Solutions For Healthcare Providers

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

Mitosol is an antimetabolite which received FDA approval in 2012 as an adjunct to ab-externo glaucoma surgery. Mitosol is the only FDA approved ophthalmic Mitomycin C formulation.

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Meet the standard of care in glaucoma surgery

  • FDA

    The only formulation of ophthalmic MMC approved by the FDA

  • USP<800>

    The only system to meet new USP<800> standardsfor containment and disposal

  • CSTD

    Closed-system transfer device minimizes risk of breakage, leakage, and exposure

FDA-approved ophthalmic MMC

The Total Package

  • Offers an on-demand reconstitution system that’s as immediate as it is precise
  • Can be stored at room temperature for up to 24 months
  • Patented, closed-system preparation and disposal

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The information contained herein is intended for use by US healthcare professionals.

Mitosol® Important Safety Information

Indication for Use

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.

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.

Product Information

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