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Get to goal fast* — reduce and normalize IGF-I levels with SOMAVERT, a first-line medical therapy

Normalizing biochemical disease markers is a primary goal of acromegaly therapy

Uncontrolled IGF-I levels are a hallmark of active disease:

• One of the primary goals of acromegaly therapy is tight biochemical control⁶
• IGF-I levels mediate the majority of the growth-promoting actions and clinical manifestations of acromegaly⁵

IGF-I levels are the primary biomarker for monitoring the effect of therapy:

• Normal IGF-I levels reflect normalization or adequate inhibition of growth hormone (GH) action due to hypersecretion⁶

Normalizing IGF-I levels improves the signs and symptoms associated with acromegaly:

• When IGF-I levels are significantly lowered, signs and symptoms improve significantly^1,7
• Complications may improve significantly when IGF-I levels are lowered^1,8

  — Normal IGF-I level range is determined by the age and sex of the patient⁹

Use SOMAVERT^® (pegvisomant for injection) as a first-line medical therapy to reduce and normalize IGF-I levels:

• 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.¹

Acromegaly treatment algorithm

Adapted from Clemmons DR, Chihara K, Freda PU, et al. J Clin Endocrinol Metab. 2003:88:4764.⁶

Please see Full Prescribing Information.

*12 weeks of therapy.

References

1. Full Prescribing Information.
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.
6. Clemmons DR, Chihara K, Freda PU, et al. Optimizing control of acromegaly: integrating a growth hormone receptor antagonist into the treatment algorithm.
   J Clin Endocrinol Metab. 2003;88:4759-4767.
7. Melmed S, Casanueva FF, Cavagnini F, et al, for the Acromegaly Treatment Consensus Workshop Participants. Consensus: guidelines for acromegaly management. J Clin Endocrinol Metab. 2002;87:4054-4058.
8. Friend KE. Acromegaly: a new therapy. Cancer Control. 2002; 9:232-235.
9. Brabant G, von zur Mühlen A, Wüster C, et al, on behalf of the German KIMS Board. Serum insulin-like growth factor I reference values for an automated chemiluminescence immunoassay system: results from a multicenter study. Horm Res. 2003;60:53-60.

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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