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AboutAboutImportance of IGF-I LevelsMechanism of ActionEfficacy & SafetyEfficacy & SafetyEfficacySafety & TolerabilityACROSTUDYPatient ProfilesDosingDecades of ResultsSupport & ServicesSupport & ServicesMaterialsVideosPatient Support & SavingsTools & Resources
Prescribing Information Indication Patient Site
ACROSTUDYACROSTUDY—a global observational registry capturing long-term safety of SOMAVERT as used in clinical practice2,12Key study information12
  • Open-label, global, non-interventional, postmarketing surveillance study open to acromegaly patients treated with SOMAVERT (pegvisomant)*
  • Primary purpose of study was to monitor the long-term safety of SOMAVERT as prescribed in clinical practice
  • Analyzed 1867 patients until December 4, 2012; 710 of those patients received monotherapy
  • 5.4±2.7 years mean duration of treatment
  • Although safety monitoring as per the recommended schedule was mandatory, not all assessments were performed at all time points for every patient. Because of this, comparison of rates of adverse events to those in the original clinical trial is not appropriate2
All recorded study data are collected as part of patient routine clinical care.SOMAVERT long-term safety results from ACROSTUDY 5-year interim analysis12Tumor monitoringLong-term pituitary size monitoring data12

MRI, magnetic resonance imaging.

Liver test monitoringLiver test monitoring (AST and ALT)12
  • At the start of pegvisomant therapy, 329 patients had normal ALT, 347 patients had normal AST, and 3 patients had >3 times ULN of ALT
  • During ACROSTUDY, of the 670 (94%) patients who underwent at least 1 LFT, 8 (1.2%) reported increases in transaminases >3 times ULN
Study limitation: Analysis revealed a low rate of LFT abnormalities of pegvisomant monotherapy; however, many patients began pegvisomant prior to enrollment into ACROSTUDY, so this figure could underrepresent the transient LFT abnormalities shown previously to be more likely early in therapy.12ALT, alanine aminotransferase; AST, aspartate aminotransferase; LFT, liver function test.Injection site reactions​​​​​Injection site reactions12
  • 16 (2.3%) out of 710 patients reported 19 adverse events related to injection site administration:
    • Lipodystrophy or lipohypertrophy (8 cases); pruritus (1 case); injection site irritation (1 case), reaction (4 cases), or condition (3 cases); skin reaction (1 case); and injection site hematoma (1 case)
ACROSTUDY—IGF-I control
  • At year 5 of ACROSTUDY12
    • 67.5% of patients had normal IGF-I levels (mean dose 17.2 mg/day)
    • 2.6% of patients had IGF-I levels below the LLN
    • 29.9% of patients had elevated IGF-I levels (mean dose 19.8 mg/day)

A limitation of the ACROSTUDY treatment outcome analysis was that central IGF-I levels were only available in some patients, which necessitated that efficacy be based on local IGF-I measurements with unknown reliability.12

LLN, lower limit of normal.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. 20 years of results for acromegaly patients Find out more Loading Connect eligible patients to support services Download form Loading

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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.