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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.
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
Pfizer initiates ACROSTUDY, an open-label, global, non-interventional, postmarketing surveillance study open to acromegaly patients treated with SOMAVERT.12,*
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.
Key study information12:
IGF-I study results showed12:
Available in 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg vials
With its presence on Facebook, Pfizer created a platform where the acromegaly community can gather to discuss topics relevant to treatment, symptoms, and more.
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:
Published in August 2021, this study represents the final long-term safety and efficacy analysis of patients in ACROSTUDY.13
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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.
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.