Mitomycin

IMPORTANT WARNING:

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 injection and to check your body's response to mitomycin injection.

Mitomycin injection must be given in a hospital or medical facility under the supervision of a doctor who is experienced in giving chemotherapy medications for cancer.

WHY is this medicine prescribed?

Mitomycin is used in combination with other medications to treat cancer of the stomach or pancreas that has spread to other parts of the body and has not improved or worsened after treatment with other medications, surgery, or radiation therapy. Mitomycin is a type of antibiotic that is only used in cancer chemotherapy. It slows or stops the growth of cancer cells in your body.

Are there OTHER USES for this medicine?

Mitomycin is also sometimes used to treat anal cancer (cancer that begins in the anus), cervical cancer, a type of lung cancer (non-small cell lung cancer; NSCLC), and malignant mesothelioma (cancer in the lining of the chest or abdomen). Mitomycin is also sometimes used intravesically (infused directly into the bladder) to treat bladder cancer. Talk to your doctor about the risks of using this medication for your condition.

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

HOW should this medicine be used?

Mitomycin comes as a powder to be mixed with liquid and injected intravenously (into a vein) by a doctor or nurse in a medical facility. It is usually injected once every 6 to 8 weeks.

Your doctor may need to delay your treatment or change your dose if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment with mitomycin injection.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

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. Ask your pharmacist for a list of the ingredients.

• 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 breast-feeding. You should not breast-feed during your treatment with mitomycin.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Mitomycin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• 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

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• pain, itching, redness, swelling, blisters, or sores on the skin especially near the injection site
• shortness of breath
• difficulty breathing
• fast, irregular, or pounding heartbeat

Mitomycin may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.