AMJEVITA is a medicine called a Tumor Necrosis Factor (TNF) blocker.

AMJEVITA is used:
• To reduce the signs and symptoms of:
◦ moderate to severe rheumatoid arthritis (RA) in adults. AMJEVITA can be used alone, with methotrexate, or with certain other medicines.
◦ moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. AMJEVITA can be used alone or with methotrexate.
◦ psoriatic arthritis (PsA) in adults. AMJEVITA can be used alone or with certain other medicines.
◦ ankylosing spondylitis (AS) in adults.
◦ moderate to severe hidradenitis suppurativa (HS) in people 12 years and older.
• To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
• To treat moderate to severe ulcerative colitis (UC) in adults. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
• To treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
• To treat non-infectious intermediate, posterior, and panuveitis in adults and children 2 years of age and older.

AMJEVITA may not be right for you. Before starting AMJEVITA, tell your doctor about all of your medical conditions, including if you:
• have an infection. See “What is the most important information I should know about AMJEVITA?”
• have or have had cancer.
• have any numbness or tingling or have a disease that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome.
• have or had heart failure.
• have recently received or are scheduled to receive a vaccine. You may receive vaccines, except for live vaccines while using AMJEVITA. Children should be brought up to date with all vaccines before starting AMJEVITA.
• are allergic to AMJEVITA or to any of its ingredients. The AMJEVITA prefilled syringe and prefilled SureClick autoinjector are not made with natural rubber latex. See the end of this Medication Guide for a list of ingredients in AMJEVITA.
• are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. You and your doctor should decide if you should take AMJEVITA while you are pregnant or breastfeeding.
• have a baby and you were using AMJEVITA during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines.Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your doctor if you use:
• ORENCIA (abatacept), KINERET (anakinra), REMICADE (infliximab), ENBREL (etanercept), CIMZIA (certolizumab pegol) or SIMPONI (golimumab), because you should not use AMJEVITA while you are also using one of these medicines.
• RITUXAN (rituximab). Your doctor may not want to give you AMJEVITA if you have received RITUXAN (rituximab) recently.
• IMURAN (azathioprine) or PURINETHOL (6-mercaptopurine, 6-MP).

Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

• AMJEVITA is given by an injection under the skin. Your doctor will tell you how often to take an injection of AMJEVITA. This is based on your condition to be treated. Do not inject AMJEVITA more often than you were prescribed.
• See the Instructions for Use inside the carton for complete instructions for the right way to prepare and inject AMJEVITA.
• Make sure you have been shown how to inject AMJEVITA before you do it yourself. You can call your doctor or 1-800-77-AMGEN (1-800-772-6436) if you have any questions about giving yourself an injection. Someone you know can also help you with your injection after they have been shown how to prepare and inject AMJEVITA.
• Do not try to inject AMJEVITA yourself until you have been shown the right way to give the injections. If your doctor decides that you or a caregiver may be able to give your injections of AMJEVITA at home, you should receive training on the right way to prepare and inject AMJEVITA.
• Do not miss any doses of AMJEVITA unless your doctor says it is okay. If you forget to take AMJEVITA, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. This will put you back on schedule. In case you are not sure when to inject AMJEVITA, call your doctor or pharmacist.
• If you take more AMJEVITA than you were told to take, call your doctor.

AMJEVITA can cause serious side effects, including:

See “What is the most important information I should know about AMJEVITA?”

• Serious Infections. Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with AMJEVITA and during treatment with AMJEVITA. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking AMJEVITA. People who had a negative TB skin test before receiving adalimumab products have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking AMJEVITA:
◦ cough that does not go away
◦ low grade fever
◦ weight loss
◦ loss of body fat and muscle (wasting)

• Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use AMJEVITA. Your doctor should do blood tests before you start treatment, while you are using AMJEVITA, and for several months after you stop treatment with AMJEVITA. Tell your doctor if you have any of the following symptoms of a possible hepatitis B infection:
◦ muscle aches
◦ feel very tired
◦ dark urine
◦ skin or eyes look yellow
◦ little or no appetite
◦ vomiting
◦ clay-colored bowel movements
◦ fever
◦ chills
◦ stomach discomfort
◦ skin rash

• Allergic reactions. Allergic reactions can happen in people who use AMJEVITA. Call your doctor or get medical help right away if you have any of these symptoms of a serious allergic reaction:
◦ hives
◦ trouble breathing
◦ swelling of your face, eyes, lips or mouth

• Nervous system problems. Signs and symptoms of a nervous system problem include: numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.

• Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.

• New heart failure or worsening of heart failure you already have. Call your doctor right away if you get new worsening symptoms of heart failure while taking AMJEVITA, including:
◦ shortness of breath
◦ sudden weight gain
◦ swelling of your ankles or feet

• Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that gets worse in the sun. Symptoms may improve when you stop AMJEVITA.

• Liver problems. Liver problems can happen in people who use TNF-blocker medicines. These problems can lead to liver failure and death. Call your doctor right away if you have any of these symptoms:
◦ feel very tired
◦ poor appetite or vomiting
◦ skin or eyes look yellow
◦ pain on the right side of your stomach (abdomen)

• Psoriasis. Some people using adalimumab products had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with AMJEVITA.

Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with AMJEVITA may be stopped.

The most common side effects of AMJEVITA include:
• injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. Call your doctor right away if you have pain, redness or swelling around the injection site that does not go away within a few days or gets worse.
• upper respiratory infections (including sinus infections).
• headaches.
• rash.

These are not all the possible side effects with AMJEVITA. Tell your doctor if you have any side effect that bothers you or that does not go away. Ask your doctor or pharmacist for more information.

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

• Store AMJEVITA in the refrigerator at 36°F to 46°F (2°C to 8°C). Store AMJEVITA in the original carton until use to protect it from light.
• Do not freeze AMJEVITA. Do not use AMJEVITA if frozen, even if it has been thawed.
• Refrigerated AMJEVITA may be used until the expiration date printed on the AMJEVITA carton, dose tray, prefilled autoinjector or prefilled syringe. Do not use AMJEVITA after the expiration date.
• If needed, for example when you are traveling, you may also store AMJEVITA at room temperature up to 77°F (25°C) for up to 14 days. Store AMJEVITA in the original carton until use to protect it from light.
• Throw away AMJEVITA if it has been kept at room temperature and not been used within 14 days.
• Record the date you first remove AMJEVITA from the refrigerator in the space provided on the carton.
• Do not store AMJEVITA in extreme heat or cold.
• Do not use a prefilled autoinjector or prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it.
• Do not drop or crush the AMJEVITA syringe. The prefilled syringe is made of glass.Keep AMJEVITA, injection supplies, and all other medicines out of the reach of children.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AMJEVITA for a condition for which it was not prescribed. Do not give AMJEVITA to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about AMJEVITA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about AMJEVITA that is written for health professionals.

Active ingredient: adalimumab-atto

Inactive ingredients: glacial acetic acid (or L-lactic acid), polysorbate 80, sucrose and Water for Injection. Sodium hydroxide is added as necessary to adjust the pH to 5.2.