This drug is most commonly dosed in a hospital setting, but can be taken at home as per specific instructions regarding preparation and storage from a doctor. The recommended dosage consists of 60 μg/kg/day. Drug interactions
Co-administration of Palifermin with Heparin should be avoided. Drug interactions with Heparin include a significantly increased systemic exposure to Palifermin. Avoid administration of Palifermin within 24 hours of myelotoxic chemotherapy, as this could result in increased oral mucositis. Pre-clinical trials
Toxicology studies
Toxicology studies were conducted by use of animal models, utilizing a variety of species, including mice, rats, and monkeys. Singles doses in rats and monkeys were given up to 30,000 and 50,000 micrograms/kg, respectively. Daily doses of 1,000 and 300 micrograms/kg, respectively, were given to rats and monkeys for 28 consecutive days. Toxic effects noted included exaggerated pharmacological effects of the drug, such as hyperkeratosis of skin and tongue and goblet cell hyperplasia in the GI tract. It was noted that the rats were more sensitive to these effects than the monkeys. Induced genetic abnormality assays including microchromosome reverse mutation and E. coli mutagenicity assays were completed using mice. There were no genotoxic effects noted from this study. Clinical trials
Phase I
Study 950170: The first in human study included administration via the subcutaneous route. This study was ended early due to the large number of adverse reactions observed around/in the injection site. Study 960136: (Dose-escalation). Intended to determine safety and tolerability, biologic activity, and pharmacokinetic profile in 61 healthy volunteers.
It was determined that after the first 30 minutes (after IV dose was administered) a rapid decline in concentration occurred, followed by a subsequent plateau once 1.5 hours had been achieved. A decline in concentration was consistently observed once 6 hours post-dose had been reached. It was also noted that with a 4X increase in dose, a 3X increase in AUC was achieved. Half-life values of 4–6 hours were noted; extravascular distribution of the drug was noted as well. Phase II
Study 980231 (Randomized, double-blind, placebo-controlled). Three dose regimens were included: "pre-post", "pre", and placebo Palifermin administration (60 micrograms/kg) by IV for three consecutive days before chemotherapy and after autologous peripheral blood progenitor cell (PBPC). Efficacy was demonstrated in the drug versus the placebo. Phase III
Study 2000162 (Randomized, double-blind, placebo-controlled). Intended to evaluate Palifermin efficacy in reducing oral mucositis in subjects with hematologic malignancy undergoing chemotherapy with autologous peripheral blood progenitor cell transplantation. Patients were administered with 3 daily, consecutive IV doses (or placebo) of Palifermin (60 micrograms/kg) before chemotherapy and Filgrastim (60 micrograms/kg) was administered after transplantation for three days consecutively. Efficacy was demonstrated in the drug versus the placebo. Costs
Palifermin costs approximately 5,000 euros per treatment for a 70 kg patient. Annual sales
The worldwide profits for years the 2008–2011 are provided below. 2008: $5.7 million
2009: $109.9 million
2010: $94.8 million
2011: $77.9 million

References
This article incorporates public domain material from Dictionary of Cancer Terms. U.S. National Cancer Institute. External links
Kepivance homepage