Sarilumab Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 1, 2022.

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

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
painful cold sores or blisters on the lips
sneezing
stuffy or runny nose

Rare

Chest tightness
difficulty swallowing
dizziness
fast heartbeat
heartburn
hives, itching, skin rash
indigestion
nausea
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
severe stomach pain, cramping, or burning
vomiting of material that looks like coffee grounds, severe and continuing

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

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^[Ref]

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]