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NYVEPRIA Dosage and Administration (pegfilgrastim-apgf)

2 DOSAGE AND ADMINISTRATION

2.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy

The recommended dosage of NYVEPRIA is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1. Do not administer NYVEPRIA between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

2.2 Administration

NYVEPRIA is administered subcutaneously via a single-dose prefilled syringe for manual use.

Prior to use‚ remove the carton from the refrigerator and allow the NYVEPRIA prefilled syringe to reach room temperature for a minimum of 30 minutes. Discard any prefilled syringe left at room temperature for greater than 15 days.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. NYVEPRIA is supplied as a clear and colorless solution. Do not administer NYVEPRIA if discoloration or particulates are observed.

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

Pediatric Patients Weighing Less than 45 kg

The NYVEPRIA prefilled syringe is not designed to allow for direct administration of doses less than 0.6 mL (6 mg). The syringe does not bear graduation marks, which are necessary to accurately measure doses of NYVEPRIA less than 0.6 mL (6 mg) for direct administration to patients. Thus, the direct administration to patients requiring dosing of less than 0.6 mL (6 mg) is not recommended due to the potential for dosing errors. Refer to Table 1.

Table 1. Dosing of NYVEPRIA for Pediatric Patients Weighing Less than 45 kg
Body WeightNYVEPRIA Dose Volume to Administer
*
For pediatric patients weighing less than 10 kg, administer 0.1 mg/kg (0.01 mL/kg) of NYVEPRIA.
Less than 10 kg*See below*See below*
10 – 20 kg1.5 mg0.15 mL
21 – 30 kg2.5 mg0.25 mL
31 – 44 kg4 mg0.4 mL
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