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Sarilumab Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 8, 2024.

Applies to sarilumab: subcutaneous solution.

Warning

Subcutaneous route (Solution)

Risk of Serious InfectionsPatients treated with sarilumab are at increased risk for developing serious infections that may lead to hospitalization or death. Opportunistic infections have also been reported in patients receiving sarilumab. Most patients who developed infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.Avoid use of sarilumab in patients with an active infection.Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before sarilumab use and during therapy. Treatment for latent infection should be initiated prior to sarilumab use. Invasive fungal infections, such as candidiasis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral and other infections due to opportunistic pathogens.Closely monitor patients for signs and symptoms of infection during treatment with sarilumab. If a serious infection develops, interrupt sarilumab until the infection is controlled.Consider the risks and benefits of treatment with sarilumab prior to initiating therapy in patients with chronic or recurrent infection.

Serious side effects of Sarilumab

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

Less common

Rare

Other side effects of Sarilumab

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

For Healthcare Professionals

Applies to sarilumab: subcutaneous solution.

General

The most frequently reported side effects included infections, upper respiratory tract infections, urinary tract infections, nasopharyngitis, neutropenia, increased ALT, injection site erythema, leukopenia, injection site pruritus, constipation, pruritic rash, myalgia, and fatigue.

The most common side effects resulting in discontinuation were neutropenia, increased ALT, infection, COVID-19, intervertebral discitis, and pneumonia.[Ref]

Dermatologic

Common (1% to 10%): Erythema, pruritus, pruritic rash

Uncommon (0.1% to 1%): Cellulitis[Ref]

Gastrointestinal

Common (1% to 10%): Oral herpes, constipation, diarrhea

Uncommon (0.1% to 1%): Diverticulitis

Rare (0.01% to 0.1%): Gastrointestinal (GI) perforation[Ref]

Reports of GI perforation was primarily reported as complications of diverticulitis including lower GI perforation and abscess.[Ref]

Genitourinary

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

Hematologic

Very common (10% or more): Neutropenia

Common (1% to 10%): Leukopenia, thrombocytopenia

Uncommon (0.1% to 1%): Decreased platelet counts[Ref]

Hepatic

Very common (10% or more): Elevated ALT (up to 43%), elevated AST (up to 30%)

Common (1% to 10%): Transaminases increased[Ref]

Hypersensitivity

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

Immunologic

Common (1% to 10%): Serious infections

Frequency not reported: Immunosuppression[Ref]

Local

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

Metabolic

Common (1% to 10%): Lipid abnormalities, hypertriglyceridemia, hypercholesterolemia[Ref]

Lipid abnormalities included elevated low-density lipoprotein, high-density lipoprotein, and triglycerides.[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, rheumatoid arthritis

Frequency not reported: Intervertebral discitis

Nervous system

Common (1% to 10%): Headache

Respiratory

Common (1% to 10%): Upper respiratory tract infection, nasopharyngitis

Uncommon: Pneumonia

Frequency not reported: COVID-19, bronchitis, influenza[Ref]

Oncologic

Common (1% to 10%): Malignancies

Other

Common (1% to 10%): Fatigue

Frequency not reported: Herpes zoster, drug specific antibody

Frequently asked questions

References

1. (2017) "Product Information. Kevzara (sarilumab)." sanofi-aventis

2. (2023) "Product Information. Kevzara (sarilumab)." sanofi-aventis

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