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The Acrostudy

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In the fixed-dose pivotal trial...
Fast results
SOMAVERT helped control IGF-I levels

Significant dose-dependent reduction from baseline vs placebo in IGF-I levels at 12 weeks:

• The placebo group experienced a 4% mean reduction (n=31)¹
• The 10 mg/day group experienced a 27% mean reduction (n=26) ( P<0.01)¹
• The 15 mg/day group experienced a 48% mean reduction (n=26) ( P<0.01)¹
• The 20 mg/day group experienced a 63% mean reduction (n=28) ( P<0.01)¹

At 12 weeks, most patients in the 15-mg and 20-mg groups had normalized IGF-I levels.

SOMAVERT normalized IGF- I levels in 82% of patients taking 20 mg/day¹

Randomized, double-blind, multicenter, placebo-controlled, fixed-dose, 12-week study of 112 patients with acromegaly who had high serum IGF-I levels despite previous treatment with surgery, radiation therapy, and/or medical therapy.

In the long-term, open-label, dose-titration trial...
92% of patients taking SOMAVERT achieved normalized IGF- I levels

POWERFUL...

Percent of patients with IGF- I levels in age-adjusted normal range after a mean of 55 weeks of treatment with SOMAVERT^2,11

Individual response to SOMAVERT^2,11

Long-term, open-label, dose-titration study (mean=55 weeks). Average reduction in 3 patients not reaching normalization: 61%.²

Data on file, Pfizer Inc., New York, NY,² and adapted from van der Lely et al. Lancet. 2001;358:1757.¹¹

DURABLE...

Once normalized, IGF- I levels remained within the normal range at 92% (403 out of 437) of all subsequent visits over a mean duration of 1 year

In the fixed-dose pivotal trial...
Fast dose-dependent improvement
Substantial dose-dependent improvement in total score for signs and symptoms at 12 weeks

Improvement in total score* for signs and symptoms for all dose levels of SOMAVERT vs placebo at week 12^1,4

*Total score for signs and symptoms was defined as the sum of all scores for soft tissue swelling, arthralgia, headache, perspiration, and fatigue, each rated from 0=absent to 8=worst possible. The possible cumulative score ranged from 0 to 40.^1,4

Percentage of patients who reported improvement in specific signs and symptoms at week 12¹

Randomized, double-blind, multicenter, placebo-controlled, fixed-dose, 12-week study in 112 patients with acromegaly. Patients were given either 10 mg (n=26), 15 mg (n=26), or 20 mg (n=28) daily.¹

Dose-dependent reduction in ring size:

• Ring size, an objective measure of soft-tissue swelling, was smaller (improved) at week 12 in the groups treated with SOMAVERT 15 mg or 20 mg, compared with placebo¹

 Please see Full Prescribing Information.

References

1. Full Prescribing Information.
2. Data on file. Pfizer Inc. New York, NY.
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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