About Soliris (eculizumab) Dosing

This information supports the use of the Soliris (eculizumab) Dosing calculator. It provides an overview of key dosing considerations for approved indications, including Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS), Generalized Myasthenia Gravis (gMG), and Neuromyelitis Optica Spectrum Disorder (NMOSD), based on the official Prescribing Information.

Calculator Outputs

The calculator provides a patient-specific dosing regimen based on the inputs provided. Key outputs include:

• Induction Phase Dosing: The initial dosing schedule, including the specific dose (in mg) and frequency (e.g., weekly for 4 weeks).
• Maintenance Phase Dosing: The long-term dosing schedule that follows the induction phase, including the dose and frequency (e.g., every 2 weeks).
• Weight-Based Adjustments: For pediatric patients with PNH or aHUS, the calculator determines the correct dosing based on specific weight categories.

How to Use the Calculator

To determine the appropriate dosing schedule, follow these steps:

1. Select Indication: Choose the appropriate condition (PNH, aHUS, gMG, or NMOSD) from the dropdown menu.
2. Select Patient Age Group: Choose either “Adult (≥18 years)” or “Pediatric (<18 years)”.
3. Enter Patient Weight (if required): For pediatric PNH and aHUS, a weight input field will appear. Enter the patient’s weight and select the correct unit (kg or lbs).
4. Calculate: Click the “Calculate Dose” button to view the recommended induction and maintenance regimen.

Dosing Overview

Soliris (eculizumab) is administered as an intravenous (IV) infusion. The dosing regimen consists of two distinct phases:

• Induction Phase: An initial period of more frequent dosing (typically weekly) to rapidly achieve therapeutic concentrations of the drug.
• Maintenance Phase: A subsequent, long-term period of less frequent dosing (typically every two weeks) to maintain steady-state concentrations.

For adults, the dosage differs between indications (PNH/aHUS vs. gMG/NMOSD). For pediatric patients with PNH or aHUS, the dosage is weight-based. Pediatric dosing for gMG and NMOSD generally follows the adult regimen as per the Prescribing Information.

Switching to Soliris

Prior to initiating Soliris, patients must be vaccinated against meningococcal infections at least 2 weeks before the first dose, unless the risks of delaying therapy outweigh the risks of developing a meningococcal infection. If Soliris must be started immediately in an unvaccinated patient, they must receive meningococcal vaccination as soon as possible and also receive treatment with appropriate antibiotics until 2 weeks after vaccination.

Missed Dose Information

If a dose of Soliris is missed, contact the prescribing healthcare provider immediately for guidance. The provider will advise on the timing of the next dose to ensure treatment continuity. Do not wait until the next scheduled dose without consulting a healthcare professional.

Safety Alerts

Frequently Asked Questions (FAQ)

Why is weight required for pediatric patients with PNH/aHUS but not for adults?

Pediatric dosing for PNH and aHUS is based on specific body weight categories (e.g., 5 to <10 kg, 10 to <20 kg) to ensure appropriate drug exposure in growing patients. Adult dosing is standardized regardless of weight.

What happens if a pediatric patient’s weight is outside the approved dosing range?

The calculator will display an error message. Per the Prescribing Information, specific dosing regimens are only established for pediatric patients weighing 5 kg or more. For patients outside this range, clinicians must refer to the full Prescribing Information and use clinical judgment.

Is the adult dosing for gMG different from PNH?

Yes. The induction dose for adults with gMG or NMOSD is 900 mg weekly for 4 weeks, followed by a maintenance dose of 1200 mg every 2 weeks. For adults with PNH or aHUS, the induction is 600 mg weekly for 4 weeks, followed by a 900 mg maintenance dose every 2 weeks.

How is the “induction phase” different from the “maintenance phase”?

The induction phase is a higher-frequency loading period at the start of therapy (e.g., weekly) to quickly reach a therapeutic level of the drug. The maintenance phase is the ongoing, lower-frequency schedule (e.g., every two weeks) designed to keep the drug level stable over the long term.

Does this calculator account for supplemental dosing in patients undergoing plasma exchange?

No. This tool provides standard dosing only. Patients undergoing plasma exchange, plasmapheresis, or fresh frozen plasma infusion may require supplemental doses of Soliris. Consult the Prescribing Information for specific recommendations.

What is the source of the dosing algorithms in this calculator?

The dosing logic is derived directly from the FDA-approved Soliris (eculizumab) Prescribing Information.

Can I use this calculator for Ultomiris (ravulizumab)?

No. This calculator is exclusively for Soliris (eculizumab). Ultomiris is a different C5 inhibitor with a distinct dosing schedule and should not be dosed using this tool.

How is Soliris administered?

Soliris is administered as an intravenous (IV) infusion, typically over 35 minutes for adults and 1 to 4 hours for pediatric patients. It should be administered by a healthcare professional.

What should I do if the calculated dose seems incorrect?

This tool is for educational purposes and is not a substitute for clinical judgment. Always verify the calculated dose against the most current official Prescribing Information before administration.

References

1. SOLIRIS® (eculizumab) injection, for intravenous use. Prescribing Information. Alexion Pharmaceuticals, Inc. View FDA Label
2. Soliris HCP Website. Alexion, AstraZeneca Rare Disease. Visit Website
3. Soliris (eculizumab) Summary of Product Characteristics (SmPC). European Medicines Agency (EMA). View EMA Page
4. Vaccination for Patients Taking Complement Inhibitors. Centers for Disease Control and Prevention (CDC). View CDC Recommendations