Arthritis Treatment Biologics What to Know About Enbrel (Etanercept) The first TNF blocker approved for rheumatoid arthritis By Carol Eustice Carol Eustice Facebook Carol Eustice is a writer covering arthritis and chronic illness, who herself has been diagnosed with both rheumatoid arthritis and osteoarthritis. Learn about our editorial process Updated on February 23, 2021 Medically reviewed Verywell Health articles are reviewed by board-certified physicians and healthcare professionals. These medical reviewers confirm the content is thorough and accurate, reflecting the latest evidence-based research. Content is reviewed before publication and upon substantial updates. Learn more. by David Ozeri, MD Medically reviewed by David Ozeri, MD LinkedIn David Ozeri, MD, is a board-certified rheumatologist. He is based in Tel Aviv, Israel, where he does research at Sheba Medical Center. Previously, he practiced at New York-Presbyterian Hospital. Learn about our Medical Expert Board Print Table of Contents View All Table of Contents Uses Before Taking Dosage Side Effects Warnings/Interactions Summary A Word From Verywell Enbrel (etanercept) is a biologic drug derived from living cells. It is used to treat rheumatoid arthritis, ankylosing spondylitis, and other types of rheumatic disease that cause pain, stiffness, and inflammation. Enbrel is classified as a TNF blocker, meaning that it suppresses immune system activity by blocking the activity of a cytokine protein in the body called tumor necrosis factor alpha (TNF-alpha). Excess TNF is closely associated with rheumatic disease. When TNF is activated, it binds to cell receptors in tissues all over the body and triggers systemic inflammation. Enbrel alleviates rheumatic symptoms by blocking TNF production so that it cannot perform this action. Although Enbrel is a highly effective medication for many people, it does come with considerable risk. This article covers the uses and benefits of Enbrel along with the risks you should know about before you take it. Uses Enbrel is approved by the U.S. Food and Drug Administration (FDA) to treat: Rheumatoid arthritis Juvenile idiopathic arthritis Psoriatic arthritis Ankylosing spondylitis Plaque psoriasis (adult and pediatric) Off-Label Uses Enbrel may be prescribed off-label for numerous conditions, including: Juvenile forms of arthritis such as of psoriatic arthritis and ankylosing spondylitis Inflammatory conditions such as Behçet's disease and pyoderma gangrenosum Autoimmune conditions such as Crohn's disease Before Taking Before you start taking any medication, you should discuss with your healthcare provider your medical and family history, any current conditions you may have, and any drugs or supplements you're taking. Precautions and Contraindications Enbrel is not recommended for: People with serious infections when starting the drug People prone to infection due to illnesses that weaken the immune system, such as uncontrolled diabetes Enbrel may trigger or worsen neurological problems in some people. Healthcare providers use caution when prescribing Enbrel to people with the following nervous system disorders: Multiple sclerosis Transverse myelitis Optic neuritis Guillain-Barre syndromes Enbrel also isn't recommended for people with moderate to severe alcoholic hepatitis due to an increased risk of death after six months of use. Pregnancy and Lactation According to the FDA, there's no statistically significant increase in the risk of birth defects in babies born to women taking Enbrel and no pattern of birth defects associated with it. A European study comparing outcomes in nine countries found a 5% increase in premature birth when a mother used TNF inhibitors as well as a significant increase in the risk of low birth weight. A 2015 review of systemic drugs' impact on fertility, pregnancy, and lactation found evidence that Enbrel has no negative impact on fertility in men or women; that it appears to cross the placenta in lower amounts than the TNF inhibitors Humira (adalimumab) and Remicade (infliximab); and that its levels in breast milk appear to be insignificant and not bio-available to healthy, full-term infants. It's unknown whether it's safe to give live or live-attenuated vaccines to babies exposed to Enbrel in the uterus. While the risk of birth defects and other problems due to Enbrel appears low, if you are pregnant and considering taking this drug, be sure to discuss your baby's health and the drug's potential impact with your health care team. Other TNF Inhibitors Enbrel was the first TNF-inhibiting drug, gaining FDA approval in 1998. Remicade became the second in 1999. Then came Humira in 2002, and Simponi (golimumab) and Cimzia (certolizumab pegol) in 2009. For Enbrel and Remicade, scientists combine human and rodent DNA to produce what are called monoclonal antibodies, which are human-made, cloned antibodies (cells that fight infection.) Humira, Simponi, and Cimzia are made from fully human proteins that produce monoclonal antibodies. How Are Enbrel, Remicade, and Humira Different? Dosage Enbrel is given by injection under the skin, which you (or a friend or family member) can do at home. It's available in pre-filled syringes, an auto-injector pen, or vials that you use to fill syringes. Indication Dosage Ankylosing spondylitis (adults) 50 milligrams (mg) per week Juvenile idiopathic arthritis (children) Based on weight; maximum of 50 mg per week Juvenile plaque psoriasis (children) Based on weight; maximum of 50 mg per week Plaque psoriasis (adults) 50 mg twice a week for 3 months, then stepped down to once weekly Psoriatic arthritis (adults) 50 mg per week Rheumatoid arthritis (adults) 50 mg per week Enbrel can be used in combination with methotrexate in patients who do not respond to methotrexate alone. The Enbrel dosage is typically the same regardless of whether it's taken alongside another drug. How to Take and Store Enbrel should be stored at a temperature of between 36 and 46 degrees F, but you should allow it to naturally warm up to room temperature before injecting it. (Don't try to heat it fast. Just take it out of the refrigerator and let it sit out.) Enbrel can be kept at room temperature for up to 14 days, if needed. It should never be stored in the freezer. According to the manufacturer, if you're traveling with your medication for more than a few hours, you should wrap Enbrel in bubble wrap and place it in a travel cooler packed with ice. Add a thermometer to the cooler and check it every few hours to make sure it's staying in the correct temperature range. You can obtain a free travel cooler and ice pack for Enbrel by calling the Enbrel Support line at 1-888-4ENBREL. If you're traveling by airplane, check with the airline for their rules and guidelines about transporting temperature-sensitive medication. Laura Porter / Verywell Side Effects All drugs come with a risk of side effects. Not everyone experiences them, but if you do, talk to your healthcare provider about them. Some side effects may go away with continued medication use, but others may be a signal that you need to stop taking the drug. Common Common side effects associated with Enbrel include: Injection site reactions Upper respiratory infections, including sinus infections Headaches Dizziness Runny nose Throat irritation These generally don't require medical attention. If any side effects become severe or persist for a long time, call your healthcare provider. Severe Enbrel is associated with some serious adverse reactions, including: New-onset multiple sclerosis or other demyelinating diseases New-onset seizure disorders Myelitis (inflammation of spinal cord) Optic neuritis (inflammation of optic nerve) Pancytopenia (low numbers of red blood cells, white blood cells, and platelets). Risk of Infections This drug carries a black box warning, the FDA's most serious type of warning, about the increased risk of serious infections, including tuberculosis. If you develop an infection while taking Enbrel, contact your healthcare provider before taking another dose. You may need to stop taking Enbrel, have special monitoring to ensure the infection doesn't become serious, or both. Warnings and Interactions In studies, Enbrel has been associated with a higher incidence of certain serious diseases, including some forms of cancer. These include: Lymphoma Leukemia Skin cancer (both melanoma and non-melanoma) Worsening of and increased risk of death from pre-existing heart disease Pancytopenia (rare) Aplastic anemia (very rare) Hepatitis B reactivation New-onset autoimmune disease An allergic reaction is possible with Enbrel. If you have symptoms including throat closure and difficulty breathing (anaphylactic shock), get emergency medical help immediately. If you have a latex allergy, be sure to alert your healthcare provider and pharmacist, as components of needles or autoinjectors may contain natural rubber, which is derived from latex. Immunizations You shouldn't get live vaccines while taking Enbrel. If your child has been prescribed this drug, you should bring them up-to-date on vaccinations before they start it, if possible. Be sure you discuss this with your pediatrician. Drug Interactions Enbrel may interact negatively with certain medications. This drug should not be combined with other immunosuppressive biologic drugs aside from azulfidine (sulfasalazine), which is one exception to this guideline. Make sure your healthcare provider knows all of the drugs you're taking, including over-the-counter medications and dietary supplements, so they can watch for any potential problems. Your pharmacist is also a valuable resource for ensuring your mix of treatments is safe. When Should You Change Your TNF Blocker? Summary A Word From Verywell Was this page helpful? Thanks for your feedback! Dealing with chronic inflammation? An anti-inflammatory diet can help. Our free recipe guide shows you the best foods to fight inflammation. Get yours today! Sign Up You're in! Thank you, {{form.email}}, for signing up. There was an error. Please try again. What are your concerns? Other Inaccurate Hard to Understand Submit 6 Sources Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy. Food and Drug Administration. Enbrel (etanercept) label. Tirado-Sánchezab A, de la Fuente-Garcíaa V, Ponce-Oliveraa RM. Off-label uses of etanercept in dermatology. Rev Méd del Hospital Gen de Méx. 2016 Mar;79(1):26-32. doi:10.1016/j.hgmx.2015.10.005 Starting Enbrel. What to expect. Weber-Schoendorfer C, Oppermann M, Wacker E, et al. Pregnancy outcome after TNF-α inhibitor therapy during the first trimester: a prospective multicentre cohort study. Br J Clin Pharmacol. 2015 Mar;80(4):727-739. doi:10.1111/bcp.12642 Grunewald S, Jank A. New systemic agents in dermatology with respect to fertility, pregnancy, and lactation. J Dtsch Dermatol Ges. 2015;13(4):277-290. doi:10.1111/ddg.12596 U.S. Food and Drug Administration. Information on tumor necrosis factor (TNF) blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi). Additional Reading U.S. Food and Drug Administration: AccessData. Enbrel: Highlights of prescribing information and Full Prescribing Information. By clicking “Accept All Cookies”, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. Cookies Settings Accept All Cookies