Enbrel (etanercept)

What is Enbrel?

Enbrel 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.

Enbrel is not a cure for any autoimmune disorder and will only treat the symptoms of your condition.

Important information about Enbrel

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).

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.

Children using this medication should be current on all childhood immunizations before starting treatment with Enbrel. You may have pain, redness, swelling, or warmth where the medicine was injected. Call your doctor if these symptoms continue for longer than 5 days. Serious and sometimes fatal infections may occur during treatment with Enbrel. Contact your doctor right away if you have signs of infection such as: fever, cough, sweating, tired feeling, or if you feel short of breath.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

Using Enbrel may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes). This risk may be greater in children and young adults. Talk to your doctor about your specific risk.

Before using Enbrel

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).

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.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using Enbrel, tell your doctor if you have:

• a weak immune system;
• any type of infection including a skin infection or open sores;
• diabetes;
• 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;
• if you have recently been vaccinated with BCG (Bacille Calmette-Guerin); or
• if you are scheduled to receive any vaccines.

Enbrel is in 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.

Using Enbrel may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes). This risk may be greater in children and young adults. Talk to your doctor about your specific risk.

How should I use Enbrel?

Before you start treatment with Enbrel, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

Enbrel is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Enbrel comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

You may need to mix Enbrel with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

A single-use prefilled syringe is for one injection only. Throw the used syringe away after one use, even if there is still medicine left in it. The prefilled Sureclick autoinjector is for use only in people who weigh 138 pounds or more.

Your care provider will show you the places on your body where you can safely inject the medication. Do not inject into the same place two times in a row. Avoid injecting into skin that is bruised, tender, red, or hard.

You may have pain, redness, swelling, or warmth where the medicine was injected. Call your doctor if these symptoms continue for longer than 5 days.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Enbrel can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. While you are using Enbrel, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using Enbrel.

If you have chronic hepatitis B you may develop liver symptoms while using Enbrel and even months after you stop using it. Your doctor may want to check your liver function at regular visits for up to several months after you stop using Enbrel. Do not miss any scheduled appointments.

Autoimmune disorders are often treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.

Store this medication in the refrigerator. Do not freeze. Enbrel that has been mixed with a diluent should be kept in a refrigerator and used within 14 days. Do not use Enbrel if the expiration date on the medicine label has passed.

You may take the prefilled syringe or autoinjector out of the refrigerator and allow it to reach room temperature before injecting the medication.

Do not shake the prefilled syringe. Vigorous shaking can ruin the medicine. Do not use the medication if it has changed colors or appears cloudy. Call your doctor for a new prescription.

What happens if I miss a dose?

Call your doctor for instructions if you miss your Enbrel dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of Enbrel is not expected to produce life-threatening symptoms.

What should I avoid while using Enbrel?

Do not receive a "live" vaccine while you are being treated with Enbrel, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox.

Enbrel side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Serious and sometimes fatal infections may occur during treatment with Enbrel. Stop using Enbrel and call your doctor right away if you have signs of infection such as:

• fever, sweating, chills, tired feeling;
• feeling short of breath;
• cough, sore throat; or
• flu symptoms, weight loss.

Call your doctor at once if you have any of these other serious side effects:

• shortness of breath with swelling, rapid weight gain;
• chest pain, ongoing cough, coughing up blood;
• easy bruising or bleeding, pale skin, unusual weakness;
• 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:

• nausea, vomiting, diarrhea, stomach pain;
• runny or stuffy nose, cold symptoms; or
• headache.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect Enbrel?

Tell your doctor about all other medications you use, especially:

• anakinra (Kineret);
• cyclophosphamide (Cytoxan, Neosar);
• sulfasalazine (Azulfidine); or
• drugs that weaken your immune system (such as cancer medicine or steroids).

This list is not complete and there may be other drugs that can interact with Enbrel. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about Enbrel.