Sarilumab (sar-IL-ue-mab)

Treats rheumatoid arthritis and polymyalgia rheumatica.

Brand Name(s):

Kevzara

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Allow the medicine to warm to room temperature for 30 minutes (for the prefilled syringe) or 60 minutes (for the prefilled pen) before using it. Do not warm this medicine in any other way.
• Check the liquid in the prefilled syringe or pen. It should be clear and colorless to pale yellow. Do not use this medicine if it is cloudy, discolored, or has particles in it, or if the prefilled syringe is damaged or broken. Do not shake the medicine.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are red, bruised, tender, hard, or have scars or stretch marks.
• Do not remove the needle cap from the prefilled syringe or pen until you are ready to use it.
• Use a new needle and syringe each time you inject your medicine. You might not use all of the medicine in each prefilled syringe or pen. Use each prefilled syringe and pen only one time. Do not save an open syringe or pen.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Keep the medicine in its original carton to protect from light. Do not use it if it has been frozen. You may also keep the medicine at room temperature for up to 14 days. Throw away unused medicine after 14 days.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how sarilumab works. Tell your doctor if you are using atorvastatin, lovastatin, theophylline, warfarin, or birth control pills.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, diabetes, high cholesterol, stomach or bowel disease (including diverticulitis, ulcers), or a weak immune system (including HIV, cancer). Tell your doctor if you have any type of infection (including hepatitis B or tuberculosis) or an infection that keeps coming back.
• This medicine may cause the following problems:
  • Increased risk for serious infections
  • Stomach or bowel problems (perforations or tears)
  • Increased risk of cancer
  • High cholesterol in the blood
• You will need a skin test for tuberculosis (TB) before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or been exposed to TB.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody, black, or tarry stools, severe stomach pain, diarrhea
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Swollen glands in the neck, underarms, or groin
• Unusual bleeding, bruising, or weakness
• Vomiting of material that looks like coffee grounds

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, bleeding, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088