IMPORTANT SAFETY INFORMATION FOR SOMAVERT
*Signs and symptoms included headache, fatigue, athralgia, soft-tissue swelling, and excessive perspiration.
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 subjects with acromegaly who may have been previously treated with surgery, radiation therapy, and/or drug therapy.Total score for signs and symptoms are 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 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.
IMPORTANT SAFETY INFORMATION AND INDICATION
SOMAVERT is contraindicated in patients with a history of hypersensitivity to any of its components.
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. 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 re-initiating 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.
The maximum indicated daily maintenance dose for SOMAVERT is 30 mg.
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.
- SOMAVERT [prescribing information]. New York, NY: Pfizer Inc; 2016.
- Giustina A, Chanson P, Bronstein MD, et al. A consensus on criteria for cure for acromegaly. J Clin Endocrinol Metab. 2010;95(7):3141-3148.
- 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.
- Melmed S. Medical progress: Acromegaly. N Engl J Med. 2006;355(24):2558-2573.
- Melmed S, Jackson I, Kleinberg D, Klibanski A. Current treatment guidelines for acromegaly. J Clin Endocrinol Metab. 1998;83(8):2646-2652.
- 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.
- 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.
- Klibanski A, Melmed S, Clemmons DR, et al. The endocrine tumor summit 2008: appraising therapeutic approaches for acromegaly and carcinoid syndrome. Pituitary. 2010;13:266-286.