Palifermin – Uses, Dosage, Side Effects, Interaction Palifermin is a modified truncated form of human keratinocyte growth factor produced by recombinant DNA technology. Palifermin is used to treat oral sores and ulcers to prevent and treat oral mucositis that arise as a result of chemo- and radiotherapy. Palifermin is a recombinant human keratinocyte growth factor (KGF). It is 140 residues long and is produced using E. coli. Palifermin was granted FDA approval on 15 December 2004.[rx] Mechanism of action Palifermin has been shown to protect oral and intestinal epithelia from the effects of radiation and chemotherapy, though the exact mechanism is not well understood.[rx] As a recombinant keratinocyte growth factor (KGF), palifermin may promote cell proliferation, reducing the severity of oral mucositis in patients in the relevant treatment groups.[rx] Agonism of fibroblast growth factor 2 may be predominantly responsible for this effect.[rx] The endogenous form if palifermin is expressed in the kidney of rats.[rx] Keratinocyte growth factor (KGF) resides in the family of fibroblast growth factor (FGF). The drug’s target is the KGF receptor. Through the binding of this drug to the aforementioned receptor, Palifermin stimulates epithelial cell proliferation, differentiation, and upregulation of cytoprotective mechanisms to reduce the symptoms of oral mucositis Used in the prevention or treatment of oral mucositis (mouth ulcers arising from chemotherapy), Kepivance binds to the human keratinocyte growth factor (KGF) receptor on buccal cell surfaces. Kepivance acts as both a cell growth and survival factor by stimulating epithelial cell proliferation, differentiation, and migration around the tongue and mouth. The KGF receptor is found on many tissues, particularly around the tongue, esophagus, salivary gland and other gastrointestinal tract organs. Indications When patients with blood cancers (leukemia and lymphoma) receive high-dose chemotherapy and radiation therapy to undergo bone marrow transplantation, they usually get severe oral mucositis.[rx] Palifermin reduces the incidence and duration of severe oral mucositis[rx][rx] by protecting those cells and stimulating the growth of new epithelial cells to build up the mucosal barrier. Palifermin is also being studied in the preve Use in Cancer Palifermin is approved to prevent and treat: Oral mucositis that is severe. It may be used in adults and children whose blood cancer is being treated with high-dose chemotherapy and radiation therapy, followed by stem cell rescue. Palifermin is also being studied in the prevention and treatment of common side effects in other types of cancer. Contraindications Kepivance is contraindicated in patients with known hypersensitivity to E coli-derived proteins, palifermin, or any other component of the product. a patient who is producing milk and breastfeeding Dosage Strengths: 6.25 mg Mucositis 60 mcg/kg IV (as a bolus) once a day, administered for 3 consecutive days before and 3 consecutive days after myelotoxic therapy 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. Decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support Supportive care for preparative regiments predicted to result in greater than or equal to WHO Grade 3 mucositis in the majority of patients Administration advice: This drug should be given as a IV bolus injection; the solution should not be filtered. If heparin is used, IV lines should be rinsed with saline prior to and after administration. Prior to administration, this drug should be allowed to reach room temperature for up to 1 hour (protected from light); however, this drug will need to be discarded in excursions exceeding 1 hour. Unopened vials: Store refrigerated (2 to 8C), and protect from light. Do not freeze. Reconstituted solution: The solution may be stored refrigerated (2 to 8C) and protected from light in its carton for up to 24 hours; the solution should be discarded after 24 hours if it is not used. Reconstituted solutions left at room temperature for longer than 1 hour should be discarded. Compatible: Sterile water for injection Other medications should not be added to solutions containing this drug. General: Safety and efficacy have not been established in patients with non-hematologic malignancies. This drug was not effective in decreasing severe mucositis in patients with hematologic malignancies who were receiving myelotoxic therapy with allogenic hematopoietic stem cell support. Once reconstituted, it is recommended that this drug is used immediately. Limitation of use: Treatment is not recommended for use with melphalan 200 mg/m2 as a conditioning regimen. Side Effects The Most Common thick tongue Fever The skin rash in severe condition change in color of the tongue change in the 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 rash hives red or itching skin difficulty breathing or swallowing swelling of the hands, feet, ankles, or lower legs More common Bad, unusual, or unpleasant (after) taste blurred vision burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings change in taste difficulty with moving discoloration of the tongue dizziness flushing or redness of the skin headache increased sensitivity to pain increased sensitivity to touch itching skin muscle pain or stiffness nervousness pain pain in the joints pounding in the ears rash (mild) slow or fast heartbeat swelling thickening of the tongue tingling in the hands and feet unusually warm skin Rare redness or swelling of the vagina redness, swelling, or pain of the skin scaling of the skin on the hands and feet ulceration of the skin Pain (including joint pain) Increase in blood pancreas enzymes Increased blood pressure Proteinuria Difficulty breathing Changes in cutaneous or mucous membrane appearance/feel (redness/rash, swelling, itching, change in color or thickness of tongue, changes in taste Drug Interactions DRUG INTERACTION Aldesleukin The therapeutic efficacy of Palifermin can be decreased when used in combination with Aldesleukin. Alemtuzumab The therapeutic efficacy of Palifermin can be decreased when used in combination with Alemtuzumab. Altretamine The therapeutic efficacy of Palifermin can be decreased when used in combination with Altretamine. Amsacrine The therapeutic efficacy of Palifermin can be decreased when used in combination with Amsacrine. Ardeparin The serum concentration of Palifermin can be increased when it is combined with Ardeparin. Arsenic trioxide The therapeutic efficacy of Palifermin can be decreased when used in combination with Arsenic trioxide. Azacitidine The therapeutic efficacy of Palifermin can be decreased when used in combination with Azacitidine. Belinostat The therapeutic efficacy of Palifermin can be decreased when used in combination with Belinostat. Bemiparin The serum concentration of Palifermin can be increased when it is combined with Bemiparin. Bendamustine The therapeutic efficacy of Palifermin can be decreased when used in combination with Bendamustine. Bexarotene The therapeutic efficacy of Palifermin can be decreased when used in combination with Bexarotene. Blinatumomab The therapeutic efficacy of Palifermin can be decreased when used in combination with Blinatumomab. Bortezomib The therapeutic efficacy of Palifermin can be decreased when used in combination with Bortezomib. Bosutinib The therapeutic efficacy of Palifermin can be decreased when used in combination with Bosutinib. Busulfan The therapeutic efficacy of Palifermin can be decreased when used in combination with Busulfan. Cabazitaxel The therapeutic efficacy of Palifermin can be decreased when used in combination with Cabazitaxel. Capecitabine The therapeutic efficacy of Palifermin can be decreased when used in combination with Capecitabine. Carbamazepine The therapeutic efficacy of Palifermin can be decreased when used in combination with Carbamazepine. Carboplatin The therapeutic efficacy of Palifermin can be decreased when used in combination with Carboplatin. Carfilzomib The therapeutic efficacy of Palifermin can be decreased when used in combination with Carfilzomib. Carmustine The therapeutic efficacy of Palifermin can be decreased when used in combination with Carmustine. Chlorambucil The therapeutic efficacy of Palifermin can be decreased when used in combination with Chlorambucil. Chloramphenicol The therapeutic efficacy of Palifermin can be decreased when used in combination with Chloramphenicol. Cisplatin The therapeutic efficacy of Palifermin can be decreased when used in combination with Cisplatin. Cladribine The therapeutic efficacy of Palifermin can be decreased when used in combination with Cladribine. Clofarabine The therapeutic efficacy of Palifermin can be decreased when used in combination with Clofarabine. Cyclophosphamide The therapeutic efficacy of Palifermin can be decreased when used in combination with Cyclophosphamide. Cytarabine The therapeutic efficacy of Palifermin can be decreased when used in combination with Cytarabine. Dacarbazine The therapeutic efficacy of Palifermin can be decreased when used in combination with Dacarbazine. Dactinomycin The therapeutic efficacy of Palifermin can be decreased when used in combination with Dactinomycin. Dalteparin The serum concentration of Palifermin can be increased when it is combined with Dalteparin. Danaparoid The serum concentration of Palifermin can be increased when it is combined with Danaparoid. Dasatinib The therapeutic efficacy of Palifermin can be decreased when used in combination with Dasatinib. Daunorubicin The therapeutic efficacy of Palifermin can be decreased when used in combination with Daunorubicin. Decitabine The therapeutic efficacy of Palifermin can be decreased when used in combination with Decitabine. Dexrazoxane The therapeutic efficacy of Palifermin can be decreased when used in combination with Dexrazoxane. Dinutuximab The therapeutic efficacy of Palifermin can be decreased when used in combination with Dinutuximab. Docetaxel The therapeutic efficacy of Palifermin can be decreased when used in combination with Docetaxel. Doxorubicin The therapeutic efficacy of Palifermin can be decreased when used in combination with Doxorubicin. Enoxaparin The serum concentration of Palifermin can be increased when it is combined with Enoxaparin. Epirubicin The therapeutic efficacy of Palifermin can be decreased when used in combination with Epirubicin. Eribulin The therapeutic efficacy of Palifermin can be decreased when used in combination with Eribulin. Etoposide The therapeutic efficacy of Palifermin can be decreased when used in combination with Etoposide. Everolimus The therapeutic efficacy of Palifermin can be decreased when used in combination with Everolimus. Floxuridine The therapeutic efficacy of Palifermin can be decreased when used in combination with Floxuridine. Flucytosine The therapeutic efficacy of Palifermin can be decreased when used in combination with Flucytosine. Fludarabine The therapeutic efficacy of Palifermin can be decreased when used in combination with Fludarabine. Fluorouracil The therapeutic efficacy of Palifermin can be decreased when used in combination with Fluorouracil. Gemcitabine The therapeutic efficacy of Palifermin can be decreased when used in combination with Gemcitabine. Gemtuzumab ozogamicin The therapeutic efficacy of Palifermin can be decreased when used in combination with Gemtuzumab ozogamicin. Heparin The serum concentration of Palifermin can be increased when it is combined with Heparin. Hydroxyurea The therapeutic efficacy of Palifermin can be decreased when used in combination with Hydroxyurea. Ibritumomab tiuxetan The therapeutic efficacy of Palifermin can be decreased when used in combination with Ibritumomab tiuxetan. Ibrutinib The therapeutic efficacy of Palifermin can be decreased when used in combination with Ibrutinib. Idarubicin The therapeutic efficacy of Palifermin can be decreased when used in combination with Idarubicin. Ifosfamide The therapeutic efficacy of Palifermin can be decreased when used in combination with Ifosfamide. Imatinib The therapeutic efficacy of Palifermin can be decreased when used in combination with Imatinib. Indomethacin The therapeutic efficacy of Palifermin can be decreased when used in combination with Indomethacin. Interferon alfa-2a The therapeutic efficacy of Palifermin can be decreased when used in combination with Interferon alfa-2a. Interferon alfa-2b The therapeutic efficacy of Palifermin can be decreased when used in combination with Interferon alfa-2b. Interferon alfa-n1 The therapeutic efficacy of Palifermin can be decreased when used in combination with Interferon alfa-n1. Interferon alfa-n3 The therapeutic efficacy of Palifermin can be decreased when used in combination with Interferon alfa-n3. Interferon alfacon-1 The therapeutic efficacy of Palifermin can be decreased when used in combination with Interferon alfacon-1. Interferon beta-1b The therapeutic efficacy of Palifermin can be decreased when used in combination with Interferon beta-1b. Interferon gamma-1b The therapeutic efficacy of Palifermin can be decreased when used in combination with Interferon gamma-1b. Irinotecan The therapeutic efficacy of Palifermin can be decreased when used in combination with Irinotecan. Ixabepilone The therapeutic efficacy of Palifermin can be decreased when used in combination with Ixabepilone. Lenalidomide The therapeutic efficacy of Palifermin can be decreased when used in combination with Lenalidomide. Linezolid The therapeutic efficacy of Palifermin can be decreased when used in combination with Linezolid. Lomustine The therapeutic efficacy of Palifermin can be decreased when used in combination with Lomustine. Mechlorethamine The therapeutic efficacy of Palifermin can be decreased when used in combination with Mechlorethamine. Melphalan The therapeutic efficacy of Palifermin can be decreased when used in combination with Melphalan. Mercaptopurine The therapeutic efficacy of Palifermin can be decreased when used in combination with Mercaptopurine. Methimazole The therapeutic efficacy of Palifermin can be decreased when used in combination with Methimazole. Methotrexate The therapeutic efficacy of Palifermin can be decreased when used in combination with Methotrexate. Mitomycin The therapeutic efficacy of Palifermin can be decreased when used in combination with Mitomycin. Mitoxantrone The therapeutic efficacy of Palifermin can be decreased when used in combination with Mitoxantrone. Mosunetuzumab The therapeutic efficacy of Palifermin can be decreased when used in combination with Mosunetuzumab. Nadroparin The serum concentration of Palifermin can be increased when it is combined with Nadroparin. Nelarabine The therapeutic efficacy of Palifermin can be decreased when used in combination with Nelarabine. Nilotinib The therapeutic efficacy of Palifermin can be decreased when used in combination with Nilotinib. Obinutuzumab The therapeutic efficacy of Palifermin can be decreased when used in combination with Obinutuzumab. Olaparib The therapeutic efficacy of Palifermin can be decreased when used in combination with Olaparib. Oxaliplatin The therapeutic efficacy of Palifermin can be decreased when used in combination with Oxaliplatin. Paclitaxel The therapeutic efficacy of Palifermin can be decreased when used in combination with Paclitaxel. Palbociclib The therapeutic efficacy of Palifermin can be decreased when used in combination with Palbociclib. Parnaparin The serum concentration of Palifermin can be increased when it is combined with Parnaparin. Peginterferon alfa-2a The therapeutic efficacy of Palifermin can be decreased when used in combination with Peginterferon alfa-2a. Peginterferon alfa-2b The therapeutic efficacy of Palifermin can be decreased when used in combination with Peginterferon alfa-2b. Peginterferon beta-1a The therapeutic efficacy of Palifermin can be decreased when used in combination with Peginterferon beta-1a. Pemetrexed The therapeutic efficacy of Palifermin can be decreased when used in combination with Pemetrexed. Penicillamine The therapeutic efficacy of Palifermin can be decreased when used in combination with Penicillamine. Pentostatin The therapeutic efficacy of Palifermin can be decreased when used in combination with Pentostatin. Phenylalanine The therapeutic efficacy of Palifermin can be decreased when used in combination with Phenylalanine. Pomalidomide The therapeutic efficacy of Palifermin can be decreased when used in combination with Pomalidomide. Ponatinib The therapeutic efficacy of Palifermin can be decreased when used in combination with Ponatinib. Procarbazine The therapeutic efficacy of Palifermin can be decreased when used in combination with Procarbazine. Propylthiouracil The therapeutic efficacy of Palifermin can be decreased when used in combination with Propylthiouracil. Raltitrexed The therapeutic efficacy of Palifermin can be decreased when used in combination with Raltitrexed. Reviparin The serum concentration of Palifermin can be increased when it is combined with Reviparin. Rituximab The therapeutic efficacy of Palifermin can be decreased when used in combination with Rituximab. Ropeginterferon alfa-2b The therapeutic efficacy of Palifermin can be decreased when used in combination with Ropeginterferon alfa-2b. Ruxolitinib The therapeutic efficacy of Palifermin can be decreased when used in combination with Ruxolitinib. Sirolimus The therapeutic efficacy of Palifermin can be decreased when used in combination with Sirolimus. Sorafenib The therapeutic efficacy of Palifermin can be decreased when used in combination with Sorafenib. Streptozocin The therapeutic efficacy of Palifermin can be decreased when used in combination with Streptozocin. Sulodexide The serum concentration of Palifermin can be increased when it is combined with Sulodexide. Tacrolimus The therapeutic efficacy of Palifermin can be decreased when used in combination with Tacrolimus. Tedizolid phosphate The therapeutic efficacy of Palifermin can be decreased when used in combination with Tedizolid phosphate. Temozolomide The therapeutic efficacy of Palifermin can be decreased when used in combination with Temozolomide. Temsirolimus The therapeutic efficacy of Palifermin can be decreased when used in combination with Temsirolimus. Teniposide The therapeutic efficacy of Palifermin can be decreased when used in combination with Teniposide. Thalidomide The therapeutic efficacy of Palifermin can be decreased when used in combination with Thalidomide. Thiotepa The therapeutic efficacy of Palifermin can be decreased when used in combination with Thiotepa. Tinzaparin The serum concentration of Palifermin can be increased when it is combined with Tinzaparin. Tioguanine The therapeutic efficacy of Palifermin can be decreased when used in combination with Tioguanine. Tofacitinib The therapeutic efficacy of Palifermin can be decreased when used in combination with Tofacitinib. Topotecan The therapeutic efficacy of Palifermin can be decreased when used in combination with Topotecan. Tositumomab The therapeutic efficacy of Palifermin can be decreased when used in combination with Tositumomab. Trabectedin The therapeutic efficacy of Palifermin can be decreased when used in combination with Trabectedin. Trastuzumab emtansine The therapeutic efficacy of Palifermin can be decreased when used in combination with Trastuzumab emtansine. Vinblastine The therapeutic efficacy of Palifermin can be decreased when used in combination with Vinblastine. Vindesine The therapeutic efficacy of Palifermin can be decreased when used in combination with Vindesine. Vinorelbine The therapeutic efficacy of Palifermin can be decreased when used in combination with Vinorelbine. Vorinostat The therapeutic efficacy of Palifermin can be decreased when used in combination with Vorinostat. Zidovudine The therapeutic efficacy of Palifermin can be decreased when used in combination with Zidovudine. Pregnancy and Lactation FDA Pregnancy Category C Pregnancy Kepivance™ has been shown to be embryotoxic in rabbits and rats when given in doses that are 2.5 and 8 times the human dose, respectively. Increased post-implantation loss and decreased fetal body weights were observed when Kepivance™ was administered to pregnant rabbits from days 6 to 18 of gestation at IV doses ≥ 150 mcg/kg/day (2.5-fold higher than the recommended human dose). However, treatment with these doses was also associated with maternal toxicity (clinical signs and reductions in body weight gain/food consumption). No evidence of developmental toxicity was observed in rabbits at doses up to 60 mcg/kg/day. Increased post-implantation loss, decreased fetal body weight, and/or increased skeletal variations were observed when Kepivance™ was administered to pregnant rats from days 6 to 17 or 19 of gestation at IV doses ≥ 500 mcg/kg/day (> 8-fold higher than the recommended human dose). Treatment with these doses was also frequently associated with maternal toxicity (clinical signs and body weight effects). No evidence of developmental toxicity was observed in rats at doses up to 300 mcg/kg/day. There are no adequate and well-controlled studies on pregnant women. Kepivance™ should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Lactation It is not known whether Kepivance™ is excreted in human milk. Because many drugs are excreted in human milk‚ caution should be exercised when Kepivance™ is administered to a nursing woman. The safety and effectiveness of Kepivance™ in pediatric patients have not been established. Why is this medication prescribed? 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. How should this medicine be used? 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. Other uses for this medicine This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. What special precautions should I follow? 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 other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: dalteparin (Fragmin), enoxaparin (Lovenox), heparin, or tinzaparin (Innohep). 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. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125103s171s172lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125103lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125103s146lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125103s146lbl.pdf https://pubchem.ncbi.nlm.nih.gov/substance/178103536 https://www.cancer.gov/about-cancer/treatment/drugs/palifermin https://go.drugbank.com/drugs/DB00039 https://www.drugs.com/mtm/palifermin.html https://medlineplus.gov/druginfo/meds/a605017.html https://en.wikipedia.org/wiki/Palifermin https://www.mayoclinic.org/drugs-supplements/palifermin-intravenous-route/proper-use/drg-20065275 https://www.webmd.com/drugs/2/drug-92309/palifermin-intravenous/details/list-contraindications Show More