Nyvepria

NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia

Patients with cancer receiving myelosuppressive chemotherapy

• •6 mg administered subcutaneously once per chemotherapy cycle. (
  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.
  )
• •Do not administer between 14 days before and 24 hours after administration of cytotoxic chemotherapy. (
  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.
  )
• •Use weight based dosing for pediatric patients weighing less than 45 kg; refer to Table 1. (
  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 Weight	NYVEPRIA Dose	Volume to Administer
  Less than 10 kgFor pediatric patients weighing less than 10 kg, administer 0.1 mg/kg (0.01 mL/kg) of NYVEPRIA.	See below	See below
  10 – 20 kg	1.5 mg	0.15 mL
  21 – 30 kg	2.5 mg	0.25 mL
  31 – 44 kg	4 mg	0.4 mL
  )

NYVEPRIA is a clear, colorless, preservative-free solution available as:

• •Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only.

Although available data with NYVEPRIA or pegfilgrastim product use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. These studies have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area). In pregnant rabbits, increased embryolethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity (

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.