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Importance of IGF–I Levels

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Efficacy

IGF-I Reduction

Signs and Symptoms

Sustained Efficacy

Endocrine Society Guidelines​​​​​​​​​​​​​​

The 2014 Endocrine Society Guidelines suggest SOMAVERT as an option for initial adjuvant medical therapy in patients with significant disease following surgery3,*

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   *ie, moderate-to-severe signs and symptoms of growth hormone excess and without local mass effects.
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SOMAVERT significantly reduced IGF-I levels1,2,†

In the pivotal trial, SOMAVERT showed significantly reduced IGF-I levels from baseline across all 3 doses at 12 weeks (primary endpoint).1,2

MEAN PERCENT CHANGE IN SERUM IGF-I CONCENTRATIONS COMPARED WITH PLACEBO1,2

Predefined visits.​​​​​​​
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SOMAVERT rapidly reduced IGF-I levels1

In the pivotal trial, SOMAVERT began to reduce IGF-I levels within 2 weeks.1

Rapid reduction: 75% of the total mean reduction in IGF-I levels occurred within 2 weeks and the reduction was sustained over the 12-week course of therapy with all doses of SOMAVERT (this was not part of the primary endpoint)1

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    †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 patients with acromegaly who may have been previously treated with surgery, radiation therapy, and/or drug therapy. The primary efficacy endpoint was IGF-I percent change in IGF-I concentrations from baseline to week 12. The mean percent change from baseline at week 12 in IGF-I was -4 for placebo, -27 at 10 mg/day, -48 at 15 mg/day, and -63 at 20 mg/day for SOMAVERT.1,2


In the pivotal trial, SOMAVERT worked for a majority of patients1,2

SOMAVERT normalized IGF-I levels for a majority of patients.1,2

PERCENTAGE OF PATIENTS ACHIEVING A NORMAL SERUM IGF-I AT WEEK 12—PIVOTAL TRIAL (SECONDARY ENDPOINT)1,2,4

   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 patients with acromegaly who may have been previously treated with surgery, radiation therapy, and/or drug therapy.1


References:
  1. 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.
  2. SOMAVERT. Prescribing information. Pfizer Inc.; 2021.
  3. 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.
  4. Data on file. Pfizer Inc., New York, NY.
  5. 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.
  6. Melmed S, Colao A, Barkan M, et al. Guidelines for acromegaly management: an update. J Clin Endocrinol Metab. 2009;94(5):1509-1517.
  7. 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.
  8. Melmed S. Acromegaly. N Engl J Med. 1990;322(14):966-977.
  9. Kopchick JJ. Discovery and mechanism of action of pegvisomant. Eur J Endocrinol. 2003;148(suppl 2):S21-S25.
  10. 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.
  11. 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.
  12. 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.

Efficacy and Safety

Endocrine Society Guidelines

  • Efficacy
  • Safety and Tolerability
  • ACROSTUDY
  • Patient Profiles
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Information on dosing and administration
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Meet a range of patients with acromegaly 

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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.

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.

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