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A breakthrough first-line medical treatment for acromegaly: SOMAVERT blocks the GH receptor

The first and only growth hormone–receptor antagonist — reduces IGF- I production at the GH-receptor level.

• By binding to cellular–GH receptors,^1,3 SOMAVERT^® (pegvisomant for injection):

SOMAVERT blocks GH receptors to block the effects of GH secretion⁵

GHR=growth hormone receptor
GHRA=growth hormone–receptor antagonist

Fast response
The biochemical effect of SOMAVERT is evident at 2 weeks

Fast dose-dependent effects.

• A dose-dependent decrease in serum IGF-I levels occurs within 2 weeks of starting therapy and quickly plateaus¹

Dose-dependent effects of SOMAVERT on key biochemical markers

Percent change in serum GH and IGF- I level concentrations¹

• As IGF-I levels fall, there is a corresponding, but limited, increase in circulating GH¹¹

  — Functional effects of increased GH are blocked as a result of receptor antagonism¹¹; therefore, patients should be carefully observed for the clinical signs and symptoms of GH-deficient state

  — IGF-I levels are the primary biomarker for monitoring therapy with SOMAVERT¹

Please see Full Prescribing Information.

References

1. Full Prescribing Information.
3. Herman-Bonert VS, Zib K, Scarlett JA, Melmed S. Growth hormone receptor antagonist therapy in acromegalic patients resistant to somatostatin analogs. J Clin Endocrinol Metab. 200085:2958-2961.
5. Drake WM, Parkinson C, Besser GM, Trainer PJ. Clinical use of a growth hormone receptor antagonist in the treatment of acromegaly. Trends Endocrinol Metab. 2001:12:408-413.
10. Fuh G, Cunningham BC, Fukunaga R, Nagata S, Goeddel DV, Wells JA. Rational design of potent antagonists to the human growth hormone receptor. Science. 1992;256:1677-1680.
11. van der Lely AJ, Hutson RK, Trainer PJ, et al. Long-term treatment of acromegaly with pegvisomant, a growth hormone receptor antagonist. Lancet. 2001;358:1754-1759.

Important Information for Healthcare Professionals:

SOMAVERT is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapies, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum IGF-I levels.

ALT, AST, TBIL, and ALP levels should be obtained prior to initiating therapy with SOMAVERT. If levels are normal, monitor at monthly intervals for the first 6 months of treatment, quarterly for the next 6 months, and then biannually for the next year. If patients exhibit symptoms suggestive of hepatitis or other liver injury, SOMAVERT should be discontinued and a comprehensive hepatic workup should be performed immediately. Please consult the full prescribing information for complete liver monitoring schedules.

SOMAVERT is contraindicated in patients with a history of hypersensitivity to any of its components. The stopper on the vial of SOMAVERT contains latex.

After initiation of therapy with SOMAVERT, glucose tolerance may increase in some patients. These patients should be carefully monitored and doses of antidiabetic medicines reduced as necessary.

Patients should be carefully observed for the clinical signs and symptoms of a GH-deficient state, and serum IGF-I level concentrations should be monitored and maintained within the age-adjusted normal range (by adjustment of the dose of SOMAVERT).

All patients with GH-secreting tumors, including those receiving SOMAVERT, should be carefully monitored for changes in tumor volume.

Patients on opioids often needed higher serum pegvisomant concentrations to achieve appropriate IGF-I level suppression compared with patients not receiving opioids.

The most common adverse events (>10% and at frequencies greater than placebo) in 1 of the 3 active treatment arms in a placebo-controlled study (n = 112) include infection, pain, diarrhea, nausea, flu syndrome, abnormal liver function tests, and injection-site reaction.

For full prescribing information, click here.

Copyright 2006 Pfizer Inc. All rights reserved. GN272936B rev. August 2006

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