About This Tool

This Udenyca (pegfilgrastim-cbqv) dosing calculator is an educational resource for healthcare professionals. It helps determine the recommended dose based on FDA-approved prescribing information for adult and pediatric patients undergoing myelosuppressive chemotherapy to decrease the incidence of infection, as manifested by febrile neutropenia.

Outputs

The calculator provides the following key outputs based on the information entered:

• Recommended Dose: The total dose in milligrams (mg), calculated according to the patient’s population type (adult or pediatric) and weight (for pediatrics).
• Administration Route: Specifies the standard route, which is a single subcutaneous injection.
• Recommended Administration Date: If the date of chemotherapy is provided, the tool suggests the earliest recommended date for Udenyca administration (approximately 24 hours after chemotherapy completion).

How to Use

Follow these steps to determine the recommended dose and administration schedule:

1. Select Patient Population: Choose either ‘Adult’ or ‘Pediatric’. The weight input field will appear for pediatric patients.
2. Enter Patient Weight (for Pediatrics): If ‘Pediatric’ is selected, enter the patient’s weight. You can toggle between kilograms (kg) and pounds (lbs).
3. Enter Chemotherapy Date (Optional): Select the date the patient received their cytotoxic chemotherapy to get a recommended administration date.
4. Review Results: The calculated dose and administration guidelines will be displayed. Always cross-reference this output with the full prescribing information.

Dosing Overview

The recommended dosage of Udenyca is based on the patient population.

Adult Patients: A single 6 mg dose administered once per chemotherapy cycle.

Pediatric Patients: Dosing is weight-based as follows:

Administration Timing: Administer Udenyca approximately 24 hours after the completion of cytotoxic chemotherapy. Do not administer within the period from 14 days before to 24 hours after chemotherapy administration.

Switching

Patients can be switched from a reference pegfilgrastim product (e.g., Neulasta®) to Udenyca. As a biosimilar, Udenyca has been shown to have no clinically meaningful differences from its reference product in terms of safety, purity, and potency. The switching process should be managed by the treating healthcare provider, and typically no dose adjustments are necessary.

Missed Dose

If a scheduled dose of Udenyca is missed, it should be administered as soon as it is remembered. The healthcare provider should be contacted to determine the appropriate course of action, ensuring that the administration schedule respects the timing window relative to the administration of cytotoxic chemotherapy. A double dose should not be administered to make up for a missed one.

Safety Alerts

Key warnings and precautions associated with Udenyca include:

• Splenic Rupture: Splenic rupture, including fatal cases, can occur. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain.
• Acute Respiratory Distress Syndrome (ARDS): ARDS can occur. Evaluate patients with fever, lung infiltrates, or respiratory distress. Discontinue Udenyca in patients with ARDS.
• Serious Allergic Reactions: Serious allergic reactions, including anaphylaxis, can occur. Permanently discontinue Udenyca in patients with serious allergic reactions.
• Sickle Cell Crises: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders.
• Glomerulonephritis: Has occurred in patients receiving pegfilgrastim. Diagnosis is based on proteinuria, hematuria, and renal biopsy. Management may include dose-reduction or withholding treatment.

Frequently Asked Questions (FAQ)

What is the standard dose of Udenyca for an adult patient?
The recommended dose for adults is a single 6 mg subcutaneous injection, administered once per chemotherapy cycle.

How does the calculator determine the pediatric dose of Udenyca?
The calculator uses the weight-based dosing tiers specified in the FDA-approved prescribing information. It automatically calculates the correct dose based on the weight in kilograms entered by the user.

What happens if I enter a pediatric weight less than 10 kg?
For patients weighing less than 10 kg, the calculator will apply the 0.1 mg/kg dosing formula to determine the precise dose.

Can I use pounds (lbs) for the patient weight input?
Yes, the tool allows you to enter pediatric weight in either kilograms (kg) or pounds (lbs). The calculator will automatically convert lbs to kg to apply the correct dosing formula.

Is the chemotherapy date field required to use the calculator?
No, this field is optional. It is used to provide a recommended administration date, which is helpful for scheduling, but the dose can be calculated without it.

What is the key timing consideration for administering Udenyca?
The most critical rule is to administer Udenyca at least 24 hours after the completion of cytotoxic chemotherapy and not within the 14-day period before the next chemotherapy dose.

Is this calculator a substitute for the official Udenyca prescribing information?
No. This tool is for educational and informational purposes only. All calculations must be confirmed against the most current full Prescribing Information before any clinical decisions are made.

Does the calculator account for renal or hepatic impairment?
The calculator does not ask for this information, as dose adjustments for Udenyca are not recommended for patients with renal or hepatic impairment according to the prescribing information.

References

1. Udenyca (pegfilgrastim-cbqv) Prescribing Information. Coherus BioSciences, Inc. Accessed via FDA.gov.
2. UDENYCA® Official HCP Website. Coherus BioSciences, Inc. Accessed at udenyca.com.
3. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Hematopoietic Growth Factors. Version 1.2024.
4. American Society of Clinical Oncology (ASCO). Clinical Practice Guideline Update: Use of White Blood Cell Growth Factors. J Clin Oncol. 2015.