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NIVESTYM™ How Supplied/Storage and Handling (filgrastim-aafi)

16 HOW SUPPLIED/STORAGE AND HANDLING

NIVESTYM injection is a clear, colorless, preservative-free solution supplied as:

Vials

Single-dose vials containing 300 mcg/mL of filgrastim-aafi solution. Dispensing packs of 10 vials (NDC 0069-0293-10).

Single-dose vials containing 480 mcg/1.6 mL (300 mcg/mL) of filgrastim-aafi solution. Dispensing packs of 10 vials (NDC 0069-0294-10).

Prefilled Syringes

Single-dose prefilled syringe with BD UltraSafe Plus™ Passive Needle Guard, containing 300 mcg/0.5 mL of filgrastim-aafi solution.

•
Pack of 1 prefilled syringe (NDC 0069-0291-01).
•
Pack of 10 prefilled syringes (NDC 0069-0291-10).

Single-dose, prefilled syringe with BD UltraSafe Plus™ Passive Needle Guard, containing 480 mcg/0.8 mL of filgrastim-aafi solution.

•
Pack of 1 prefilled syringe (NDC 0069-0292-01).
•
Pack of 10 prefilled syringes (NDC 0069-0292-10).

The NIVESTYM syringe plunger stopper and needle cover are not made with natural rubber latex [see Dosage and Administration (2.5)].

Storage

Store NIVESTYM in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not leave NIVESTYM in direct sunlight. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard NIVESTYM if frozen more than once. Avoid shaking. Transport via a pneumatic tube has not been studied.

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