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Prescribing Information Indication Patient Site
Patient ProfilesMeet a range of patients with acromegalyDo you recognize them? A closer examination of 4 patient types:60 years old with acromegaly and diabetes Clinical presentation
  • Age at diagnosis of acromegaly: 55
  • IGF-I level: 2.7x upper limit of normal (ULN)
  • Type 2 diabetes
  • Presenting symptoms: soft-tissue swelling and joint pain
Treatment history
  • Began treatment with transsphenoidal surgery, followed by an SSA
  • IGF-I level decreased but blood glucose level rose
  • After switching SSAs and instituting more stringent dietary restrictions, Steve’s IGF-I levels remain persistently elevated

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.

Monitor SOMAVERT patients with diabetes for hypoglycemia
  • 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 hypoglycemia
  • By binding to GH receptors, SOMAVERT blocks GH action, thereby improving glucose tolerance in some patients
  • SOMAVERT does not block glucagon or insulin secretion
46 years old with persistent acromegaly symptoms Clinical presentation
  • Age at diagnosis of acromegaly: 44
  • IGF-I level: 1.2x ULN
  • Presenting symptoms: headache, soft-tissue swelling, and joint pain
Treatment history
  • Underwent transsphenoidal surgery
  • Nine months postsurgery, Alice’s IGF-I level is 1.5x ULN and her symptoms have persisted
In the pivotal trial, SOMAVERT improved the signs and symptoms of acromegalySOMAVERT improved ring size and total score of signs and symptoms, compared with placebo1,2

In a post hoc analysis of the pivotal study, 88% of patients who achieved IGF-I normalization in the 12-week pivotal trial also experienced an improved signs and symptoms score4

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

Total score for signs and symptoms is 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 by 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 15.2.1,2

Study Description: In a post hoc analysis, of the 112 patients randomized and treated in the study, 60 patients (53.6%) had IGF-I levels within the normal range at some point during the study follow-up. Among these 60 patients, 59 also had their acromegaly signs and symptoms total score reported at or after the IGF-I normalization visit. Fifty-two out of 59 patients (88%) had reported improved acromegaly signs and symptoms at the clinical visit or later at which IGF-I levels were reported as normalized.4

51 years old with a history of using an SSA Clinical presentation
  • Age at diagnosis of acromegaly: 48
  • IGF-I level: 1.6x ULN
  • Presenting symptoms: headache, soft-tissue swelling, and joint pain
Treatment history
  • Underwent transsphenoidal surgery after receiving MRI confirmation of the presence of a pituitary tumor and initiated SSA therapy soon after
  • Titrated dosage strength over the course of 1 year
  • Patient is seeking an alternate treatment option

IGF-I levels in patients who changed treatment from prior SSA therapy

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

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

These data do not represent head-to-head studies of SOMAVERT versus octreotide LAR and no direct comparisons of efficacy, safety, or implied superiority of SOMAVERT relative to octreotide LAR should be inferred.

From weeks 4 through 12 there was overlapping effect of pegvisomant and octreotide LAR. Overlapping pharmacological effects on IGF-I concentrations must be taken into consideration when the dose of pegvisomant is titrated within the first 3-4 months of octreotide LAR therapy discontinuation.538 years old and searching for an alternative treatment option Clinical presentation
  • Age at diagnosis of acromegaly: 37
  • Initial IGF-I level: 1.5x ULN
  • Presenting symptoms: fatigue, headache, and soft-tissue swelling
Treatment history
  • Upon transsphenoidal surgery, started SSA therapy but developed adverse reactions that prevented her from continuing treatment
  • Lynne’s IGF-I level is still 1.5x ULN and her symptoms remain persistent
  • Her next therapy should offer an at-home, self-administered treatment option

In the pivotal trial, SOMAVERT significantly reduced IGF-I levels1,2,†

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

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

Patients who have had an inadequate response to surgery or radiation therapy or for whom these therapies are not appropriate.2 Individual results may vary. All patients may not respond to treatment with SOMAVERT.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.