Etanercept

What it is used for

Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with: Rheumatoid Arthritis (RA) Psoriatic Arthritis (PsA) Ankylosing Spondylitis (AS) Plaque Psoriasis (PsO) Pediatric patients with: Polyarticular Juvenile Idiopathic Arthritis (pJIA), 2 years of age or older Juvenile Psoriatic Arthritis, 2 years of age or older (JPsA) Plaque Psoriasis, 4 years of age or older 1.1 Rheumatoid Arthritis Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA).

Enbrel can be initiated in combination with methotrexate (MTX) or used alone. 1.2 Polyarticular Juvenile Idiopathic Arthritis Enbrel is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older. 1.3 Psoriatic Arthritis Enbrel is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in adult patients with psoriatic arthritis (PsA).

Enbrel can be used with or without methotrexate. 1.4 Ankylosing Spondylitis Enbrel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS). 1.5 Plaque Psoriasis Enbrel is indicated for the treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

1.6 Juvenile Psoriatic Arthritis Enbrel is indicated for the treatment of active juvenile psoriatic arthritis (JPsA) in pediatric patients 2 years of age and older.

The most important thing to know

Enbrel may cause serious side effects, including: 1. Risk of Infection 2. Risk of Cancer 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 healthcare provider should test you for TB before starting Enbrel. Your healthcare provider should monitor you closely for symptoms of TB during treatment with Enbrel even if you tested negative for TB. Your healthcare provider 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 healthcare provider says it is okay. 2. Risk of cancer There have been cases of unusual cancers, some resulting in death, in children and teenagers 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, especially those with very active disease, may be more likely to get lymphoma. Before starting Enbrel, be sure to talk to your healthcare provider: Enbrel may not be right for you. Before starting Enbrel, tell your healthcare provider about all of your medical conditions, including: Infections.

Tell your healthcare provider if you: have an infection. are being treated for an infection. think you have an infection. have symptoms of an infection such as fever, sweats or chills, cough or flu-like symptoms, shortness of breath, blood in your phlegm, weight loss, muscle aches, warm, red or painful areas on your skin, sores on your body, diarrhea or stomach pain, burning when you urinate or urinating more often than normal, and feel very tired.

have any open cuts on your body. get a lot of infections or have infections that keep coming back. have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections. have TB, or have been in close contact with someone with TB. were born in, lived in, or traveled to countries where there is a risk for getting TB.

Ask your healthcare provider if you are not sure. live, have lived in, or traveled to certain parts of the country (such as the Ohio and Mississippi River valleys, or the Southwest) where there is a greater risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, blastomycosis). These infections may happen or become more severe if you use Enbrel.

Ask your healthcare provider if you do not know if you live or have lived in an area where these infections are common. have or have had hepatitis B. Also, before starting Enbrel, tell your healthcare provider: About all the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements including: - Orencia (abatacept) or Kineret (anakinra).

You have a higher chance for serious infections when taking Enbrel with Orencia or Kineret. - Cyclophosphamide (Cytoxan). You may have a higher chance for getting certain cancers when taking Enbrel with cyclophosphamide. - Anti-diabetic medicines. If you have diabetes and are taking medicine to control your diabetes, your healthcare provider may decide you need less anti-diabetic medicine while taking Enbrel.

Keep a list of all your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine. Ask your healthcare provider if you are not sure if your medicine is one listed above. Other important medical information you should tell your healthcare provider before starting Enbrel, includes if you: have or had a nervous system problem such as multiple sclerosis or Guil

Side effects, and when to stop

" below for more information. What is Enbrel? Enbrel is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker. Enbrel is used to treat: moderately to severely active rheumatoid arthritis (RA). Enbrel can be used alone or with a medicine called methotrexate. moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) in children 2 years of age or older.

psoriatic arthritis (PsA) in adults. Enbrel can be used alone or with methotrexate. active juvenile psoriatic arthritis (JPsA) in children 2 years of age or older. ankylosing spondylitis (AS). chronic moderate to severe plaque psoriasis (PsO) in children 4 years of age or older and adults who may benefit from taking injections or pills (systemic therapy) or phototherapy (ultraviolet light).

You may continue to use other medicines that help treat your condition while taking Enbrel, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and prescription steroids, as recommended by your healthcare provider. Enbrel can help reduce joint damage and the signs and symptoms of the above-mentioned diseases. People with these diseases have too much of a protein called tumor necrosis factor (TNF), which is made by your immune system.

Enbrel can reduce the effect of TNF in the body and block the damage that too much TNF can cause, but it can also lower the ability of your immune system to fight infections. and " What are the possible side effects of Enbrel? " Who should not use Enbrel? Do not use Enbrel if you: have an infection that has spread through your body (sepsis).

How should I use Enbrel? Enbrel is given as an injection under the skin (subcutaneous or SC). If your healthcare provider decides that you or a caregiver can give the injections of Enbrel at home, you or your caregiver should receive training on the right way to prepare and inject Enbrel. Do not try to inject Enbrel until you have been shown the right way by your healthcare provider or nurse.

Enbrel is available in the forms listed below. Your healthcare provider will prescribe the type that is best for you. - Single-dose Prefilled Syringe - Single-dose Prefilled SureClick Autoinjector - Single-dose Vial - Multiple-dose Vial - Enbrel Mini single-dose cartridge for use with the AutoTouch reusable autoinjector See the detailed Instructions for Use with this Medication Guide for instructions about the right way to store, prepare, and give your Enbrel injections at home.

Your healthcare provider will tell you how often you should use Enbrel. Do not miss any doses of Enbrel. If you forget to use Enbrel, inject your dose as soon as you remember. Then, take your next dose at your regular(ly) scheduled time. In case you are not sure when to inject Enbrel, call your healthcare provider or pharmacist.

Do not use Enbrel more often than as directed by your healthcare provider. Your child's dose of Enbrel depends on his or her weight. Your child's healthcare provider will tell you which form of Enbrel to use and how much to give your child. What are the possible side effects of Enbrel? Enbrel can cause serious side effects, including: Infections.

Enbrel can make you more likely to get infections or make any infection that you have worse. Call your healthcare provider right away if you have any symptoms of an infection. See " Before starting Enbrel, be sure to talk to your healthcare provider " for a list of symptoms of infection. Previous Hepatitis B infection. If you have been previously infected with the hepatitis B virus (a virus that affects the liver), the virus can become active while you use Enbrel.

Your healthcare provider may do a blood test before you start treatment with Enbrel and while you use Enbrel. Nervous system problems. Rarely, people who use TNF-blocker medicines have developed nervous system problems such as multiple sclerosis, seizu

Storing it

Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C). Store Enbrel in the original carton to protect from light or damage. If needed, you may store your dose tray for the multiple-dose vial at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days. - When the dose tray has reached room temperature, do not put it back in the refrigerator.

- Throw away the dose tray that has been stored at room temperature after 14 days. Mixed Enbrel multiple-dose vials should be used right away or kept in the refrigerator between 36°F to 46°F (2°C to 8°C) for up to 14 days. If needed, you may store the Enbrel prefilled syringe, SureClick autoinjector, single-dose vial, or Enbrel Mini cartridge at room temperature between 68°F to 77°F (20°C to 25°C) for up to 30 days.

- When Enbrel has reached room temperature, do not put it back in the refrigerator. - Throw away Enbrel that has been stored at room temperature after 30 days. Do not store Enbrel in extreme heat or cold such as in your vehicle's glove box or trunk. Do not shake. Do not freeze. Keep Enbrel and all medicines out of the reach of children.