Sarilumab Injection

IMPORTANT WARNING:

Sarilumab injection may decrease your ability to fight infection and increase the risk that you will get a serious infection, including severe fungal, bacterial, or viral infections that spread throughout the body. These infections may need to be treated in a hospital and may cause death. Tell your doctor if you often get any type of infection or if you think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores), and chronic infections that do not go away. Also tell your doctor if you have or have ever had diabetes, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B (a viral infection that affects the liver), hepatitis C virus infection (HCV: an ongoing liver infection), herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past), or any other condition that affects your immune system. You should also tell your doctor if you live, have ever lived, of if you have traveled to areas such as the Ohio or Mississippi river valleys where severe fungal infections are more common. Ask your doctor if you are not sure if these infections are common in your area. Also, tell your doctor if you are taking medications that decrease the activity of the immune system.

Your doctor will monitor you for signs of infection during and after your treatment. If you have any of the following symptoms before you begin your treatment or if you experience any of the following symptoms during or shortly after your treatment, call your doctor immediately: fever; sweating; chills; muscle aches; cough; coughing up bloody mucus; shortness of breath; weight loss; warm, red, or painful skin; sores on the skin; frequent, painful, or burning feeling during urination; diarrhea; stomach pain; or excessive tiredness.

You may already be infected with tuberculosis (TB; a serious lung infection) but not have any symptoms of the disease. In this case, using sarilumab injection may make your infection more serious and cause you to develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection before you begin your treatment with sarilumab injection. If necessary, your doctor will give you medication to treat this infection before you start using sarilumab injection. Tell your doctor if you have or have ever had TB, if you have lived in or visited a country where TB is common, or if you have been around someone who has TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, coughing up bloody mucus, weight loss, loss of muscle tone, or fever.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with sarilumab injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

Sarilumab injection is used alone or with other medications to treat rheumatoid arthritis (RA: condition in which the body attacks its own joints causing pain, swelling, and loss of function) in adults who were not helped by other disease-modifying antirheumatic drugs (DMARDs) or when these medications could not be tolerated. Sarilumab injection is also used to treat polymyalgia rheumatica (disorder that causes muscle pain and weakness) in adults when other medications did not help or could not be tolerated. Sarilumab injection is also used to treat polyarticular juvenile idiopathic arthritis (PJIA; a type of childhood arthritis that affects five or more joints during the first six months of the condition, causing pain, swelling, and loss of function) in children weighing 139 pounds (63 kg) or more. Sarilumab injection is in a class of medications called interleukin-6 (IL-6) receptor inhibitors. It works by blocking the activity of interleukin-6, a substance in the body that causes inflammation.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Sarilumab injection comes as a prefilled syringe and a prefilled pen to inject subcutaneously (under the skin). It is usually used once every 2 weeks. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use sarilumab injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You will receive your first dose of sarilumab injection in a doctor's office. After that, your doctor may decide that you or your caregiver can perform the injections at home. Your doctor will show you or the person who will be injecting the medication how to inject it. You or the person who will be injecting the medication should also read the written instructions for use that come with the medication. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication.

Remove the prefilled syringe or prefilled pen from the refrigerator, place it on a flat surface, and allow it to reach room temperature (30 minutes for the prefilled syringe and 60 minutes for the prefilled pen) before your are ready to inject the medication. Do not try to warm the medication by heating it in a microwave, placing it in warm water or in direct sunlight, or through any other method. Do not remove the cover from the prefilled syringe or the cap from the prefilled pen while the medication is warming. You should remove the cover or cap just before you inject the medication.

Always look at sarilumab solution before injecting it. Check that the expiration date has not passed and that the liquid is clear and colorless to slightly yellow. The liquid should not contain visible particles. Do not use if it is expired or if the liquid is cloudy, discolored, or contains particles.

You may inject sarilumab injection on the front of the thighs or anywhere on your stomach except your navel (belly button) and the area 2 inches around it. If another person is injecting your medication, the outer area of the upper arms also may be used. Do not inject the medication into skin that is tender, bruised, damaged, or scarred. Choose a different spot each time you inject the medication.

Use each syringe and pen only once. Throw away used syringes and pens in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of thepuncture-resistant container.

Your doctor will monitor you carefullyand may adjust your dose or temporarily or permanently stop your treatment depending on your response to this medication or the sides effects that you experience. Talk to your doctor about how you are feeling during your treatment with sarilumab injection.

Sarilumab injection may help control your symptoms, but it will not cure your condition. Continue to use sarilumab injection even if you feel well. Do not stop using sarilumab injection without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before using sarilumab injection,

• tell your doctor and pharmacist if you are allergic to sarilumab, any other medications, or any of the ingredients in sarilumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• The following nonprescription or herbal product may interact with sarilumab: aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin), and naproxen (Aleve, Anaprox, others). Be sure to let your doctor and pharmacist know that you are taking this medication before you start using sarilumab injection. Do not start this medication while using sarilumab injection without discussing it with your healthcare provider.

• tell your doctor if you have or have ever had diverticulitis (small pouches in the lining of the large intestine that can become inflamed), ulcers in your stomach or intestines, cancer, increased amounts of cholesterol (a fat-like substance) and other fatty substances in the blood, or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using sarilumab injection, call your doctor. If you received sarilumab injections while you were pregnant, tell your doctor before the baby receives any vaccinations.

• ask your doctor whether you should receive any vaccinations before you begin your treatment with sarilumab injection. If possible, all vaccinations for children should be brought up to date before beginning treatment. Also, tell your doctor if you have recently received or are scheduled to receive any vaccines. You should not receive any vaccinations while you are using sarilumab injection without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Ask your doctor what to do if you forget to inject a dose. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Sarilumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• stuffy or runny nose
• redness or itching near the spot the medication was injected

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• bleeding or bruising easily
• rash
• hives
• difficulty swallowing or breathing
• swelling of your lips, tongue, or face
• chest pain
• feeling dizzy or faint
• stomach pain
• vomiting

Medications similar to sarilumab injection may cause an increased risk of developing cancer. Talk to your doctor about the risks of using this medication.

Sarilumab injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the carton it came in to protect it from light, tightly closed, and out of reach of children. Store it in the refrigerator but do not freeze. If the medication was stored out of the refrigerator, it should be used within 14 days.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to sarilumab injection.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.