Medical Information
United States
 

In order to provide you with relevant and meaningful content we need to know more about you.

Please choose the category that best describes you.

Información selecta para pacientes y cuidadores que se encuentra disponible en Español.

This content is intended for U.S. Healthcare Professionals. Would you like to proceed?

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

SOMAVERT® WITH PREFILLED DILUENT SYRINGE How Supplied/Storage and Handling (pegvisomant with PREFILLED DILUENT SYRINGE)

16 HOW SUPPLIED/STORAGE AND HANDLING

SOMAVERT (pegvisomant) for injection is a white lyophilized powder supplied in the following strengths and package configurations:

One Day Package Configuration
StrengthNDCDescription
10 mg per vial0009-7166-01One single-dose vial with one prefilled syringe containing 1 mL of diluent (Sterile Water for Injection, USP) and a separate 27 -gauge ½ inch safety needle per carton
15 mg per vial0009-7168-01
20 mg per vial0009-7188-01
25 mg per vial0009-7199-01
30 mg per vial0009-7200-01
30-Day Package Configuration
StrengthNDCDescription
10 mg per vial0009-7166-30Each outer carton contains three intermediate cartons, 30 prefilled syringes containing 1 mL of diluent (Sterile Water for Injection, USP), and 30 separate 27-gauge ½ inch safety needles. Each intermediate carton contains ten single-dose vials of Somavert.
15 mg per vial0009-7168-30
20 mg per vial0009-7188-30
25 mg per vial0009-7199-30
30 mg per vial0009-7200-30

Storage

Prior to reconstitution:

  • The One Day Package of SOMAVERT should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F).
  • For the 30-Day Package, remove the three intermediate cartons containing the SOMAVERT vials and store in a refrigerator at 2°C to 8°C (36°F to 46°F).
  • For convenience, the One Day Package and intermediate cartons in the 30-Day Package containing the SOMAVERT vial(s), may be stored at room temperature up to 25°C (77°F) for a single period of up to 30 days.
    • In the space provided on the carton, record the date when the carton was removed from the refrigerator and the discard date (30 days after removal from the refrigerator).
    • Once the carton has been stored at room temperature, it should not be placed back into the refrigerator. If not used within 30 days at room temperature, the vial(s) should be discarded.

Discard the SOMAVERT vial(s) after the expiration date printed on the carton or the discard date, whichever is sooner.

The prefilled syringe(s) may be stored at a temperature up to 30°C (86°F) until the expiration date printed on the carton, at which point they should be discarded.

Do not freeze.

Did you find an answer to your question? Yes No
Didn’t find what you were looking for? Contact us.
Report Adverse Event