Palifermin
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
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
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
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
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
Interactions
Busulfan , Tretinoin , Thioguanine , Daunorubicin , Cisplatin , Fludarabine phosphate , Lomustine , Fluorouracil , Axitinib , Aldesleukin , Heparin , thiotepa , brigatinib , Pemetrexed , Arsenic trioxide , Necitumumab , Copanlisib , Dabrafenib , Acalabrutinib , Cabazitaxel , Bendamustine , Porfimer , Tisagenlecleucel , Axicabtagene ciloleucel , Pazopanib , Pralatrexate , Palbociclib , Decitabine , Floxuridine , Crizotinib , Carmustine , Vorinostat , Abemaciclib , Gefitinib , Gemtuzumab , nivolumab , belinostat , vemurafenib , Famtrastuzumab , HalavenAntineoplastic 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
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
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 ESTABLISHEDBased 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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