Ultomiris

(ravulizumab-cwvz)

Provider Summary

Primary Uses

Complement-mediated disorders including PNH, aHUS, generalized myasthenia gravis, and NMOSD (indication depends on diagnosis) per label and payer criteria.

Mechanism of Action

Terminal complement inhibitor (C5) with extended duration, preventing complement-mediated hemolysis/tissue injury.

Pre-treatment / Baseline Requirement

Boxed warning risk: meningococcal infection. Vaccinate against meningococcal bacteria at least 2 weeks prior when feasible; REMS participation; educate on urgent infection symptoms; screen for active infection.

Common side effects

Headache, upper respiratory infections, nausea/diarrhea (varies by indication).

Serious adverse effects / key risks

Boxed warning: serious, life-threatening meningococcal infections; other serious infections with encapsulated organisms.

REMS & Vaccination

Meningococcal vaccination is required per REMS. If treatment must start before vaccines are effective, follow prescriber PI guidance regarding prophylactic antibiotics and urgent-start protocols.

Referral requirements

Standard infusion referral form + drug-specific checklist

Ultomiris

Patient & Caregiver Education

Meningitis risk

vaccination is required. Seek emergency care for sudden fever, severe headache, stiff neck, rash, confusion, or sensitivity to light.

What it treats

Complement-mediated disorders including PNH, aHUS, generalized myasthenia gravis, and NMOSD

How it works

Blocks complement (C5), preventing immune-mediated damage in certain rare conditions.

Before treatment

Tell your clinician if you have an active infection/fever, are pregnant/planning pregnancy, or have major heart/nerve problems. Depending on the medication, you may need labs or screening tests (e.g., TB/hepatitis) and a vaccine review.

Common side effects

Headache, upper respiratory infections, nausea/diarrhea.

Get urgent help for:

Boxed warning: serious, life-threatening meningococcal infections; other serious infections with encapsulated organisms