\n</dl>\n</td><td valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>diarrhea</dd>\n<dt>o</dt>\n<dd>shortness of breath</dd>\n<dt>o</dt>\n<dd>upper respiratory tract infection</dd>\n</dl>\n</td><td class=\"Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>back pain</dd>\n<dt>o</dt>\n<dd>fever</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">The most common side effects of POMALYST in people with KS include:</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\"></td><td colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>tiredness</dd>\n<dt>o</dt>\n<dd>diarrhea</dd>\n<dt>o</dt>\n<dd>abnormal kidney function tests</dd>\n<dt>o</dt>\n<dd>decreased phosphate and calcium in the blood</dd>\n<dt>o</dt>\n<dd>rash. See <span class=\"Bold\">\"Severe allergic reactions and severe skin reactions\"</span> above.</dd>\n</dl>\n</td><td class=\"Rrule\" colspan=\"2\" valign=\"top\">\n<dl>\n<dt>o</dt>\n<dd>nausea</dd>\n<dt>o</dt>\n<dd>constipation</dd>\n<dt>o</dt>\n<dd>increased blood sugar</dd>\n<dt>o</dt>\n<dd>decreased albumin in the blood</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">These are not all the possible side effects of POMALYST.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">How should I store POMALYST?</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<dl>\n<dt>•</dt>\n<dd>Store POMALYST at room temperature between 68°F to 77°F (20°C to 25°C).</dd>\n<dt>•</dt>\n<dd>Return any unused POMALYST to PS-Pomalidomide REMS by calling 1-888-423-5346 or your healthcare provider.</dd>\n</dl>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Keep POMALYST and all medicines out of the reach of children.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">General information about the safe and effective use of POMALYST.</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take POMALYST for conditions for which it was not prescribed. Do not give POMALYST to other people, even if they have the same symptoms you have. It may harm them and may cause birth defects.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about POMALYST that is written for health professionals.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">For more information, call 1-888-423-5436 or go to www.PS-PomalidomideREMS.com.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">What are the ingredients in POMALYST?</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Active ingredient</span>: pomalidomide</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Inactive ingredients:</span> mannitol, pregelatinized starch, and sodium stearyl fumarate.</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">The 1-mg capsule shell contains gelatin, titanium dioxide, FD&amp;C blue 2, yellow iron oxide, white ink, and black ink.<br/>The 2-mg capsule shell contains gelatin, titanium dioxide, FD&amp;C blue 2, yellow iron oxide, FD&amp;C red 3, and white ink. <br/>The 3-mg capsule shell contains gelatin, titanium dioxide, FD&amp;C blue 2, yellow iron oxide, and white ink. <br/>The 4-mg capsule shell contains gelatin, titanium dioxide, FD&amp;C blue 1, FD&amp;C blue 2, and white ink.</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule\" colspan=\"5\" valign=\"top\">\n<p class=\"First\">Marketed by: Bristol-Myers Squibb Company, Princeton, NJ 08543 USA<br/> POMALYST<span class=\"Sup\">®</span> is a trademark of Celgene Corporation, a Bristol-Myers Squibb company.<br/> POMMG.015</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

NDC 59572-501-21Pomalyst® (pomalidomide) capsules1 mgWARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS.Rx only21 CapsulesBristol Myers Squibb

{ "type": "p", "children": [], "text": "NDC 59572-501-21Pomalyst® (pomalidomide) capsules1 mgWARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS.Rx only21 CapsulesBristol Myers Squibb" }

NDC 59572-502-21Pomalyst® (pomalidomide) capsules2 mgWARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS.Rx only21 CapsulesBristol Myers Squibb

{ "type": "p", "children": [], "text": "NDC 59572-502-21Pomalyst® (pomalidomide) capsules2 mgWARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS.Rx only21 CapsulesBristol Myers Squibb" }

NDC 59572-503-21Pomalyst® (pomalidomide) capsules3 mgWARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS.Rx only21 CapsulesBristol Myers Squibb

{ "type": "p", "children": [], "text": "NDC 59572-503-21Pomalyst® (pomalidomide) capsules3 mgWARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS.Rx only21 CapsulesBristol Myers Squibb" }

NDC 59572-504-21Pomalyst® (pomalidomide) capsules4 mgWARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS.Rx only21 CapsulesBristol Myers Squibb

{ "type": "p", "children": [], "text": "NDC 59572-504-21Pomalyst® (pomalidomide) capsules4 mgWARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS.Rx only21 CapsulesBristol Myers Squibb" }