Below is a list of Frequently Asked Questions (FAQs) about Mitosol
General
What is Mitosol?
Learn more about What is Mitosol?
What is a trabeculectomy procedure?
A trabeculectomy procedure is done to relieve pressure in the eye caused by glaucoma
Why is Mitosol used during a trabeculectomy?
Trabeculectomy is performed to treat glaucoma, a bleb is created during the procedure. Mitosol is used to prevent bleb failure. Learn more about Mitosol and trabeculectomy
What if I waste the kit or it expires?
No problem, Mobius has always and will continue to offer no charge replacements for any kits that either expire and/or are opened but not used on a patient.
What concentration is Mitosol?
The Mitosol kit contains 1 vial with 0.2mg of dry lyophilized mitomycin-c powder. When the entire contents of the 1mL syringe are injected into the vial, the resultant concentration is 0.02%.
What are your approved indications?
Mitosol® (mitomycin for solution) 0.2 mg/vial kit for Ophthalmic Use is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery.
Are you contracted with any GPOs?
No, Mobius believes in a direct facility based pricing approach which allows maximum savings to be passed onto our customers. Please contact us to discuss pricing for your facility.
Can I get Mitosol through my wholesaler?
Mitosol is available for order at list price through Cardinal Specialty Pharmacy.
Can I buy just one kit?
No, the FDA approved Mitosol as a box of 3 kits and hence we cannot dispense single kits.
How many kits come in a box?
3 individual use kits come in a box
How do I place an order?
Ordering is easy, You can call, fax, email, or submit an order online. Please visit Place an Order
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.
What is an Ex-PRESS® Shunt Procedure?
A surgeon implants an Ex-PRESS Shunt under the scleral flap to allow drainage and relieve intraocular pressure. Learn more about an Ex-PRESS Shunt Procedure here.
Benefits
How does Mitosol deliver a consistent result?
Mitomycin-c begins degrading immediately upon reconstitution. Because the Mitosol kit is reconstituted at the time surgery, the typical degradation associated with compound MMC is avoided and hence the ability to ensure the same concentration of drug across all patients.
How does Mitosol ensure sterility?
As an FDA approved drug, Mobius Therapeutics is required to adhere to the strict standards established by the FDA. In addition, the leadership at Mobius has years of experience in sterile manufacturing of bulk products making us singularly unique in the sterile processing of mitomycin-c for ophthalmology.
Does Mitosol require refrigeration?
No, Mitosol requires no refrigeration.
What is the typical shelf life on compounded MMC?
The noted shelf life of MMC from compounders varies substantially, however, the average is about 2 weeks. All shelf life of compounded mitomycin-c assumes refrigeration and light shielding – something that is unnecessary with Mitosol®.
What is the shelf life of Mitosol?
Mitosol has a 2-year shelf life from the date of manufacture and does not require refrigeration and/or light shielding. Should your Mitosol expire before use, Mobius will replace at no charge.
Handling
What should I do if my skin or eyes come in contact with Mitosol?
First aid measures listed in MSDS
How do I handle a spill?
Please follow the step by step instructions in How to handle a Mitosol spill?
Does the contraindication for pregnancy include pregnant health care workers who work with Mitosol?
Unfortunately, safe use during pregnancy has not been established. The following is a statement from the American Academy of Ophthalmology regarding use of MMC in pregnant/lactating patients. Learn more
Do I need to wear special gloves when handling Mitosol?
Natural rubber latex, Neoprene and Nitrile gloves display the highest resistance to permeation by Mitosol.
Disposal
Can I put the Mitosol kit in the sharps container?
Per disposal guidelines, chemotherapy drugs should be disposed of in approved yellow or black waste containers. As such, it is never advised that Mitosol parts be disposed of in red sharps containers.
How do I dispose of Mitosol?
Legislation
My compounder is a traditional (503A) compounding pharmacy – what does this mean?
A 503A pharmacy practices the traditional art and science of compounding. That is to say, they will create individual doses for individually identified patients only with a patient specific prescription. Additionally, 503A compounders are not required to adhere to the same strict standards of sterile processing as an FDA approved manufacturer.
How can I check if my compounder has been inspected by the FDA?
Please follow the link to the FDA’s website for the most current list of inspections. Compounding: Inspections Recalls and other actions.
My compounder is a 503B – what does this mean?
503B is a voluntary designation by which facilities agree to adhere to strict, cGMP (FDA regulated) manufacturing parameters, not make copies of FDA approved drugs, and produce compounded products only from a pre-specified list of substances. In return, these facilities are permitted to manufacture and distribute selected drugs without prescriptions.
Is Mitosol USP 800 compliant?
Yes, Mitosol is already packaged with a closed system transfer device and conforms to the regulations.
What is USP 800?
USP 800 is an extension of the USP 797 guidelines stating that necessary precautions must be taken by healthcare workers to prevent unwanted exposure to hazardous drugs, all the way to the point of patient administration. Of most relevance to the ophthalmic OR, USP 800 will require the use of closed system transfer devices when handling mitomycin-c.
What is DQSA and how does this impact my facility?
DQSA (the Drug Quality and Security Act) is a law that was passed following the New England Compounding Center tragedies to establish oversight of compounding pharmacies. The law was the first step to ensuring compounders are held to a higher standard, not making copies of FDA approved drugs, and more specifically will establish a list of active pharmaceutical ingredients approved to be compounded. We have a recent DQSA Webinar posted on our corporate site, to learn more visit DQSA Webinar
Training
Do you have online training tools?
Yes, visit the Mitosol Resource Center There is an inservice video, package insert, instructions for use, and MSDS sheets available.
Do you provide training?
Absolutely….in fact we highly encourage it….while the product is simple, nothing replaces a little bit of good ol’ fashion face to face interaction. Please contact your local Mitosol representative to coordinate.
WMI-032 Rev 01/2018