Sutimlimab Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 24, 2025.

Applies to sutimlimab: intravenous solution.

Precautions

It is very important that your doctor check your progress closely and at regular visits to make sure this medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious infections (eg, meningitis, pneumonia, influenza). Check with your doctor right away if you have chest pain or tightness, chills, confusion, cough, drowsiness, fever, general feeling of illness, joint pain, loss of appetite, muscle aches and pains, nausea, runny nose, severe headache, sore throat, stiff neck, sweating, trouble breathing, unusual tiredness or weakness, or vomiting.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have back pain, chest tightness, chills, fast heartbeat, fever, flushing, headache, nausea, trouble breathing, or weakness.

Using this medicine may increase your risk of having autoimmune disease (eg, systemic lupus erythematosus). Check with your doctor right away if you have blisters or itching, chest pain, fever and chills, general feeling of discomfort or illness, hair loss, headache, muscle or joint pain, skin rash, sore throat, swollen glands, or trouble breathing.

Serious side effects of sutimlimab

Along with its needed effects, sutimlimab 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 sutimlimab:

Other side effects of sutimlimab

Some side effects of sutimlimab 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 sutimlimab: intravenous solution.

General adverse events

The most common adverse reactions in 1 study were rhinitis, headache, hypertension, acrocyanosis, and Raynaud's phenomenon. The most common adverse reactions in another study were urinary tract infection, respiratory tract infection, bacterial infection, dizziness, fatigue, peripheral edema, arthralgia, cough, hypertension, and nausea.^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (up to 25%), acrocyanosis (up to 21%), Raynaud's phenomenon (up to 18%)

Hypertension included increased blood pressure and essential hypertension.

Dermatologic

• Frequency not reported: Skin infections, pruritus

Gastrointestinal

• Very common (10% or more): Nausea (up to 25%), abdominal pain (up to 21%)
• Frequency not reported: Upper abdominal pain

Abdominal pain included upper abdominal pain and abdominal tenderness.

Genitourinary

• Very common (10% or more): Urinary tract infection (up to 38%)
• Frequency not reported: Urinary tract infection with sepsis, bacterial urinary tract infection, urosepsis

Urinary tract infection included cystitis and urosepsis.

Immunologic

• Very common (10% or more): Antidrug antibodies (up to 12%)
• Common (1% to 10%): Relapse/worsening of autoimmune disease

Musculoskeletal

• Very common (10% or more): Arthralgia (up to 25%)

Nervous system

• Very common (10% or more): Dizziness (up to 29%), headache (up to 23%)

Dizziness included postural dizziness and vertigo.

Other

• Very common (10% or more): Fatigue (up to 33%), infusion-related reactions (up to 29%), bacterial infection (up to 25%), peripheral edema (up to 25%), viral infection (up to 21%), pyrexia (up to 21%), serious bacterial and viral infections (up to 15%)
• Frequency not reported: Sepsis with urinary tract infection, otomastoiditis, febrile infection, chest discomfort, viral infection

Fatigue included asthenia, malaise, and mental fatigue.

Infusion-related reactions (e.g., shortness of breath, rapid heartbeat, nausea, flushing, headache, hypotension, chest discomfort, pruritus, rash, injection-site reaction, and dizziness) were reported in 29% of patients from 2 clinical trials. In 1 clinical trial, infusion-related reaction included stress cardiomyopathy and feeling cold; all occurred within 24 hours of the start of the infusion.

Bacterial infection included Escherichia urinary tract infection, bacterial urinary tract infection, bacterial cystitis, Escherichia sepsis, pneumococcal sepsis, Klebsiella pneumonia, streptococcal sepsis, and staphylococcal wound infection.

Peripheral edema included peripheral swelling.

Viral infection included oral herpes, herpes zoster, viral respiratory tract infection, viral upper respiratory tract infection, and Herpes simplex viremia.

Renal

• Frequency not reported: Increased blood creatinine

Respiratory

• Very common (10% or more): Respiratory tract infection (up to 25%), cough (up to 25%), nasopharyngitis (up to 21%), rhinitis (up to 18%)
• Frequency not reported: Pneumonia, Klebsiella pneumonia, coronavirus disease 2019 (COVID-19) pneumonia

Respiratory tract infection included upper respiratory tract infection, bronchitis, lower respiratory tract infection, and COVID-19 pneumonia.

Cough included productive cough.

See also:

Further information

Sutimlimab 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