Fylnetra Dosage

Patients with Cancer Receiving Myelosuppressive Chemotherapy

The recommended dosage of FYLNETRA 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 FYLNETRA between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome

The recommended dose of FYLNETRA is two doses, 6 mg each, administered subcutaneously one week apart. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1. Administer the first dose as soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray (Gy). Administer the second dose one week after the first dose.

Obtain a baseline complete blood count (CBC). Do not delay administration of FYLNETRA if a CBC is not readily available. Estimate a patient’s absorbed radiation dose (i.e., level of radiation exposure) based on information from public health authorities, biodosimetry if available, or clinical findings such as time to onset of vomiting or lymphocyte depletion kinetics.

2.3 Administration

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

Prior to use‚ remove the carton from the refrigerator and allow the FYLNETRA prefilled syringe to reach room temperature for a minimum of 30 minutes. Discard any prefilled syringe left at room temperature for greater than 72 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer FYLNETRA if discoloration or particulates are observed.

The needle cap on the prefilled syringe is not made with natural rubber latex.

Pediatric Patients weighing less than 45 kg

The FYLNETRA 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 FYLNETRA 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 FYLNETRA for pediatric patients weighing less than 45 kg

*For pediatric patients weighing less than 10 kg, administer 0.1 mg/kg (0.01 mL/kg) of FYLNETRA.