Mitosol

Mitosol is a prescription eye solution used during glaucoma surgery. Mitomycin belongs to a group of drugs called antimetabolites. These work by decreasing the intraocular pressure (IOP) of the eye which is important in glaucoma treatment.

This medication is available as a topical eye solution to be used by a healthcare professional.

Common side effects of mitomycin eye solution include serious eye inflammation, loss of sight, cataract.

Injectable:

Mitomycin is a prescription medication used to treat cancer of the stomach or pancreas. It is used when the cancer has spread to other parts of the body and has not improved or worsened after other forms of treatment.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Topical:

Mitomycin eye solution is used as part of procedure for glaucoma surgery.

• Mobius Therapeutics LLC

Injectable:

Common side effects include the following:

• fever
• loss of appetite
• nausea
• vomiting

Topical:

Common side effects of mitomycin eye solution include serious eye inflammation, loss of sight, cataract.

Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention if you have every received doxorubicin (Adriamycin, Rubex). Your doctor may need to monitor you carefully for side effects.

Injectable:

• Mitomycin can cause a severe decrease in the number of blood cells in your bone marrow. This may cause certain symptoms and may increase the risk that you will develop a serious infection or bleeding. If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, ongoing cough and congestion, or other signs of infection; unusual bleeding or bruising.
• Mitomycin may cause hemolytic uremic syndrome (a potentially life-threatening condition that involves injury to red blood cells, causing anemia and kidney problems). If you experience any of the following symptoms, tell your doctor immediately: red or bloody stools or diarrhea; decreased urination; swelling of the face, arms, hands, feet, ankles, or lower legs; or unusual tiredness or weakness.
• Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before and during your treatment to see if it is safe for you to receive mitomycin and to check your body's response to mitomycin.

Do not use mitomycin injection if you

• are allergic to it or to any inactive ingredients
• are pregnant

Topical:

Serious side effects with mitomycin include the following:

• Cell Death. Use of mitomycin in high concentrations or use for longer than intended may lead to unintended eye damage including thinning or perforation.
• Hypotony (low eye pressure). The use of mitomycin has been associated with an increased instance of post-operative hypotony.
• Cataract development

Do not use mitomycin eye solution if you

• allergic to it or to any inactive ingredients
• are pregnant

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of mitomycin, there are no specific foods that you must exclude from your diet.

Before receiving mitomycin

• tell your doctor and pharmacist if you are allergic to mitomycin, any other medications, or any of the ingredients in mitomycin injection
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention if you have every received doxorubicin (Adriamycin, Rubex). Your doctor may need to monitor you carefully for side effects.
• tell your doctor if you have a blood or bleeding disorder or if you recently noticed any unusual bruising or bleeding. Your doctor may not want you to receive mitomycin injection.
• tell your doctor if you have or have ever had kidney disease
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You should not breastfeed during your treatment with mitomycin.

The FDA categorizes medications based on safety for use during pregnancy.

Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Mitomycin falls into category X. It has been shown that women taking mitomycin during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if mitomycin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using mitomycin.

Injectable:

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Topical:

This medication is available in a topical eye solution form to be applied by a healthcare professional.
 

Injectable:

• 20 mg/m2 intravenously as a single dose at 6 to 8 week intervals

Topical:

• The dose is 0.2 mg of mitomycin per application.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Injectable:

Mitomycin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.

Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of mitomycin.

Hemolytic Uremic Syndrome (HUS) a serious complication of chemotherapy, consisting primarily of microangiopathic hemolytic anemia, thrombocytopenia, and irreversible renal failure has been reported in patients receiving systemic mitomycin. The syndrome may occur at any time during systemic therapy with mitomycin as a single agent or in combination with other cytotoxic drugs, however, most cases occur at doses ≥60 mg of mitomycin. Blood product transfusion may exacerbate the symptoms associated with this syndrome.

The incidence of the syndrome has not been defined.