Learn more about What is Mitosol?

A trabeculectomy procedure is done to create a controlled drainage path from inside the eye, relieving high pressure inside the eye.

The surgery creates a path for controlled drainage of fluid from the eye. Mitosol mitigates scar formation, improving the chance of surgical success.  Learn more about Mitosol and trabeculectomy by clicking on this link.

Learn more about an EX-PRESS® Glaucoma Filtration Device Procedure by clicking on this link.

Each kit contains 1 vial with 0.2mg of lyophilized mitomycin-c and a 1mL syringe of sterile water for injection. When the entire contents of the syringe is injected into the vial, the resulting concentration is 0.2 mg/mL or 0.02%.

• By Phone: Dial 1-877-EYE-MITO (877-323-6486), Option 1.
• By Fax: Fax order to 1-844-FAX-MITO (844-329-6486)
• By Email: Orders@MobiusTx.com

For convenience, Mitosol is also available from Cardinal Specialty Pharmacy.

Each box contains three single patient use kits.

No. Our approval allows for a single presentation; a box containing three kits.

Yes. Ask your local representative for further details.

Mobius™ offers no charge replacements for any kits that either expire and/or are opened and not used on a patient.

While uncommon, should you receive a defective product, please contact your local representative or give us a call at 1-877-EYE-MITO.

Liquid mitomycin-c degrades immediately and constantly. Because the Mitosol is reconstituted at the time use, such degradation is avoided.

Mobius Therapeutics™ adheres to the strict Good Manufacturing Practices standards established and enforced by the FDA. Every lot of lyophilized Mitosol for reconstitution is tested for sterility.

No. Mitosol is always “shelf ready” at room temperature and in ambient light

Mitosol has a 24 month shelf life from the date of manufacture, without refrigeration and/or light shielding. Mobius’™ “Evergreen Policy” replaces product at no charge should your Mitosol expire before use.

Yes. According to USP <800>, a new standard for specific personal protective equipment is required when handling HD’s. Mobius™ has published a free education manual on USP <800>, which can be download by clicking on this link.

Safe use during pregnancy has never been established.  The American Academy of Ophthalmology states: “Mitomycin C is an antifibrotic agent which is frequently applied in glaucoma surgery…There are no studies reporting the teratogenic effect of this drug in the human fetus, though the mechanism of action of the drug strongly suggests a possible teratogenic risk.” The American Society of Ophthalmic Registered Nurses advises, “MMC should not be handled by anyone breastfeeding, pregnant or trying to conceive.”

Detailed first aid measures are listed in Mitosol’s Safety Data Sheet, to be found by clicking on this link.

• Cleaning a HD Spill: Mitosol is somewhat unique, as spills are possible both on the sterile field and off the sterile field. Detailed information on how to clean spills can be found in the Mobius USP <800> Resource Manual. This can be downloaded by clicking on this link.
• Documentation of HD Spills: All HD spills must be documented. Document the circumstances of how the spill occurred, the details of spill clean-up and disposal, and an action plan to prevent this type of spill from occurring again. Utilize your facility’s existing document forms that are used for unusual occurrences, e.g. incident report.

No. Antineoplastic drugs should be disposed of in approved yellow or black waste containers. It should NEVER be disposed of in a red bag or in a sharps container.

Detailed disposal instructions may be found by clicking on this link.

The Drug Quality and Security Act (DQSA) was enacted in response to the deaths and patient injuries caused by the New England Compounding Center tragedy of 2012; detailed information can be found by clicking on this link. It is meant to ensure that compounded medications are safe and effective by establishing FDA purview of compounding pharmacies. Enacted by Congress on November 27, 2013, its details are still being implemented.

A 503a pharmacy creates individual doses of drugs for specific patients with specialized needs. An advance, patient specific prescription is always required. 503a pharmacies provide a necessary and valuable service to patients and providers. They are not required to adhere to the same standards as those applied to an FDA approved manufacturer.

A 503b Outsourcing Facility or 503b pharmacy has voluntarily registered with the FDA, enabling it to mass produce drugs not currently available in an FDA approved formulation. They must adhere to cGMP (FDA regulated) manufacturing standards, must submit to inspection and regulation by the FDA and may not make copies of FDA approved drugs. Unlike a 503a pharmacy, these facilities are permitted to manufacture and distribute selected drugs without prescriptions.

The FDA publishes an active database on pharmacy inspections and their findings when inspected.  This database may be accessed by clicking on this link. 

Effective December 2019, U.S. Pharmacopeia’s (USP) General Chapter <800> revises the standards for safe handling of hazardous drugs (HDs) to minimize the risk of exposure to healthcare personnel, patients and the environment. This applies to all areas of a hospital, pharmacy, infusion center, and/or operating room.

USP <800> compliance requires far more than just using Mitosol. Mitosol conforms with USP <800> standards and is one part of a much more complex system of compliance. Critical analyses, attestations, training, and documentation are also required. These resources can be downloaded by clicking on this link.

Yes, many. If you visit the Mitosol Resource Center by clicking on this link, you will find extensive materials, to include an in-service video, instructions for use, safe handling and disposal tips, package insert, safety data sheet, and a full compliance module for USP <800>.

Yes, of course. Clinical Applications Nurses and Medical Directors are available for consultation and instruction to meet needs from the most basic to the most technical. Contact your Mitosol representative for details.