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Powerful, precise SOMAVERT is generally well tolerated

The majority of reported adverse events:

Were of mild to moderate intensity and limited duration¹
Did not appear to be dose dependent¹

Incidence of gastrointestinal side effects (diarrhea, nausea) was <15% in all groups¹

Adverse events occurring at >10%* in a 12-week randomized study¹

Adverse event	Placebo (n=32)	SOMAVERT 10 mg/day (n=26)	SOMAVERT 15 mg/day (n=26)	SOMAVERT 20 mg/day (n=28)
Infection^†	2 (6%)	6(23%)	0 (0%)	0 (0%)
Pain	2 (6%)	2 (8%)	1 (4%)	4 (14%)
Injection-related reaction	0 (0%)	2 (8%)	1 (4%)	3 (11%)
Flu syndrome	0 (0%)	1 (4%)	3 (12%)	2 (7%)
Abnormal liver function tests	1 (3%)	3 (12%)	1 (4%)	1 (4%)
Diarrhea	1 (3%)	1 (4%)	0 (0%)	4 (14%)
Nausea	1 (3%)	0 (0%)	2 (8%)	4 (14%)

*And at frequencies greater than 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).¹

Powerful, precise SOMAVERT reduces IGF- I levels without changing mean tumor volume

In a clinical trial of 131 patients, SOMAVERT did not affect tumor growth:

Overall, mean tumor volume change was not affected by duration of treatment^1,11
Tumor volume change did not appear to be influenced by whether or not patients had previously received radiation therapy¹¹
— 78 patients in the study had previously received radiation therapy; 53 had not received radiation therapy¹¹

— 2 patients in the study manifested tumor size progression; both entered the study with large, globular tumors that impinged on the optic chiasm and were already relatively resistant to medical therapy^1,11
Tumors that secrete growth hormone may expand and cause serious complications. Therefore, all patients with GH-secreting tumors, including those receiving SOMAVERT, should be carefully monitored for changes in tumor volume^1,11

Important information for patients with acromegaly and diabetes

SOMAVERT increases glucose tolerance

After initiation of therapy with SOMAVERT, glucose tolerance may increase in some patients and therefore should be carefully monitored¹
Data suggest increases in insulin sensitivity¹
Reductions in dosage of antidiabetic agents may be advisable¹

After 12 and 18 months, SOMAVERT decreased fasting serum insulin and fasting serum glucose.

Increase in glucose tolerance after 12 and 18 months of SOMAVERT^2,11

Sources: Data on file. Pfizer Inc., New York, NY,² and van der Lely et al. Lancet. 2001;358:1756.¹¹

Important safety information concerning liver test monitoring

In clinical studies with SOMAVERT, 2 patients (0.8%) experienced elevations of ALT and AST serum concentrations >10x the upper limit of normal (ULN)¹

In both patients, the elevations normalized after discontinuation of the medicine¹

ALT was >3x but <10x the ULN in patients treated with SOMAVERT (1.2%) vs placebo (2.1%)¹

ALT and AST elevations occurred within 4 to 12 weeks after the start of therapy and did not appear to be related to the dose¹

Liver test monitoring schedules

Baseline serum ALT, AST, TBIL, and ALP levels should be obtained prior to initiating therapy with SOMAVERT.

The following table lists recommendations regarding initiation of treatment with SOMAVERT based on results of liver tests (LTs)¹

Baseline LT Levels	Recommendations
Normal	May treat with SOMAVERT. Monitor LTs at monthly intervals during the first 6 months of treatment, quarterly for the next 6 months, and then biannually for the next year.
Elevated, but less than or equal to 3 times upper limit of normal (ULN)	May treat with SOMAVERT; however, monitor LTs monthly for at least 1 year after initiation of therapy and then biannually for the next year.
Greater than 3 times ULN	Do not treat with SOMAVERT until a comprehensive workup establishes the cause of the patient’s liver dysfunction. Determine if cholelithiasis or choledocholithiasis is present, particularly in patients with a history of prior therapy with somatostatin analogs. Based on the workup, consider initiation of therapy with SOMAVERT. If the decision is to treat, LTs and clinical symptoms should be monitored very closely.

If a patient develops LT elevation or any other signs or symptoms of liver dysfunction while receiving SOMAVERT, the following patient management is recommended.

Continuation of treatment with SOMAVERT based on results of liver tests¹

LT levels and clinical signs/symptoms	Recommendations
Greater than or equal to 3 but less than 5 times ULN (without signs/symptoms of hepatitis or other liver injury, or increase in serum TBIL)	May continue therapy with SOMAVERT. However, monitor LTs weekly to determine if further increases occur (see below). In addition, perform a comprehensive hepatic workup to discern if an alternative cause of liver dysfunction is present.
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. Perform a comprehensive hepatic workup, including serial LTs, to determine if and when serum levels return to normal. If LTs normalize (regardless of whether an alternative cause of the liver dysfunction is discovered), consider cautious reinitiation of therapy with SOMAVERT, with frequent LT monitoring.
Signs or symptoms suggestive of hepatitis or other liver injury (eg, jaundice, bilirubinuria, fatigue, nausea, vomiting, right upper quadrant pain, ascites, unexplained edema, easy bruisability)	Immediately perform a comprehensive hepatic workup. If liver injury is confirmed, the medicine should be discontinued.

Please see Full Prescribing Information.

References

Full Prescribing Information.
Data on file. Pfizer Inc. New York, NY.
van der Lely AJ, Hutson RK, Trainer PJ, et al. Long-term treatment of acromegaly with pegvisomant, a growth hormone receptor antagonist. Lancet. 2001;358:1754-1759.

Important Information for Healthcare Professionals:

SOMAVERT is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapies, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum IGF-I levels.

ALT, AST, TBIL, and ALP levels should be obtained prior to initiating therapy with SOMAVERT. If levels are normal, monitor at monthly intervals for the first 6 months of treatment, quarterly for the next 6 months, and then biannually for the next year. If patients exhibit symptoms suggestive of hepatitis or other liver injury, SOMAVERT should be discontinued and a comprehensive hepatic workup should be performed immediately. Please consult the full prescribing information for complete liver monitoring schedules.

SOMAVERT is contraindicated in patients with a history of hypersensitivity to any of its components. The stopper on the vial of SOMAVERT contains latex.

After initiation of therapy with SOMAVERT, glucose tolerance may increase in some patients. These patients should be carefully monitored and doses of antidiabetic medicines reduced as necessary.

Patients should be carefully observed for the clinical signs and symptoms of a GH-deficient state, and serum IGF-I level concentrations should be monitored and maintained within the age-adjusted normal range (by adjustment of the dose of SOMAVERT).

All patients with GH-secreting tumors, including those receiving SOMAVERT, should be carefully monitored for changes in tumor volume.

Patients on opioids often needed higher serum pegvisomant concentrations to achieve appropriate IGF-I level suppression compared with patients not receiving opioids.

The most common adverse events (>10% and at frequencies greater than placebo) in 1 of the 3 active treatment arms in a placebo-controlled study (n = 112) include infection, pain, diarrhea, nausea, flu syndrome, abnormal liver function tests, and injection-site reaction.

For full prescribing information, click here.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.

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