Kevzara (Sarilumab Prefilled Pens)

• If you have an allergy to Kevzara (sarilumab prefilled pens) or any part of Kevzara (sarilumab prefilled pens).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have liver disease or raised liver enzymes.
• If you have a low platelet count or a low white blood cell count.
• If you are taking any of these drugs: Abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, natalizumab, rituximab, or tocilizumab.
• If you are taking tofacitinib.

This is not a list of all drugs or health problems that interact with Kevzara (sarilumab prefilled pens).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Kevzara (sarilumab prefilled pens) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use Kevzara (sarilumab prefilled pens) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin on the top of the thigh or the belly area.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Follow how to use as you have been told by the doctor or read the package insert.
• If stored in a refrigerator, let Kevzara (sarilumab prefilled pens) come to room temperature before using it. Leave it at room temperature for at least 60 minutes. Do not heat Kevzara (sarilumab prefilled pens).
• Do not remove the cap or cover until ready to use.
• Wash your hands before and after use.
• Do not shake.
• Do not use if the solution is cloudy, leaking, or has particles.
• This medicine is colorless to a faint yellow. Do not use if the solution changes color.
• Move the site where you give the shot with each shot.
• Do not give into skin that is irritated, bruised, red, infected, or scarred.
• Do not give into skin within 2 inches of the belly button.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Be sure you know what to do if you forget to take a dose.
• If you are not sure what to do if you miss a dose, call your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Very bad belly pain.
• Throwing up blood or throw up that looks like coffee grounds.
• Black, tarry, or bloody stools.
• Shortness of breath.
• Chest pain.
• Dizziness or passing out.
• Warm, red, or painful skin or sores on the body.
• Sweating a lot.
• Muscle pain or weakness.
• Weight loss.
• Loose stools (diarrhea).
• Feeling very tired or weak.
• Low platelet counts have rarely happened with Kevzara (sarilumab prefilled pens). This may lead to a higher chance of bleeding. Call your doctor right away if you have any unexplained bruising or bleeding.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where the shot is given.
• Signs of a common cold.
• Stuffy nose.
• Runny nose.
• Sore throat.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Kevzara (sarilumab prefilled pens) is refilled. If you have any questions about Kevzara (sarilumab prefilled pens), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.