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Statement of Medical NecessityHow to obtain SOMAVERT® (pegvisomant for injection)Click here to view the Statement of Medical Necessity (SMN). Print and complete the SMN form and fax it to the Pfizer Bridge Program™ 
Viewing and printing the SMN requires Adobe® Reader® software to be installed on your computer. Most computers come with this software already installed. Otherwise, you can download it for free at www.adobe.com or by clicking on the icon to the left. |
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. Copyright 2006 Pfizer Inc. All rights reserved. GN272936B rev. August 2006 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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