GENOTROPIN® How Supplied/Storage and Handling

(somatropin)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

GENOTROPIN (somatropin) for injection is a white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains the diluent.

GENOTROPIN lyophilized powder is available in the following packages:

5 mg single‑patient‑use two-chamber cartridge (with preservative)

•
After reconstitution the final concentration is 5 mg/mL
•
For use with the GENOTROPIN PEN 5 Growth Hormone Delivery Device.
•
Package of 1    NDC 0013-2626-81

12 mg single‑patient‑use two-chamber cartridge (with preservative)

•
After reconstitution the final concentration is 12 mg/mL
•
For use with the GENOTROPIN PEN 12 Growth Hormone Delivery Device.
•
Package of 1    NDC 0013-2646-81

GENOTROPIN MINIQUICK, a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge of GENOTROPIN (without preservative)

•
After reconstitution, each GENOTROPIN MINIQUICK delivers 0.25 mL, regardless of strength.

GENOTROPIN MINIQUICK is available in the following strengths, each in a package of 7:

Strength

NDC Number

0.2 mg

NDC 0013-2649-02

0.4 mg

NDC 0013-2650-02

0.6 mg

NDC 0013-2651-02

0.8 mg

NDC 0013-2652-02

1 mg

NDC 0013-2653-02

1.2 mg

NDC 0013-2654-02

1.4 mg

NDC 0013-2655-02

1.6 mg

NDC 0013-2656-02

1.8 mg

NDC 0013-2657-02

2 mg

NDC 0013-2658-02

16.2 Storage and Handling

The 5 mg and 12 mg GENOTROPIN single-patient-use cartridges:

•
Store GENOTROPIN lyophilized powder under refrigeration at 36°F to 46°F (2°C to 8°C) until the expiration date. Store in the package to protect from light. Do not freeze.
•
After reconstitution, store the pen (with the cartridge) in the pen box with the pen cap on to protect from light. Store under refrigeration at 36°F to 46°F (2°C to 8°C) between each use, for up to 28 days. Do not shake. Discard the cartridge and any unused medication after 28 days. Use a GENOTROPIN PEN 5, a medical device, to reconstitute the 5 mg two-chamber cartridge, and use a GENOTROPIN PEN 12 to reconstitute the 12 mg two-chamber cartridge.

The 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg and 2 mg single-dose Growth Hormone Delivery Devices containing a two-chamber cartridge (GENOTROPIN MINIQUICK):

•
Store GENOTROPIN MINIQUICK under refrigeration at 36°F to 46°F (2°C to 8°C) until the expiration date. If needed, may be stored for up to 3 months at room temperature at or below 77°F (25°C) prior to reconstitution. Do not freeze.
•
After reconstitution, store GENOTROPIN MINIQUICK in the package with the pen cap on to protect from light. If needed, may be stored under refrigeration at 36°F to 46°F (2°C to 8°C) for up to 24 hours before use. Do not shake. The GENOTROPIN MINIQUICK should be used only once and then discarded.

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How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

GENOTROPIN (somatropin) for injection is a white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains the diluent.

GENOTROPIN lyophilized powder is available in the following packages:

5 mg single‑patient‑use two-chamber cartridge (with preservative)

•
After reconstitution the final concentration is 5 mg/mL
•
For use with the GENOTROPIN PEN 5 Growth Hormone Delivery Device.
•
Package of 1    NDC 0013-2626-81

12 mg single‑patient‑use two-chamber cartridge (with preservative)

•
After reconstitution the final concentration is 12 mg/mL
•
For use with the GENOTROPIN PEN 12 Growth Hormone Delivery Device.
•
Package of 1    NDC 0013-2646-81

GENOTROPIN MINIQUICK, a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge of GENOTROPIN (without preservative)

•
After reconstitution, each GENOTROPIN MINIQUICK delivers 0.25 mL, regardless of strength.

GENOTROPIN MINIQUICK is available in the following strengths, each in a package of 7:

Strength

NDC Number

0.2 mg

NDC 0013-2649-02

0.4 mg

NDC 0013-2650-02

0.6 mg

NDC 0013-2651-02

0.8 mg

NDC 0013-2652-02

1 mg

NDC 0013-2653-02

1.2 mg

NDC 0013-2654-02

1.4 mg

NDC 0013-2655-02

1.6 mg

NDC 0013-2656-02

1.8 mg

NDC 0013-2657-02

2 mg

NDC 0013-2658-02

16.2 Storage and Handling

The 5 mg and 12 mg GENOTROPIN single-patient-use cartridges:

•
Store GENOTROPIN lyophilized powder under refrigeration at 36°F to 46°F (2°C to 8°C) until the expiration date. Store in the package to protect from light. Do not freeze.
•
After reconstitution, store the pen (with the cartridge) in the pen box with the pen cap on to protect from light. Store under refrigeration at 36°F to 46°F (2°C to 8°C) between each use, for up to 28 days. Do not shake. Discard the cartridge and any unused medication after 28 days. Use a GENOTROPIN PEN 5, a medical device, to reconstitute the 5 mg two-chamber cartridge, and use a GENOTROPIN PEN 12 to reconstitute the 12 mg two-chamber cartridge.

The 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg and 2 mg single-dose Growth Hormone Delivery Devices containing a two-chamber cartridge (GENOTROPIN MINIQUICK):

•
Store GENOTROPIN MINIQUICK under refrigeration at 36°F to 46°F (2°C to 8°C) until the expiration date. If needed, may be stored for up to 3 months at room temperature at or below 77°F (25°C) prior to reconstitution. Do not freeze.
•
After reconstitution, store GENOTROPIN MINIQUICK in the package with the pen cap on to protect from light. If needed, may be stored under refrigeration at 36°F to 46°F (2°C to 8°C) for up to 24 hours before use. Do not shake. The GENOTROPIN MINIQUICK should be used only once and then discarded.
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