s factor antibody cA2. Neurology 1996;47:1531.
Arnason BGW, et al. (Lenercept Multiple Sclerosis Study Group). TNF neutralization in MS: Results of a randomized, placebo-controlled multicenter study. Neurology 1999;53:457.
Fisher CJ Jr, Agosti JM, Opal SM, et al. Treatment of septic shock with the tumor necrosis factor receptor: Fc fusion protein. The Soluble TNF Receptor Sepsis Study Group. N Engl J Med 1996;334(26):1697.
National Cancer Institute. Surveillance, Epidemiology, and End Results Database (SEER) Program. SEER Incidence Crude Rates, 11 Registries, 1992-1999.
Mellemkjaer L, Linet MS, Gridley G, et al. Rheumatoid Arthritis and Cancer Risk. Eur J Cancer 1996;32A(10):1753-1757.
Baecklund E, Ekbom A, Sparen P, et al. Disease Activity and Risk of Lymphoma in Patients With Rheumatoid Arthritis: Nested Case-Control Study. BMJ 1998;317:180-181.
[Amgen Logo]
[Wyeth Logo]
Manufactured by:
Immunex Corporation
Thousand Oaks, CA 91320-1799
U.S. License Number 1132
Marketed by Amgen Inc. and Wyeth Pharmaceuticals
© 1998 – 2009 Immunex Corporation. All rights reserved.
1XXXXXX – v38
Issue Date: 11/2009
Patents covering methods, vectors, and/or host cells for making the product or methods for using the product:
U.S. Patent Nos. 5,395,760; 5,605,690, Re. 36,755.
Medication Guide
ENBREL® (en-brel)
(etanercept)
Read the Medication Guide that comes with ENBREL® before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. It is important to remain under your doctor’s care while using ENBREL®.
ENBREL® is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker that affects your immune system.
What is the most important information I should know about ENBREL®?
ENBREL may cause serious side effects, including:
1. Risk of infection
ENBREL® can lower the ability of your immune system to fight infections. Some people have serious infections while taking ENBREL®. These infections include tuberculosis (TB), and infections caused by viruses, fungi or bacteria that spread throughout their body. Some people have died from these infections.
Your doctor should test you for TB before starting ENBREL®.
Your doctor should monitor you closely for symptoms of TB during treatment with ENBREL® even if you tested negative for TB.
Your doctor should check you for symptoms of any type of infection before, during, and after your treatment with ENBREL®.
You should not start taking ENBREL® if you have any kind of infection unless your doctor says it is okay.
2. Risk of cancer
There have been cases of unusual cancers in children and teenage patients who started using TNF-blocking agents at less than 18 years of age.
For children, teenagers, and adults taking TNF-blocker medicines, including ENBREL, the chances of getting lymphoma or other cancers may increase.
People with rheumatoid arthritis or psoriasis, especially those with very active disease, may be more likely to get lymphoma.
Before starting ENBREL®, be sure to talk to your doctor:
ENBREL® may not be right for you. Before starting ENBREL®, tell your doctor about all of your medical conditions, including:
Infections – tell your doctor if you:
have an infection. (See “What is the most important infor |
