Palifermin

Palifermin is used to prevent and to speed the healing of severe sores in the mouth and throat that may be caused by chemotherapy and radiation therapy used to treat cancers of the blood or bone marrow (soft fatty material in the middle of bones that makes blood cells). Palifermin may not be safe to use to prevent and treat mouth sores in patients who have other types of cancer. Palifermin is in a class of medications called human keratinocyte growth factors. It works by stimulating the growth of cells in the mouth and throat.

Palifermin comes as a powder to be mixed with liquid to be injected intravenously (into a vein). It is usually given once a day for 3 days in a row before you receive your chemotherapy treatment and then once a day for 3 days in a row after you receive your chemotherapy for a total of 6 doses. You will not be given palifermin on the same day that you are given your cancer chemotherapy treatment. Palifermin must be given at least 24 hours before and at least 24 hours after you receive your chemotherapy treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving palifermin,

• tell your doctor and pharmacist if you are allergic to palifermin, any other medications, or any of the ingredients in palifermin injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving palifermin. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving palifermin, call your doctor.

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

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

• thick tongue
• change in color of tongue
• change in ability to taste food
• increased or decreased feelings when touched, especially in and around the mouth
• burning or tingling, especially in and around the mouth
• joint pain
• fever

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• rash
• hives
• red or itching skin
• difficulty breathing or swallowing
• swelling of the hands, feet, ankles, or lower legs

Palifermin may cause some tumors to grow faster. Talk to your doctor about the risks of taking this medication.

Palifermin 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

Symptoms of overdose may include:

• thick tongue
• change in color of tongue
• change in ability to taste food
• increased or decreased feelings when touched, especially in and around the mouth
• burning or tingling, especially in and around the mouth
• joint pain
• rash
• red or itching skin
• swelling of the hands, feet, ankles, or lower legs
• fever

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.

• Kepivance^®