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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

Dermatologic

Frequency not reported: Cellulitis[Ref]

Hematologic

Common (1% to 10%): Neutropenia, leukopenia
Uncommon (0.1% to 1%): Decreased platelet counts
Frequency not reported: Thrombocytopenia

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions[Ref]

Immunologic

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]

Local

Common (1% to 10%): Injection site reactions (e.g., erythema, pruritus)[Ref]

Metabolic

Common (1% to 10%): Lipid abnormalities (elevated LDL, HDL, and triglycerides)[Ref]

Genitourinary

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

Hepatic

Very common (10% or more): Elevated alanine aminotransferase (ALT) (up to 43%), elevated aspartate aminotransferase (AST) (up to 30%)[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection
Frequency not reported: Pneumonia[Ref]

General

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]

Gastrointestinal

Frequency not reported: GI perforation[Ref]

References

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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