Filgrastim

Discontinue NEUPOGEN if sickle cell crisis occurs. 5.5 Glomerulonephritis Glomerulonephritis has occurred in patients receiving NEUPOGEN. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation of NEUPOGEN.

Important Administration Instructions NEUPOGEN (for subcutaneous or intravenous use) is supplied in single-dose vials and single-dose prefilled syringes [see Dosage Forms and Strengths ] . Administration Instructions for 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 ] . If the patient or caregiver misses a dose of NEUPOGEN, instruct them to contact their healthcare provider.

Patients who will self-administer and caregivers who will administer to the patient may benefit from training by a healthcare professional. Training 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 of 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 prefilled syringe or whether the patient would benefit from the NEUPOGEN vial presentation. If a patient or caregiver experiences difficulty measuring the required dose, especially if it is other than the entire content of the NEUPOGEN prefilled syringe, use of the NEUPOGEN vial may be considered [see Instructions for Use] .

Instructions for the Vial Prior to use, remove the vial from the refrigerator and allow NEUPOGEN to reach room temperature 20°C to 25°C (68°F to 77°F) , for a minimum of 30 minutes and a maximum of 24 hours. Discard any vial 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 vial; do not re-enter the vial. Do not save unused drug for later 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).

Prior to use, remove the prefilled syringe from the refrigerator and allow NEUPOGEN to reach room temperature 20°C to 25°C (68°F to 77°F) , for a minimum of 30 minutes and a maximum of 24 hours. Discard any 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 prefilled syringe. Do not save unused drug for later administration, Administration Instructions for Dilution If required for intravenous administration, NEUPOGEN may be diluted in 5% Dextrose Injection, USP to concentrations between 5 mcg/mL to 15 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 Sodium Chloride Injection 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.