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Sarilumab Side Effects

For the Consumer

Applies to sarilumab: subcutaneous solution

Along with its needed effects, sarilumab 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 immediately if any of the following side effects occur while taking sarilumab:

More common
  • Bloody, black, or tarry stools
  • chills
  • cough
  • fever
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • sore throat
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Less common
  • Bladder pain
  • bloody or cloudy urine
  • body ache or pain
  • difficulty breathing
  • ear congestion
  • frequent urge to urinate
  • headache
  • loss of voice
  • nasal congestion
  • painful cold sores or blisters on the lips
  • runny nose
  • sneezing
Rare

Some side effects of sarilumab 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, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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.

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.

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