Applies to inebilizumab: intravenous solution.

Serious side effects of Inebilizumab

Along with its needed effects, inebilizumab 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 inebilizumab:

More common

• Black, tarry stools
• bladder pain
• bloody or cloudy urine
• chills
• cough
• difficult, burning, or painful urination
• dizziness
• facial swelling
• fever
• frequent urge to urinate
• headache
• lower back or side pain
• muscle aches
• nausea
• pale skin
• skin rash
• sore throat
• stuffy or runny nose
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Other side effects of Inebilizumab

Some side effects of inebilizumab 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

• Back or joint pain
• difficulty in moving
• muscle stiffness

Incidence not known

• Pain, itching, burning, swelling, or redness at the injection site

For Healthcare Professionals

Applies to inebilizumab: intravenous solution.

General

The most commonly reported adverse events include infusion reaction, nasopharyngitis, urinary tract infection, arthralgia, back pain, and headache.

Hematologic

Common (1% to 10%): Neutropenia

Frequency not reported: Lymphocytopenia^[Ref]

Immunologic

Common (1% to 10%): Anti-drug antibodies^[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia , back pain^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (20%)

Respiratory

Very common (10% or more): Nasopharyngitis (13%)

Common (1% to 10%): Upper respiratory tract infection, influenza^[Ref]

Other

Very common (10% or more): Infusion reaction (11.6%)^[Ref]

Nervous system

Common (1% to 10%): Headache^[Ref]