Drug information of Palifermin

Palifermin

Drug group:

Palifermin is used to help prevent or heal mouth sores and ulcers in people being treated with chemotherapy and stem cell treatment.

Palifermin is used in people receiving chemotherapy to treat blood cancers (Hodgkin's disease, multiple myeloma, leukemia). palifermin is not a treatment for the cancer itself.

Palifermin may also be used for purposes not listed in this medication guide

Mechanism of effect

Palifermin is a recombinant keratinocyte growth factor (KGF) produced in E. coli. Endogenous KGF is produced by mesenchymal cells in response to epithelial tissue injury. KGF binds to the KGF receptor resulting in proliferation, differentiation and migration of epithelial cells in multiple tissues, including (but not limited to) the tongue, buccal mucosa, esophagus, and salivary gland

Pharmacodynamic

Onset of Action
Epithelial cell proliferation (dose-dependent): 48 hours
Half life
4.5 
hours

Drug indications

Oral mucositis: To decrease the incidence and duration of severe oral mucositis associated with hematologic malignancies in patients receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support (when the preparative regimen is expected to result in mucositis ≥ grade 3 in most patients).

Dosage

Usual Adult Dose for Mucositis
60
 mcg/kg IV (as a bolus) once a day, administered for 3 consecutive days before and 3 consecutive days after myelotoxic therapy

Drug contraindications

There are no contraindications listed in the manufacturer's labeling.

Side effects

>10%:
Cardiovascular: Edema
Central nervous system: Pain, dysesthesia (includes hypoesthesia, oral hyperesthesia, paresthesia)
Dermatologic: Skin rash, pruritus, erythema
Gastrointestinal: Increased serum amylase, increased serum lipase, mouth discoloration, swelling of mouth, tongue discoloration, tongue edema, dysgeusia
Miscellaneous: Fever
1%
 to 10%
Immunologic: Antibody development
Neuromuscular & skeletal: Arthralgia
<1%, postmarketing, and/or case reports: Cataract, cough, genital edema (vaginal), hyperpigmentation (flexural), palmar-plantar erythrodysesthesia (hand-foot syndrome), perineal pain, rhinitis, vaginal disease (erythema

Antineoplastic Agents, Heparin, Heparins (Low Molecular Weight)

Alerts

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose

Palifermin is not approved for use by anyone younger than 1 year old

Points of recommendation

Palifermin may cause growth in tumors that are not related to a blood cancer. Talk to your doctor if you have a history of any type of tumor

Palifermin may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant

palifermin may affect fertility (your ability to have children), whether you are a man or a woman

alifermin is given as an infusion into a vein. A healthcare provider will give you this injection before and after your chemotherapy treatment

Your palifermin injections are timed to take place at certain intervals as part of your treatment. Carefully follow your doctor's instructions about when to receive each injection

Palifermin should not be given within 24 hours before you receive your chemotherapy

Prior to myelotoxic therapy: The third dose should be administered 24 to 48 hours prior to beginning the myelotoxic agent

Following myelotoxic therapy: The first dose should be administered on the day of hematopoietic stem cell infusion after the infusion is complete, AND at least 7 days after the most recent dose of this drug

Pregnancy level

HAVE NOT BEEN ESTABLISHED

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 of major birth defects and miscarriage or adverse maternal or fetal outcomes

Breast feeding warning

There are no data on presence of drug in human milk, effect on breastfed child, or on milk production; since many drugs are secreted into human milk, and because of potential for serious adverse reactions in a nursing child, breastfeeding should be discontinued during treatment and for at least 2 weeks after last dose

Drug forms

Kepivance

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