Palifermin is a medication used in the field of oncology and hematology. It is a recombinant human keratinocyte growth factor (rHuKGF) that is used to prevent and treat mucositis, a common and painful side effect of certain cancer treatments, particularly high-dose chemotherapy and radiation therapy. Mucositis is characterized by inflammation and ulceration of the mucous membranes lining the digestive tract, including the mouth and throat, leading to symptoms such as pain, difficulty swallowing, and increased risk of infection.

Palifermin works by stimulating the growth and proliferation of cells that line the mucous membranes, helping to protect these tissues from damage caused by chemotherapy and radiation. By promoting the regeneration of healthy cells, palifermin can reduce the severity and duration of mucositis, improving patients' quality of life during cancer treatment.

A human keratinocyte growth factor called Palifermin (Kepivance) is created using recombinant technology. In individuals receiving myelotoxic chemotherapy, it is utilized to lower the occurrence of mucositis.

Palifermin Uses:

• Oral mucositis:
  • It is indicated in patients on myelotoxic therapy for hematological malignancies who are undergoing autologous hematopoietic stem cell transplantation to reduce the incidence of oral mucositis.
  • It is indicated when the preparative regimen is expected to result in mucositis of grade 3 or more.
  • Limitations of use:
    • Patients undergoing chemotherapy for non-hematological malignancies have not been subjected to studies to determine the drug's safety and effectiveness.
    • It is also not recommended with conditioning regimens that contain melphalan 200 mg/m².
    • Additionally, it was found to be ineffective in patients who received allogeneic hematopoietic stem cell support while also receiving myelotoxic chemotherapy.

Palifermin (Kepivance) Dose in Adults

Therapy of oral mucositis brought on by autologous hematopoietic stem cell transplant (HSCT) conditioning regimens with palifermin (Kepivance) dosage

• You get it through a vein (IV).
• The dose is 60 micrograms per kilogram of your weight per day.
• You take it for 3 days before and 3 days after your chemotherapy.
• That's a total of 6 doses.

Here's a schedule to follow:

• Take the first 3 doses before your chemotherapy.
• Take the third dose 1 to 2 days before starting your chemotherapy.
• Take the last 3 doses after finishing your chemotherapy.
• Take the first of these doses on the same day as your stem cell transplant (HSCT) and at least 7 days after your last dose of palifermin.

Dose in children:

Not indicated.

Pregnancy Risk Factor C

• Pregnancy Risk Factor C means that there have been adverse events in animals during pregnancy studies.

Palifermin use during breastfeeding:

• It's uncertain whether palifermin passes into breast milk.
• Because there's a risk of serious side effects for the nursing baby, the manufacturer advises considering stopping breastfeeding or the medication, balancing the importance of treatment for the mother.

Dose in Kidney Disease:

• The manufacturer's labeling doesn't specify any dosage adjustments for palifermin. However, according to a pharmacokinetic study, renal impairment doesn't significantly affect how palifermin behaves in the body.

Dose in Liver Disease:

• The manufacturer's labeling doesn't include any dosage adjustments for hepatic impairment since it hasn't been studied specifically for this condition.

Common Side Effects of Palifermin (Kepivance):

• Miscellaneous:
  • Fever
• Cardiovascular:
  • Edema
• Dermatologic:
  • Erythema
  • Skin Rash
  • Pruritus
• Central Nervous System:
  • Pain
  • Dysesthesia
• Gastrointestinal:
• • Increased Serum Amylase
  • Increased Serum Lipase
  • Mouth Discoloration
  • Swelling Of Mouth
  • Tongue Discoloration
  • Tongue Edema
  • Dysgeusia

Less Common Side Effects Of Palifermin (Kepivance):

• Immunologic:
  • Antibody Development
• Neuromuscular & Skeletal:
  • Arthralgia

Contraindications to Palifermin (Kepivance):

The manufacturer's labeling doesn't list any contraindications for palifermin.

Warnings and precautions

Mucocutaneous effects:

• Sometimes, when taking palifermin, you might experience some effects on your skin and mucous membranes like swelling, redness, itching, rashes, weird feelings in your mouth or around it, changes in taste, or changes in the appearance and thickness of your tongue.
• It's important to tell your doctor if you notice any of these effects.
• Usually, these skin issues start about 6 days after the first dose and last for about 5 days.

Nonhematologic malignancies

• Palifermin hasn't been proven to be safe or effective for treating non-blood-related cancers, called nonhematologic malignancies.
• We're not sure how it affects the growth of tumors that have KGF receptors outside of the blood system.
• In lab tests, palifermin has been shown to boost the growth of certain types of cancer cells that make up the outer layer of skin and other organs.

Monitoring Parameters:

• Make sure to keep an eye out for any signs of oral mucositis.
• This means watching for any soreness, ulcers, or discomfort in your mouth during treatment.
• If you notice any of these symptoms, be sure to tell your doctor right away.
• They can help manage the condition and make you more comfortable.

How to administer Palifermin (Kepivance)?

• Administer Palifermin through an IV bolus.
• If using heparin to keep the IV line open, flush the line with saline before and after giving Palifermin.
• Avoid giving Palifermin during chemotherapy or within 24 hours before or after chemotherapy.
• Let the solution warm up to room temperature before giving it. Don't use it if it's been at room temperature for more than an hour.
• Do not filter the solution.

Mechanism of action of Palifermin (Kepivance):

• Palifermin is a man-made version of a natural protein called keratinocyte growth factor (KGF).
• It's made in a lab using a bacteria called E. coli.
• In our bodies, KGF is produced by certain cells when tissues like the skin or inner lining of organs get injured.
• KGF works by attaching to special receptors on cells called KGF receptors.
• This attachment helps cells in places like the tongue, inner cheeks, throat, and salivary glands grow, change, and move around.

The beginning of action:

• Palifermin starts working by making epithelial cells grow and divide.
• This process begins about 48 hours after taking the medication.
• The speed of this action depends on the dose given.

Half-life elimination:

• Once you take palifermin, it stays in your body for a certain amount of time.
• The half-life of palifermin, which is how long it takes for half of the medication to leave your body, is about 4.5 hours.
• This time can vary a bit, usually falling between 3.3 to 5.7 hours.

International Brand Names of Palifermin:

• Kepivance

Palifermin Brand Names in Pakistan:

No Brands Available in Pakistan.