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Mitosol Package Insert

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

BRIEF SUMMARY: Please consult package insert for full prescribing information.

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Mitosol Package Insert

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

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

WARNINGS AND PRECAUTIONS: 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. Hypotony: The use of mitomycin has been associated with an increased incidence of post-operative hypotony. Cataract Formation: Use in phakic patients has been correlated to a higher incidence of lenticular change and cataract formation. 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.

ADVERSE REACTIONS: Ophthalmic Adverse Reactions: 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.

USE IN SPECIFIC POPULATIONS: Pregnancy: Risk Summary: Based on findings in animals and mechanism of action, 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. 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.
Data: Animal Data – Parenteral administration of mitomycin in animal reproduction studies produced fetal malformations and embryofetal lethality. Lactation: Risk Summary: 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®. Females and Males of Reproductive Potential: Mitosol® can cause fetal harm when administered to pregnant women. Pregnancy Testing: Verify pregnancy status in females of reproductive potential prior to using Mitosol®. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: No overall differences in safety and effectiveness have been observed between elderly and younger patients.

More detailed information is available upon request.
For information about Mitosol® contact: 1-877-EYE-MITO (1-877-393-6486) Please also see full Prescribing Information at Mitosol.com

Manufactured for:
Mobius Therapeutics, LLC
1000 Executive Parkway
Suite 224
St. Louis MO 63141 USA
(314) 615-6930
Mitosol® is a registered trademark of Mobius Therapeutics, LLC

© 2021 Mobius Therapeutics, LLC  MOB0022 BS 07/01/2021

WMI-056 Rev 07/2021

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INDICATION

Mitosol® (mitomycin for solution) 0.2 mg/vial Kit for Ophthalmic Use is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery.

Dosage & Administration

Mitosol® is intended for topical application to the surgical site of glaucoma filtration surgery and must be reconstituted prior to application. Sponges provided within the Mitosol® kit should be fully saturated with the entire reconstituted contents in a manner prescribed in the Instructions For Use. The sponge(s) should be applied to the treatment area for two minutes. Reconstituted Mitosol® should be used within one hour of reconstitution.

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.

Product Information

Please click here for full Product Information for Mitosol®

IMPORTANT SAFETY INFORMATION
Contraindications

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

Warnings & Precautions

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 sclera damage including thinning or perforation. Direct contact with the corneal endothelium will result in cell death. Hypotony: The use of mitomycin has been associated with an increased instance of post-operative hypotony. Cataract Development: Use in phakic patients has been correlated to a higher instance of lenticular change and cataract formation. 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.

Adverse Events & Reactions

The most frequent adverse reactions to Mitosol® occur locally and include hypotony, hypotony maculopathy, blebitis, endophthalmitis, vascular reactions, corneal reactions, and cataract. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088.

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