These Highlights Do Not Include All The Information Needed To Use Mitosol®

Mitosol ^®

(mitomycin for solution)

0.2 mg/vial

Kit for Ophthalmic Use

Read INSTRUCTIONS FOR USE Before Proceeding

Instructions for Use

DISPOSE OF CHEMOTHERAPY WASTE BAG AND ITS CONTENTS AS CHEMOTHERAPY WASTE

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

Animal Data

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

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.

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

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.

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.

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:

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.

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.

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).

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.

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.

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

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.

• •
  Hypersensitivity to mitomycin. (4.1)

The following clinically significant adverse reactions are described elsewhere in the labeling:

• •
  Cell Death [see Warnings and Precautions (5.1)]
• •
  Hypotony [see Warnings and Precautions (5.2)]
• •
  Cataract Formation [see Warnings and Precautions (5.3)]

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

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

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

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.

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)].

• •
  Cell Death: 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. (5.1)
• •
  Hypotony: The use of mitomycin has been associated with an increased incidence of post-operative hypotony. (5.2)
• •
  Cataract Development: Use in phakic patients has been correlated to a higher incidence of lenticular change and cataract formation. (5.3)
• •
  Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to use. (5.4, 8.1, 8.3)

Mitosol^® is intended for topical application to the surgical site of glaucoma filtration surgery. It is not intended for intraocular administration. (2)

• •
  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 has dissolved into solution. (2.2)
• •
  Fully saturate sponges provided within the Mitosol^® Kit utilizing the entire reconstituted contents of the vial in the manner prescribed in the Instructions for Use. (2.3)
• •
  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. (2.3)

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.

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.

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.

• •
  Instruct patients to discuss with their physician if they are pregnant or if they might become pregnant [see Use in Specific Populations (8.1)].
• •
  Instruct patients to discuss with their physician if they have demonstrated a hypersensitivity to mitomycin in the past [see Contraindications (4.1)].
• •
  Nursing mothers should be advised that it is not known if Mitosol^® is excreted in human milk. 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^® [see Use in Specific Populations ( 8.2 )].
• •
  Patients should be advised of the toxicity of Mitosol^® and potential complications.

Manufactured for:

Mobius Therapeutics, LLC

1000 Executive Parkway

Suite 224

St. Louis, MO 63141

NDC 49771-002-02

Mitosol^®

(mitomycin for solution)

0.2 mg/vial

Lyophilized Mitomycin for

reconstitution

For ophthalmic use

Protect from light.

Single Use Vial

Dose: See Package Insert.

Rx Only

Store at 20°-25°C (68°-77°F).

Manufactured for:

Mobius Therapeutics, LLC

1000 Executive Parkway

Suite 224

St. Louis, MO 63141

Manufactured by:

Intas Pharmaceuticals Ltd.

Ahmedabad-382 210, INDIA.

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

10 9480 0 6029283 INL5021

NDC 49771-002-02

Mitosol^®

(mitomycin for solution)

0.2 mg/vial

Lyophilized Mitomycin for

reconstitution

For ophthalmic use

Protect from light.

Single Use Vial

Dose: See Package Insert.

Rx Only

Store at 20°-25°C (68°-77°F).

Manufactured for:

Mobius Therapeutics, LLC

1000 Executive Parkway

Suite 224

St. Louis, MO 63141

Lot:

EXP Date

YYYY-MM-DD

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^®.

Mitosol^®

(mitomycin for solution)

0.2 mg/vial

Kit for Ophthalmic Use

Manufactured for:

Mobius Therapeutics, LLC

1000 Executive Parkway

Suite 224

St. Louis, MO 63141 USA

+1 314-615-6930

1-877-EYE-MITO (1-877-393-6486)

Rx ONLY

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

mobius

therapeutics™

A1426418-1

Rev. 8/19

NDC #49771-002-01

Re-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

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.

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

HD CAUTION: HAZARDOUS DRUG

OBSERVE SPECIAL HANDLING, ADMINISTRATION

AND DISPOSAL REQUIREMENTS

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

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.

Mitosol ^®

(mitomycin for solution)

0.2 mg/vial

Kit for Ophthalmic Use

Read INSTRUCTIONS FOR USE Before Proceeding

Instructions for Use

DISPOSE OF CHEMOTHERAPY WASTE BAG AND ITS CONTENTS AS CHEMOTHERAPY WASTE

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

Animal Data

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

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.

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

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.

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.

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:

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.

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.

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).

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.

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.

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

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.

• •
  Hypersensitivity to mitomycin. (4.1)

The following clinically significant adverse reactions are described elsewhere in the labeling:

• •
  Cell Death [see Warnings and Precautions (5.1)]
• •
  Hypotony [see Warnings and Precautions (5.2)]
• •
  Cataract Formation [see Warnings and Precautions (5.3)]

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

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

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

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.

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)].

• •
  Cell Death: 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. (5.1)
• •
  Hypotony: The use of mitomycin has been associated with an increased incidence of post-operative hypotony. (5.2)
• •
  Cataract Development: Use in phakic patients has been correlated to a higher incidence of lenticular change and cataract formation. (5.3)
• •
  Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to use. (5.4, 8.1, 8.3)

Mitosol^® is intended for topical application to the surgical site of glaucoma filtration surgery. It is not intended for intraocular administration. (2)

• •
  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 has dissolved into solution. (2.2)
• •
  Fully saturate sponges provided within the Mitosol^® Kit utilizing the entire reconstituted contents of the vial in the manner prescribed in the Instructions for Use. (2.3)
• •
  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. (2.3)

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.

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.

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.

• •
  Instruct patients to discuss with their physician if they are pregnant or if they might become pregnant [see Use in Specific Populations (8.1)].
• •
  Instruct patients to discuss with their physician if they have demonstrated a hypersensitivity to mitomycin in the past [see Contraindications (4.1)].
• •
  Nursing mothers should be advised that it is not known if Mitosol^® is excreted in human milk. 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^® [see Use in Specific Populations ( 8.2 )].
• •
  Patients should be advised of the toxicity of Mitosol^® and potential complications.

Manufactured for:

Mobius Therapeutics, LLC

1000 Executive Parkway

Suite 224

St. Louis, MO 63141

NDC 49771-002-02

Mitosol^®

(mitomycin for solution)

0.2 mg/vial

Lyophilized Mitomycin for

reconstitution

For ophthalmic use

Protect from light.

Single Use Vial

Dose: See Package Insert.

Rx Only

Store at 20°-25°C (68°-77°F).

Manufactured for:

Mobius Therapeutics, LLC

1000 Executive Parkway

Suite 224

St. Louis, MO 63141

Manufactured by:

Intas Pharmaceuticals Ltd.

Ahmedabad-382 210, INDIA.

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

10 9480 0 6029283 INL5021

NDC 49771-002-02

Mitosol^®

(mitomycin for solution)

0.2 mg/vial

Lyophilized Mitomycin for

reconstitution

For ophthalmic use

Protect from light.

Single Use Vial

Dose: See Package Insert.

Rx Only

Store at 20°-25°C (68°-77°F).

Manufactured for:

Mobius Therapeutics, LLC

1000 Executive Parkway

Suite 224

St. Louis, MO 63141

Lot:

EXP Date

YYYY-MM-DD

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^®.

Mitosol^®

(mitomycin for solution)

0.2 mg/vial

Kit for Ophthalmic Use

Manufactured for:

Mobius Therapeutics, LLC

1000 Executive Parkway

Suite 224

St. Louis, MO 63141 USA

+1 314-615-6930

1-877-EYE-MITO (1-877-393-6486)

Rx ONLY

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

mobius

therapeutics™

A1426418-1

Rev. 8/19

NDC #49771-002-01

Re-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

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.

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

HD CAUTION: HAZARDOUS DRUG

OBSERVE SPECIAL HANDLING, ADMINISTRATION

AND DISPOSAL REQUIREMENTS

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

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.