Rozanolixizumab Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 23, 2024.

Applies to rozanolixizumab: subcutaneous solution.

Serious side effects of Rozanolixizumab

Along with its needed effects, rozanolixizumab 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 rozanolixizumab:

More common

• Bladder pain
• bloody or cloudy urine
• body aches or pain
• burning or stinging of the skin
• chills
• cough
• difficult, burning, or painful urination
• ear congestion
• fast heartbeat
• fever
• frequent urge to urinate
• headache
• lower back or side pain
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• skin itching, rash, or redness
• sneezing
• sore throat
• stuffy or runny nose
• swelling of the face, throat, or tongue
• trouble breathing
• unusual tiredness or weakness

Incidence not known

• Nausea
• stiff neck or back
• vomiting

Other side effects of Rozanolixizumab

Some side effects of rozanolixizumab 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

• Bleeding, blistering, burning, coldness, discoloration of 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
• diarrhea
• difficulty in moving
• joint pain
• muscle pain or stiffness
• stomach pain

For Healthcare Professionals

Applies to rozanolixizumab: subcutaneous solution.

General

Headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea were the prevailing adverse reactions observed in a minimum of 10% of patients who received treatment with this drug.^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (20%), nausea (10%)

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

Genitourinary

Common (1% to 10%): Urinary tract infections^[Ref]

Hypersensitivity

Very common (10% or more): Hypersensitivity reactions (11%)^[Ref]

-During clinical trials, hypersensitivity reactions were observed within a range of 1 day to 2 weeks following administration of this drug.

-One patient discontinued treatment with this drug due to a hypersensitivity reaction.

-Furthermore, local reactions at the site of administration were reported within 1 to 3 days after the most recent infusion of this drug.^[Ref]

Local

Common (1% to 10%): Administration site reactions^[Ref]

Musculoskeletal

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

Nervous system

Very common (10% or more): Headache (44%)^[Ref]

-Cases of severe headache were reported in 5.3% of patients.

-A patient required hospitalization due to a severe headache, while another patient discontinued treatment as a result of a severe headache accompanied by fever, photophobia, phonophobia, nausea, and vertigo.^[Ref]

Other

Very common (10% or more): Any infection (23%), pyrexia (17%)

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

Respiratory

Very common (10% or more): COVID-19 infection (14%)

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

Three fatal cases of pneumonia were identified, with two cases attributed to COVID-19 infection and one case caused by an unknown pathogen.^[Ref]

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.

Medical Disclaimer