Pegvisomant dosing

In 112 patients with active acromegaly who received pegvisomant in a 12 week, randomized, double-blind study of three different daily subcutaneous doses of pegvisomant (10,15, and 20 mg), headache was reported in the placebo group as often as in the active treatment groups (12%) (2). In a longer follow-up study for up to 18 months, 26% of 160 patients had headache, but there was no control group for comparison (3). 

Dopamine agonists provide advantages of oral dosing and reduced cost when compared to somatostatin analogs and pegvisomant. However, dopamine agonists effectively normalize IGF-I concentrations in only 10% of patients. 

Pegvisomant is commercially available in the United States for daily subcutaneous use. The first dose should be administered under the supervision of a physician as a 40-mg loading dose. Subsequent doses are self-administered by the patient starting at a dose of 10 mg daily. The dose can be adjusted in 5-mg increments based on serum IGF-I concentrations every 4 to 6 weeks, up to a maximum daily dose of 30 mg." " ... 

In clinical trials, pegvisomant at higher doses significantly decreased serum IGF-1 to normal age- and sex-adjusted... 

New formulation In an open-label, randomised, single-dose, two-way crossover, phase I study of healthy male and female subjects (N = 28), the safety and tolerability of a new 1 x 30 mg/ml subcutaneous injection formulation of pegvisomant did not differ from the marketed 2 x 15 mg/ml subcutaneous formulation [47 ]. The new formulation may serve to minimise injection-site reactions by decreasing tiie number of injections required for effective treatment, although larger studies are required to properly assess this possibility. 

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