Mitosol® is an antimetabolite indicated for use as an adjunct to ab externo glaucoma surgery.

{ "type": "p", "children": [], "text": "Mitosol® is an antimetabolite indicated for use as an adjunct to ab externo glaucoma surgery. " }

Mitosol® is intended for topical application to the surgical site of glaucoma filtration surgery. Mitosol® is a cytotoxic drug. It is not intended for intraocular administration. If intraocular administration occurs, cell death leading to corneal infarction, retinal infarction, and ciliary body atrophy may result. Verify pregnancy status in females of reproductive potential prior to using Mitosol®.

Each vial of Mitosol® contains 0.2 mg of mitomycin and mannitol in a 1:2 concentration ratio. To reconstitute, add 1 mL of Sterile Water for Injection, then shake to dissolve. If product does not dissolve immediately, allow to stand at room temperature until the product dissolves into solution.

Sponges provided within the Mitosol® Kit should be fully saturated with the entire reconstituted contents in the manner prescribed in the Instructions for Use. A treatment area approximating 10mm x 6mm +/- 2mm should be treated with the Mitosol®. Apply fully saturated sponges equally to the treatment area, in a single layer, with the use of a surgical forceps. Keep the sponges on the treatment area for two (2) minutes, then remove and return to the Mitosol® Tray for defined disposal in the Chemotherapy Waste Bag provided.

Lyophilized Mitosol® stored at 20°C to 25°C (68°F to 77°F) is stable for the shelf life indicated on the package. Avoid excessive heat. Protect from light.

Reconstituted with 1 mL of Sterile Water for Injection at a concentration of 0.2 mg/mL, mitomycin is stable for one (1) hour at room temperature.

Mitosol® is a sterile lyophilized mixture of mitomycin and mannitol, which, when reconstituted with Sterile Water for Injection, provides a solution for application in glaucoma filtration surgery. Mitosol® is supplied in vials containing 0.2 mg of mitomycin. Each vial also contains mannitol 0.4 mg, at a 1:2 ratio of mitomycin to mannitol. Each mL of reconstituted solution contains 0.2 mg mitomycin and has a pH between 5.0 and 8.0.

{ "type": "p", "children": [], "text": "Mitosol® is a sterile lyophilized mixture of mitomycin and mannitol, which, when reconstituted with Sterile Water for Injection, provides a solution for application in glaucoma filtration surgery. Mitosol® is supplied in vials containing 0.2 mg of mitomycin. Each vial also contains mannitol 0.4 mg, at a 1:2 ratio of mitomycin to mannitol. Each mL of reconstituted solution contains 0.2 mg mitomycin and has a pH between 5.0 and 8.0. " }

Mitosol® is contraindicated in patients that have demonstrated a hypersensitivity to mitomycin in the past.

Mitomycin is cytotoxic. Use of mitomycin in concentrations higher than 0.2 mg/mL or use for longer than 2 minutes may lead to unintended corneal and/or scleral damage including thinning or perforation. Direct contact with the corneal endothelium will result in cell death.

The use of mitomycin has been associated with an increased incidence of post-operative hypotony.

Use in phakic patients has been correlated to a higher incidence of lenticular change and cataract formation.

Based on findings in animals and mechanism of action, Mitosol® can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, parenteral administration of mitomycin resulted in teratogenicity [see Use in Specific Populations (8.1, 8.3) and Clinical Pharmacology (12.1)].

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. The most frequent adverse reactions to Mitosol® occur locally, as an extension of the pharmacological activity of the drug. These reactions include:

Blebitis: bleb ulceration, chronic bleb leak, encapsulated/cystic bleb, bleb-related infection, wound dehiscence, conjunctival necrosis, thin-walled bleb

Cornea: corneal endothelial damage, epithelial defect, anterior synechiae, superficial punctuate keratitis, Descemet's detachment, induced astigmatism

Endophthalmitis

Hypotony: choroidal reactions (choroidal detachment, choroidal effusion, serous choroidal detachment, suprachoroidal hemorrhage, hypotony maculopathy, presence of supraciliochoroidal fluid, hypoechogenic suprachoroidal effusion)

Inflammation: iritis, fibrin reaction

Lens: cataract development, cataract progression, capsule opacification, capsular constriction and/or capsulotomy rupture, posterior synechiae

Retina: retinal pigment epithelial tear, retinal detachment (serous and rhegatogenous)

Scleritis: wound dehiscence

Vascular: hyphema, central retinal vein occlusion, hemiretinal vein occlusion, retinal hemorrhage, vitreal hemorrhage and blood clot, subconjunctival hemorrhage, disk hemorrhage

Additional Reactions: macular edema, sclera thinning or ulceration, intraocular lens capture, disk swelling, malignant glaucoma, lacrimal drainage system obstruction, ciliary block, corneal vascularization, visual acuity decrease, cystic conjunctival degeneration, upper eyelid retraction, dislocated implants, severe loss of vision.

Based on findings in animals and mechanism of action [see Clinical Pharmacology (12.1)], Mitosol® can cause fetal harm when administered to a pregnant woman. There are no available data on Mitosol® use in pregnant women to inform the drug-associated risk. In animal reproduction studies, parenteral administration of mitomycin resulted in teratogenicity (see Data). Advise pregnant women of the potential risk to a fetus.

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

Animal Data

Parenteral administration of mitomycin in animal reproduction studies produced fetal malformations and embryofetal lethality.

There are no data on the presence of mitomycin in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during and for 1 week following administration of Mitosol®.

Mitosol® can cause fetal harm when administered to pregnant women [see Use in Specific Populations (8.1)].

Verify pregnancy status in females of reproductive potential prior to using Mitosol®.

Safety and effectiveness in pediatric patients have not been established.

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Mitomycin is an antibiotic isolated from the broth of Streptomyces verticillus Yingtanensis which has been shown to have antimetabolic activity.

{ "type": "p", "children": [], "text": "Mitomycin is an antibiotic isolated from the broth of Streptomyces verticillus Yingtanensis which has been shown to have antimetabolic activity. " }

Mitomycin is a blue-violet crystalline powder with the molecular formula of C15H18N4O5 and a molecular weight of 334.33. Its chemical name is 7-amino-9α-methoxymitosane and it has the following structural formula:

{ "type": "p", "children": [], "text": "Mitomycin is a blue-violet crystalline powder with the molecular formula of C15H18N4O5 and a molecular weight of 334.33. Its chemical name is 7-amino-9α-methoxymitosane and it has the following structural formula: " }

Mitosol® is a sterile lyophilized mixture of mitomycin and mannitol, which, when reconstituted with Sterile Water for Injection, provides a solution for application in glaucoma filtration surgery. Mitosol® is supplied in vials containing 0.2 mg of mitomycin. Each vial also contains mannitol 0.4 mg, at a 1:2 ratio of mitomycin to mannitol. Each mL of reconstituted solution contains 0.2 mg mitomycin and has a pH between 5.0 and 8.0.

{ "type": "p", "children": [], "text": "Mitosol® is a sterile lyophilized mixture of mitomycin and mannitol, which, when reconstituted with Sterile Water for Injection, provides a solution for application in glaucoma filtration surgery. Mitosol® is supplied in vials containing 0.2 mg of mitomycin. Each vial also contains mannitol 0.4 mg, at a 1:2 ratio of mitomycin to mannitol. Each mL of reconstituted solution contains 0.2 mg mitomycin and has a pH between 5.0 and 8.0. " }

Mitosol® inhibits the synthesis of deoxyribonucleic acid (DNA). The guanine and cytosine content correlates with the degree of mitomycin-induced cross-linking. Cellular RNA and protein synthesis may also be suppressed.

Absorption

The systemic exposure of mitomycin following ocular administration of Mitosol® in humans is unknown. Based on a comparison of the proposed dose of up to 0.2 mg to intravenous (IV) doses of mitomycin used clinically for treatment of oncologic indications (up to 20 mg/m2), systemic concentrations in humans upon ocular administration are expected to be multiple orders of magnitude lower than those achieved by IV administration.

Elimination

Metabolism

In humans, mitomycin is cleared from ophthalmic tissue after intraoperative topical application and irrigation, as metabolism occurs in other affected tissues. Systemic clearance is affected primarily by metabolism in the liver. The rate of clearance is inversely proportional to the maximal serum concentration because of saturation of the degradative pathways.

Excretion

Approximately 10% of an injectable dose of mitomycin is excreted unchanged in the urine. Since metabolic pathways are saturated at relatively low doses, the percent of a dose excreted in urine increases.

Adequate long-term studies in animals to evaluate carcinogenic potential have not been conducted with Mitosol®. Intravenous administration of mitomycin has been found to be carcinogenic in rats and mice. At doses approximating the recommended clinical injectable dose in humans, mitomycin produces a greater than 100 percent increase in tumor incidence in male Sprague-Dawley rats, and a greater than 50 percent increase in tumor incidence in female Swiss mice.

The effect of Mitosol® on fertility is unknown.

In placebo-controlled studies reported in the medical literature, mitomycin reduced intraocular pressure (IOP) by 3 mmHg in patients with open-angle glaucoma when used as an adjunct to ab externo glaucoma surgery by Month 12.

{ "type": "p", "children": [], "text": "In placebo-controlled studies reported in the medical literature, mitomycin reduced intraocular pressure (IOP) by 3 mmHg in patients with open-angle glaucoma when used as an adjunct to ab externo glaucoma surgery by Month 12. " }

In studies with a historical control reported in the medical literature, mitomycin reduced intraocular pressure (IOP) by 5 mmHg in patients with open-angle glaucoma when used as an adjunct to ab externo glaucoma surgery by Month 12.

{ "type": "p", "children": [], "text": "In studies with a historical control reported in the medical literature, mitomycin reduced intraocular pressure (IOP) by 5 mmHg in patients with open-angle glaucoma when used as an adjunct to ab externo glaucoma surgery by Month 12. " }

Mitosol® (mitomycin for solution) is available in a kit containing:

One             Vial containing 0.2 mg mitomycin

One             1 mL syringe (Sterile Water For Injection) with Safety Connector

One             Plunger Rod

One             Vial Adapter with Spike

One             1 mL TB Syringe, Luer Lock

One             Sponge Container

Six               3 mm Absorbent Sponges

Six               6 mm Absorbent Sponges

Six               Half Moon Sponges

One             Instrument Wedge Sponge

One             Protective Foam Pouch

One             Chemotherapy Waste Bag

One             Label, MMC (mitomycin)

Three kits are supplied in each carton (NDC 49771-002-03).

Storage

Store kits at 20°C to 25°C (68°F to 77°F). Avoid excessive heat. Protect from light.

Handling Procedures

Mitosol® is a cytotoxic drug. Procedures for Proper Handling and Disposal of anti-cancer drugs should be followed. Appropriate containment and disposal devices are included within the Mitosol® (mitomycin for solution) Kit for Ophthalmic Use.

{ "type": "", "children": [], "text": "" }

Manufactured for:Mobius Therapeutics, LLC1000 Executive ParkwaySuite 224St. Louis, MO 63141

{ "type": "p", "children": [], "text": "Manufactured for:Mobius Therapeutics, LLC1000 Executive ParkwaySuite 224St. Louis, MO 63141 " }

Mitosol® (mitomycin for solution)0.2 mg/vial Kit for Ophthalmic Use

{ "type": "p", "children": [], "text": "\nMitosol® \n(mitomycin for solution)0.2 mg/vial\nKit for Ophthalmic Use\n" }

Read INSTRUCTIONS FOR USE Before Proceeding

{ "type": "p", "children": [], "text": "\nRead INSTRUCTIONS FOR USE Before Proceeding\n" }

Instructions for Use

{ "type": "p", "children": [], "text": "\nInstructions for Use\n" }

<div class="scrollingtable"><table cellpadding="7.2pt" width="100%"> <col width="47%"/> <col width="53%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">A. <span class="Bold">Outer Pack</span> <br/>     (Figure A)<br/> <br/> </p> <p>     One   Sterile Chemotherapy Waste Bag</p> <p>     One   Instructions for Use</p> <p>     One   Package Insert</p> <p>     One   Inner Tray</p> <p>     Two  Patient Chart Labels</p> <p> <br/> <br/> <span class="Italics">The Outer Pack is to be handled, opened, and its </span><span class="Bold">STERILE </span><span class="Italics">contents dispensed by the non-sterile circulating nurse.</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id41642182"></a><img alt="Figure A: Outer Pack" src="/dailymed/image.cfm?name=image-02.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">B. <span class="Bold">STERILE Inner Tray<br/> </span>     (Figure B)<br/> <br/> </p> <p>     One   Vial Containing 0.2 mg mitomycin (inside protective foam pouch)</p> <p>     One   1 mL Syringe (Sterile Water for Injection) with Safety Connector</p> <p>     One   Plunger Rod</p> <p>     One   Vial Adaptor with Spike (inside protective foam pouch)</p> <p>     One   1 mL TB Syringe, Luer Lock</p> <p>     One   Sponge Container Containing:</p> <p>     •   Six   3 mm Absorbent Sponges</p> <p>     •   Six   6 mm Absorbent Sponges</p> <p>     •   Six   Half Moon Sponges</p> <p>     •   One  Instrument Wedge Sponge</p> <p>     One   Label, MMC (mitomycin)</p> <p> <br/> <br/> <span class="Italics">The Sterile Inner Tray is to be handled, opened, and its contents assembled and dispensed by the sterile scrub technician.</span> </p> <p> <span class="Bold"><span class="Italics">This tray and its contents are STERILE.</span></span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id-66269582"></a><img alt="Figure B: Sterile Inner Tray" src="/dailymed/image.cfm?name=image-03.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979"/></td> </tr> <tr> <td class="Botrule" valign="top"></td><td class="Botrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">1. Getting Started<br/> <br/> </span> </p> <p> <span class="Bold"><span class="Underline">Non-Sterile Circulating Nurse:</span></span> </p> <p>Open outer pack. Affect sterile transfer of <span class="Bold">ALL </span>contents to the sterile field.<br/> <br/> </p> <p> <span class="Bold"><span class="Underline">Sterile Surgical Technician:</span></span> </p> <p>Open sterile inner tray.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1437801377"></a><img alt="Figure 1" src="/dailymed/image.cfm?name=image-04.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979"/></td> </tr> <tr> <td class="Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">2. Reconstituting Mitosol<span class="Sup">®</span> <br/> </span> <br/> </p> <p>a.  Remove vial and vial adapter from blue foam pouch.<br/> <br/> </p> <p>b.  <span class="Bold"><span class="Underline">Screw</span></span> white plunger rod to rubber plunger of pre‑filled syringe. <span class="Bold">(Fig. 1)<br/> <br/> </span> </p> <p>c.  <span class="Bold"><span class="Underline">Press firmly</span></span> and screw the <span class="Bold"><span class="Underline">blue end</span></span> of the vial adapter into the <span class="Bold"><span class="Underline">blue end</span></span> of the syringe connector. <span class="Bold">(Fig. 2)</span> <br/> <br/> </p> <p> <span class="Bold">NOTE: Do not force plunger. Syringe will not operate if vial adapter and syringe connector are not properly connected. Forcing plunger may result in syringe leakage and Mitosol<span class="Sup">®</span> exposure.</span> </p> </td><td align="center" class="Lrule Rrule Toprule" valign="top"><a name="id-279266892"></a><img alt="Figure 2" src="/dailymed/image.cfm?name=image-05.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">d.  Stand vial upright on a sturdy, flat surface and push on the vial lid until seated and secure. <span class="Bold">(Fig. 3)</span> <br/> <br/> </p> <p>e.  Inject entire contents of sterile water (1 ml) into vial. <span class="Bold">(Fig. 4) </span>Do not force syringe plunger. See note at step 2.<br/> <br/> </p> <p>f.  <span class="Bold"><span class="Underline">IMPORTANT</span>: </span>INVERT VIAL REPEATEDLY to saturate <span class="Bold">ALL </span>drug product, including that adhering to stopper, then shake until complete reconstitution of Mitosol<span class="Sup">®</span>. If product does not dissolve immediately, allow to stand at room temperature until the product has dissolved into solution.</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"><a name="id-1633088545"></a><img alt="Figure 3" src="/dailymed/image.cfm?name=image-06.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979"/><a name="id-392825239"></a><img alt="Figure 4" src="/dailymed/image.cfm?name=image-07.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979"/></td> </tr> <tr> <td class="Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">3. Preparing sponges<br/> <br/> </span> </p> <p>a.  <span class="Bold"><span class="Italics">Invert vial and syringe</span></span> and draw full volume of medication into syringe. <span class="Bold">(Fig. 5)<br/> <br/> </span> </p> <p>b.  Remove all sponges from sponge tray.<br/> <br/> </p> <p>c.  Return to sponge tray only those sponges to be saturated with Mitosol<span class="Sup">®</span>.<br/> <br/> </p> <p>d. Unscrew the syringe with safety connector from vial and vial adapter. <span class="Bold">(Fig. 6)</span> Note: <span class="Bold">DO NOT</span> remove safety connector from syringe.<span class="Bold"> <br/> <br/> </span> </p> <p>e.  Place vial and vial adaptor in chemotherapy waste disposal bag (yellow bag), and set bag aside, within sterile field, for additional use.<br/> <br/> </p> <p>f.  Take sponge container from sterile inner tray.<br/> <br/> </p> <p>g.  Screw both syringes into sponge container; the TB syringe to one end, the syringe with reconstituted Mitosol<span class="Sup">®</span> to the other.</p> </td><td align="center" class="Lrule Rrule Toprule" valign="top"><a name="id-342558533"></a><img alt="Figure 5" src="/dailymed/image.cfm?name=image-08.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979"/><a name="id1978640171"></a><img alt="Figure 6" src="/dailymed/image.cfm?name=image-09.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979"/></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">h.  <span class="Bold"><span class="Italics">Mitosol<span class="Sup">®</span> must be used within 1 hour of reconstitution:<br/> <br/> </span></span> </p> <p>•  Inject medication into sponge container, saturating sponges. Reconstituted Mitosol<span class="Sup">®</span> should remain undisturbed in sponge container for <span class="Bold"><span class="Underline">60 seconds</span></span>. <span class="Bold">(Fig. 7)</span> Do not force syringe plunger. See note at step 2.<br/> <br/> </p> <p>•  If any excess fluid remains, withdraw plunger of TB syringe, drawing excess fluid/air into syringe.</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"><a name="id126750795"></a><img alt="Figure 7" src="/dailymed/image.cfm?name=image-10.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979"/></td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">4. Using Mitosol<span class="Sup">®</span> <br/> <br/> </span> </p> <p>a.  With both syringes connected, the TB syringe to one end, the pre-filled syringe to the other, open sponge container, offering contents to surgeon for placement on surgical site. <span class="Bold">(Fig. 8)<br/> <br/> </span> </p> <p>b.  Apply saturated sponges to surgical site for two minutes. Remove sponges from eye and copiously irrigate surgical site.<br/> <br/> </p> <p>c.  As used sponges are removed from surgical site, accept used sponges back into sponge container for disposal. Close container lid.<br/> <br/> </p> <p>d.  With syringes still connected to sponge container, remove entire assembly from surgical field in chemotherapy waste disposal bag.</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"><a name="id1731190523"></a><img alt="Figure 8" src="/dailymed/image.cfm?name=image-11.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table cellpadding=\"7.2pt\" width=\"100%\">\n<col width=\"47%\"/>\n<col width=\"53%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">A. <span class=\"Bold\">Outer Pack</span>\n<br/>     (Figure A)<br/>\n<br/>\n</p>\n<p>     One   Sterile Chemotherapy Waste Bag</p>\n<p>     One   Instructions for Use</p>\n<p>     One   Package Insert</p>\n<p>     One   Inner Tray</p>\n<p>     Two  Patient Chart Labels</p>\n<p>\n<br/>\n<br/>\n<span class=\"Italics\">The Outer Pack is to be handled, opened, and its </span><span class=\"Bold\">STERILE </span><span class=\"Italics\">contents dispensed by the non-sterile circulating nurse.</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id41642182\"></a><img alt=\"Figure A: Outer Pack\" src=\"/dailymed/image.cfm?name=image-02.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">B. <span class=\"Bold\">STERILE Inner Tray<br/>\n</span>     (Figure B)<br/>\n<br/>\n</p>\n<p>     One   Vial Containing 0.2 mg mitomycin (inside protective foam pouch)</p>\n<p>     One   1 mL Syringe (Sterile Water for Injection) with Safety Connector</p>\n<p>     One   Plunger Rod</p>\n<p>     One   Vial Adaptor with Spike (inside protective foam pouch)</p>\n<p>     One   1 mL TB Syringe, Luer Lock</p>\n<p>     One   Sponge Container Containing:</p>\n<p>     •   Six   3 mm Absorbent Sponges</p>\n<p>     •   Six   6 mm Absorbent Sponges</p>\n<p>     •   Six   Half Moon Sponges</p>\n<p>     •   One  Instrument Wedge Sponge</p>\n<p>     One   Label, MMC (mitomycin)</p>\n<p>\n<br/>\n<br/>\n<span class=\"Italics\">The Sterile Inner Tray is to be handled, opened, and its contents assembled and dispensed by the sterile scrub technician.</span>\n</p>\n<p>\n<span class=\"Bold\"><span class=\"Italics\">This tray and its contents are STERILE.</span></span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-66269582\"></a><img alt=\"Figure B: Sterile Inner Tray\" src=\"/dailymed/image.cfm?name=image-03.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule\" valign=\"top\"></td><td class=\"Botrule Toprule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">1. Getting Started<br/>\n<br/>\n</span>\n</p>\n<p>\n<span class=\"Bold\"><span class=\"Underline\">Non-Sterile Circulating Nurse:</span></span>\n</p>\n<p>Open outer pack. Affect sterile transfer of <span class=\"Bold\">ALL </span>contents to the sterile field.<br/>\n<br/>\n</p>\n<p>\n<span class=\"Bold\"><span class=\"Underline\">Sterile Surgical Technician:</span></span>\n</p>\n<p>Open sterile inner tray.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1437801377\"></a><img alt=\"Figure 1\" src=\"/dailymed/image.cfm?name=image-04.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979\"/></td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">2. Reconstituting Mitosol<span class=\"Sup\">®</span>\n<br/>\n</span>\n<br/>\n</p>\n<p>a.  Remove vial and vial adapter from blue foam pouch.<br/>\n<br/>\n</p>\n<p>b.  <span class=\"Bold\"><span class=\"Underline\">Screw</span></span> white plunger rod to rubber plunger of pre‑filled syringe. <span class=\"Bold\">(Fig. 1)<br/>\n<br/>\n</span>\n</p>\n<p>c.  <span class=\"Bold\"><span class=\"Underline\">Press firmly</span></span> and screw the <span class=\"Bold\"><span class=\"Underline\">blue end</span></span> of the vial adapter into the <span class=\"Bold\"><span class=\"Underline\">blue end</span></span> of the syringe connector. <span class=\"Bold\">(Fig. 2)</span>\n<br/>\n<br/>\n</p>\n<p>\n<span class=\"Bold\">NOTE: Do not force plunger. Syringe will not operate if vial adapter and syringe connector are not properly connected. Forcing plunger may result in syringe leakage and Mitosol<span class=\"Sup\">®</span> exposure.</span>\n</p>\n</td><td align=\"center\" class=\"Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-279266892\"></a><img alt=\"Figure 2\" src=\"/dailymed/image.cfm?name=image-05.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">d.  Stand vial upright on a sturdy, flat surface and push on the vial lid until seated and secure. <span class=\"Bold\">(Fig. 3)</span>\n<br/>\n<br/>\n</p>\n<p>e.  Inject entire contents of sterile water (1 ml) into vial. <span class=\"Bold\">(Fig. 4) </span>Do not force syringe plunger. See note at step 2.<br/>\n<br/>\n</p>\n<p>f.  <span class=\"Bold\"><span class=\"Underline\">IMPORTANT</span>: </span>INVERT VIAL REPEATEDLY to saturate <span class=\"Bold\">ALL </span>drug product, including that adhering to stopper, then shake until complete reconstitution of Mitosol<span class=\"Sup\">®</span>. If product does not dissolve immediately, allow to stand at room temperature until the product has dissolved into solution.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\"><a name=\"id-1633088545\"></a><img alt=\"Figure 3\" src=\"/dailymed/image.cfm?name=image-06.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979\"/><a name=\"id-392825239\"></a><img alt=\"Figure 4\" src=\"/dailymed/image.cfm?name=image-07.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979\"/></td>\n</tr>\n<tr>\n<td class=\"Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">3. Preparing sponges<br/>\n<br/>\n</span>\n</p>\n<p>a.  <span class=\"Bold\"><span class=\"Italics\">Invert vial and syringe</span></span> and draw full volume of medication into syringe. <span class=\"Bold\">(Fig. 5)<br/>\n<br/>\n</span>\n</p>\n<p>b.  Remove all sponges from sponge tray.<br/>\n<br/>\n</p>\n<p>c.  Return to sponge tray only those sponges to be saturated with Mitosol<span class=\"Sup\">®</span>.<br/>\n<br/>\n</p>\n<p>d. Unscrew the syringe with safety connector from vial and vial adapter. <span class=\"Bold\">(Fig. 6)</span> Note: <span class=\"Bold\">DO NOT</span> remove safety connector from syringe.<span class=\"Bold\">\n<br/>\n<br/>\n</span>\n</p>\n<p>e.  Place vial and vial adaptor in chemotherapy waste disposal bag (yellow bag), and set bag aside, within sterile field, for additional use.<br/>\n<br/>\n</p>\n<p>f.  Take sponge container from sterile inner tray.<br/>\n<br/>\n</p>\n<p>g.  Screw both syringes into sponge container; the TB syringe to one end, the syringe with reconstituted Mitosol<span class=\"Sup\">®</span> to the other.</p>\n</td><td align=\"center\" class=\"Lrule Rrule Toprule\" valign=\"top\"><a name=\"id-342558533\"></a><img alt=\"Figure 5\" src=\"/dailymed/image.cfm?name=image-08.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979\"/><a name=\"id1978640171\"></a><img alt=\"Figure 6\" src=\"/dailymed/image.cfm?name=image-09.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979\"/></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">h.  <span class=\"Bold\"><span class=\"Italics\">Mitosol<span class=\"Sup\">®</span> must be used within 1 hour of reconstitution:<br/>\n<br/>\n</span></span>\n</p>\n<p>•  Inject medication into sponge container, saturating sponges. Reconstituted Mitosol<span class=\"Sup\">®</span> should remain undisturbed in sponge container for <span class=\"Bold\"><span class=\"Underline\">60 seconds</span></span>. <span class=\"Bold\">(Fig. 7)</span> Do not force syringe plunger. See note at step 2.<br/>\n<br/>\n</p>\n<p>•  If any excess fluid remains, withdraw plunger of TB syringe, drawing excess fluid/air into syringe.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\"><a name=\"id126750795\"></a><img alt=\"Figure 7\" src=\"/dailymed/image.cfm?name=image-10.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979\"/></td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">4. Using Mitosol<span class=\"Sup\">®</span>\n<br/>\n<br/>\n</span>\n</p>\n<p>a.  With both syringes connected, the TB syringe to one end, the pre-filled syringe to the other, open sponge container, offering contents to surgeon for placement on surgical site. <span class=\"Bold\">(Fig. 8)<br/>\n<br/>\n</span>\n</p>\n<p>b.  Apply saturated sponges to surgical site for two minutes. Remove sponges from eye and copiously irrigate surgical site.<br/>\n<br/>\n</p>\n<p>c.  As used sponges are removed from surgical site, accept used sponges back into sponge container for disposal. Close container lid.<br/>\n<br/>\n</p>\n<p>d.  With syringes still connected to sponge container, remove entire assembly from surgical field in chemotherapy waste disposal bag.</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><a name=\"id1731190523\"></a><img alt=\"Figure 8\" src=\"/dailymed/image.cfm?name=image-11.jpg&amp;setid=244002c6-c61d-43fe-9326-072797113979\"/></td>\n</tr>\n</tbody>\n</table></div>" }

DISPOSE OF CHEMOTHERAPY WASTE BAG AND ITS CONTENTS AS CHEMOTHERAPY WASTE

{ "type": "p", "children": [], "text": "\nDISPOSE OF CHEMOTHERAPY WASTE BAG AND ITS CONTENTS AS CHEMOTHERAPY WASTE\n" }

US Patents #7,806,265, #8,186,511, #D685,962, #D685,963, #9,205,075, #9,539,241 and #9,649,428; other international patents issued and pending.

{ "type": "p", "children": [], "text": "US Patents #7,806,265, #8,186,511, #D685,962, #D685,963, #9,205,075, #9,539,241 and #9,649,428; other international patents issued and pending." }

A4807998-2 Rev. 07/20

{ "type": "p", "children": [], "text": "\nA4807998-2 Rev. 07/20\n" }

{ "type": "", "children": [], "text": "" }

NDC 49771-002-02

{ "type": "p", "children": [], "text": "NDC 49771-002-02" }

Mitosol® (mitomycin for solution)

{ "type": "p", "children": [], "text": "\nMitosol®\n\n(mitomycin for solution)" }

0.2 mg/vial

{ "type": "p", "children": [], "text": "\n0.2 mg/vial\n" }

Lyophilized Mitomycin forreconstitutionFor ophthalmic useProtect from light.Single Use VialDose: See Package Insert.

{ "type": "p", "children": [], "text": "Lyophilized Mitomycin forreconstitutionFor ophthalmic useProtect from light.Single Use VialDose: See Package Insert." }

Rx Only

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

Store at 20°-25°C (68°-77°F).

{ "type": "p", "children": [], "text": "Store at 20°-25°C (68°-77°F)." }

Manufactured for: Mobius Therapeutics, LLC1000 Executive ParkwaySuite 224St. Louis, MO 63141

{ "type": "p", "children": [], "text": "Manufactured for: Mobius Therapeutics, LLC1000 Executive ParkwaySuite 224St. Louis, MO 63141" }

Manufactured by:Intas Pharmaceuticals Ltd.Ahmedabad-382 210, INDIA.

{ "type": "p", "children": [], "text": "Manufactured by:Intas Pharmaceuticals Ltd.Ahmedabad-382 210, INDIA." }

Mfg. Lic. No.: G/28/1026

{ "type": "p", "children": [], "text": "Mfg. Lic. No.: G/28/1026" }

10 9480 0 6029283 INL5021

{ "type": "p", "children": [], "text": "10 9480 0 6029283 INL5021" }

{ "type": "", "children": [], "text": "" }

NDC 49771-002-02

{ "type": "p", "children": [], "text": "NDC 49771-002-02" }

Mitosol® (mitomycin for solution)

{ "type": "p", "children": [], "text": "\nMitosol®\n\n(mitomycin for solution)" }

0.2 mg/vial

{ "type": "p", "children": [], "text": "\n0.2 mg/vial\n" }

Lyophilized Mitomycin forreconstitutionFor ophthalmic useProtect from light.Single Use VialDose: See Package Insert.

{ "type": "p", "children": [], "text": "Lyophilized Mitomycin forreconstitutionFor ophthalmic useProtect from light.Single Use VialDose: See Package Insert." }

Rx Only

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

Store at 20°-25°C (68°-77°F).

{ "type": "p", "children": [], "text": "Store at 20°-25°C (68°-77°F)." }

Manufactured for: Mobius Therapeutics, LLC1000 Executive ParkwaySuite 224St. Louis, MO 63141

{ "type": "p", "children": [], "text": "Manufactured for: Mobius Therapeutics, LLC1000 Executive ParkwaySuite 224St. Louis, MO 63141" }

Lot:EXP DateYYYY-MM-DD

{ "type": "p", "children": [], "text": "Lot:EXP DateYYYY-MM-DD" }

{ "type": "", "children": [], "text": "" }

Mitosol® (mitomycin for solution)0.2 mg/vial

{ "type": "p", "children": [], "text": "\nMitosol®\n\n(mitomycin for solution)0.2 mg/vial" }

Kit for Ophthalmic Use

{ "type": "p", "children": [], "text": "\nKit for Ophthalmic Use\n" }

Manufactured for:Mobius Therapeutics, LLC1000 Executive ParkwaySuite 224St. Louis, MO 63141 USA+1 314-615-69301-877-EYE-MITO (1-877-393-6486)

{ "type": "p", "children": [], "text": "Manufactured for:Mobius Therapeutics, LLC1000 Executive ParkwaySuite 224St. Louis, MO 63141 USA+1 314-615-69301-877-EYE-MITO (1-877-393-6486)" }

Rx ONLY

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

US Patents #7,806,265, #8,186,511, #D685,962,#D685,963, #9,205,075, #9,539,241 and #9,649,428;other international patents issued and pending.

{ "type": "p", "children": [], "text": "US Patents #7,806,265, #8,186,511, #D685,962,#D685,963, #9,205,075, #9,539,241 and #9,649,428;other international patents issued and pending." }

©2019 Mobius Therapeutics, LLC

{ "type": "p", "children": [], "text": "©2019 Mobius Therapeutics, LLC" }

mobius therapeutics™

{ "type": "p", "children": [], "text": "\nmobius\ntherapeutics™" }

A1426418-1 Rev. 8/19

{ "type": "p", "children": [], "text": "A1426418-1 Rev. 8/19" }

NDC #49771-002-01Re-Order #MOB.2

{ "type": "p", "children": [], "text": "NDC #49771-002-01Re-Order #MOB.2" }

Each Mitosol® Kit Contains:   One   Chemotherapy Waste Bag   One   Instructions for Use   One   Package Insert   One   Inner Tray   Two  Patient Chart Labels

{ "type": "p", "children": [], "text": "Each Mitosol® Kit Contains:   One   Chemotherapy Waste Bag   One   Instructions for Use   One   Package Insert   One   Inner Tray   Two  Patient Chart Labels" }

Inner Tray Contains:   One   Vial Containing 0.2 mg mitomycin             (inside protective foam pouch)   One   1 mL Syringe (Sterile Water for Injection)              with Safety Connector   One   Plunger Rod   One   Vial Adaptor with Spike (inside protective foam pouch)   One   1 mL TB Syringe, Luer Lock   One   Sponge Container Containing:      Six    3 mm Absorbent Sponges      Six    6 mm Absorbent Sponges      Six    Half Moon Sponges      One   Instrument Wedge Sponge   One   Label, MMC

{ "type": "p", "children": [], "text": "Inner Tray Contains:   One   Vial Containing 0.2 mg mitomycin             (inside protective foam pouch)   One   1 mL Syringe (Sterile Water for Injection)              with Safety Connector   One   Plunger Rod   One   Vial Adaptor with Spike (inside protective foam pouch)   One   1 mL TB Syringe, Luer Lock   One   Sponge Container Containing:      Six    3 mm Absorbent Sponges      Six    6 mm Absorbent Sponges      Six    Half Moon Sponges      One   Instrument Wedge Sponge   One   Label, MMC" }

Contents STERILE in unopened undamaged package.

{ "type": "p", "children": [], "text": "\nContents STERILE in unopened undamaged package.\n" }

Storage: Store kits at 20° - 25° C (68° - 77° F). Protect from light.

{ "type": "p", "children": [], "text": "Storage: Store kits at 20° - 25° C (68° - 77° F). Protect from light." }

HD CAUTION: HAZARDOUS DRUG OBSERVE SPECIAL HANDLING, ADMINISTRATIONAND DISPOSAL REQUIREMENTS

{ "type": "p", "children": [], "text": "\nHD CAUTION: HAZARDOUS DRUG\nOBSERVE SPECIAL HANDLING, ADMINISTRATIONAND DISPOSAL REQUIREMENTS" }