About This Information

This page provides supplementary information for the Fulphila (pegfilgrastim-jmdb) Dosing Calculator. The content explains the calculator's outputs, the basis for its calculations, and provides general guidance on drug administration, safety, and frequently asked questions. Always consult the full prescribing information and exercise independent clinical judgment.

Calculator Outputs

After entering the required patient information, the calculator provides the following key outputs:

• Recommended Dose: The specific dose of Fulphila in milligrams (mg) based on patient type and, if applicable, body weight.
• Administration Details: Key information on the route (subcutaneous), frequency (once per cycle), and critical timing related to chemotherapy administration.
• Dosing Rationale: An optional explanation detailing how the dose was determined based on FDA-approved guidelines for the patient's specific weight category or type.

How to Use the Calculator

To determine the correct dose, follow these steps using the tool:

• Step 1: Select Patient Type: Choose either "Adult Patient" or "Pediatric Patient." For adults, a fixed dose is recommended, and no further input is needed.
• Step 2: Enter Pediatric Body Weight: If "Pediatric Patient" is selected, a field will appear to enter the patient's body weight. You can input the weight in either kilograms (kg) or pounds (lb). The tool will automatically convert pounds to kilograms for the calculation.
• Step 3: Calculate Dose: Click the "Calculate Dose" button to see the results based on the information provided.

Dosing Overview

The recommended dosing for Fulphila is based on guidelines from the prescribing information to reduce the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

Adult Patients:

• A fixed dose of 6 mg is administered subcutaneously once per chemotherapy cycle.

Pediatric Patients:

• The dose is based on body weight, administered subcutaneously once per chemotherapy cycle:
• Weight less than 10 kg: Safety and effectiveness not established.
• Weight 10 to < 20 kg: 1.5 mg
• Weight 20 to < 30 kg: 3 mg
• Weight 30 to < 45 kg: 4.5 mg
• Weight 45 kg or greater: 6 mg

For pediatric patients requiring less than 6 mg, the appropriate volume must be aseptically prepared from the Fulphila prefilled syringe.

Switching Between Pegfilgrastim Products

Fulphila (pegfilgrastim-jmdb) is a biosimilar to Neulasta (pegfilgrastim). While biosimilars have no clinically meaningful differences from their reference product, they are not automatically considered interchangeable by the FDA. The decision to switch from another pegfilgrastim product to Fulphila should be made by a qualified healthcare professional.

Missed Dose

If a dose of Fulphila is missed, it should be administered as soon as possible. The subsequent chemotherapy cycle should be adjusted to maintain the recommended interval between Fulphila administration and chemotherapy. Do not administer a dose between 14 days before and 24 hours after administration of cytotoxic chemotherapy. Patients should consult their healthcare provider for specific instructions.

Safety Alerts

Frequently Asked Questions (FAQ)

1. What is the dose for an adult weighing more than 100 kg?

The recommended dose for all adult patients, regardless of body weight, is a fixed 6 mg dose once per chemotherapy cycle.

2. What is the correct dose for a pediatric patient weighing exactly 45 kg?

For pediatric patients weighing 45 kg or more, the recommended dose is 6 mg, the same as the adult dose.

3. Why does the calculator show a warning for children under 10 kg?

The safety and effectiveness of Fulphila have not been established in clinical trials for pediatric patients weighing less than 10 kg.

4. Can Fulphila be administered on the same day as chemotherapy?

No. To ensure efficacy and safety, do not administer Fulphila in the period between 14 days before and 24 hours after the administration of cytotoxic chemotherapy.

5. How is the dose for a 33 lb child calculated?

The calculator first converts the weight to kilograms (33 lb ≈ 15 kg). Since 15 kg falls into the '10 to < 20 kg' tier, the recommended dose is 1.5 mg.

6. What does the "-jmdb" suffix in pegfilgrastim-jmdb signify?

The four-letter suffix is assigned by the FDA to distinguish non-interchangeable biological products, including biosimilars like Fulphila, from their reference products and other biosimilars.

7. How should doses less than 6 mg be prepared for pediatric patients?

The required volume must be aseptically withdrawn from the 6 mg/0.6 mL single-dose prefilled syringe into a sterile, graduated syringe for administration.

8. Does this calculator apply to other pegfilgrastim products like Neulasta® or Udenyca®?

This calculator is specifically designed for Fulphila (pegfilgrastim-jmdb). While dosing is similar across pegfilgrastim products, you should always refer to the specific prescribing information for the product being administered.

References

• Fulphila (pegfilgrastim-jmdb) Full Prescribing Information. U.S. Food and Drug Administration.
• Fulphila® Official Healthcare Professional Website. Viatris Inc.
• Biosimilar and Interchangeable Products. U.S. Food and Drug Administration.