Palifermin

(USAN, rINN)
Synonyms: AMJ-9701; Palifermina; Palifermine; Paliferminum; rHu-KGF. 24163 Fibroblast growth factor 7 (human).
Cyrillic synonym: Палифермин.

💊 Chemical information

CAS — 162394-19-6; 178254-26-7.
ATC — V03AF08.
ATC Vet — QV03AF08.

💊 Adverse Effects

Adverse reactions reported with palifermin therapy have included rash, erythema, oedema, pruritus, perioral dysaesthesia, tongue discoloration and thickening, and altered taste. Fever, and gastrointestinal and respiratory disturbances have also been reported. The safety and efficacy of palifermin in patients given treatment for non-haematological neoplasms has not been established; stimulation and growth of tumour cell lines have been found in animal and in-vitro models of non-haematopoietic human tumours.

💊 Pharmacokinetics

The pharmacokinetics of palifermin were approximately doselinear after a single intravenous dose in healthy subjects given larger than usual doses. The terminal elimination half-life is about 4.5 hours.
1. Zia-Amirhosseini P, et al. Pharmacokinetics, pharmacodynamics, and safety assessment of palifermin (rHuKGF) in healthy volunteers. Clin Pharmacol Ther 2006; 79: 558–69
2. Gillespie B, et al. Effect of renal function on the pharmacokinetics of palifermin. J Clin Pharmacol 2006; 46: 1460–8.

💊 Uses and Administration

Palifermin is a human recombinant keratinocyte growth factor (KGF) used to reduce the incidence and duration of severe oral mucositis in patients with haematological neoplasms who receive myelotoxic chemotherapy, with or without radiotherapy, followed by haematopoietic stem cell transplantation. The recommended course of palifermin is 6 doses of 60 micrograms/kg, by intravenous bolus injection. A dose is given on each of 3 consecutive days before, and 3 consecutive days after, myelotoxic therapy. Palifermin should not be given during, or for 24 hours before or after, myelotoxic therapy. Thus, the third pre-chemotherapy dose of palifermin should be given 24 to 48 hours before myelotoxic therapy, and the first post-chemotherapy dose of palifermin should be given after, but on the same day as, the haematopoietic stem cell infusion, and at least 4 days after the third pre-myelotoxic dose.

Mucositis.

Palifermin is a human recombinant keratinocyte growth factor (KGF) that binds to KGF receptors and repairs damaged epithelium by stimulating the proliferation, differentiation, and migration of epithelial cells.1,2 Controlled studies have shown it to be effective in reducing the severity and duration of oral mucositis in patients receiving myelotoxic therapy for haematological neoplasms and requiring haematopoietic stem cell support.3,4 It has also shown benefit compared with placebo in reducing the incidence of oral mucositis and diarrhoea in patients receiving fluorouracil and leucovorin for metastatic colorectal cancer.5
1. Siddiqui MAA, Wellington K. Palifermin: in myelotoxic therapy-induced oral mucositis. Drugs 2005; 65: 2139–46
2. McDonnell AM, Lenz KL. Palifermin: role in the prevention of chemotherapy- and radiation-induced mucositis. Ann Pharmacother 2007; 41: 86–94
3. Spielberger R, et al. Palifermin for oral mucositis after intensive therapy for hematologic cancers. N Engl J Med 2004; 351: 2590–8
4. Stiff PJ, et al. Palifermin reduces patient-reported mouth and throat soreness and improves patient functioning in the hematopoietic stem-cell transplantation setting. J Clin Oncol 2006; 24: 5186–93
5. Rosen LS, et al. Palifermin reduces the incidence of oral mucositis in patients with metastatic colorectal cancer treated with fluorouracil-based chemotherapy. J Clin Oncol 2006; 24: 5194–5200.

💊 Preparations

Proprietary Preparations

Austral.: Kepivance; Cz.: Kepivance; Fin.: Kepivance; Fr.: Kepivance; Gr.: Kepivance; Hung.: Kepivance; Irl.: Kepivance; Neth.: Kepivance; Pol.: Kepivance; Port.: Kepivance; Swed.: Kepivance; UK: Kepivance; USA: Kepivance.
Published May 08, 2019.