Pronunciation:

blee-oh-MYE-sin

Brand Names:

• Blenoxane

Dosage Forms:

• Powder for Solution

Warnings:

Pulmonary fibrosis is the most severe toxicity for bleomycin and its most frequent presentation is pneumonitis occasionally progressing to pulmonary fibrosis. Its occurrence is higher in elderly patients and in those receiving greater than 400 units total dose, but pulmonary toxicity has been observed in young patients and those treated with low doses. A severe idiosyncratic reaction consisting of hypotension, mental confusion, fever, chills, and wheezing has been reported in lymphoma patients treated with bleomycin .

Classifications:

Therapeutic—

Antibiotic

Uses of This Medicine:

Bleomycin 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.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Brentuximab Vedotin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ascorbic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fosphenytoin
• Phenytoin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• 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

Proper Use of This Medicine:

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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions While Using This Medicine:

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.

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

Side Effects of 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 immediately if any of 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 doctor as soon as possible if any of the following side effects occur:

More common

Cough

shortness of breath

sores in mouth and on lips

Some 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 using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Cough

shortness of breath

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

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