MITOMYCIN INTRAVENOUS

Mitomycin may cause serious blood and bone marrow disorders (e.g., low red blood cells/white blood cells/platelets). These problems can affect your body’s ability to stop bleeding or fight infection. Tell your doctor immediately if you develop easy bleeding/bruising or signs of an infection (e.g., fever, chills, persistent sore throat).

This drug may cause a certain serious, sometimes fatal side effect (hemolytic uremic syndrome). This condition may result in anemia, low platelet counts, and kidney disease. Blood transfusions may make the symptoms worse. Tell your doctor immediately if you notice symptoms such as pink/bloody urine or change in amount of urine.

See also Warning section.

Nausea, vomiting, stomach/abdominal pain, or loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Severe nausea and vomiting may infrequently result in a loss of too much body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration such as unusual decreased urination, unusual dry mouth/increased thirst, lack of tears, dizziness/lightheadedness, or pale/wrinkled skin.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: unusual bleeding/bruising (e.g., small red spots on the skin, black/bloody stools, vomit that looks like coffee grounds), numbness/tingling feelings, unusual tiredness/weakness.

Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

If this medication accidentally leaks into the skin/muscle around the injection site, it may cause severe damage. Symptoms may occur both during treatment or weeks to months after receiving a dose. Tell your doctor immediately if you notice redness, pain, or swelling at or near the injection site.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing (especially with cough).

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions:

Before using mitomycin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding disorders (e.g., anemia, low blood cell counts), current infection, kidney disease, liver disease, radiation treatment.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist that you are using this medication.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. To avoid pregnancy, both males and females using this drug should use reliable form(s) of birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor for details and to discuss effective forms of birth control.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions:

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include: other anti-cancer drugs (especially vinca alkaloids such as vinblastine).

Overdose:

If overdose is suspected, contact a poison control center or emergency room immediately.

Notes

Laboratory and/or medical tests (e.g., complete blood counts, kidney function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule.

Storage

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Brands:

Available Brands:

Kyowa Mitomycin-C [ Kyowa Hakko Kirin ]

Mytoxid [ Korea United Pharma ]