Ultomiris Side Effects

Generic name: ravulizumab

Medically reviewed by Philip Thornton, DipPharm. Last updated on Feb 16, 2024.

Note: This document provides detailed information about Ultomiris.

Applies to ravulizumab: solution Side Effects associated with ravulizumab. Some dosage forms listed on this page may not apply specifically to the brand name Ultomiris.

Applies to ravulizumab: solution.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Ravulizumab-cwvz may increase your chance of having serious infections, including a meningococcal infection. Avoid people who are sick or have infections. Tell your doctor right away if you or your child develop headaches, nausea, vomiting, fever, a stiff neck or back, rash, confusion, muscle aches, or if your eyes have become sensitive to light. Make sure you have received a vaccine to prevent meningococcus infections at least 2 weeks before you receive this medicine. You may also be given antibiotic medicines for 2 weeks to prevent infections if you are to use this medicine right away. If you have already received the meningococcal vaccine in the past, your doctor will decide if you need another dose.

Ask your doctor for a patient safety card. This card will list the symptoms of meningococcus infections and what to do if you have them. Carry the card with you at all times during treatment and for 8 months after your last dose. You will need to show the card to any doctor who treats you.

You could develop hemolysis (breakdown of red blood cells) when you stop receiving this medicine for PNH. Your doctor will monitor you closely for at least 16 weeks after the last dose of this medicine. Be sure to keep all appointments.

Ravulizumab-cwvz may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

You could also develop a condition called thrombotic microangiopathy (TMA) when you or your child stop receiving this medicine for aHUS. Tell your doctor right away if you or your child have confusion, seizures, chest pain, trouble breathing, blood clots, or stroke.

Tell your doctor if you are also receiving other procedures (eg, plasma exchange, plasmapheresis) or medicines (eg, efgartigimod, immunoglobulin injection) for myasthenia gravis.

The on-body injector contains acrylic adhesive, which may cause allergic reactions in people who are sensitive to the adhesive.

Serious side effects of Ultomiris

Along with its needed effects, ravulizumab (the active ingredient contained in Ultomiris) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking ravulizumab:

Other side effects of Ultomiris

Some side effects of ravulizumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to ravulizumab: intravenous solution.

General adverse events

The most frequent adverse drug reactions (greater than 10%) with are upper respiratory tract infection and headache.^[Ref]

Local

• Rare (0.01% to 0.1%): Infusion reactions (e.g., lower back pain, drop in blood pressure, infusion-related pain)^[Ref]

Musculoskeletal

• Common (1% to 10%): Pain in extremity, arthralgia^[Ref]

Respiratory

• Very common (10% or more): Upper respiratory tract infection (e.g., nasopharyngitis, upper respiratory tract infection, oropharyngeal pain, viral

upper respiratory tract infection, rhinitis, respiratory tract infection, rhinorrhea, pharyngitis, upper respiratory tract inflammation) (39%)^[Ref]

Other

• Common (1% to 10%): Hyperthermia, pyrexia^[Ref]

Immunologic

• Frequency not reported: Immunogenicity, increased susceptibility to encapsulated bacterial infections (especially infections caused by Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae), life-threatening meningococcal infections (e.g., septicemia and/or meningitis)^[Ref]

Nervous system

• Very common (10% or more): Headache (32%)
• Common (1% to 10%): Dizziness^[Ref]

Gastrointestinal

• Common (1% to 10%): Diarrhea, nausea, abdominal pain^[Ref]

See also:

Frequently asked questions

• How does Ultomiris compare to Soliris for PNH?
• How long does an Ultomiris infusion take?
• How long does it take for Ultomiris to work?
• How does Ultomiris work for myasthenia gravis?

Further information

Ultomiris side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer