Drug Interactions- summary

Heparin - Palifermin has been shown to bind to heparin. Therefore if heparin is used to
 maintain an IV line, use saline to rinse the line to and after palifermin administration

Chemotherapy - do not administer palifermin within 24 hours before, during infusion of ,
or 24 hours after administration of myelotoxic chemotherapy. Admin. of palefermin
within 24 hours of chemotherapy resulted in increased severity and duration of oral mucositis

Oral mucositis

Adverse reactions-

 Serious adverse reactions -Most common- skin rash, fever, GI events, and respiratory events

Most common- dysesthesia, oral toxicites eg.alteration of taste, tongue discoloration,
tongue thickening, pain arthalgias and skin toxicities eg. edema, eryhthema, pruritus, rash

CNS- dysethesia   -   10%

Dermatologic - erythema  30%,   pruritus  32%   rash   60%

GI - mouth tongue thickening/discoloration  12%   taste altered   15%

Metabolic-  elevated serum amylase   60%   elevated serum lipase 25%

Musculoskeletal  - arthalgia  10%  

Miscellaneous -   edema  25%   fever 35%  pain 15% 

Hypersensitivity to  E.coli , proteins, pilifermin, or any other components

Warnings-

Potential for stimulation of tumor growth- Palifermin has shown to enhance the growth of
human epithelial tumor cell lines in vitro and to increase the rate of tumor lines growth in
human carcinoma xenograft model.

Pregnancy- no adequate and well controlled studies in pregnant women. Use during
pregnancy only if the potential benefit justifies the potential risk to the  fetus.

Lactation- Excercise caution when palifermin is administered to a breast feeding woman

Children- safety and efficacy of paliferamin in pediatric patients have not been established

Indication-

Oral mucositis

Dosage-
Recommended dose is 60mcg/kg/day administered as an intervenous IV bolus injection
for 3 consecutive days before and 3 consecutive days after myelotoxic therapy for a
total of 6 days

Premyelotoxic therapy- administer the first  3 doses prior to myelotoxic therapy, with the
third dose with the third dose 24 to48 hours before myelotoxic therapy

1. Inform patients of the possible side effects of palifermin, including mucocutaneous adveser
effects eg. rash, edema, tongue discoloration.

2. Instruct patients to report side effects immediately to the doctor

Pharmacology-
KGF is an endogenous protein in  the fibroblast growth factor FGF family that binds to the
KGF receptor.

Palifermin has been shown to enhance the growth of epithelial tumor cells in vitro.

Pregnancy-

No adequate and well controlled studies in pregnant women. Use during
pregnancy only if the potential benefit justifies the potential risk to the  fetus.

Lactation-

Excercise caution when palifermin is administered to a breast feeding woman

Children-

Safety and efficacy of paliferamin in pediatric patients have not been established