Common Side Effects of Ultomiris
Ultomiris (ravulizumab) causes upper respiratory tract infections in about 28% of patients, nasopharyngitis in 23%, headache in 21%, and nausea in 13%. Other frequent issues include fatigue, diarrhea, musculoskeletal pain, dizziness, and injection-site reactions.[1][2]
Serious Side Effects and Risks
Serious infections occur due to meningococcal risk—increased susceptibility lasts for the drug's duration plus 8 months after the last dose. Patients need vaccination and prophylaxis. Other risks include meningococcal sepsis, pneumonia, and rare Haemophilus influenzae infections. Infusion-related reactions (fever, chills, back pain) affect 4-7%; severe anaphylaxis is possible. Hemolysis may worsen upon discontinuation, requiring monitoring.[1][2][3]
Side Effects by Condition Treated
In paroxysmal nocturnal hemoglobinuria (PNH), common effects mirror the overall profile, with 2% discontinuing due to adverse events. For atypical hemolytic uremic syndrome (aHUS), hypertension (17%) and pyrexia (16%) stand out alongside infections. In generalized myasthenia gravis (gMG), COVID-19 infections and falls are notable, though possibly disease-related.[2][3]
What Happens During Infusion or Injection
Reactions during or within hours of administration include chest tightness, hypertension, tremor, and dyspnea. Premedicate with antihistamines or pain relievers if prior issues occur; slow infusion rate for management.[1][3]
Long-Term Risks and Monitoring
No new safety signals emerge after 4+ years in PNH/aHUS trials. Monitor CBC, kidney function, and infection signs. Avoid live vaccines; antibiotic prophylaxis recommended for some.[2]
Differences from Soliris (Eculizumab)
Ultomiris, a longer-acting version, shows similar side effect profiles but lower infection rates due to less frequent dosing (every 8 weeks vs. every 2). Meningococcal risk persists identically.[3]
[1]: Ultomiris Prescribing Information, AstraZeneca, 2023. https://www.azpicentral.com/piultomiris/ultomiris.pdf
[2]: Drugs.com - Ultomiris Side Effects. https://www.drugs.com/sfx/ultomiris-side-effects.html
[3]: FDA Label for Ultomiris. https://www.accessdata.fda.gov/drugsatfdadocs/label/2023/761214s017lbl.pdf