Frequently Asked Questions about Mitosol
What is Mitosol?
Learn more about What is Mitosol?
What is a trabeculectomy procedure?
A trabeculectomy procedure is done to create a controlled drainage path from inside the eye, relieving high pressure inside the eye.
Why is Mitosol used during a trabeculectomy?
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.
What is an EX-PRESS® Glaucoma Filtration Device Procedure?
What concentration is Mitosol?
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%.
How do I place an order?
- 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
Can I get Mitosol through my wholesaler?
For convenience, Mitosol is also available from Cardinal Specialty Pharmacy.
How many kits come in a box?
Each box contains three single patient use kits.
Can I buy just one kit?
No. Our approval allows for a single presentation; a box containing three kits.
Do you participate in GPO agreements?
Yes. Ask your local representative for further details.
What if I waste the kit or it expires?
Mobius™ offers no charge replacements for any kits that either expire and/or are opened and not used on a patient.
How do I return a defective product?
While uncommon, should you receive a defective product, please contact your local representative or give us a call at 1-877-EYE-MITO.
How does Mitosol deliver a consistent result?
Liquid mitomycin-c degrades immediately and constantly. Because the Mitosol is reconstituted at the time use, such degradation is avoided.
How does Mitosol ensure sterility?
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.
Does Mitosol require refrigeration and light shielding?
No. Mitosol is always “shelf ready” at room temperature and in ambient light
What is the shelf life of Mitosol?
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.
Do I need to wear protective equipment when handling Mitosol?
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.
Is there a risk to pregnant or nursing healthcare workers when using Mitosol?
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.”
What if I come into direct contact with Mitosol?
Detailed first aid measures are listed in Mitosol’s Safety Data Sheet, to be found by clicking on this link.
What is the proper way to manage a spill?
- 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.
May I dispose of Mitosol in a sharps container?
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.
How do I dispose of Mitosol?
Laws, Standards and Regulations
What is DQSA and how does it impact my facility?
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.
What is a 503a compounding pharmacy?
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.
What is a 503b pharmacy or a “Registered Outsourcing Facility”?
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.
How can I check if my compounder has been inspected by the FDA?
The FDA publishes an active database on pharmacy inspections and their findings when inspected. This database may be accessed by clicking on this link.
What is USP <800>?
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.
Is Mitosol USP <800> compliant?
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.
Do you have online training tools?
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>.
Do you provide training?
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.
WMI-032 Rev 11/2019