Uses of Kevzara:

• It is used to treat rheumatoid arthritis.

What do I need to tell my doctor BEFORE I take Kevzara?

• If you are allergic to Kevzara (sarilumab prefilled syringes); any part of Kevzara (sarilumab prefilled syringes); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• 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, rituximab, secukinumab, tocilizumab, ustekinumab, or vedolizumab.
• If you are taking tofacitinib.

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

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 syringes) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Kevzara?

• Tell all of your health care providers that you take Kevzara (sarilumab prefilled syringes). This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Low white blood cell counts have happened with Kevzara (sarilumab prefilled syringes). Talk with your doctor.
• Talk with your doctor before getting any vaccines while you take Kevzara (sarilumab prefilled syringes) and after you stop taking it. Vaccine use with Kevzara (sarilumab prefilled syringes) may either raise the chance of an infection or make the vaccine not work as well. Talk with your doctor.
• This medicine may cause high cholesterol and triglyceride levels. Talk with the doctor.
• Holes in the GI (gastrointestinal) tract may rarely happen.
• This medicine may add to the chance of getting some types of cancer. Talk with the doctor.
• If you are 65 or older, use Kevzara (sarilumab prefilled syringes) with care. You could have more side effects.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking Kevzara (sarilumab prefilled syringes).
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Kevzara (sarilumab prefilled syringes) while you are pregnant.
• If you used Kevzara (sarilumab prefilled syringes) when you were pregnant, tell your baby's doctor.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Kevzara) best taken?

Use Kevzara (sarilumab prefilled syringes) 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.
• If stored in a refrigerator, let Kevzara (sarilumab prefilled syringes) come to room temperature before using it. Leave it at room temperature for at least 30 minutes. Do not heat Kevzara (sarilumab prefilled syringes).
• 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.

What are some side effects that I need to call my doctor about right away?

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.
• Diarrhea.
• Feeling very tired or weak.
• Low platelet counts have rarely happened with Kevzara (sarilumab prefilled syringes). This may lead to a higher chance of bleeding. Call your doctor right away if you have any unexplained bruising or bleeding.

What are some other side effects of Kevzara?

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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

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.

How do I store and/or throw out Kevzara?

• Store in a refrigerator. Do not freeze.
• Store in original container.
• Protect from light.
• If needed, you may store at room temperature for up to 14 days. Write down the date you take Kevzara (sarilumab prefilled syringes) out of the refrigerator. If stored at room temperature and not used within 14 days, throw Kevzara (sarilumab prefilled syringes) away.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• 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.
• 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 syringes) is refilled. If you have any questions about Kevzara (sarilumab prefilled syringes), 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.

Frequently asked questions

• What are the new drugs for the treatment of rheumatoid arthritis (RA)?
• Does Kevzara cause weight gain?
• How long does it take for Kevzara to work?
• How do you use Kevzara (sarilumab) for the treatment of rheumatoid arthritis?

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