• 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

Corporate Responsibility

NOTICE: This information is provided pursuant to the requirements of California Health & Safety Code, Section 119402, which requires pharmaceutical companies doing business in California to make available their Compliance Program and annual written declaration of compliance with the Compliance Program.

Section 119402 of the California Health & Safety Code requires a pharmaceutical company to adopt a Compliance Program that is in accordance with the U.S. Department of Health and Human Services, Office of Inspector General’s (“OIG”) “Compliance Program Guidance for Pharmaceutical Manufacturers,”, Pharmaceutical Research and Manufacturers of America (“PhRMA”) Code and the Advanced Medical Technology Association (“AdvaMed”) Code of Ethics On Interactions With Health Care Professionals. To this end, the Company has adopted and is implementing a Compliance Program that it believes is consistent with a reasonable interpretation of the OIG Compliance Guidance and the PhRMA Code. To request a copy of the Mobius Therapeutics, LLC Compliance Program Overview, please call our Customer Service Department at 1-314-615-6930 or submit an e-mail to Corporate.Compliance@MobiusTx.com. The overview can also be downloaded below.

Icon

Mobius Corporate Compliance

1 file(s) 207.72 KB
Download

To the best of its knowledge and based upon a good faith understanding of the California statutory requirements, the Company declares that it is in material compliance with both its Compliance Program and Section 119402 of the California Health and Safety Code as of June 1, 2022.

WMI-026 Rev 05/2022

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