sarilumab

What is the most important information I should know about sarilumab?

What is sarilumab?

Sarilumab is used to treat moderate to severe rheumatoid arthritis in adults. Sarilumab is sometimes given together with other arthritis medicines.

Sarilumab is usually given after other treatments have failed.

Sarilumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking sarilumab?

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

Tell your doctor if you have ever had:

• an active or chronic infection;
• diabetes;
• HIV or AIDS;
• a weak immune system;
• hepatitis or other liver problems;
• stomach pain, diverticulitis, or stomach or intestinal ulcers;
• cancer; or
• if you have received or are scheduled to receive any vaccines.

Using sarilumab may increase your risk of developing certain types of cancers. Ask your doctor about this risk.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of sarilumab on the baby.

How should I take sarilumab?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Sarilumab is injected under the skin, usually given once every 2 weeks. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy or has particles in it. Call your pharmacist for new medicine.

Sarilumab affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Before injecting your dose, take the medicine out of the refrigerator and let it reach room temperature (for 30 minutes if using the prefilled syringe, or for 60 minutes if using the injection pen). Once at room temperature, the medicine must be used within 14 days.

Each prefilled syringe or injection pen is for one use only. Throw it away after one use, even if there is still medicine left inside.

Place used needles, syringes, or injection pens in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking sarilumab?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using sarilumab, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What are the possible side effects of sarilumab?

• fever, chills, sweating, body aches;
• cough with bloody mucus;
• feeling short of breath;
• diarrhea, stomach pain, weight loss;
• sores on your skin;
• pain or burning when you urinate; or
• feeling very tired.

• fever;
• ongoing stomach pain; or
• a change in bowel habits.

Common side effects may include:

• runny or stuffy nose, sinus pain, sore throat;
• abnormal liver function tests;
• painful urination; or
• skin redness where an injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect sarilumab?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect sarilumab, especially:

• any other medicines to treat rheumatoid arthritis, such as abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab, or tofacitinib.

This list is not complete and many other drugs may affect sarilumab. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about sarilumab.