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Prescribing Information Indication Patient Site
Celebrating 20 Years of Treating Patients With Acromegaly

Pfizer’s commitment to advancing the field of endocrinology is evident in the 20 years that SOMAVERT has been helping patients with acromegaly. SOMAVERT helps patients overcome symptoms of acromegaly by achieving normal IGF-I concentrations.2

Scroll down to explore the various ways our treatment and support have evolved over the years, as we continue to meet our patients’ changing needs.

2003A new class of acromegaly treatment was approved!

Actual acromegaly patient.

With its FDA approval in 2003, Pfizer introduced SOMAVERT, a new treatment option for patients with acromegaly. Today, the indication for SOMAVERT is 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.2

2004 An open-label, postmarketing surveillance study open to acromegaly patients treated with SOMAVERT

Pfizer initiates ACROSTUDY, an open-label, global, non-interventional, postmarketing surveillance study open to acromegaly patients treated with SOMAVERT.12,*

  • Primary purpose of ACROSTUDY was to monitor the long-term safety of SOMAVERT as prescribed in clinical practice
  • 1867 patients were analyzed across 15 countries until December 4, 2012
  • 5.4±2.7 years mean duration of treatment

Timing of visits, pegvisomant dose, and dose titration were at the discretion of the treating physician/investigator.

*All recorded study data were collected as part of patient routine clinical care.

2015Publication of data for 710 patients who received SOMAVERT monotherapy for up to 5 years12

Key study information12:

  • Open-label, global, non-interventional, postmarketing surveillance study open to acromegaly patients treated with SOMAVERT
  • Primary purpose of the study was to monitor the long-term safety and efficacy of SOMAVERT as prescribed in clinical practice

IGF-I study results showed12:

2016Pfizer introduces a simple injection preparation with a prefilled diluent syringe2

Available in 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg vials

  • The recommended loading dose of SOMAVERT is 40 mg SC
    • On the next day following the loading dose, begin 10-mg SC daily injections
  • The recommended dosage range is between 10 mg and 30 mg SC daily
Patients with acromegaly can easily track their symptomsPfizer launches AcroTracker, a free app for iPhone and Android devices that helps patients easily keep track of their acromegaly symptoms. With the AcroTracker, patients can record their symptoms of acromegaly and then share them with their healthcare provider at their next visit.AcroTracker is a free app for iPhone® and Android™ devices.
The AcroTracker helps your patients keep a record of their symptoms.
iPhone and App Store are service marks of Apple Inc., registered in the U.S. and other countries.
Android and Google Play are trademarks of Google LLC.Welcome Brand AmbassadorsPfizer selects Brand Ambassadors for SOMAVERT who help increase awareness of acromegaly and inform others about the benefits of SOMAVERT. 
Actual acromegaly patients.
2020SOMAVERT Facebook page launched

With its presence on Facebook, Pfizer created a platform where the acromegaly community can gather to discuss topics relevant to treatment, symptoms, and more.

2021Packaging and storage that's more convenient for patients

SOMAVERT 30-day packaging configuration is approved as an alternative to the original one-day packaging, enhancing patient convenience.2

One 30-day package includes2:

  • 3 intermediate cartons containing a total of 30 single-dose vials of SOMAVERT
  • 30 prefilled syringes containing 1 mL of diluent (Sterile Water for Injection, USP)
  • 30 separate 27-gauge ½-inch safety needles
ACROSTUDY: Over a decade of real-world experience

Published in August 2021, this study represents the final long-term safety and efficacy analysis of patients in ACROSTUDY.13

  • This report focused on the full analysis population, which included all patients who were enrolled in ACROSTUDY from 2004 to 2017 and received at least 1 dose of SOMAVERT
  • ACROSTUDY is the largest cohort of acromegaly patients with the longest follow-up date
Today20 years and countingTo learn more about the milestones we’ve achieved over the past 2 decades, click on the years above.
ReferencesTrainer 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.
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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.