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|Kepivance

PALIFERMIN (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Kepivance

† Not commercially available in Canada.

Category

• Antineoplastic adjunct
• cytoprotective agent

Description

Palifermin (pal-ee-FER-min) is used to help prevent or lessen some side effects caused by other medicines or radiation therapy that are used to treat cancer.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

• Parenteral
• Injection (U.S.)

Before Using This Medicine

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to palifermin. Also tell your doctor and pharmacist if you are allergic to any other substances, such as E. coli- derived proteins.

Pregnancy—Palifermin has not been studied in pregnant women. However, studies in animals have shown that palifermin causes unwanted effects. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether palifermin passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of palifermin in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of palifermin in the elderly with use in other age groups.

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. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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

• Non-hematologic malignancies (e.g., other cancerous tumors)—May be worsened by palifermin

Proper Use of This Medicine

Dosing—The dose of palifermin will be different for different patients. It depends on the patient"s size. The medicine will be given by, or under the immediate supervision of, the doctor treating you for cancer.

• For parenteral dosage form (injection):
  • For preventing or lessening side effects caused by medicines used to treat cancer:
    • Adults—60 milligrams (mg) per square meter of body surface area, injected into a vein for 3 consecutive days before and 3 consecutive days after myelotoxic therapy for a total of 6 doses.
    • Children—Use and dose must be determined by your doctor.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store in the refrigerator.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Your doctor will want to check your progress at regular visits.

This medicine may cause some other tumors (not bone marrow tumors) to grow in animal models.Make sure your doctor knows if you have had any other type of tumor or cancer.

The importance of reporting any side effects to your doctor

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.

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

Developed: 05/10/2005

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