• Skip to primary navigation
  • Skip to main content
  • Skip to footer
Mitosol Logo

Mitosol®

Mitosol Has It All

  • HOME
  • CONTACT
  • ORDER
  • RESOURCES
    • Mitosol Resource Center
    • The Mitosol Kit
    • What is Mitosol?
    • Getting Started with Mitosol
  • ABOUT US
The Mitosol Kit

What is Mitosol?

Mitosol is a sterile, lyophilized mixture of 0.2 mg mitomycin-c and 0.4 mg mannitol. When reconstituted with 1 mL sterile water for injection, the solution contains 0.2 mg/mL mitomycin-c. It provides a solution for topical application in glaucoma filtration surgery.

Mitosol is the only FDA approved formulation of mitomycin-c bearing an ophthalmic indication. The kit was developed with the goal of solving the problems associated with the safe formulation, storage, delivery, and disposal of mitomycin-c in the ophthalmic surgical setting.

The Mitosol Kit prepares a single ophthalmic dose at the time of use.  This ensures consistent potency to every patient, every time. Other components within the kit are provided to allow for safe and sterile use of mitomycin-c, within a closed system.  This combination of components provides consistent concentration, safe handling, and unmatched convenience.

Mitosol has been specified by name as a companion drug in pivotal MIGS clinical trials, to include the XEN® Gel Stent.⁽¹⁾⁽²⁾ Additionally, the Mitosol kit is compliant with the USP <800> guidelines, as well as the Drug Quality and Security Act (DQSA).


¹ Grover DS, Flynn WJ, Bashford KP, Lewis RA, Duh Y-J, Nangia RS, Niksch B, Performance and Safety of a New Ab Interno
Gelatin Stent in Refractory Glaucoma at 12 Months, American Journal of Ophthalmology (2017), doi: 10.1016/j.ajo.2017.07.023

² Xen® is a registered trademark of Allergan PLC

WMI-033 Rev 02/2021

Footer

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.

This site is intended only for US residents.
Use of website is governed by the Terms of Use and Privacy Policy
Corporate Responsibility