NGENLA® How Supplied/Storage and Handling

(somatrogon-ghla)

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

NGENLA (somatrogon-ghla) injection is a clear and colorless to slightly light yellow solution containing a preservative and supplied as one single-patient-use disposable prefilled pen per carton available in the following packages:

24 mg/1.2 mL Prefilled Pen

NDC: 0069-0505-02
60 mg/1.2 mL Prefilled Pen

NDC: 0069-0520-02

Somatrogon-ghla solution concentration

20 mg/mL

50 mg/mL

Color scheme

Lilac pen cap, injection button and label

Blue pen cap, injection button and label

Dose increments

0.2 mg/0.01 mL

0.5 mg/0.01 mL

Maximum dose

12 mg (0.6 mL)

30 mg (0.6 mL)

Not made with natural rubber latex.

Sterile needles are required for administration but not included. Consult the Instructions for Use for needles that can be used.

Storage and Handling

Before first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.

After first use: Store the pen refrigerated at 36°F to 46°F (2°C to 8°C) between each use, for up to 28 days.

Do not freeze or shake. Do not expose to heat. Do not use if it has been frozen. Store away from direct sunlight.

Always remove and safely discard the needle after each injection and store the NGENLA prefilled pen without an injection needle attached. Always use a new needle for each injection. Replace the cap on your prefilled pen when it is not in use. Write the date of first use in the space provided on the pen label. The prefilled pen should not be used more than 28 days after first use.

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Health Professional Information

How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

NGENLA (somatrogon-ghla) injection is a clear and colorless to slightly light yellow solution containing a preservative and supplied as one single-patient-use disposable prefilled pen per carton available in the following packages:

24 mg/1.2 mL Prefilled Pen

NDC: 0069-0505-02
60 mg/1.2 mL Prefilled Pen

NDC: 0069-0520-02

Somatrogon-ghla solution concentration

20 mg/mL

50 mg/mL

Color scheme

Lilac pen cap, injection button and label

Blue pen cap, injection button and label

Dose increments

0.2 mg/0.01 mL

0.5 mg/0.01 mL

Maximum dose

12 mg (0.6 mL)

30 mg (0.6 mL)

Not made with natural rubber latex.

Sterile needles are required for administration but not included. Consult the Instructions for Use for needles that can be used.

Storage and Handling

Before first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.

After first use: Store the pen refrigerated at 36°F to 46°F (2°C to 8°C) between each use, for up to 28 days.

Do not freeze or shake. Do not expose to heat. Do not use if it has been frozen. Store away from direct sunlight.

Always remove and safely discard the needle after each injection and store the NGENLA prefilled pen without an injection needle attached. Always use a new needle for each injection. Replace the cap on your prefilled pen when it is not in use. Write the date of first use in the space provided on the pen label. The prefilled pen should not be used more than 28 days after first use.

Medication Guide

Health Professional Information

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