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What Is Ravulizumab?

Ravulizumab-cwvz is a prescription monoclonal antibody marketed under the brand name Ultomiris. It is a complement C5 inhibitor used to treat selected disorders involving abnormal complement activity, including paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, generalized myasthenia gravis, and neuromyelitis optica spectrum disorder. Approved age groups and eligibility criteria differ by condition. Ravulizumab is administered by intravenous infusion using weight-based schedules. It carries a boxed warning for serious meningococcal infections, which can occur even in vaccinated patients. Treatment requires meningococcal vaccination assessment and participation in a restricted safety program.

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What Is Ravulizumab?

Ravulizumab-cwvz is a prescription monoclonal antibody marketed under the brand name Ultomiris. It is a complement C5 inhibitor used to treat selected disorders involving abnormal complement activity, including paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, generalized myasthenia gravis, and neuromyelitis optica spectrum disorder. Approved age groups and eligibility criteria differ by condition. Ravulizumab is administered by intravenous infusion using weight-based schedules. It carries a boxed warning for serious meningococcal infections, which can occur even in vaccinated patients. Treatment requires meningococcal vaccination assessment and participation in a restricted safety program.

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How Does Ravulizumab Work?

Ravulizumab binds to complement protein C5 and prevents its cleavage into C5a and C5b. These fragments normally contribute to inflammation and formation of the membrane attack complex, which can damage cells when complement activity is uncontrolled. Blocking C5 reduces complement-mediated destruction of red blood cells in paroxysmal nocturnal hemoglobinuria and helps limit complement-related tissue damage in certain other disorders. It also reduces activity in complement pathways involved in antibody-mediated neurological conditions. Ravulizumab does not correct the underlying genetic or autoimmune cause of these diseases. Blocking terminal complement activity increases vulnerability to serious infections caused by Neisseria meningitidis.

What Conditions Does Ravulizumab Treat?

Ravulizumab is approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome in adults and children aged one month and older. The atypical hemolytic uremic syndrome indication targets complement-mediated thrombotic microangiopathy and does not include Shiga toxin-producing E. coli-related hemolytic uremic syndrome. Ravulizumab is also approved for adults with generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive and adults with neuromyelitis optica spectrum disorder who are anti-aquaporin-4 antibody-positive. An appropriate specialist confirms the diagnosis, evaluates treatment history, and assesses infection prevention requirements before prescribing treatment.

How Is Ravulizumab Administered?

Ravulizumab is administered by intravenous infusion using a weight-based loading dose followed by maintenance treatment. For adults weighing at least 40 kg, maintenance infusions are generally given every eight weeks, starting two weeks after the loading dose. Younger or smaller pediatric patients may require maintenance infusions every four or eight weeks according to body weight. Dosing changes may be needed after plasma exchange, plasmapheresis, or intravenous immunoglobulin treatment. Patients should receive or update meningococcal vaccinations at least two weeks before the first dose whenever possible. If treatment cannot be delayed, antibiotic prophylaxis and prompt vaccination are required according to the label.

What Are the Side Effects and Warnings of Ravulizumab?

Possible adverse effects include headache, upper respiratory infections, diarrhea, nausea, and infusion-related reactions. Ravulizumab carries a boxed warning for serious, potentially fatal meningococcal infections. Vaccination lowers but does not eliminate this risk, and patients require urgent evaluation for symptoms suggesting meningitis or bloodstream infection. Other serious infections and hypersensitivity or infusion reactions can occur. Stopping treatment may lead to recurrence of disease activity, including hemolysis in paroxysmal nocturnal hemoglobinuria or thrombotic microangiopathy in atypical hemolytic uremic syndrome. Fever with headache, neck stiffness, confusion, a rash, or severe weakness requires immediate medical attention.

Common Questions About Ravulizumab

Is ravulizumab the same as Ultomiris?

Yes. Ultomiris contains ravulizumab-cwvz, a monoclonal antibody that blocks complement protein C5.

Can ravulizumab treat myasthenia gravis?

Yes. Ravulizumab is approved for adults with generalized myasthenia gravis who test positive for anti-acetylcholine receptor antibodies.

How often is ravulizumab administered?

Adults weighing at least 40 kg generally receive maintenance infusions every eight weeks following a loading dose. Pediatric schedules depend on body weight and indication.

Why are meningococcal vaccines required before ravulizumab treatment?

Ravulizumab blocks part of the immune system that helps defend against meningococcal bacteria. Vaccination reduces risk but does not eliminate the possibility of serious infection.

References

DailyMed - ULTOMIRIS (ravulizumab-cwvz) injection. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a9a590d9-0217-43c7-908d-e62a71279791. Date Accessed November 3, 2026.

Ravulizumab Demonstrates Long-Term Efficacy, Safety and Favorable Patient Survival in Patients With Paroxysmal Nocturnal Hemoglobinuria. PubMed. https://pubmed.ncbi.nlm.nih.gov/39841198/. Date Accessed November 3, 2026.

Ravulizumab-cwvz Injection. MedlinePlus. https://medlineplus.gov/druginfo/meds/a619014.html. Date Accessed November 3, 2026.

ULTOMIRIS (ravulizumab-cwvz) Prescribing Information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761108s037lbl.pdf. Date Accessed November 3, 2026.

Ultomiris. European Medicines Agency. https://www.ema.europa.eu/en/medicines/human/EPAR/ultomiris. Date Accessed November 3, 2026.