Somavert (Pegvisomant) - Indications and Dosage

INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

SOMAVERT is available in single-dose, sterile glass vials in the following strengths:

10 mg (as protein) vial           NDC 0009-5176-01

15 mg (as protein) vial           NDC 0009-5178-01

20 mg (as protein) vial           NDC 0009-5180-01

Each package of SOMAVERT also includes a single-dose LifeShield^® plastic fliptop vial containing 10 mL of Sterile Water for Injection, USP.

The stopper on the vial of SOMAVERT contains latex.

Storage

Prior to reconstitution, SOMAVERT should be stored in a refrigerator at 2 to 8[ordm ]C (36 to 46[ordm ]F). Protect from freezing.

After reconstitution, SOMAVERT should be administered within six hours. Only one dose should be administered from each vial.

Manufactured for:

Pharmacia & Upjohn Company

A subsidiary of Pharmacia Corporation

Kalamazoo, MI 49001, USA

by:

Abbott Laboratories

North Chicago, IL 60064, USA

U.S. Patent Nos. 5,350,836; 5,681,809; 5,849,535; 5,958,879; 6,057,292; 6,583,115.

Revised June 2003

818 727 001

692842