Enbrel (etanercept)

Generic name: etanercept (ee TAN er sept)
Brand name: Enbrel
Drug class: Antirheumatics, TNF alfa inhibitors

Enbrel (etanercept) is a tumor necrosis factor (TNF) blocker. It works by decreasing TNF, a protein produced by the immune system to helps the body fight infections. In people with autoimmune disorders, the immune system produces too much TNF and mistakenly attacks healthy cells.

Enbrel is used to treat rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, and to prevent joint damage caused by these conditions.

Enbrel is also used to treat polyarticular juvenile idiopathic arthritis in children who are at least 2 years old.

Enbrel is also used to treat plaque psoriasis in adults and children who are at least 4 years old.

Enbrel is sometimes used with another medicine called methotrexate when treating rheumatoid arthritis and psoriatic arthritis.

Warnings

Using Enbrel may increase your risk of developing certain types of cancer, including a rare type of lymphoma. Ask your doctor about your specific risk. This has occurred mainly in teenagers and young adults using Enbrel or similar medicines to treat Crohn's disease or ulcerative colitis. Call your doctor at once if you have any of the following symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a small amount, pain in your upper stomach that may spread to your shoulder, nausea, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Enbrel can weaken your immune system. Serious and sometimes fatal infections may occur. Call your doctor right away if you have signs of infection such as: fever, chills, cough, sweating, body aches, skin sores or redness, diarrhea, burning when you urinate, or feeling very tired or short of breath.

Before taking this medicine

You should not use Enbrel if you are allergic to etanercept, or if you have a severe infection such as sepsis (infection throughout your body).

To make sure Enbrel is safe for you, tell your doctor if you have:

• a weak immune system, HIV or AIDS, tuberculosis, or any type of recurring infection;
• symptoms of an active infection such as fever, flu symptoms, diarrhea, or painful urination;
• an open cut or skin sores;
• diabetes;
• congestive heart failure;
• a history of nerve disorders such as multiple sclerosis, Guillain-Barré syndrome, 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; or
• if you are scheduled to receive any vaccines, or if you have recently been vaccinated with BCG (Bacille Calmette-Guerin).

Tell your doctor if you have ever had tuberculosis, were exposed to tuberculosis indicated by a positive PPD test, if anyone in your household has tuberculosis, or if you have recently traveled to an area where certain infections are common (Ohio River Valley, Mississippi River Valley, and the Southwest).

Children should be current on all childhood immunizations before starting treatment with Enbrel.

Using Enbrel may increase your risk of developing certain types of cancer, including a fast-growing lymphoma that can be fatal. This rare lymphoma has occurred in male teenagers and young men using a combination of immunosuppressant medicines to treat Crohn's disease or ulcerative colitis. However, people with autoimmune disorders (including rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma. Talk to your doctor about your individual risk.

Tell your doctor if you are pregnant or plan to become pregnant while using this medicine. If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Enbrel on the baby.

Etanercept can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

How should I use Enbrel?

Before you start treatment with Enbrel, your doctor may perform tests to make sure you do not have an infection.

Enbrel is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Do not shake this medicine. Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

You may need to mix Enbrel with a liquid (diluent). When using injections by yourself, be sure you understand how to properly mix and store the medicine.

Etanercept doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

If you need surgery, tell the surgeon ahead of time that you are using Enbrel.p

Enbrel affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

If you've ever had hepatitis B, using Enbrel can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

Carefully follow all storage instructions provided with your medicine.

• Store Enbrel in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Store Enbrel in the original carton to protect from light or physical damage.
• If needed, you may store the Enbrel prefilled syringe or the unmixed Enbrel multiple-dose vial and diluent syringe (dose tray) at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days.
• Once an Enbrel prefilled syringe or an unmixed multiple-dose vial has reached room temperature, do not put it back in the refrigerator.
• Throw away any Enbrel that has been stored at room temperature after 14 days.
• A mixed (reconstituted) Enbrel multiple-dose vial should be used right away or kept in the refrigerator at 36°F to 46°F (2°C to 8°C) for up to 14 days.
• Do not store the Enbrel in extreme heat or cold. For example, avoid storing Enbrel in your vehicle’s glove box or trunk.
• Do not use after the expiration date on the label has passed.
• Do not freeze.
• Do not shake.

Each cartridge, injection pen, or prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Detailed Enbrel dosage information

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Enbrel?

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

Do not receive a "live" vaccine while using Enbrel. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, one form of typhoid, yellow fever, varicella (chickenpox), the older form of the shingles vaccine, and nasal flu (influenza) vaccine.

Enbrel side effects

Get emergency medical help if you have signs of an allergic reaction to Enbrel: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur. Call your doctor right away if you have signs of infection such as: fever, chills, cough, sweating, body aches, skin sores or redness, diarrhea, weight loss, burning when you urinate, coughing up blood, or feeling very tired or short of breath.

Also call your doctor at once if you have:

• fever, chills, flu symptoms;
• pale skin, easy bruising or bleeding;
• pain, redness, or swelling where etanercept was injected (for longer than 5 days after injection);
• signs of lymphoma - fever, night sweats, weight loss, stomach pain or swelling, swollen glands (in your neck, armpits, or groin);
• signs of tuberculosis - cough, night sweats, loss of appetite, weight loss, feeling very tired;
• new or worsening psoriasis - skin redness or scaly patches, raised bumps filled with pus;
• nerve problems - dizziness, numbness or tingling, problems with vision, or weak feeling in your arms or legs;
• signs of heart failure - shortness of breath, swelling in your lower legs;
• lupus-like syndrome - joint pain or swelling, chest discomfort, feeling short of breath, skin rash on your cheeks or arms (worsens in sunlight); or
• liver problems - right-sided upper stomach pain, vomiting, tiredness, loss of appetite, yellowing of your skin or eyes.

Common Enbrel side effects may include:

• pain, swelling, itching, or redness where the medicine was injected;
• headache; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Enbrel?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• abatacept (Orencia);
• anakinra (Kineret);
• cyclophosphamide (Cytoxan); or
• insulin or oral diabetes medicine.

This list is not complete. Other drugs may interact with etanercept, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.