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Prescribing Information Indication Patient Site
Safety and TolerabilitySOMAVERT has a well-established tolerability and safety profilePatients with acromegaly reporting adverse events in the 12-week pivotal trial with SOMAVERT2,* Includes only those events that were reported in at least 2 patients and at a higher incidence in patients treated with SOMAVERT than in patients with placebo.The 6 events coded as “infection” in the group treated with SOMAVERT 10 mg were reported as cold symptoms (3), upper respiratory infection (1), blister (1), and ear infection (1). The 2 events in the placebo group were reported as cold symptoms (1) and chest infection (1).
Monitor SOMAVERT patients with diabetes for hypoglycemia2CHANGES IN SERUM GLUCOSE LEVELS AFTER 6, 12, AND 18 MONTHS OF SOMAVERT IN A LONG-TERM DOSE-TITRATION TRIAL10,‡CHANGES IN SERUM INSULIN LEVELS AFTER 6, 12, AND 18 MONTHS OF SOMAVERT IN A LONG-TERM DOSE-TITRATION TRIAL10,‡
  • Patients with acromegaly and diabetes mellitus being treated with insulin and/or oral hypoglycemic agents should be carefully monitored and may require dose reductions of these therapeutic agents after the initiation with SOMAVERT to avoid hypoglycemia2
  • By binding to GH receptors, SOMAVERT blocks GH action, thereby improving glucose tolerance in some patients2
  • SOMAVERT does not block glucagon or insulin secretion11
Study Description: Data from an open-label, dose titration trial in 160 patients treated with SOMAVERT for an average of 425 days. Patients were placed in cohorts on the basis of whether they had completed at least 6, 12, or 18 months of continuous daily SOMAVERT treatment at the time of data cutoff. The cohorts were constructed in cumulative fashion, such that all the patients in the 18-month treatment cohort were also included in the 6-month and 12-month cohorts, and the patients in the 12-month cohort were also included in the 6-month cohort. Dosing began at 10 mg/day and was titrated up or down as necessary in 5-mg/day increments until the patient's serum IGF-I levels were normal or until the maximum dose (in this study) of 40 mg/day was reached (mean dose at 12 months was 18.0 mg/day; mean dose at 18 months was 19.6 mg/day). For serum glucose, at 6 months, P=0.0130 vs baseline; at 12 months, P=0.0531 vs baseline; at 18 months, P=0.0125 vs baseline. For serum insulin, at 6 months, P=0.0717 vs baseline; at 12 months, P=0.0075; at 18 months, P=0.0393 vs baseline.10 

The maximum indicated daily maintenance dose for SOMAVERT is 30 mg.2​​
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 weeks5,§CHANGES IN HbA1c AT WEEK 4 AND WEEK 325

HbA1c, glycated hemoglobin.

Click here to see study schematic

Study 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.
Long-term safety results from ACROSTUDY 5-year interim analysis See the resultsLoading Financial support is available for eligible patients Find out moreLoading

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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.