About This Information

This section provides supplemental clinical context for the Empaveli (pegcetacoplan) Dosing Calculator. Empaveli is a targeted C3 therapy approved for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). The information below outlines the standard fixed-dose regimen, administration guidelines, and key safety considerations to support the use of the calculator.

Outputs Explained

When a treatment start date is entered, the calculator generates the following key information based on the approved prescribing information:

• Dosing Summary: Confirms the standard dose (1080 mg), route (subcutaneous infusion), and frequency (twice weekly).
• Personalized Dosing Schedule: Provides a list of specific calendar dates for the first 8 weeks of treatment, helping to plan administrations and appointments.
• Administration Guidance: Details practical aspects of the infusion, including the required number of infusion sites, approximate infusion time, and best practices for site rotation.
• Key Monitoring & Safety: Highlights critical safety information, including the boxed warning regarding serious infections, vaccination requirements, and necessary patient monitoring before and after treatment.

How to Use the Calculator

The dosing calculator is designed for simplicity and requires only one piece of information to generate a schedule:

• Treatment Start Date: Use the date picker to select the day the patient will receive their first dose of Empaveli.
• After selecting a date, click “Generate Schedule” to view the results. The “Reset” button will clear all inputs and outputs.

Dosing Overview

The recommended dosage of Empaveli for adults with PNH is a fixed dose, administered twice weekly via subcutaneous infusion.

• Recommended Dose: 1080 mg
• Frequency: Twice weekly
• Administration: Subcutaneous (SC) infusion using a commercially available infusion pump. The 1080 mg dose should be divided equally into two separate infusion sites (540 mg per site).
• Infusion Time: Approximately 30 minutes when using two sites simultaneously. The time may extend to ~60 minutes if sites are used sequentially.

Switching from C5 Inhibitors

For patients switching from a C5 inhibitor (e.g., eculizumab or ravulizumab) to Empaveli, a specific induction period is required to ensure continuous complement inhibition.

• Switching from Eculizumab: Initiate Empaveli 1080 mg twice weekly while continuing eculizumab at its therapeutic dose for the first 4 weeks. After 4 weeks, discontinue eculizumab and continue with Empaveli monotherapy.
• Switching from Ravulizumab: Initiate Empaveli 1080 mg twice weekly no later than 4 weeks after the last dose of ravulizumab. No overlap period is required.

Missed Dose Guidance

If a dose of Empaveli is missed, it should be administered as soon as possible. After the missed dose is taken, the patient should resume their regular twice-weekly dosing schedule from that point forward. Do not administer a double dose to make up for a missed one.

Safety Alerts

Empaveli can increase the risk of serious and life-threatening infections, particularly those caused by encapsulated bacteria.

• Monitoring: Patients should be monitored for signs of hemolysis, including elevated LDH levels. After discontinuing Empaveli, monitoring should continue for at least 8 weeks to detect severe intravascular hemolysis.
• REMS Program: Due to the risk of meningococcal infections, Empaveli is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).

Frequently Asked Questions (FAQ)

• Why does the dosing schedule alternate between 3 and 4 days?

  This cadence (e.g., Monday/Thursday, Tuesday/Friday) is the standard method to achieve a consistent “twice-weekly” frequency over a 7-day week.

• What is the dose after the first 8 weeks shown in the calculator?

  The dose remains 1080 mg subcutaneously twice weekly for as long as the patient is prescribed the medication.

• Does this calculator apply to other indications besides PNH?

  No. This calculator is based on the dosing regimen specifically approved for adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).

• Can the 1080 mg dose be administered in a single infusion site?

  No. The Prescribing Information specifies that the total dose must be divided and administered via two separate subcutaneous infusion sites.

• How should Empaveli be stored?

  Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.

• Why is vaccination required before starting treatment?

  Empaveli works by inhibiting the complement system, a part of the immune system crucial for defending against encapsulated bacteria. Vaccination helps protect against these potentially life-threatening infections.

• What should a patient do if they develop signs of an infection?

  Patients should seek immediate medical attention if they experience any signs or symptoms of a serious infection, such as fever, headache with neck stiffness, rash, or body aches with flu-like symptoms.

• Where can I find the complete Prescribing Information?

  The full official Prescribing Information can be found on the manufacturer’s website or through the FDA’s drug database (see References).

References

• 1. EMPAVELI® (pegcetacoplan) Prescribing Information. Waltham, MA: Apellis Pharmaceuticals, Inc.; 2023.
• 2. Empaveli HCP Official Website. Apellis Pharmaceuticals, Inc.
• 3. U.S. Food and Drug Administration. Drugs@FDA: Empaveli (pegcetacoplan).
• 4. Centers for Disease Control and Prevention. Meningococcal Disease.
• 5. Hillmen P, et al. Pegcetacoplan versus Eculizumab in Paroxysmal Nocturnal Hemoglobinuria. N Engl J Med. 2021;384(11):1028-1037. doi:10.1056/NEJMoa2029073