IMPORTANT SAFETY INFORMATION FOR SOMAVERT

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.

Rx only

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.

REFERENCES

  1. SOMAVERT [prescribing information]. New York, NY: Pfizer Inc; 2016.
  2. 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.
  3. 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.
  4. Melmed S. Medical progress: Acromegaly. N Engl J Med. 2006;355(24):2558-2573.
  5. Melmed S, Jackson I, Kleinberg D, Klibanski A. Current treatment guidelines for acromegaly. J Clin Endocrinol Metab. 1998;83(8):2646-2652.
  6. Data on file. Pfizer Inc, New York, NY.
  7. 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.
  8. 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.
  9. 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.
  10. 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.

Safety and Tolerability

SOMAVERT has an established tolerability and safety profile

Most adverse events did not appear to be dose dependent1,8

Within this section, you will learn about overall Adverse Events, and important safety information about Glycemic Parameters and Liver Testing

  • 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%)1,8
  • There have been cases of lipohypertrophy in patients treated with SOMAVERT. In a double-blind, 12-week, placebo-controlled study, there was one case (1.3%) of injection-site lipohypertrophy reported in a subject receiving 10 mg/day. The subject recovered while on treatment. Injection sites should be rotated daily to help prevent lipohypertrophy (different area than last injection)1,8
  • Overall, mean tumor size was unchanged during the course of treatment with SOMAVERT in clinical studies8

*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 treated 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 for changes in liver function

  • Baseline serum liver tests should be obtained prior to initiating therapy with SOMAVERT1
  • Elevations of serum concentrations of ALT and AST greater than 10 times the ULN were reported in 2 patients (0.8%) exposed to SOMAVERT in pre-approval clinical studies1
  • The transaminase elevations were not dose dependent, generally occurred within 4 to 12 weeks of initiation of therapy, and were not associated with any identifiable biochemical, phenotypic, or genetic predictors1

Initiation of Treatment with SOMAVERT Based on Results of Liver Tests

Monitor SOMAVERT patients with diabetes for hypoglycemia

  • 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 therapy with SOMAVERT1
  • By binding to growth hormone (GH) receptors, SOMAVERT blocks GH action, thereby improving glucose tolerance in some patients1
  • SOMAVERT does not block glucagon or insulin secretion9

ACROSTUDY

SOMAVERT safety data from the 4-year, 1288-patient ACROSTUDY1

ACROSTUDY — the largest global observational registry capturing long-term safety of SOMAVERT as used in clinical practice

Key study information
  • ACROSTUDY is an international observational registry that captures long-term safety data (mean duration of treatment 3.7 years) in patients with acromegaly treated with SOMAVERT, as used in clinical practice. Treatment, dose and schedule were at the discretion of each treating physician1
  • 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 appropriate1