Class: Biological Therapy

Generic Name: Etanercept

 Trade Name: Enbrel®

For which conditions is this drug approved? Enbrel is approved for use in adults who have been diagnosed with the following inflammatory conditions: moderately to severely active rheumatoid arthritis (RA); psoriatic arthritis; ankylosing spondylitis; chronic moderate to severe psoriasis. Enbrel can be used alone or with a medicine called methotrexate and in patients who have not responded well to methotrexate alone.

What is the mechanism of action? Enbrel is a medicine called a tumor necrosis factor (TNF) blocker. These drugs can help treat inflammatory conditions by reducing inflammation and stopping disease progression. They work by blocking TNF, a chemical produced by the immune system that causes inflammation. TNF is present in higher levels in people with inflammatory conditions, which leads to more inflammation and symptoms.

How is Enbrel typically given (administered)? Enbrel is given by an injection under the skin. You can learn how to give the injection yourself or have someone help you.

How are patients typically monitored? Enbrel affects your immune system, which can increase your risk for infection. During treatment with Enbrel, your doctor will monitor you for infections, including blood poisoning (bacterial sepsis) and tuberculosis (TB). If you develop an infection, your doctor will treat the infection with medication. If the infection is serious, you may have to stop taking Enbrel.

What are the common (occur in 30% or more of patients) side effects of treatment with Enbrel?

• Injection-site reactions
• Non-upper respiratory infection

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Enbrel?

• Upper respiratory infection
• Headache
• Rhinitis (irritation and inflammation of the mucous membrane inside the nose)

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Follow your doctor’s instructions for given yourself or having someone give you Enbrel injections.
• Do not use Enbrel more often than your doctor prescribes.
• Try not to miss a dose of Enbrel. If you do miss a dose, call your doctor. He or she will tell you when to take your missed dose.
• Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
• Keep a list of all the medicines you take and show it to your pharmacist each time you get a new prescription.

Are there any special precautions patients should be aware of before starting treatment?

Tell your doctor if:

• You are being treated for an infection or think you might have an infection.
• You have any open sores on your body.
• Get a lot of infections or have infections that keep coming back.
• Have diabetes or an immune system problem. (These conditions raise your risk for infection.)
• You have TB or if you have been in close contact with someone who has had TB. (Your doctor should test you for TB before starting treatment with Enbrel).
• You use the medicine Kineret® (anakinra) for RA.
• You have or have had hepatitis B.
• You have seizures, any numbness or tingling, or a disease that affects your nervous system, such as multiple sclerosis.
• You have heart failure.
• You are scheduled to have surgery.
• You are scheduled for any vaccines. All vaccines should be brought up-to-date before starting Enbrel. You should not receive live vaccines while you are taking Enbrel.
• You are allergic to rubber or latex. (The needle cover on the single-use prefilled syringe and the single-use prefilled SureClick™ autoinjector contain latex.)
• Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Enbrel has not been studied in pregnant women or nursing mothers. It’s not known if it can harm your unborn baby or if it is secreted in breast milk.

When should patients notify their physician?

• Tell your doctor if you have any side effects that bother you or don’t go away.
• Tell your doctor if you think you have an infection.
• Tell your doctor if you have signs of an infection, including: fever, cough, flu-like symptoms.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Updated: 11/15