Important Safety Information and Indications

USES
HYRIMOZ® (adalimumab-adaz) is a prescription medicine called a tumor necrosis factor (TNF) blocker used:

• To reduce the signs and symptoms of:

1. Moderate to severe rheumatoid arthritis (RA) in adults. HYRIMOZ can be used alone, or with methotrexate, or with certain other medicines. HYRIMOZ may prevent further damage to your bones and joints and may help your ability to perform daily activities
2. Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HYRIMOZ can be used alone or with methotrexate
3. Psoriatic arthritis (PsA) in adults. HYRIMOZ can be used alone or with certain other medicines. HYRIMOZ may prevent further damage to your bones and joints and may help your ability to perform daily activities
4. Ankylosing spondylitis (AS) in adults
5. Moderate to severe hidradenitis suppurativa (HS) in adults

• 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 (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about HYRIMOZ?
HYRIMOZ is a TNF-blocker medication that affects your immune system. HYRIMOZ can lower the ability of your immune system to fight infections. You should discuss the potential benefits and risks of HYRIMOZ with your doctor. You should not start taking HYRIMOZ if you have any kind of infection unless your doctor says it is okay.

• Serious infections have happened in people taking adalimumab products. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HYRIMOZ and check you closely for signs and symptoms of TB during treatment with HYRIMOZ, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB
• Cancer. For children and adults taking TNF blockers, including HYRIMOZ, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including HYRIMOZ, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types of cancer are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn’t heal

What should I tell my doctor BEFORE starting HYRIMOZ?
Tell your doctor about all of your health conditions, including if you:

• Think you have an infection, are being treated for infection, or have symptoms of an infection, such as:

1. Fever, sweats, or chills
2. Muscle aches
3. Cough
4. Shortness of breath
5. Blood in phlegm
6. Weight loss
7. Warm, red, or painful skin or sores on your body
8. Diarrhea or stomach pain
9. Burning when you urinate or urinating more often than normal
10. Feeling very tired

• Get a lot of infections or have infections that keep coming back
• Have diabetes
• Have TB or have been in close contact with someone with TB; or were born in, lived in, or traveled where there is more risk for getting TB
• Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use HYRIMOZ. Ask your doctor if you do not know if you have lived in an area where these infections are common
• Have or have had hepatitis B
• Are scheduled for major surgery
• Have or have had cancer
• Have numbness or tingling or a nervous system disease 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 HYRIMOZ. Children should be brought up to date on all vaccines before starting HYRIMOZ
• Are allergic to HYRIMOZ or to any of its ingredients
• Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
• Have a baby and you were using HYRIMOZ during your pregnancy. Tell your baby's doctor before your baby receives any vaccines

Also tell your doctor about all the medicines you take. You should not take HYRIMOZ with Orencia® (abatacept), Kineret® (anakinra), Remicade® (infliximab), Enbrel® (etanercept), Cimzia® (certolizumab pegol), or Simponi® (golimumab). Tell your doctor if you have ever used Rituxan® (rituximab), Imuran® (azathioprine), or Purinethol® (6-mercaptopurine, 6-MP).

What should I watch for AFTER starting HYRIMOZ?
HYRIMOZ can cause serious side effects, including:

• Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle
• Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash
• Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth
• Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness
• Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale
• Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain
• Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun
• Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death
• Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps filled with pus

Call your doctor or get medical care right away if you develop any of the above symptoms.

What are the most common side effects of HYRIMOZ?
Common side effects of HYRIMOZ include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, and rash.

These are not all the possible side effects with HYRIMOZ. Tell your doctor if you have any side effect that bothers you or that does not go away.

This is the most important information to know about HYRIMOZ. For more information, talk to your doctor or pharmacist.

Please see full Prescribing Information for HYRIMOZ, including Boxed Warning and Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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