Mitomycin

Mitomycin is a prescription medication used to treat cancer of the stomach or pancreas that has spread to other parts of the body and has not improved with other medications, surgery, or radiation therapy. It should only be used in combination with other medications and is not generally effective as single-agent treatment for cancer.

Mitomycin can also be used during glaucoma surgery.

Mitomycin is an antibiotic. It slows or stops the growth of cells, including cancer cells. Mitomycin is not used to treat bacterial infections.

This medication is used as a topical solution for application to the surgery site in glaucoma surgery. It cannot be injected into the eye.

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

Common side effects of mitomycin for injection include fever, loss of appetite, nausea, and vomiting. Mitomycin solution for the eye can cause eye inflammation, loss of vision, and cataract.

Mitomycin can also cause blurred vision and drowsiness. Do not drive or operate heavy machinery until you know how mitomycin affects you.

Topical:

Mitomycin solution is used during glaucoma surgery.

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

Injectable:

Mitomycin is a prescription medication used to treat cancer of the stomach or pancreas that has spread to other parts of the body and has not improved with other medications, surgery, or radiation therapy. It should only be used in combination with other medications and is not effective as single-agent treatment for cancer.

Mitomycin may be found in some form under the following brand names:

• Mitosol

• Mutamycin

Topical:

Serious side effects have been reported with mitomycin solution for glaucoma surgery. See the “Mitomycin Precautions” section.

Common side effects of mitomycin for the eyes include the following:

• inflammation of the eye
• eye infections
• loss of vision
• cataract

Injectable:

Serious side effects have been reported with mitomycin for injection. See the “Mitomycin Precautions” section.

Common side effects of mitomycin include the following:

• nausea
• vomiting
• loss of appetite or weight
• sores in the mouth and throat
• headache
• fainting
• blurred vision
• hair loss
• loss of strength and energy
• rash

This is not a complete list of mitomycin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take or have ever taken doxorubicin (Adriamycin, Rubex).

This is not a complete list of mitomycin drug interactions. Ask your doctor or pharmacist for more information.

Topical:

Serious side effects have been reported with mitomycin for the eyes including the following:

• damage to the cornea
• increased pressure inside the eye
• loss of vision

Injectable:

Serious side effects have been reported with mitomycin for injection including the following:

• bone marrow toxicity. Decreased function of the bone marrow leads to decreased production of immune, oxygen-carrying, and clot-forming cells. This can lead to life-threatening infections, severe anemia, and spontaneous bleeding. Your healthcare provider should routinely check your blood cell counts while you are receiving mitomycin.
• hemolytic uremic syndrome (HUS). HUS is a serious complication of chemotherapy that causes hemolytic anemia, decreased blood cell counts, and irreversible kidney damage. Tell your healthcare provider right away if you have some or all of the following symptoms of HUS:
  • extreme shortness or breath or difficult breathing
  • wheezing or gasping for breath
  • rapid or irregular heartbeat
  • increased blood pressure
  • changes in mental status or altered levels of consciousness

Mitomycin can also cause blurred vision and drowsiness. Do not drive or operate heavy machinery until you know how mitomycin affects you.

Do not take mitomycin if you:

• are allergic to mitomycin or to any of its ingredients
• are pregnant or breastfeeding
• have blood clotting disorders or an increased risk of bleeding

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 when receiving this medication.

Before taking mitomycin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to mitomycin or to any of its ingredients
• have a blood or bleeding disorder
• have or have had kidney disease
• are pregnant, planning to become pregnant, or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

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, it is recommended that women stop nursing when receiving mitomycin.

Mitomycin should be used exactly as prescribed by your healthcare provider.

Topical:

Mitomycin is available for topical application during glaucoma surgery.

Injectable:

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

Mitomycin should only be used under the direction of a healthcare provider in a healthcare setting.

Mitomycin should be used exactly as prescribed by your healthcare provider.

Topical:

The recommended dose of mitomycin for glaucoma surgery is the topical application of mitomycin-soaked sponges to the treatment area for 2 minutes.

Injectable:

The dose of mitomycin for injection your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your body surface area, which is determined by your height and weight

The recommended dose of mitomycin for cancer treatment is based on the number of white blood cells and platelets in your blood.

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

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

Topical:

• Store mitomycin for topical application at room temperature.

Injectable:

• Store mitomycin for injection at 25ºC.
• Protect from exposure to heat and light.
• Keep this and all medicines out of the reach of children.

WARNING

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.