NYVEPRIA How Supplied/Storage and Handling

(pegfilgrastim-apgf)

16 HOW SUPPLIED/STORAGE AND HANDLING

NYVEPRIA (pegfilgrastim-apgf) injection is a clear, colorless solution supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim-apgf, supplied with a 27-gauge 1/2-inch needle and a BD UltraSafe Plus™ Passive Needle Guard.

The NYVEPRIA syringe plunger stopper and needle cover are not made with natural rubber latex.

NYVEPRIA is provided in a dispensing pack containing one sterile 6 mg/0.6 mL prefilled syringe (NDC 0069-0324-01).

NYVEPRIA prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (6 mg/0.6 mL) for direct administration. Use of the prefilled syringe is not recommended for direct administration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents of the syringe.

Store refrigerated between 36°F to 46°F (2°C to 8°C) in the carton to protect from light. Do not shake. Discard syringes stored at room temperature for more than 15 days. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.

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How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

NYVEPRIA (pegfilgrastim-apgf) injection is a clear, colorless solution supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim-apgf, supplied with a 27-gauge 1/2-inch needle and a BD UltraSafe Plus™ Passive Needle Guard.

The NYVEPRIA syringe plunger stopper and needle cover are not made with natural rubber latex.

NYVEPRIA is provided in a dispensing pack containing one sterile 6 mg/0.6 mL prefilled syringe (NDC 0069-0324-01).

NYVEPRIA prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (6 mg/0.6 mL) for direct administration. Use of the prefilled syringe is not recommended for direct administration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents of the syringe.

Store refrigerated between 36°F to 46°F (2°C to 8°C) in the carton to protect from light. Do not shake. Discard syringes stored at room temperature for more than 15 days. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.
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