Mitosol FAQs

What should I do if my skin or eyes come in contact with Mitosol?

First aid measures listed in MSDS

Eyes: Remove any contact lenses. Immediately flush eyes with water for 15 minutes keeping eyelids open. Cold water may be used. Do not use an eye ointment. Seek medical help

Skin: Gently wash thoroughly the contaminated skin with water and non-abrasive soap. Cold water may be used. Cover the irritated skin with an emollient. If irritation persists, seek medical attention. If the chemical gets on your clothing, remove the contaminated clothing carefully, using personal protective equipment, and wash areas of body. Wash clothing before reusing. For serious skin contact: Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek immediate medical attention.

Inhalation: Remove to fresh air, seek immediate medical attention. For serious inhalation: Remove to fresh air. Loosen clothing. If having difficulty breathing, administer oxygen. Giving mouth-to-mouth resuscitation may be dangerous. Seek immediate medical attention.

Ingestion: Have conscious person drink several glasses of water or milk. INDUCE VOMITING by sticking finger in throat or give Ipecac if ingestion has been less than 30 minutes. If greater than 30 minutes or unknown, activated charcoal may be administered if victim is alert and conscious (15-30g children; 50-100g adults). Seek immediate medical attention.

Accidental Injection: Seek prompt medical attention.

How do I handle a spill?

On the sterile field-   Place a disposable towel or small stack of 4x4s onto the spill and allow it to be absorbed, then place in yellow chemotherapy disposal bag. Gloves must be changed after cleaning a spill. Place used gloves in yellow bag.

Off the sterile field- Don gloves. Place disposable towel onto the spill and allow it to be absorbed, then wipe area of spill with a bleach wipe. Place towel and bleach wipe into yellow chemotherapy disposal bag. Remove gloves and place in yellow bag. Wash hands.

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.

“Mitomycin C is an antifibrotic agent which is frequently applied in glaucoma surgery. A decrease of mean litter size and body weight and an increase of exencephaly in second gestation mice were associated with mitomycin use.29 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.” -EyeWiki

Although this addresses use in pregnant patients, the issue is exposure to the drug.  The Mitosol kit is designed to make the use of MMC in the operating room as safe as possible, however, there is always a potential for exposure, either by contact or inhalation.  Therefore, we recommend that pregnant or nursing health care workers avoid working with it if possible.  Due to the lack of information on chemotherapy and pregnant healthcare workers, our advice is it’s better to be safe than sorry.

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.

What is Mitosol? Why is it used during a trabeculectomy?

Trabeculectomy is performed to treat glaucoma, a disease that causes blindness due to increased pressure on the optic nerve caused by compromised outflow of aqueous humor from the anterior chamber of the eye. A portion of the trabecular meshwork is removed by the surgeon to create a bypass drain for the aqueous humor. The surgeon cuts the conjunctiva and separates it from the sclera, then creates a scleral flap to access the trabecular meshwork underneath. Once the portion of the trabecular meshwork is removed, aqueous outflow is established. The aqueous collects in the space between the sclera and conjunctiva, creating a bleb, where it is reabsorbed by the body.

Over time, the sclera and the conjunctiva eventually “scar up” and the bleb is no longer functional.

Mitosol is Mitomycin C, an antimetabolite (chemotherapy agent) that destroys the fibroblasts that cause scarring of those tissues. The surgeon applies Mitosol between the sclera and conjunctiva to target the fibroblasts and prevent bleb failure.

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 that require – based upon the physician’s judgment – something that is not available in an FDA approved format. Advance prescriptions with individually identified patients are required for each and every dose. Similarly, they may not create something that is an essential copy of an FDA approved medication. Drugs produced by these compounding pharmacies are not FDA approved nor are the processes under which they are made subject to FDA oversight.

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.

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339771.htm

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 producing to a specific list of required 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 site, if you’d like to learn more.

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®.

Can I put the Mitosol kit in the sharpie 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?

Do not disconnect the syringes from the sponge receptacle- the sponge receptacle with attached syringes is intended to remain intact for disposal. The used vial, the sponge receptacle with attached syringes and any other disposable items that have come in contact with Mitosol must be placed in a disposal bin designated for chemotherapy- usually they are yellow or black. (Your waste management provider will provide special bins for this purpose.) The yellow disposal bag provided in kit is intended for disposal at the surgical field and to transport the used items to the chemotherapy bin. The yellow bag is not a substitute for the chemotherapy bin!

Chemotherapy is incinerated at a much higher temperature than other OR trash or the red bins. The goal is to break down the components of the drug to keep it out of our water supply. Your facility could be fined heavily if chemotherapy waste is found in bins or bags not designated for chemotherapy.

Do you have online training tools?

Yes, under the resources section of our website, there is an inservice video, package insert, instructions for use, and MSDS sheets available.

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 you 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?

Yes, please contact your local representative to inquire.

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.

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.

How do I place an order?

Ordering is easy, please see the Place an Order section of our website.  You can call, fax, email, or submit an order online.

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.

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 representative to coordinate.