Posology : מינונים

4.2. Posology and method of administration

Treatment should be initiated under the supervision of a physician experienced in the treatment of acromegaly.

Posology

A loading dose of 80 mg pegvisomant should be administered subcutaneously under medical supervision.
Following this, SOMAVERT 10 mg reconstituted in 1 ml of solvent should be administered once daily as a subcutaneous injection.

Dose adjustments should be based on serum IGF-I levels. Serum IGF-I concentrations should be measured every four to six weeks and appropriate dose adjustments made in increments of 5 mg/day in order to maintain the serum IGF-I concentration within the age-adjusted normal range and to maintain an optimal therapeutic response.

The maximum dose should not exceed 30 mg/day.

For the different dose regimens the following strengths are available: SOMAVERT® 10 mg, SOMAVERT® 15 mg, SOMAVERT® 20 mg, SOMAVERT® 25 mg and SOMAVERT® 30 mg.

Paediatric population
SOMAVERT® is not indicated for children and adolescents under 18 years old.

Elderly
No dose adjustment is required.
Hepatic or renal impairment
The safety and efficacy of SOMAVERT® in patients with renal or hepatic insufficiency has not been established.

Method of administration

Pegvisomant should be administered by subcutaneous injection.
The site of injection should be rotated daily to help prevent lipohypertrophy.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.