Uses

This medication is used to treat rheumatoid arthritis or polymyalgia rheumatica (PMR). Sarilumab belongs to a class of drugs known as monoclonal antibodies. It helps reduce pain and swelling by blocking Interleukin-6, a substance made by the body that causes swelling (inflammation).

Other Uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used for COVID-19, but is only effective in hospitalized patients who need supplemental oxygen or a mechanical ventilator to breathe.

How To Use

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using sarilumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package.

Remove this medication from the refrigerator and leave it at room temperature before injecting, for at least 30 minutes if you are using the syringe or 60 minutes if you are using the pen. Do not warm up this medication any other way such as by heating in the microwave or placing in hot water. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Inject this medication under the skin of the thigh, abdomen, or upper arm as directed by your doctor, usually once every 2 weeks. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is tender, damaged, or has bruises or scars.

Learn how to store and discard medical supplies safely.

The dosage is based on your medical condition, lab tests, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, mark the days you need to inject the medication on a calendar.

Tell your doctor if your condition does not get better or if it gets worse.

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.

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 breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include warfarin, some cholesterol drugs such as atorvastatin/lovastatin/simvastatin, among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests (such as complete blood counts, liver function, cholesterol tests) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments.

Missed Dose

If you miss a dose and it has been 3 days or less since the missed dose, use it as soon as you remember. Use your next dose at the regular time. Do not double the dose to catch up. If it has been 4 days or longer, ask your doctor or pharmacist right away for a new dosing schedule.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store in the original package in the refrigerator away from light and moisture. Do not freeze. Do not store in the bathroom. After taking this medication out of the refrigerator, use it within 14 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.