Mitosol® (mitomycin for solution) 0.2 mg/vial Kit for Ophthalmic Use Rx only
BRIEF SUMMARY: Please consult package insert for full prescribing information.
Mitosol Package Insert
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
