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.
Also known as an ear pit or preauricular sinus. (Q26.6) Portal vein-hepatic artery fistula
(Q38.0) Congenital fistula of lip
(Q38.4) Congenital fistula of salivary gland
(Q42.0) Congenital absence, atresia and stenosis of rectum with fistula
(Q42.2) Congenital absence, atresia and stenosis of anus with fistula
(Q43.6) Congenital fistula of rectum and anus
(Q51.7) Congenital fistulae between uterus and digestive and urinary tracts
(Q52.2) Congenital rectovaginal fistula

T: External causes
(T14.5) Traumatic arteriovenous fistula
(T81.8) Persistent postoperative fistula

Causes
Disease: Infections including an anorectal abscess and inflammatory diseases including Crohns disease and ulcerative colitis can result in fistulas. Fistulas to the anus may occur in hidradenitis suppurativa. In women, fistulas can also occur following pelvic infection and inflammation. Surgical and medical treatment: Complications from gallbladder surgery can lead to biliary fistulas. As well as being congenital or resulting from trauma, arteriovenous fistulas are created purposefully for hemodialysis. Radiation therapy to the pelvis can lead to vesicovaginal fistulas. Persistent gastrocutenaous fistulas can develop after gastrostomy. Trauma: Prolonged childbirth can lead to fistulas in women, in whom abnormal connections may occur between the bladder and vagina, or the rectum and vagina. An obstetric fistula develops when blood supply to the tissues of the vagina and the bladder (and/or rectum) is cut off during prolonged obstructed labor. The tissues die and a hole forms through which urine and/or feces pass uncontrollably. Vesicovaginal and rectovaginal fistulas may also be caused by rape, in particular gang rape, and rape with foreign objects, as evidenced by the abnormally high number of women in conflict areas who have developed fistulae.