Important Information about ENBREL

Read these instructions carefully before you start taking ENBREL (etanercept). The information in this website does not take the place of talking to your doctor before you start taking this medication and at checkups. Please ask your doctor or healthcare provider if you do not understand any of this information or if you want to know more about this medicine. A toll-free information service is also available Enliven 1.877.9ENBREL (1.877.936.2735) to answer any questions you may have. Keep this information for your reference because you may want to read it again.

What important information do I need to know about ENBREL?

All medicines have side effects. In studies comparing ENBREL to placebo (inactive injection), the side effects that occurred more frequently in patients treated with ENBREL were:

• Reactions at the site of injection. These reactions are usually mild and included redness, swelling, itching or bruising. These usually go away within 3 to 5 days. If you have pain, redness or swelling around the injection site that doesn’t go away or gets worse, call your doctor.
• Upper respiratory infections (sinus infections).
• Headaches.

Medicines, like ENBREL, that affect your immune system can cause serious side effects. The possible serious side effects include:

Serious Warnings and Precautions

• Serious infections: There have been cases where patients taking ENBREL or other TNF-blocking agents have developed serious infections, including tuberculosis (TB) and infections caused by bacteria, viruses or fungi that have spread throughout their body. Some patients have died from these infections. In very rare cases, hepatitis B recurred in patients with previous hepatitis. If you tend to get infections easily or if you develop an infection while taking ENBREL, you should tell your doctor right away.
• Malignancies: There have been cases, sometimes fatal, of unusual cancers in children and teenage patients who started using TNF-blocking agents, including ENBREL, at less than 18 years of age.
• Nervous System Diseases:There have been rare cases of disorders that affect the nervous system of people taking ENBREL or other TNF blockers, such as multiple sclerosis, seizures or inflammation of the nerves of the eyes. Signs include: numbness or tingling throughout your body, problems with your vision, weakness in your arms and/or legs and dizziness.
• Blood Problems:In some patients the body may fail to produce enough of the blood cells that can help your body fight infections or help you to stop bleeding. This can lead to death. If you develop a fever that doesn’t go away, bruise or bleed very easily or look very pale or feel faint, call your doctor right away. Your doctor may decide to stop treatment. Some people have also had symptoms that resemble lupus (rash on your face and arms that gets worse in the sun) that may go away when you stop taking ENBREL.
• Heart Problems:You should also tell your doctor if you have ever been treated for heart failure. Symptoms include shortness of breath or swelling of your ankles and feet. If so your doctor may choose not to start you on ENBREL, or may want to monitor you more closely.
• Allergic Reactions:Some patients have had allergic reactions to ENBREL. If you develop a severe rash, swollen face or difficulty breathing while taking ENBREL, call your doctor right away.
• Malignancies:Patients with inflammatory diseases including rheumatoid arthritis, ankylosing spondylitis or psoriasis, particularly those with highly active disease, may be at higher risk for lymphoma (a type of cancer). For children and adults taking TNF blocker medicines including ENBREL, the chances of getting lymphoma or other cancers may increase. Whether treatment with ENBREL might influence the development and course of malignancies in adults is unknown.
• Liver Problems (autoimmune hepatitis):Liver problems can happen in people who use TNF blocker medicines, including ENBREL. These problems can lead to liver failure and death. Call your doctor right away if you have any of these symptoms: feel very tired, skin or eyes look yellow, poor appetite or vomiting, pain on the right side of your stomach (abdomen). These symptoms may occur several months after starting and even after ENBREL has been stopped.
• Psoriasis:Some people using ENBREL developed new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps which may be filled with pus. Your doctor may decide to stop your treatment with ENBREL.
• Serious Infections: ENBREL can lower the ability of your immune system to fight infections. So, taking ENBREL can make you more prone to getting infections or make any infection that you may have worse. Some people have serious infections while taking ENBREL including infections that spread through the body such as tuberculosis (TB), legionellosis (usually a bacterial pneumonia), and listeriosis (usually from contaminated food). Other infections caused by viruses, fungi, bacteria or parasites may occur. Some people have died from these infections

Before you start taking ENBREL, you should tell your doctor if you

• have an infection. This could put you at risk for serious side effects from ENBREL.
• have symptoms of an infection such as fever, sweats or chills, cough or flu-like symptoms, shortness of breath, blood in your phlegm, weight loss, muscle aches, warm, red or painful areas on your skin, sores on your body, diarrhea or stomach pain, burning when you urinate or urinate more often than normal and feel very tired.
• have a history of infections that keep coming back or other conditions – like diabetes, HIV or a weak immune system – that might increase your risk of infections.
• have tuberculosis (TB), or have been in close contact with someone who has or has had TB. You will need to be evaluated for TB. Your doctor should test you for TB before starting ENBREL.
• were born in, lived in, or travelled to countries where there is a risk for getting TB. Ask your doctor if you are not sure.
• live in, have lived in, or have travelled to areas where there is a greater risk for certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, blastomycosis). These infections may develop or become more severe if you take ENBREL. If you don’t know if you have lived in an area where these infections are common, ask your doctor.
• have or have had hepatitis B.
• have or have had persistent numbness, tingling and muscle weakness or a disease such as multiple sclerosis, Guillain-Barré or a Guillain-Barré-like syndrome, which causes inflammation of the nervous system, either in the brain and spinal cord or nerves going to your hands and feet.
• have been newly diagnosed or are being treated for congestive heart failure.
• are scheduled to have major surgery.
• have recently received or are scheduled to receive a vaccine. All vaccines should be brought up-to-date before starting ENBREL. Patients taking ENBREL should not receive live vaccines.
• use the medication Kineret® (anakinra), Orencia® (abatacept) or cyclophosphamide (for more information, see the ENBREL Consumer Information sheet included in your ENBREL package).
• have been around someone with varicella zoster (chicken pox, shingles)

Know the medicines you take. Keep a list of them to show your doctor and pharmacist each time you get a new medicine.

Your doctor should monitor you closely for signs and symptoms of TB during treatment with ENBREL even if you have tested negative for TB. If you develop any of the symptoms of TB (a dry cough that doesn’t go away, weight loss, fever or night sweats), call your doctor.

If you are not sure or have any questions about any of this information, ask your doctor.

For complete information, please refer to the ENBREL patient handbook or the consumer information section of the ENBREL Product Monograph.