Sarilumab

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

Sarilumab is usually given after other treatments have not worked.

Sarilumab may also be used for reasons not mentioned in this medication guide.

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.

Store this medicine in its original container in a refrigerator. Protect from light. Do not shake or freeze the medicine. Keep this medicine cold even while traveling.

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.

Sarilumab affects your immune system. You may get infections more easily, including serious or fatal infections. Tell your doctor if you have a fever, chills, tiredness, cough, diarrhea, stomach pain, weight loss, skin sores, or painful urination.

Sarilumab may cause a tear in your stomach or intestines. This risk is higher if you have diverticulitis or a stomach ulcer, or if you also take steroids, methotrexate, or an NSAID (nonsteroidal anti-inflammatory drug). Call your doctor right away if you have a fever and ongoing stomach pain.

You should not use sarilumab if you are allergic to it.

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 areas 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.

It is not known whether sarilumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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

You should not breast-feed while using sarilumab.

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, difficult breathing, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with sarilumab. Stop using sarilumab and call your doctor right away if you have signs of infection such as:

• 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.

Also call your doctor at once if you have signs of perforation (a hole or tear) in your stomach or intestines:

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

Common side effects of sarilumab 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.

Usual Adult Dose for Rheumatoid Arthritis:

200 mg subcutaneously every 2 weeksComments:-This drug may be used as monotherapy or in combination with methotrexate (MTX) or other conventional disease-modifying antirheumatic drugs (DMARDs).-Test patients for latent tuberculosis (TB); if positive, consider treating for TB prior to initiating therapy.-Avoid using this drug with biological DMARDs because of the possibility of increased immunosuppression and increased risk of infection; concurrent use of this drug with biological DMARDs such as TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies, and selective co-stimulation modulators has not been studied.-Avoid use in patients with active infections.Use: For the treatment of patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to 1 or more DMARDs

Usual Adult Dose for Polymyalgia Rheumatica:

200 mg subcutaneously every 2 weeksComments:-For polymyalgia rheumatica, this drug is administered in combination with a tapering course of systemic corticosteroids.-This drug can be used as monotherapy following discontinuation of corticosteroids.-Test patients for latent tuberculosis (TB); if positive, consider treating for TB prior to initiating therapy.-Avoid using this drug with biological DMARDs because of the possibility of increased immunosuppression and increased risk of infection; concurrent use of this drug with biological DMARDs such as TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies, and selective co-stimulation modulators has not been studied.-If neutropenia, thrombocytopenia, or liver enzyme abnormalities develop, discontinue therapy.-Avoid use in patients with active infections.Use: For treatment of patients with polymyalgia rheumatica who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper

Call your doctor for instructions if you miss a dose.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Avoid close contact with people who are sick or have infections. Notify your doctor immediately if you notice any signs of infection.

Do not get a "live" vaccine while using sarilumab, as this could lead to a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and the nasal flu (influenza) vaccine.

Sometimes it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medications less effective.

Tell your doctor about all the medicines you are currently taking. Many drugs can affect sarilumab, especially:

• any other medicines used 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.