NEUPOGEN is supplied in single-dose vials (for subcutaneous use or intravenous infusion) and single-dose prefilled syringes (for subcutaneous use) [see Dosage Forms and Strengths (3)]. Prior to use‚ remove the vial or prefilled syringe from the refrigerator and allow NEUPOGEN to reach room temperature for a minimum of 30 minutes and a maximum of 24 hours. Discard any vial or prefilled syringe left at room temperature for greater than 24 hours. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (the solution is clear and colorless). Do not administer NEUPOGEN if particulates or discoloration are observed.

Discard unused portion of NEUPOGEN in vials or prefilled syringes; do not re-enter the vial. Do not save unused drug for later administration.

Subcutaneous Injection

Inject NEUPOGEN subcutaneously in the outer area of upper arms, abdomen, thighs, or upper outer areas of the buttock. If patients or caregivers are to administer NEUPOGEN, instruct them in appropriate injection technique and ask them to follow the subcutaneous injection procedures in the Instructions for Use for the vial or prefilled syringe [see Patient Counseling Information (17)].

Training by the healthcare provider should aim to demonstrate to those patients and caregivers how to measure the dose of NEUPOGEN, and the focus should be on ensuring that a patient or caregiver can successfully perform all the steps in the Instructions for Use for the vial or prefilled syringe. If a patient or caregiver is not able to demonstrate that they can measure the dose and administer the product successfully, you should consider whether the patient is an appropriate candidate for self-administration of NEUPOGEN or whether the patient would benefit from a different NEUPOGEN presentation. If a patient or caregiver experiences difficulty measuring the required dose, especially if it is other than the entire contents of the NEUPOGEN prefilled syringe, use of the NEUPOGEN vial may be considered.

If the patient or caregiver misses a dose of NEUPOGEN, instruct them to contact their healthcare provider.

Administration Instructions for the Prefilled Syringe

Persons with latex allergies should not administer the NEUPOGEN prefilled syringe, because the needle cap contains dry natural rubber (derived from latex).

Administration Instructions for Dilution (Vial Only)

If required for intravenous administration‚ NEUPOGEN (vial only) may be diluted in 5% Dextrose Injection, USP from a concentration of 300 mcg/mL to 5 mcg/mL (do not dilute to a final concentration less than 5 mcg/mL). NEUPOGEN diluted to concentrations from 5 mcg/mL to 15 mcg/mL should be protected from adsorption to plastic materials by the addition of Albumin (Human) to a final concentration of 2 mg/mL. When diluted in 5% Dextrose Injection, USP or 5% Dextrose plus Albumin (Human)‚ NEUPOGEN is compatible with glass bottles‚ polyvinyl chloride (PVC) and polyolefin intravenous bags‚ and polypropylene syringes. Do not dilute with saline at any time because the product may precipitate.

Diluted NEUPOGEN solution can be stored at room temperature for up to 24 hours. This 24-hour time period includes the time during room temperature storage of the infusion solution and the duration of the infusion.