Bleomycin

IMPORTANT WARNING:

Bleomycin may cause severe or life-threatening lung problems. Severe lung problems may occur more commonly in older patients and in those receiving higher doses of this medication. Tell your doctor if you have or have ever had lung disease. If you experience any of the following symptoms, call your doctor immediately: difficulty breathing, shortness of breath, wheezing, fever, or chills.

Some people who have received bleomycin injection for treatment of lymphomas had a severe allergic reaction. This reaction may occur immediately or several hours after the first or second dose of bleomycin is given. If you experience any of the following symptoms, call your doctor immediately: difficulty breathing, fever, chills, fainting, dizziness, blurred vision, upset stomach, or confusion.

You will receive each dose of medication in a medical facility and your doctor will monitor you carefully while you are receiving the medication and afterwards.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to bleomycin.

WHY is this medicine prescribed?

Bleomycin injection is used alone or in combination with other medications to treat head and neck cancer (including cancer of the mouth, lip, cheek, tongue, palate, throat, tonsils, and sinuses) and cancer of the penis, testicles, cervix, and vulva (the outer part of the vagina). Bleomycin is also used to treat Hodgkin's lymphoma (Hodgkin's disease) and non-Hodgkin's lymphoma (cancer that begins in the cells of the immune system) in combination with other medications. It is also used to treat pleural effusions (a condition when fluid collects in the lungs) that are caused by cancerous tumors. Bleomycin 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?

Bleomycin is also sometimes used to treat Kaposi's sarcoma related to acquired immunodeficiency syndrome (AIDS). 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?

Bleomycin comes as a powder to be mixed with liquid and injected intravenously (into a vein), intramuscularly (into a muscle), or subcutaneously (under the skin) by a doctor or nurse in a medical office or hospital outpatient department. It is usually injected once or twice a week. When bleomycin is used to treat pleural effusions, it is mixed with liquid and placed in the chest cavity through a chest tube (plastic tube that is placed in the chest cavity through a cut in the skin).

What SPECIAL PRECAUTIONS should I follow?

Before taking bleomycin,

• tell your doctor and pharmacist if you are allergic to bleomycin or any of the ingredients in bleomycin injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements, you are taking or plan to take. Your doctor may need to monitor you carefully for side effects.

• tell your doctor if you have or have ever had kidney or lung disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant while you are receiving bleomycin injection. If you become pregnant while receiving bleomycin, call your doctor. Bleomycin may harm the fetus.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive bleomycin, call your doctor as soon as possible.

What SIDE EFFECTS can this medicine cause?

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

• redness, blistering, tenderness, or thickening of the skin
• darkened skin color
• rash
• hair loss
• sores on the mouth or tongue
• vomiting
• loss of appetite
• weight loss

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:

• sudden numbness or weakness of face, arm, or leg on one side of the body
• sudden confusion or trouble speaking or understanding
• sudden dizziness. loss of balance or coordination
• sudden severe headache
• chest pain
• decreased urination

Bleomycin may cause other side effects. Call your doctor if you have any unusual problems while taking 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.