Sarilumab Side Effects
For the Consumer
Applies to sarilumab: subcutaneous solution prefilled syringe
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
- Very bad belly pain.
- Throwing up blood or throw up that looks like coffee grounds.
- Black, tarry, or bloody stools.
- Shortness of breath.
- Chest pain.
- Dizziness or passing out.
- Warm, red, or painful skin or sores on the body.
- Sweating a lot.
- Muscle pain or weakness.
- Coughing up blood.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Irritation where the shot is given.
- Signs of a common cold.
- Stuffy nose.
- Runny nose.
- Sore throat.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to sarilumab: subcutaneous solution
Frequency not reported: Cellulitis[Ref]
Common (1% to 10%): Neutropenia, leukopenia
Uncommon (0.1% to 1%): Decreased platelet counts
Frequency not reported: Thrombocytopenia
Uncommon (0.1% to 1%): Hypersensitivity reactions[Ref]
Common (1% to 10%): Serious (sometimes fatal) infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens which can be chronic or recurrent
Frequency not reported: Immunosuppression[Ref]
Common (1% to 10%): Injection site reactions (e.g., erythema, pruritus)[Ref]
Common (1% to 10%): Lipid abnormalities (elevated LDL, HDL, and triglycerides)[Ref]
Common (1% to 10%): Urinary tract infection[Ref]
Very common (10% or more): Elevated alanine aminotransferase (ALT) (up to 43%), elevated aspartate aminotransferase (AST) (up to 30%)[Ref]
Common (1% to 10%): Upper respiratory tract infection
Frequency not reported: Pneumonia[Ref]
The most frequent adverse reactions (occurring in at least 3% of patients treated with this drug in combination with DMARDs) were neutropenia, increased ALT, injection site erythema, upper respiratory infections, and urinary tract infections.[Ref]
Frequency not reported: GI perforation[Ref]
1. "Product Information. Kevzara (sarilumab)." sanofi-aventis, Bridgewater, NJ.
Some side effects of sarilumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
More about sarilumab
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- Support Group
- En Español
- 3 Reviews – Add your own review/rating
- Drug class: antirheumatics
Other brands: Kevzara
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