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Sarilumab

Warning

This medication may lower your ability to fight an infection. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Your risk may be increased if you are also taking other drugs that can lower your ability to fight an infection (such as methotrexate or corticosteroids). Before using sarilumab, tell your doctor your medical history, especially of any kind of infection. During treatment, tell your doctor right away if you develop any signs of infection (such as cough, sore throat, fever, chills, pain when urinating).

Before and during treatment with this medication, your doctor will test you for tuberculosis (TB). If needed, treatment for tuberculosis or other infections should be done before receiving this medication.

Precautions

Before using sarilumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, past/current/returning infections, liver problems, blood/bleeding problems, stomach/abdominal problems (such as ulcers, diverticulitis).

Sarilumab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, tuberculosis, flu). Tell your doctor if you live in, have lived in, or have traveled to certain areas where there is an increased chance of getting certain kinds of fungal infections (blastomycosis, coccidioidomycosis, histoplasmosis). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using sarilumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Drugs that affect the immune system (such as sarilumab) may increase your risk of certain cancers. Tell your doctor if you have ever had any type of cancer.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Side Effects

See also Warning section.

Irritation, redness, or pain at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.