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 vial

0009-7166-01

One 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 vial

0009-7168-01

20 mg per vial

0009-7188-01

25 mg per vial

0009-7199-01

30 mg per vial

0009-7200-01

30-Day Package Configuration
StrengthNDCDescription

10 mg per vial

0009-7166-30

Each 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 vial

0009-7168-30

20 mg per vial

0009-7188-30

25 mg per vial

0009-7199-30

30 mg per vial

0009-7200-30

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.
o
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).
o
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.

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How Supplied/Storage and Handling

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 vial

0009-7166-01

One 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 vial

0009-7168-01

20 mg per vial

0009-7188-01

25 mg per vial

0009-7199-01

30 mg per vial

0009-7200-01

30-Day Package Configuration
StrengthNDCDescription

10 mg per vial

0009-7166-30

Each 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 vial

0009-7168-30

20 mg per vial

0009-7188-30

25 mg per vial

0009-7199-30

30 mg per vial

0009-7200-30

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.
o
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).
o
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.
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Health Professional Information

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