Enbrel (etanercept) works by decreasing a certain protein produced by the immune system. The immune system helps the body fight infections. In people with autoimmune disorders, the immune system mistakes the body’s own cells for invaders and attacks them.
Enbrel is used to treat the symptoms of rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, and to prevent joint damage caused by these conditions. Enbrel is also used to treat plaque psoriasis in adults and polyarticular juvenile idiopathic arthritis in children who are at least 2 years old.
You should not use Enbrel if you are allergic to etanercept, or if you have a severe infection such as sepsis (infection of the blood). Some people using Enbrel have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using Enbrel or similar medicines to treat Crohn’s disease or ulcerative colitis. However, people with autoimmune disorders (including psoriasis) may have a higher risk of lymphoma. Talk to your doctor about your individual risk.
Before using Enbrel, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.
To make sure you can safely use Enbrel, tell your doctor if you have any of these other conditions:
- a weak immune system, or any type of infection including a skin infection or open sores;
- congestive heart failure;
- a nerve disorder such as multiple sclerosis, myelitis, or optic neuritis;
- epilepsy or other seizure disorder;
- asthma or other breathing disorder;
- if you have ever had hepatitis B;
- if you are allergic to latex rubber; or
- if you are scheduled to receive any vaccines, or if you have recently been vaccinated with BCG (Bacille Calmette-Guerin).
FDA pregnancy category B. Enbrel is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether etanercept passes into breast milk or if it could harm a nursing baby. Do not use Enbrel without telling your doctor if you are breast-feeding a baby. Children using this medication should be current on all childhood immunizations before starting treatment with Enbrel.
Get emergency medical help if you have any of these signs of an allergic reaction to Enbrel: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Enbrel and call your doctor right away if you have any of these symptoms of lymphoma:
- fever, night sweats, weight loss, tiredness;
- feeling full after eating only a small amount;
- pain in your upper stomach that may spread to your shoulder;
- easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Stop using Enbrel and call your doctor at once if you have any of these other serious side effects:
- signs of infection (fever, chills, sore throat, body aches, confusion, neck stiffness, flu symptoms);
- shortness of breath with swelling, rapid weight gain;
- chest pain, ongoing cough, coughing up mucus or blood;
- signs of skin infection such as itching, swelling, warmth, redness, or oozing;
- black, bloody, or tarry stools;
- changes in mood or personality (in children);
- numbness, burning, pain, or tingly feeling;
- joint pain or swelling with fever, swollen glands, muscle aches, chest pain, unusual thoughts or behavior, and/or seizure (convulsions); or
- patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).
Less serious Enbrel side effects may include:
- mild nausea, vomiting, mild diarrhea, mild stomach pain;
- runny or stuffy nose, cold symptoms; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.