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Somavert

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Somavert

Somavert

INDICATIONS

SOMAVERT 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.

DOSAGE AND ADMINISTRATION

Dosage Information

The recommended loading dose of SOMAVERT is 40 mg given subcutaneously, under healthcare provider supervision. Provide proper training in subcutaneous injection technique to patients or their caregivers so they can receive once daily subcutaneous injections. On the next day following the loading dose, instruct patients or their caregivers to begin daily subcutaneous injections of 10 mg of SOMAVERT.

Titrate the dosage to normalize serum IGF-I concentrations (serum IGF-I concentrations should be measured every four to six weeks). The dosage should not be based on growth hormone (GH) concentrations or signs and symptoms of acromegaly. It is unknown whether patients who remain symptomatic while achieving normalized IGF-I concentrations would benefit from increased SOMAVERT dosage.

  • Increase the dosage by 5 mg increments every 4-6 weeks if IGF-I concentrations are elevated.
  • Decrease the dosage by 5 mg decrements every 4-6 weeks if IGF-I concentrations are below the normal range.

The recommended dosage range is between 10 to 30 mg given subcutaneously once daily and the maximum daily dosage is 30 mg given subcutaneously once daily.

Assess Liver Tests Prior To Initiation Of SOMAVERT

Prior to the start of SOMAVERT, patients should have an assessment of baseline levels of liver tests [serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL), and alkaline phosphatase (ALP)]. For recommendations regarding initiation of SOMAVERT based on baseline liver tests and recommendations for monitoring of liver tests while on SOMAVERT, refer to Table 1 in WARNINGS AND PRECAUTIONS.

Loading Dose Injection Procedure

The following instructions are for the healthcare provider to reconstitute and prepare the 40 mg loading dose. The healthcare provider will need to reconstitute 1 vial of lyophilized powder of SOMAVERT containing 20 mg of pegvisomant with supplied diluent (two vials of lyophilized powder and two vials of diluet will be needed for the 40 mg loading dose). The healthcare provider will also need to inject the reconstituted SOMAVERT solution twice into the patient's upper arm, upper thigh, abdomen, or buttocks (each injection in a different area).

  1. Before administering the loading dose, remove the first package (1 vial of lyophilized powder of SOMAVERT containing 20 mg of pegvisomant and 1 vial containing the diluent) from the refrigerator about 10 minutes prior to the planned injection time.
  2. Withdraw 1 mL of the supplied diluent (Sterile Water for Injection) and inject slowly onto the sides of the vial containing lyophilized powder of SOMAVERT. Do not inject the diluent directly on the powder.
  3. Do not invert the vial or shake the solution as this may cause denaturation of the pegvisomant protein. Slowly swirl the solution to ensure that all of the lyophilized powder has gone into solution. If foaming of the reconstituted SOMAVERT solution is seen, the solution is likely damaged and therefore inappropriate to inject.
  4. Visually inspect the reconstituted SOMAVERT solution for particulate matter and discoloration prior to administration. The reconstituted solution should be clear. If the solution is cloudy, do not use it. Once reconstituted, the solution will contain 20 mg of pegvisomant in 1 mL of solution.
  5. Withdraw the 1 mL reconstituted SOMAVERT solution. The solution must be administered within 6 hours of reconstitution.
  6. Inject the first reconstituted SOMAVERT solution (20 mg/mL) subcutaneously into the patient's upper arm, upper thigh, abdomen, or buttocks using a 90-degree angle.
  7. Repeat steps (a) to (e) to reconstitute the second Somavert dose of 20mg.
  8. Finally, inject the second reconstituted SOMAVERT solution (20 mg/mL) subcutaneously into the patient's upper arm, upper thigh, abdomen, or buttocks using a 90-degree angle (different area than the first injection).

Maintenance Dose Injection Procedure

For patient or caregiver instructions for reconstitution and administration of daily doses (10 to 30 mg), see the Patient's Instructions for Use.

  1. Before administering the dose, remove one package (1 vial of lyophilized powder of SOMAVERT containing 10, 15 or 20 mg of pegvisomant and 1 vial containing the diluent) from the refrigerator about 10 minutes prior to the planned injection time.
  2. Withdraw 1 mL of the supplied 10 ml diluent (Sterile Water for Injection) and inject slowly onto the sides of the vial containing lyophilized powder of SOMAVERT. Do not inject the diluent directly on the powder.
  3. Do not invert the vial or shake the solution as this may cause denaturation of the pegvisomant protein. Slowly swirl the solution to ensure that all of the lyophilized powder has gone into solution. If foaming of the reconstituted SOMAVERT solution is seen, the solution is likely is damaged and therefore inappropriate to inject.
  4. Visually inspect the reconstituted SOMAVERT solution for particulate matter and discoloration prior to administration. The reconstituted solution should be clear. If the solution is cloudy, do not use it. Once reconstituted, the solution will contain 10, 15 or 20 mg of pegvisomant in 1 mL of solution.
  5. Withdraw the 1 mL reconstituted SOMAVERT solution. The solution must be administered within 6 hours of reconstitution.
  6. Inject the reconstituted SOMAVERT solution subcutaneously into the upper arm, upper thigh, abdomen, or buttocks using a 90-degree angle.
  7. If the total daily dosage is 25 or 30 mg then, repeat steps (a) to (e) to reconstitute the second Somavert dose to achieve a total dose of 25 or 30 mg.
  8. If the total daily dosage is 25 or 30 mg, inject the second reconstituted SOMAVERT solution subcutaneously into the upper arm, upper thigh, abdomen, or buttocks using a 90-degree angle (different area than the first injection).

HOW SUPPLIED

Dosage Forms And Strengths

For injection: 10 mg, 15 mg, and 20 mg lyophilized powder in a single-use vial for reconstitution with supplied Sterile Water for Injection, in a separate glass vial.

Storage And Handling

SOMAVERT (pegvisomant) is supplied in the following strengths and package configurations:

SOMAVERT (pegvisomant) for injection
Package Configuration NDC 6 mL vial NDC 8 mL vial
Single 10 mg dose vial NDC 0009-517601 NDC 0009-517602
Single 15 mg dose vial NDC 0009-517801 NDC 0009-517802
Single 20 mg dose vial NDC 0009-518001 NDC 0009-518002

Each package of SOMAVERT also includes a single-dose vial containing Sterile Water for Injection, USP.

Storage

Prior to reconstitution, SOMAVERT should be stored in a refrigerator at 2 to 8°C (36 to 46°F). Do not freeze.

Distributed by: Pharmacia & Upjohn Co., Division of Pfizer Inc, NY, NY 10017. Revised: December 2013

Last reviewed on RxList: 12/19/2013
This monograph has been modified to include the generic and brand name in many instances.

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