ABRILADA™ How Supplied/Storage and Handling

(adalimumab-afzb)

16 HOW SUPPLIED/STORAGE AND HANDLING

ABRILADA™ (adalimumab-afzb) is supplied as a preservative-free, sterile, clear and colorless to very light brown solution for subcutaneous administration. The following packaging configurations are available.

ABRILADA Pen Carton - 40 mg/0.8 mL (One Count)
ABRILADA (adalimumab-afzb) injection is supplied in a carton containing two alcohol preps and a single-dose pen. The single-dose pen contains a 1 mL prefilled glass syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.8 mL of ABRILADA. The needle cover is not made with natural rubber latex.
The NDC numbers are 0069-0325-01 and 0025-0325-01.
ABRILADA Pen Carton - 40 mg/0.8 mL (Two Counts)
ABRILADA (adalimumab-afzb) injection is supplied in a carton containing two alcohol preps and two single-dose pens. Each single-dose pen contains a 1 mL prefilled glass syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.8 mL of ABRILADA. The needle cover is not made with natural rubber latex.
The NDC numbers are 0069-0325-02 and 0025-0325-02.
Prefilled Syringe Carton - 40 mg/0.8 mL (One Count)
ABRILADA is supplied in a carton containing two alcohol preps and one dose tray. The dose tray consists of a single-dose, 1 mL prefilled glass syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.8 mL of ABRILADA. The needle cover is not made with natural rubber latex.
The NDC numbers are 0069-0328-01 and 0025-0328-01.
Prefilled Syringe Carton - 40 mg/0.8 mL (Two Counts)
ABRILADA is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose, 1 mL prefilled glass syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.8 mL of ABRILADA. The needle cover is not made with natural rubber latex.
The NDC numbers are 0069-0328-02 and 0025-0328-02.
Prefilled Syringe Carton - 20 mg/0.4 mL (Two Counts)
ABRILADA is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose, 1 mL prefilled glass syringe with a fixed thin wall, ½ inch needle, providing 20 mg/0.4 mL of ABRILADA. The needle cover is not made with natural rubber latex.
The NDC numbers are 0069-0333-02 and 0025-0333-02.
Prefilled Syringe Carton - 10 mg/0.2 mL (Two Counts)
ABRILADA is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose, 1 mL prefilled glass syringe with a fixed thin wall, ½ inch needle, providing 10 mg/0.2 mL of ABRILADA. The needle cover is not made with natural rubber latex.
The NDC numbers are 0069-0347-02 and 0025-0347-02.
Single-Dose Institutional Use Vial Carton - 40 mg/0.8 mL
ABRILADA is supplied for institutional use only in a carton containing a single-dose, glass vial, providing 40 mg/0.8 mL of ABRILADA. The vial stopper is not made with natural rubber latex.
The NDC numbers are 0069-0319-01 and 0025-0319-01.

Storage and Stability

Do not use beyond the expiration date on the container. ABRILADA must be refrigerated at 36°F to 46°F (2°C to 8°C). DO NOT FREEZE. Do not use if frozen even if it has been thawed.

Store in original carton until time of administration to protect from light.

If needed, for example when traveling, ABRILADA may be stored at room temperature up to a maximum of 86°F (30°C) for a period of up to 30 days, with protection from light. ABRILADA should be discarded if not used within the 30-day period. Record the date when ABRILADA is first removed from the refrigerator in the spaces provided on the ABRILADA pen carton or the prefilled syringe carton.

Do not store ABRILADA in extreme heat or cold.

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How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

ABRILADA™ (adalimumab-afzb) is supplied as a preservative-free, sterile, clear and colorless to very light brown solution for subcutaneous administration. The following packaging configurations are available.

ABRILADA Pen Carton - 40 mg/0.8 mL (One Count)
ABRILADA (adalimumab-afzb) injection is supplied in a carton containing two alcohol preps and a single-dose pen. The single-dose pen contains a 1 mL prefilled glass syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.8 mL of ABRILADA. The needle cover is not made with natural rubber latex.
The NDC numbers are 0069-0325-01 and 0025-0325-01.
ABRILADA Pen Carton - 40 mg/0.8 mL (Two Counts)
ABRILADA (adalimumab-afzb) injection is supplied in a carton containing two alcohol preps and two single-dose pens. Each single-dose pen contains a 1 mL prefilled glass syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.8 mL of ABRILADA. The needle cover is not made with natural rubber latex.
The NDC numbers are 0069-0325-02 and 0025-0325-02.
Prefilled Syringe Carton - 40 mg/0.8 mL (One Count)
ABRILADA is supplied in a carton containing two alcohol preps and one dose tray. The dose tray consists of a single-dose, 1 mL prefilled glass syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.8 mL of ABRILADA. The needle cover is not made with natural rubber latex.
The NDC numbers are 0069-0328-01 and 0025-0328-01.
Prefilled Syringe Carton - 40 mg/0.8 mL (Two Counts)
ABRILADA is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose, 1 mL prefilled glass syringe with a fixed thin wall, ½ inch needle, providing 40 mg/0.8 mL of ABRILADA. The needle cover is not made with natural rubber latex.
The NDC numbers are 0069-0328-02 and 0025-0328-02.
Prefilled Syringe Carton - 20 mg/0.4 mL (Two Counts)
ABRILADA is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose, 1 mL prefilled glass syringe with a fixed thin wall, ½ inch needle, providing 20 mg/0.4 mL of ABRILADA. The needle cover is not made with natural rubber latex.
The NDC numbers are 0069-0333-02 and 0025-0333-02.
Prefilled Syringe Carton - 10 mg/0.2 mL (Two Counts)
ABRILADA is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose, 1 mL prefilled glass syringe with a fixed thin wall, ½ inch needle, providing 10 mg/0.2 mL of ABRILADA. The needle cover is not made with natural rubber latex.
The NDC numbers are 0069-0347-02 and 0025-0347-02.
Single-Dose Institutional Use Vial Carton - 40 mg/0.8 mL
ABRILADA is supplied for institutional use only in a carton containing a single-dose, glass vial, providing 40 mg/0.8 mL of ABRILADA. The vial stopper is not made with natural rubber latex.
The NDC numbers are 0069-0319-01 and 0025-0319-01.

Storage and Stability

Do not use beyond the expiration date on the container. ABRILADA must be refrigerated at 36°F to 46°F (2°C to 8°C). DO NOT FREEZE. Do not use if frozen even if it has been thawed.

Store in original carton until time of administration to protect from light.

If needed, for example when traveling, ABRILADA may be stored at room temperature up to a maximum of 86°F (30°C) for a period of up to 30 days, with protection from light. ABRILADA should be discarded if not used within the 30-day period. Record the date when ABRILADA is first removed from the refrigerator in the spaces provided on the ABRILADA pen carton or the prefilled syringe carton.

Do not store ABRILADA in extreme heat or cold.

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