Pegfilgrastim-jmdbdosage

Patients with cancer receiving myelosuppressive chemotherapy

6 mg administered subcutaneously once per chemotherapy cycle.

Do not administer 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.

2.1 Patients with

Cancer Receiving Myelosuppressive Chemotherapy The recommended dosage of Fulphila 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 Fulphila between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

2.2 Administration

Fulphila is administered subcutaneously via a single-dose prefilled syringe for manual use. Prior to use‚ remove the carton from the refrigerator and allow the Fulphila 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 Fulphila if discoloration or particulates are observed. Pediatric Patients weighing less than 45 kg The Fulphila 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 Fulphila 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 Fulphila for pediatric patients weighing less than 45 kg Body Weight Fulphila Dose Volume to Administer Less than 10 kg For pediatric patients weighing less than 10 kg, administer 0.1 mg/kg (0.01 mL/kg) of Fulphila. See below See below 10 to 20 kg 1.5 mg 0.15 mL 21 to 30 kg 2.5 mg 0.25 mL 31 to 44 kg 4 mg 0.4 mL