Acromegaly is most often induced by a benign tumor of the pituitary gland.
DTwo new dosages are added to the SOMAVERT powder and solvent for solution for injection (pegvisomant) range, in addition to SOMAVERT 10 mg, 15 mg and 20 mg, which are already available. They correspond to the highest dosages:
- SOMAVERT 25 mg: after reconstitution, the solution contains 25 mg of pegvisomant per mL;
- SOMAVERT 30 mg: after reconstitution, the solution contains 30 mg of pegvisomant per mL.
The therapeutic indication for SOMAVERT is common to all dosages:
- treatment of acromegaly in adult patients who have had an inadequate response to surgery and/or radiation therapy and in whom appropriate medical treatment with somatostatin analogues has not normalized IGF-1 concentrations (insuline-like growth factor) or was not tolerated.
Dosages corresponding to the different therapeutic regimens
As the High Authority for Health (HAS) points out in its 2015 opinion [1]SOMAVERT 25 mg and 30 mg make it possible to “have all the dosages corresponding to the different possible therapeutic regimens” and provided for by the marketing authorization (AMM).
As a reminder, after a loading dose of 80 mg, the recommended initial dose is 10 mg/day.
Depending on the serum levels of IGF-1, this dose must be adjusted in increments of 5 mg/day, hence the interest of having a dosage of 15 mg, 20 mg and, now, 25 mg. . There is no SOMAVERT 5 mg.
The SOMAVERT 30 mg dosage corresponds to the maximum recommended dose of 30 mg/day.
Subcutaneous injection after reconstitution
Pegvisomant should be administered by subcutaneous (SC) injection. The injection site should be rotated daily to prevent the occurrence of lipohypertrophy.
Like the other dosages, SOMAVERT 25 mg and 30 mg are presented in powder and solvent for solution for injection, for single use. The methods for reconstituting the solution for injection are common to all SOMAVERT specialties.
Administrative identity
Liste I
Initial annual hospital prescription reserved for specialists in endocrinology or internal medicine
Unrestricted renewal
SOMAVERT 25 mg, box of 30 vials + 30 syringes of 1 mL of solvent and safety needle, CIP 3400930023860, prix public TTC = 4 121,55 euros [2]
SOMAVERT 30 mg, box of 30 vials + 30 syringes of 1 mL of solvent and safety needle, CIP 3400930023877, prix public TTC = 4 919,16 euros [2]
100% refundable [3]
Approval to communities [4]
Pfizer Laboratory