palifermin 5.16 mg intravenous solution

Generic name:
Palifermin - injection

Pronunciation
(PAL-ee-FER-min)

Brand name(s)
Kepivance

Palifermin is used by people with blood or bone marrow cancer (such as leukemia, multiple myeloma) who are receiving chemotherapy or radiation along with stem cell transplant. The chemotherapy or radiation can cause severe sores in the mouth and throat (mucositis). Palifermin is used to decrease the risk of these sores and to decrease the time it takes for these sores to heal. Palifermin may work by increasing the growth of cells in the mouth and throat.

This medication should only be used by patients with blood or bone marrow cancer, and not by patients with other types of cancer.

This medication is given by injection into a vein by a health care professional as directed by your doctor. It is usually given daily for 3 days in a row before the cancer treatment and daily for 3 days in a row after the cancer treatment. The doses must be given at least 24 hours before and at least 24 hours after the cancer treatment. The dosage is based on your weight.

Tell your doctor if your condition does not get better or if it gets worse.

Numbness/tingling or increased sensitivity around the mouth/tongue, change in tongue color, or change in taste may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving palifermin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 2 weeks after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• melphalan

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.