Enbrel

Generic name: Etanercept

What is Enbrel?

Enbrel is a medication that blocks the action of a substance your body's immune system makes called tumor necrosis factor (TNF). People with an immune disease such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis have too much TNF in their bodies. Enbrel can reduce the amount of TNF in the body to normal levels, helping to treat your disease.

Enbrel can also be used to treat juvenile arthritis in children ages 2 years and older.

What is the most important information I should know about Enbrel?

In reducing TNF in your body, Enbrel can also lower the ability of your immune system to fight infection and may cause serious infection, such as sepsis. This medication should not be started in people who already have an infection. When taking Enbrel, tell your doctor right away if you notice any signs of infection such as: fever, chills, or sore throat; unusual nausea, vomiting, stomach pain, or diarrhea; fast heartbeat; decreased mental alertness; rapid breathing; new or worsening cough; shortness of breath; chest pain or discomfort; swelling of the lymph nodes; or general feeling of being unwell.

Enbrel may cause serious nervous system disorders, such as multiple sclerosis (MS), seizures, or inflammation of the nerves of the eyes.

The needle cap on the prefilled syringe and on the SureClick autoinjector contains dry natural rubber (made from latex) which may cause allergic reactions in people sensitive to latex.

Do not drive or perform other possibly unsafe tasks until you know how you react to Enbrel; this drug may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines.

Enbrel may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

Enbrel may increase the risk of developing lymphoma (blood cancer) or other types of cancer. Contact your doctor right away if you develop symptoms of lymphoma such as unusual lumps or swelling (in your neck, armpit, or groin), night sweats, recurring fever, unusual tiredness or weakness, persistent unexplained itching, or unexplained weight loss.

If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Contact your doctor if you come into contact with these infections.

Before you use Enbrel, discuss your vaccination history with your doctor to be sure that you are up to date on vaccinations.

Do not receive a live vaccine (such as measles or mumps) while you are taking Enbrel. Talk with your doctor before you receive any vaccine.

It may take several weeks for Enbrel to work. Do not stop using Enbrel without checking with your doctor.

Tell your doctor or dentist that you take Enbrel before you receive any medical or dental care, emergency care, or surgery.

If you develop any of the symptoms of tuberculosis (TB) (such as a dry cough that does not go away, weight loss, fever, night sweats), call your doctor. You will need to be examined for TB and have a skin test.

Injection site reactions (such as redness, itching, rash, swelling, or bruising) usually go away within 3 to 5 days. If you have pain, redness, or swelling around the injection site that does not go away or gets worse, contact your doctor.

Who should not take Enbrel?

Do not take Enbrel if you are allergic to any of its ingredients. Do not take Enbrel is you have an infection that has spread through your body (sepsis).

What should I tell my doctor before I take the first dose of Enbrel?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Enbrel. Also, talk to your doctor about your complete medical history, especially if you have a nervous system problem, MS, seizures, diabetes, any kind of infection in one place of your body (such as an open sore), an infection in your entire body (such as the flu), congestive heart failure, a blood disease, any lupus-like disease, rectal bleeding, shingles, Wegener granulomatosis, history of lymphoma or cancer, history of TB, a positive TB skin test or close contact with someone who has had TB, or inflammation of the nerves in the eye. In addition, tell your doctor if you are pregnant, plan to become pregnant, or if you are breastfeeding.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Plaque Psoriasis

Adults: The recommended starting dose of Enbrel for adult patients is a 50 mg dose given twice weekly (administered 3 or 4 days apart) for 3 months followed by a reduction to a maintenance dose of 50 mg per week. Starting doses of Enbrel of 25 mg or 50 mg per week were also shown to be efficacious.

Rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis

Adults: The usual dosage of Enbrel is 50 milligrams (mg) injected just under the skin every week. The dosage may be split into two 25 mg injections given the same day or 3-4 days apart.

Juvenile idiopathic arthritis (JIA)

Children: Children 2 to 17 years old: The recommended dose of Enbrel for pediatric patients ages 2 to 17 years with active polyarticular-course JIA is 0.8 mg/kg per week (up to a maximum of 50 mg per week). The 25 mg prefilled syringe is not recommended for pediatric patients weighing less than 31 kg (68 pounds). The 50 mg prefilled syringe autoinjector may be used for pediatric patients weighing 63 kg (138 pounds) or more.

How should I take Enbrel?

You and/or your caregiver should be instructed on the injection technique as well as proper syringe and needle disposal. Enbrel should be taken exactly as prescribed; do not take this drug more often than prescribed by your doctor.

Wash your hands with soap and warm water before using Enbrel. The dose tray containing the vials of powder must be refrigerated. Do not freeze. Use an alcohol swab to clean the gray stopper on the vial. Do not touch the stopper with your hands.

Do not use Enbrel if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

This drug should be rotated between sites for injection (thigh, abdomen, or upper arm). Never inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, try not to inject directly into any raised, red, thick, or scaly skin patches

The syringe, needles, and vial adapter should never be reused. Never recap a needle.

You may see improvement of your symptoms as soon as 1 to 2 weeks after starting Enbrel. Up to 3 months of treatment may be needed for some patients.

What should I avoid while taking Enbrel?

Do not drive or perform other possibly unsafe tasks until you know how you react to Enbrel; this drug may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines.

Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Contact your doctor if you come into contact with these infections.

Never inject into areas where the skin is tender, bruised, red, or hard. This drug should be rotated between sites for injection (thigh, abdomen, or upper arm).

Avoid areas with scars or stretch marks. If you have psoriasis, try not to inject directly into any raised, red, thick, or scaly skin patches

The syringe, needles, and vial adapter should never be reused. Never recap a needle.

Do not use Enbrel if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

Enbrel should be taken exactly as prescribed; do not take this drug more often than prescribed by your doctor.

Do not receive a live vaccine (such as measles, mumps) while you are taking Enbrel. Talk with your doctor before you receive any vaccine.

What are possible food and drug interactions associated with Enbrel?

If Enbrel is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Enbrel with the following: amphetamines such as dextroamphetamine; co-stimulation modulators such as abatacept; cyclophosphamide; decongestants such as pseudoephedrine; interleukin-1 receptor antagonists such as anakinra; lithium; salicylates such as aspirin; and sulfonylureas such as glipizide.

What are the possible side effects of Enbrel?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: cough, dizziness, headache, injection site reaction, mouth sores, nausea, nose infection, sinus infection, throat infection, upper/lower respiratory tract infection

Injection site reactions (such as redness, itching, rash, swelling, or bruising) usually go away within 3 to 5 days. If you have pain, redness, or swelling around the injection site that does not go away or gets worse contact your doctor.

Enbrel may cause serious nervous system disorders, such as multiple sclerosis (MS), seizures, or inflammation of the nerves of the eyes.

Can I receive Enbrel if I am pregnant or breastfeeding?

Enbrel drug has not been shown to be harmful while pregnant, but should only be taken if clearly needed. Also, Enbrel may pass into your breast milk. Talk to your doctor if you are pregnant, plan to become pregnant, or breastfeeding.

What should I do if I miss a dose of Enbrel?

If you miss a dose of Enbrel, contact your doctor right away to find out when to take your next dose.

How should I store Enbrel?

Store Enbrel in the refrigerator at 36° to 46°F (2° to 8°C). Do not freeze. Keep Enbrel in the original carton to protect from light. Keep Enbrel and all medicines out of the reach of children.