In the U.S.—

In Canada—

• Antineoplastic

Bleomycin ( blee-oh-MYE-sin) belongs to the general group of medicines called antineoplastics. It is used to treat several types of cancer, including cervix and uterus cancer, head and neck cancer, testicle and penile cancer, and certain types of lymphoma. Bleomycin also may used for other conditions, as determined by your doctor.

Bleomycin seems to act by interfering with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by bleomycin, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like darkening of skin or hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with bleomycin, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Bleomycin is to be administered only by or under the immediate supervision of your doctor. It is available in the following dosage form:

Parenteral
• Injection (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For bleomycin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to bleomycin.

Pregnancy—Studies have not been done in pregnant women. However, there is a chance that this medicine may cause birth defects if either the male or female is receiving it at the time of conception or if it is used during pregnancy. Studies in mice given large doses of bleomycin have shown that it causes birth defects. In addition, many cancer medicines may cause sterility which could be permanent. Although sterility has not been reported with this medicine, the possibility should be kept in mind.

Be sure that you have discussed this with your doctor before receiving this medicine. It is best to use some kind of birth control while you are receiving bleomycin. Tell your doctor right away if you think you have become pregnant while receiving bleomycin.

Breast-feeding—Because bleomycin may cause serious side effects, breast-feeding is generally not recommended while you are receiving it.

Children—Although there is no specific information comparing use of bleomycin in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Older adults—Lung problems are more likely to occur in elderly patients (over 70 years of age), who are usually more sensitive to the effects of bleomycin.

• Kidney disease—Effects of bleomycin may be increased because of slower removal from the body

• Liver disease—Bleomycin can cause liver problems

• Lung disease—Bleomycin may worsen the condition

Smoking

Tell your doctor if you smoke. The risk of lung problems is increased in people who smoke.

Bleomycin is sometimes given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each medicine at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to take them at the right times.

Bleomycin often causes nausea, vomiting, and loss of appetite. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Dosing—

The dose of bleomycin will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patient's weight, and whether or not other medicines are also being taken. If you are receiving bleomycin at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of bleomycin, ask your doctor.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are receiving or have received this medicine.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Check with your doctor or nurse immediately if the following side effects occur:

• More common
  • Fever and chills (occurring within 3 to 6 hours after a dose)  
  
  

• Less common
  • Confusion;  faintness;  wheezing 
  
  

• Rare
  • Chest pain (sudden severe);  weakness in arms or legs (sudden) 
  
  

Check with your health care professional as soon as possible if any of the following side effects occur:

• More common
  • Cough;  shortness of breath;  sores in mouth and on lips 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• More common
  • Darkening or thickening of skin;  dark stripes on skin;  itching of skin;  skin rash or colored bumps on fingertips, elbows, or palms;  skin redness or tenderness;  swelling of fingers;  vomiting and loss of appetite 
  
  

• Less common
  • Changes in fingernails or toenails;  weight loss 
  
  

Bleomycin may cause a temporary loss of hair in some people. After treatment has ended, normal hair growth should return, although it may take several months.

Side effects that affect your lungs (for example, cough and shortness of breath) may be more likely to occur if you smoke.

After you stop receiving bleomycin, it may still produce some side effects that need attention. During this period of time, check with your health care professional immediately if you notice either of the following:

• Cough;  shortness of breath 

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your health care professional.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, bleomycin is used in certain patients with the following medical conditions:

• Bone cancer
• Kaposi's sarcoma
• Malignant melanoma
• Mycosis fungoides (a type of lymphoma)
• Skin cancer
• Thyroid cancer
• Verruca vulgaris (warts)

For patients being treated with bleomycin for warts:

• Bleomycin is used to treat severe cases of warts when other treatments have not worked.
• Before using bleomycin, tell your doctor if you have problems with circulation. Bleomycin can cause paleness or coldness in fingers treated for warts.
• Bleomycin is injected directly into the wart. Because it is not absorbed into the body, it does not cause loss of hair, lung problems, or other unwanted effects described above. However, it may cause burning or pain at the place of injection. Skin rash or itching, nail loss, and pain or coldness in the finger where bleomycin was injected have also been reported.

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.