Sarilumab Solution for injection

SARILUMAB (sar IL ue mab) treats autoimmune conditions, such as arthritis. It works by slowing down an overactive immune system. It is a monoclonal antibody.

This medication is injected under the skin. You will be taught how to prepare and give it. Take it as directed on the prescription label at the same time every day. Keep taking it unless your care team tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Stomach pain that is severe, does not go away, or gets worse
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Pain, redness, or irritation at injection site
• Runny or stuffy nose
• Sore throat

Keep out of the reach of children and pets.

Store in a refrigerator or at room temperature between 20 and 25 degrees C (68 and 77 degrees F).

Refrigeration (preferred): Store in the refrigerator. Do not freeze. Protect from light. Keep in the original container until you are ready to take it. Get rid of any unused medication after the expiration date.

Room temperature: This medication may be stored at room temperature for up to 14 days. Protect from light. Keep it in the original carton until you are ready to take it. Get rid of any unused medication after 14 days or after it expires, whichever is first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Ask your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

They need to know if you have any of these conditions:

• Cancer
• Diabetes
• Diverticulitis
• Hepatitis B or history of hepatitis B infection
• High cholesterol
• Immune system problems
• Infection, especially a viral infection, such as chickenpox, cold sores, herpes
• Liver disease
• Low blood cell levels (white cells, platelets, or red blood cells)
• Recent or upcoming vaccine
• Scheduled to have surgery
• Stomach or intestine problems
• Tuberculosis, a positive skin test for tuberculosis, or recent close contact with someone who has tuberculosis
• An unusual or allergic reaction to sarilumab, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

Do not take this medication with any of the following:

• Live virus vaccines

This medication may also interact with the following:

• Biologic medications, such as abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, ofatumumab, rituximab, secukinumab, tocilizumab, tofacitinib, ustekinumab

This medication may affect how other medications work. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. You may need blood work done while you are taking this medication.

This medication can increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick. If you have not had the measles or chickenpox vaccines, tell your care team right away if you are around someone with these viruses.

If you are going to need surgery or other procedure, tell your care team that you are using this medication.

Talk to your care team about your risk of cancer. You may be at risk for certain types of cancers if you take this medication.