etanercept, Enbrel

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Pharmacy Author:

Omudhome Ogbru, PharmD

Omudhome Ogbru, PharmD

Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

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Medical and Pharmacy Editor:

Jay W. Marks, MD

Jay W. Marks, MD

Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

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GENERIC NAME: etanercept

BRAND NAME: Enbrel

DRUG CLASS AND MECHANISM: Etanercept is an injectable drug that is used for treating rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. It works by blocking tumor necrosis factor alpha (TNF alpha). Other drugs that block TNF alpha include adalimumab (Humira), certolizumab (Cimzia), golimumab (Simponi), and infliximab (Remicade).

TNF alpha is a protein that the body produces during when there is inflammation, the body's reaction to injury. TNF alpha promotes inflammation and its associated fever and signs (pain, tenderness, and swelling) in several inflammatory conditions including rheumatoid arthritis and ankylosing spondylitis. Etanercept is a synthetic (man-made) protein that binds to TNF alpha. It thereby acts like a sponge to remove most of the TNF alpha from the joints and blood. This prevents TNF alpha from promoting inflammation and the fever, pain, tenderness, and swelling of joints in patients with rheumatoid or psoriatic arthritis and ankylosing spondylitis. Etanercept prevents the progressive destruction of the joints in patients with rheumatoid arthritis and the arthritis of psoriasis. The FDA approved etanercept in November 1998.

GENERIC AVAILABLE: No

PRESCRIPTION: Yes

PREPARATIONS: 25 mg multiple use vial; 25 or 50 mg prefilled syringe; 50 mg prefilled autoinjector.

STORAGE: Sterile powder and pre-filled syringes should be refrigerated at 2-8 C (36-46 F). Reconstituted solutions made from the powder should be used as soon as possible but may be stored in the vial at 2-8 C (36-46 F) for 14 days.

PRESCRIBED FOR: Etanercept is used as primary treatment to reduce the pain, swelling, and tenderness of joints resulting from moderate to severe rheumatoid arthritis in adults. It also may be used when rheumatoid arthritis has not adequately responded to other drugs (called disease-modifying drugs for rheumatoid arthritis). For example, etanercept can be used in combination with methotrexate (Rheumatrex, Trexall) in patients who do not respond adequately to methotrexate alone.

Etanercept also is used to reduce the signs and symptoms of moderately to severely active, polyarticular-course, juvenile rheumatoid arthritis in children who have had an inadequate response to one or more disease-modifying drugs.

Etanercept is approved for the treatment of ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. It can prevent the progressive destruction of joints and improve physical function with psoriatic arthritis.

Etanercept is not recommended for persons with preexisting disease of the central nervous system (brain and/or spinal cord) or for those with multiple sclerosis, myelitis, or optic neuritis.

DOSING: Etanercept is injected under the skin.

• Adult rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis: 50 mg weekly
• Plaque psoriasis: 50 mg twice weekly for 3 months, followed by 50 mg once weekly
• Juvenile rheumatoid arthritis: 0.8 mg/kg weekly, with a maximum of 50 mg per week

DRUG INTERACTIONS: Because etanercept may reduce the response of the immune system, etanercept should not be administered with live vaccines. Combining etanercept with anakinra (Kineret) or abatacept (Orencia), drugs that also reduce the response of the immune system may increase the risk of serious infections.

PREGNANCY: Studies have not been conducted in pregnant women. Animal studies using doses 60-100 times human doses did not reveal toxicity to the fetus. Since animal studies are not always predictive of human response, etanercept is only used in pregnant women when there is a clear need.

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