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Prescribing Information Indication Patient Site
Dosing and Administration

Dosing

Storage

Tab Number 3

Tab Number 4

Tab Number 5

Getting started on SOMAVERTEstablish baseline for IGF-I and liver testing2
  • IGF-I levels are the biomarker of efficacy with SOMAVERT
  • Baseline serum liver tests should be obtained prior to initiating therapy with SOMAVERT
  • If baseline liver test levels are >3 times ULN, do not treat with SOMAVERT until a comprehensive workup establishes the cause of the patient's liver dysfunction
Dosage information2
  • The recommended loading dose of SOMAVERT is 40 mg SC
    • ​​​​​​ On the next day following the loading dose, begin 10-mg SC daily injections​​​​​​​​​​​​​​​​​​​​​​​​​​​​
  • ​​​​​​​The recommended dosage range is between 10 and 30 mg SC daily​​​​​​​​​​​​​​
SC, subcutaneously.Simple injection preparation:

SOMAVERT is available with a prefilled diluent syringe2

SOMAVERT is available in 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg vials

Titrate the dose to normalize serum IGF-I concentrations2
  • The dosage should not be based on GH concentrations or signs and symptoms of acromegaly
  • Serum IGF-I concentrations should be measured every 4 to 6 weeks:
    • Increase the dosage by 5-mg increments if IGF-I concentrations are elevated
    • ​​​​​​​Decrease the dosage by 5-mg decrements if IGF-I concentrations are below the normal range
Monitoring patients while on SOMAVERT2
  • Monitor IGF-I levels every 6 months once normalized
  • If a patient develops liver test elevations ≥3 but <5 times ULN (without signs/symptoms of hepatitis or other liver injury, or increase in serum TBIL), continue therapy with SOMAVERT. However, monitor liver tests weekly to determine if further increases occur
  • If liver test levels are at least 5 times ULN, or transaminase elevations at least 3 times ULN associated with any increase in serum TBIL (with or without signs/symptoms of hepatitis or other liver injury), discontinue SOMAVERT immediately
TBIL, total bilirubin.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.
Header
Enhancing patient convenience with alternative storage and packaging options for SOMAVERT SOMAVERT is approved for patients to store at room temperature and available in a 30-day package option2,4

SOMAVERT gives patients flexibility in packaging with a one-day package configuration and a 30-day package configuration designed to take up to 35% less refrigerator space. Be sure to discuss with your patients which option may be right for them.2,4

Refrigerator storage2
  • Recommended for longer-term storage prior to reconstitution
  • The one-day package of SOMAVERT and 3 intermediate cartons of the 30-day package should be kept at 36°F to 46°F (2°C-8°C)
  • Patients should not freeze SOMAVERT
Room temperature storage2,*
  • Appropriate for when refrigeration is less convenient or not an option
  • The one-day package of SOMAVERT and 3 intermediate cartons of the 30-day package can be stored at room temperature up to 77°F (25°C) for a maximum single period of up to 30 days
  • Once removed, patients should not return SOMAVERT to the refrigerator
  • The prefilled syringe(s) may be stored at a temperature up to 86°F (30°C) until the expiration date printed on the carton, at which point they should be discarded 
  • This does not change the requirement to store vials in a refrigerator prior to dispensing to patients
Room temperature storage does not apply for the existing stock of SOMAVERT one-day packages. Current supplies of SOMAVERT one-day packages should still be stored in the refrigerator at 36°F to 46°F (2°C-8°C). Patients should follow the Package Insert instructions for the packaging they have.Simple injection preparation2
  • SOMAVERT is available with a prefilled diluent syringe
  • SOMAVERT should be administered immediately after reconstitution or else thrown away
Discarding SOMAVERT2
  • The SOMAVERT vial(s) should be discarded after the expiration date printed on the carton or the discard date, 30 days after removal from the refrigerator, whichever is sooner
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.
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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.