SOMAVERT® (pegvisomant for injection) Dosage and Administration

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Prescribing Information

SOMAVERT^® (pegvisomant for injection)
Dosage and Administration


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A loading dose of 40 mg of SOMAVERT should be administered subcutaneously under physician supervision. The patient should then be instructed to begin daily subcutaneous injections of 10 mg of SOMAVERT. Serum IGF-I concentrations should be measured every four to six weeks, at which time the dosage of SOMAVERT should be adjusted in 5-mg increments if IGF-I levels are still elevated (or 5-mg decrements if IGF-I levels have decreased below the normal range). While the goals of therapy are to achieve (and then maintain) serum IGF-I concentrations within the age-adjusted normal range and to alleviate the signs and symptoms of acromegaly, titration of dosing should be based on IGF-I levels. It is unknown whether patients who remain symptomatic while achieving normalized IGF-I levels would benefit from increased dosing with SOMAVERT.

The maximum daily maintenance dose should not exceed 30 mg.

SOMAVERT is supplied as a lyophilized powder. Each vial of SOMAVERT should be reconstituted with 1 mL of the diluent provided in the package (Sterile Water for Injection, USP). Instructions regarding reconstitution and administration are included in the package of SOMAVERT and should be closely followed. To prepare the solution, withdraw 1 mL of Sterile Water for Injection, USP and inject it into the vial of SOMAVERT, aiming the stream of liquid against the glass wall. Hold the vial between the palms of both hands and gently roll it to dissolve the powder. DO NOT SHAKE THE VIAL, as this may cause denaturation of pegvisomant. Discard the diluent vial containing the remaining water for injection. After reconstitution, each vial of SOMAVERT contains 10,15, or 20 mg of pegvisomant protein in one mL of solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The solution should be clear after reconstitution. If the solution is cloudy, do not inject it. Only one dose should be administered from each vial. SOMAVERT should be administered within six hours after reconstitution.

Pegvisomant may be given in the thigh, buttocks, upper arm, or abdomen; the site of SC injections should be rotated daily to help prevent lipohypertrophy.

SOMAVERT Safety Information

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.

Important Safety Information for Health Care Professionals

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

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

Functional effects of increased GH are prevented by GH receptor blockade; therefore, patients should be carefully observed for the clinical signs and symptoms of a GH-deficient state.

Acromegalic patients with diabetes mellitus being treated with insulin and/or oral hypoglycemic agents may require dose reductions of these therapeutic agents after the initiation of therapy with SOMAVERT.

Important safety information regarding periodic tumor size monitoring

Tumors that secrete GH may expand and cause serious complications. All patients with GH-secreting tumors, including those receiving SOMAVERT^®, should be carefully monitored for changes in tumor volume
Overall, mean tumor size was unchanged during the course of treatment in clinical studies
Tumor volume change did not appear to be influenced by whether or not patients had previously received radiation therapy

Important safety information regarding liver test monitoring

Monitor liver tests based on baseline values and changes during therapy according to the schedule in the full prescribing information
ALT was >3X but <10X the upper limit of normal (ULN) in patients treated with SOMAVERT (1.2%) vs placebo (2.1%)
– ALT and AST elevations occurred within 4 to 12 weeks after the start of therapy and did not appear to be related to the dose
In clinical studies with SOMAVERT, 2 patients (0.8%) experienced elevations of ALT and AST serum concentrations >10X the upper limit of normal (ULN)
– In both patients, the elevations normalized after discontinuation of the medicine

If a patient develops liver test elevations, or any other symptoms of liver dysfunction while receiving SOMAVERT, please see Liver Tests section of full Prescribing Information.

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.

Injection sites should be rotated daily to help prevent lipohypertrophy.

The maximum daily maintenance dose should not exceed 30 mg/day.

Please see full prescribing information.

SOMAVERT^® (pegvisomant for injection) PI

Please see Patient Package Insert.

SOMAVERT^® (pegvisomant for injection) PPI

somavert_safety_information.htm