Renal Dose Adjustment
- Renal impairment: Dose adjustments not defined
Hepatic Dose Adjustment [based on baseline LT (liver tests) levels]
- Elevated but
3times the ULN: May treat with pegvisomant; but monitor LTs monthly for 1 yr after therapy initiation and then biannually for the next year 
3 times the ULN: Do not treat until the cause of patient’s liver dysfunction is established. Determine if cholelithiasis or choledocholithiasis is present, especially in patient with a history of prior therapy with somatostatin analogs. Carefully monitor LTs and clinical symptoms if pegvisomant has to be started
- Tumors that secrete GH may expand and cause serious complications; to avoid such complications, carefully monitor such patients with periodic imaging scans of the sella turcica
- GH opposes the effects of insulin on carbohydrate metabolism by decreasing insulin sensitivity; thus patients receiving pegvisomant may have increased glucose tolerance. These patients should be carefully monitored and the doses of anti-diabetics reduced as required
- A state of functional GH deficiency may occur from pegvisomant administration, despite an increase in serum GH levels; adjust the dose of pegvisomant by carefully monitoring the clinical signs/symptoms of GH-deficient state and serum IGF-I concentrations
- Elevations of serum concentrations of ALT and AST >10 times the ULN (upper limit of normal) have been reported; elevated transaminase levels are normalized after discontinuation of therapy
- Prior to initiating therapy, liver enzymes should be assessed. Do not start therapy if liver enzymes are greater than 3 times the ULN. Monitor liver enzymes monthly for 1 yr after initiation of therapy and then biannually for the next year if liver enzymes are elevated but less than or equal to 3 times the ULN
- Patients receiving pegvisomant have reported lipohypertrophy
Cautious: Use cautiously in
- Elderly patients
- Diabetes mellitus
- Hepatic impairment
- Patients allergic to latex as the vial stopper contains latex
Pregnancy Category:B
Breastfeeding: It is poorly excreted in breastmilk. Unlikely to adversely affect the breastfed infant because it is not orally absorbed. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 25 April 2011). Manufacturer advises caution.
