Palifermin

Palifermin is a prescription medication indicated for severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support. Palifermin is also indicated as supportive care for preparative regimens predicted to result in many patients' WHO grade 3 or greater mucositis.

• Palifermin is available under the following different brand names: Kepivance

Common side effects of Palifermin include:

• skin irritation (rash, redness, swelling, itching)
• burning or tingling sensation in the mouth
• tongue discoloration
• tongue thickening
• changes in taste
• swelling
• pain
• joint pain
• increases in blood pancreas enzymes
• increased blood pressure
• protein in the urine

Serious side effects of Palifermin include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• blurred vision
• tunnel vision
• eye pain, and
• seeing halos around lights

Rare side effects of Palifermin include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Powder for Injection

• 6.25 mg

Oral Mucositis

Adult dosage

• 60 mcg/kg IV bolus 3 consecutive days before and 3 consecutive days after myelotoxic therapy (6 doses total)  

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Palifermin has severe interactions with no other drugs
• Palifermin has serious interactions with at least 175 other drugs
• Palifermin has moderate interactions with the following drugs:
  • lomustine
  • siponimod
• Palifermin has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to palifermin or E. coli–derived proteins

Effects of drug abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Palifermin?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Palifermin?"

Cautions

• Do not administer less than 24 hours before, during, or after myelotoxic treatment; may worsen mucositis
• Potential for tumor growth stimulation
• Safety/efficacy not established for nonhematologic malignancies
• Do not freeze the reconstituted solution
• Not recommended for use with melphalan 200 mg/m2 as a conditioning regimen

Pregnancy and Lactation

• Based on findings in animal studies, therapy may cause fetal harm when administered to pregnant women; there are no data available on use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage or adverse maternal or fetal outcomes
• Reproductive potential
  • Based on findings from animal studies, drugs may impair fertility in women and men of reproductive potential; the reversibility of effects on fertility is unknown
• Lactation
  • There are no data on the presence of drugs in human milk, their effect on breastfed children, or milk production; because many drugs are secreted into human milk and because of the potential for serious adverse reactions in a nursing child, breastfeeding should be discontinued during treatment and for at least 2 weeks after last dose