Skip to Content

Ultomiris Side Effects

Generic name: ravulizumab

Medically reviewed by Drugs.com. Last updated on Sep 15, 2020.

Note: This document contains side effect information about ravulizumab. Some of the dosage forms listed on this page may not apply to the brand name Ultomiris.

For the Consumer

Applies to ravulizumab: intravenous solution

Warning

Intravenous route (Injectable)

Warning: Serious Meningococcal InfectionsLife-threatening meningococcal infections/sepsis have occurred in patients treated with ravulizumab-cwvz. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies. Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of ravulizumab-cwvz, unless the risks of delaying ravulizumab-cwvz therapy outweigh the risk of developing a meningococcal infection. Vaccination reduces, but does not eliminate, the risk of meningococcal infections Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected. Ravulizumab-cwvz is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the ravulizumab-cwvz REMS, prescribers must enroll in the program.

Side effects requiring immediate medical attention

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:

More common

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • body aches or pain
  • chills
  • cough
  • difficulty with breathing
  • dizziness
  • ear congestion
  • extremely high fever or body temperature
  • fast, shallow breathing
  • fast, weak heartbeat
  • fever
  • headache
  • loss of voice
  • muscle cramps
  • nervousness
  • pale, clammy skin
  • pounding in the ears
  • rapid weight gain
  • runny or stuffy nose
  • sneezing
  • slow or fast heartbeat
  • sore throat
  • thirst
  • tingling of the hands or feet
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss

Side effects not requiring immediate medical attention

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:

More common

  • Diarrhea
  • difficulty having a bowel movement (stool)
  • fear
  • hair loss or thinning of the hair
  • muscle spasms
  • nausea or vomiting
  • pain in the arms or legs
  • stomach pain

Less common

  • Difficulty with moving
  • joint pain
  • muscle pain or stiffness

Incidence not known

  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

For Healthcare Professionals

Applies to ravulizumab: intravenous solution

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]

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]

General

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

References

1. "Product Information. Ultomiris (ravulizumab)." Alexion Pharmaceuticals Inc, Cheshire, CT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.