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Prescribing Information Indication Patient Site
Efficacy

IGF-I Reduction

Signs and Symptoms

Sustained Efficacy

Endocrine Society Guidelines

The 2014 Endocrine Society Guidelines suggest SOMAVERT as an option for initial adjuvant medical therapy in patients with significant disease following surgery3,*

ie, moderate-to-severe signs and symptoms of growth hormone excess and without local mass effects.SOMAVERT significantly reduced IGF-I levels1,2,†

In the pivotal trial, SOMAVERT showed significantly reduced IGF-I levels from baseline across all 3 doses at 12 weeks (primary endpoint).1,2

MEAN PERCENT CHANGE IN SERUM IGF-I CONCENTRATIONS COMPARED WITH PLACEBO1,2 Predefined visits.SOMAVERT rapidly reduced IGF-I levels1In the pivotal trial, SOMAVERT began to reduce IGF-I levels within 2 weeks.1

Rapid reduction: 75% of the total mean reduction in IGF-I levels occurred within 2 weeks and the reduction was sustained over the 12-week course of therapy with all doses of SOMAVERT (this was not part of the primary endpoint)1

Study Description: Data from a randomized, double-blind, multicenter, placebo-controlled, fixed daily pegvisomant dose (10 mg, 15 mg, and 20 mg), 12-week study in 112 patients with acromegaly who may have been previously treated with surgery, radiation therapy, and/or drug therapy. The primary efficacy endpoint was IGF-I percent change in IGF-I concentrations from baseline to week 12. The mean percent change from baseline at week 12 in IGF-I was -4 for placebo, -27 at 10 mg/day, -48 at 15 mg/day, and -63 at 20 mg/day for SOMAVERT.1,2In the pivotal trial, SOMAVERT worked for a majority of patients1,2SOMAVERT normalized IGF-I levels for a majority of patients.1,2PERCENTAGE OF PATIENTS ACHIEVING A NORMAL SERUM IGF-I AT WEEK 12—PIVOTAL TRIAL (SECONDARY ENDPOINT)1,2,4

​​​​​Study Description: Data from a randomized, double-blind, multicenter, placebo-controlled, fixed daily pegvisomant dose (10 mg, 15 mg, and 20 mg), 12-week study in 112 patients with acromegaly who may have been previously treated with surgery, radiation therapy, and/or drug therapy.1

Endocrine Society Guidelines

The 2014 Endocrine Society Guidelines suggest SOMAVERT as an option for initial adjuvant medical therapy in patients with significant disease following surgery3,*

ie, moderate-to-severe signs and symptoms of growth hormone excess and without local mass effects.SOMAVERT improved the signs and symptoms of acromegaly1,2

SOMAVERT improved ring size and total score of signs and symptoms, compared with placebo.1,2

 MEAN CHANGE FROM BASELINE IN RING SIZE AND SIGNS AND SYMPTOMS OF ACROMEGALY AT WEEK 12 (PIVOTAL TRIAL SECONDARY ENDPOINT)1,2

In a post hoc analysis of the pivotal study, 88% of patients who achieved IGF-I normalization in the 12-week pivotal trial also experienced an improved signs and symptoms score4

Study Description: Data from a randomized, double-blind, multicenter, placebo-controlled, fixed daily pegvisomant dose (10 mg, 15 mg, and 20 mg), 12-week study in 112 patients with acromegaly who may have been previously treated with surgery, radiation therapy, and/or drug therapy.1​​​​​​

Total score for signs and symptoms is based on scores for 5 symptoms, each graded in severity from 0 (absent) to 8 (worst). Thus, the total possible score ranged from 0 to 40. The 5 symptoms graded were fatigue, excessive perspiration, headache, arthralgia, and soft-tissue swelling. The mean change from baseline for each dose was calculated by averaging the change in total score at 12 weeks across all patients in that dosing arm. Mean baseline total score for signs and symptoms in all dose groups combined was 15.2.1,2

​​​​In a post hoc analysis, of the 112 patients randomized and treated in the study, 60 patients (53.6%) had IGF-I levels within the normal range at some point during the study follow-up. Among these 60 patients, 59 also had their acromegaly signs and symptoms total score reported at or after the IGF-I normalization visit. Fifty-two out of 59 patients (88%) had reported improved acromegaly signs and symptoms at the clinical visit or later at which IGF-I levels were reported as normalized.4​​​​

Endocrine Society Guidelines

The 2014 Endocrine Society Guidelines suggest SOMAVERT as an option for initial adjuvant medical therapy in patients with significant disease following surgery3,*

ie, moderate-to-severe signs and symptoms of growth hormone excess and without local mass effects.SOMAVERT provided sustained efficacy2Continued control: In an open-label extension to the pivotal study, reduction in serum IGF-I concentrations was sustained for up to 43 weeks of treatment.2

In an open-label extension to the pivotal study, 93% of patients showed normalized IGF-I levels during at least 1 visit over a mean treatment exposure of 43 weeks2

Study Description: In the open-label extension to the 12-week pivotal study, 109 subjects (including 6 new patients) with mean treatment exposure of 42.6 weeks (range 1 day to 82 weeks) were evaluated for safety, tolerability, and efficacy of pegvisomant. The study had a dose titration phase to lower IGF-I from baseline as primary endpoint and to normalize IGF-I as secondary endpoint, followed by a maintenance phase to mimic eventual clinical practice. A total of 100 (92.6%) of the 108 patients with available IGF-I data had a normalized IGF-I concentration during at least 1 visit during the study.2

IGF-I levels in patients who changed treatment from prior SSA therapy5STUDY DESIGN: PRIOR SSA THERAPY5
  • Octreotide LAR patients had been on therapy for a median of 562 days (range: 107-1336 days)5
  • Four weeks after their final dose of octreotide LAR, patients started SOMAVERT therapy5
No loading dose was administered in this study. Fixed dose escalation regimen allowed for a maximum dose of pegvisomant of 20 mg/day in most patients, except in 2 patients (40 mg/day).5From weeks 4 through 12 there was overlapping effect of pegvisomant and octreotide LAR. Overlapping pharmacological effects on IGF-I concentrations must be taken into consideration when the dose of pegvisomant is titrated within the first 3-4 months of octreotide LAR therapy discontinuation.5

In a multicenter, open-label, 32-week study, patients who discontinued prior therapy were treated with SOMAVERT at week 4 for a total of 28 weeks.5​​​​​

 PERCENTAGE OF PATIENTS WITH IGF-I CONCENTRATIONS WITHIN NORMAL AGE-ADJUSTED RANGE5 LAR, long-acting release; SSA, somatostatin analogue.These data do not represent head-to-head studies of SOMAVERT versus octreotide LAR and no direct comparisons of efficacy, safety, or implied superiority of SOMAVERT relative to octreotide LAR should be inferred.From weeks 4 through 12 there was overlapping effect of pegvisomant and octreotide LAR. Overlapping pharmacological effects on IGF-I concentrations must be taken into consideration when the dose of pegvisomant is titrated within the first 3-4 months of octreotide LAR therapy discontinuation.5Study Description: Results from a multicenter, open-label, 32-week study (N=53) involving patients with acromegaly previously treated with octreotide LAR for at least 12 weeks. Changes in IGF-I levels, glycemic control, liver function, and tumor size were monitored. SOMAVERT was initiated 4 weeks (baseline) after the last dose of octreotide LAR, at which time 29% of patients had IGF-I concentrations within the normal range.5
References:Trainer PJ, Drake WM, Katznelson L, et al. Treatment of acromegaly with the growth hormone–receptor antagonist pegvisomant. N Engl J Med. 2000;342(16):1171-1177.SOMAVERT. Prescribing information. Pfizer Inc.; 2021. Katznelson L, Laws ER Jr, Melmed S, et al. Acromegaly: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2014;99(11):3933-3951.Data on file. Pfizer Inc., New York, NY.Barkan AL, Burman P, Clemmons DR, et al. Glucose homeostasis and safety in patients with acromegaly converted from long-acting octreotide to pegvisomant. J Clin Endocrinol Metab. 2005;90(10):5684-5691.Melmed S, Colao A, Barkan M, et al. Guidelines for acromegaly management: an update. J Clin Endocrinol Metab. 2009;94(5):1509-1517.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. 2000;85(8):2958-2961.Melmed S. Acromegaly. N Engl J Med. 1990;322(14):966-977.Kopchick JJ. Discovery and mechanism of action of pegvisomant. Eur J Endocrinol. 2003;148(suppl 2):S21-S25.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(9295):1754-1759.Parkinson C, Drake WM, Roberts ME, Meeran K, Besser GM, Trainer PJ. A comparison of the effects of pegvisomant and octreotide on glucose, insulin, gastrin, cholecystokinin, and pancreatic polypeptide responses to oral glucose and a standard mixed meal. J Clin Endocrinol Metab. 2002;87(4):1797-1804.Freda PU, Gordon MB, Kelepouris N, Jonsson P, Koltowska-Haggstrom M, van der Lely AJ. Long-term treatment with pegvisomant as monotherapy in patients with acromegaly: experience from ACROSTUDY. Endocr Pract. 2015;21(3):264-274.Fleseriu M, Führer-Sakel D, van der Lely AJ, et al. More than a decade of real-world experience of pegvisomant for acromegaly: ACROSTUDY. Eur J Endocrinol. 2021;185(4):525-538. Information on dosing and administrationGet started nowLoading Meet a range of patients with acromegaly View patient typesLoading

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PP-SOM-USA-1218
INDICATION SOMAVERT® (pegvisomant for injection) is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-I (IGF-I) levels.

Please see full Prescribing Information.
Important Safety Information

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

Patients with acromegaly and diabetes mellitus being treated with insulin and/or oral hypoglycemic agents may require dose reductions of these therapeutic agents after the initiation of treatment with SOMAVERT.

Important safety information regarding liver test monitoring

Baseline serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL), and alkaline phosphatase (ALP) levels should be obtained prior to initiating therapy with SOMAVERT. Monitor liver tests based on baseline values and changes during therapy according to the schedule in the full Prescribing Information.

Asymptomatic, transient elevations in transaminases up to 15 times ULN have been observed in <2% of subjects among two open-label trials (with a total of 147 patients). These reports were not associated with an increase in bilirubin. Transaminase elevations normalized with time, most often after suspending treatment. Postmarketing reports have identified elevations in serum hepatic transaminases up to >20 times ULN associated with elevation in total bilirubin >2 times ULN. In many of these cases, discontinuation of SOMAVERT therapy resulted in improvement or resolution of hepatic laboratory abnormalities. If a patient develops liver test elevations, or any other symptoms of liver dysfunction while receiving SOMAVERT, please see Liver Tests section of the full Prescribing Information.

In subjects with systemic hypersensitivity reactions, caution and close monitoring should be exercised when reinitiating SOMAVERT therapy.

The most common adverse events (>6% and at frequencies greater than placebo) in the active treatment arms in a placebo-controlled study (N=112) included infection (23%), pain (14%), nausea (14%), diarrhea (14%), abnormal liver function tests (12%), flu syndrome (12%), and injection-site reaction (11%).

Lipohypertrophy has been reported in patients treated with SOMAVERT; therefore, injection sites should be rotated daily.

Indication

SOMAVERT® (pegvisomant for injection) is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-I (IGF-I) levels.
 

Please see full Prescribing Information.