Uses of Enbrel:

• It is used to treat some types of arthritis.
• It is used to treat ankylosing spondylitis.
• It is used to treat plaque psoriasis.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Enbrel?

• If you have an allergy to etanercept or any other part of Enbrel (etanercept vials).
• If you are allergic to Enbrel (etanercept vials); any part of Enbrel (etanercept vials); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have Wegener's granulomatosis.
• If you are taking any of these drugs: Abatacept or anakinra.
• If you are taking cyclophosphamide.

This is not a list of all drugs or health problems that interact with Enbrel (etanercept vials).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Enbrel (etanercept vials) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Enbrel?

• Tell all of your health care providers that you take Enbrel (etanercept vials). This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Talk with your doctor before getting any vaccines. Use of some vaccines with Enbrel (etanercept vials) may either raise the chance of an infection or make the vaccine not work as well.
• Make sure you are up to date with all your vaccines before treatment with Enbrel (etanercept vials).
• Do not get a weakened bacteria like BCG for bladder cancer while you use Enbrel (etanercept vials). Talk with your doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• The chance of skin cancer may be raised. Avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Have your skin checked. Tell your doctor if you have any skin changes like a new wart, skin sore or reddish bump that bleeds or does not heal, or a change in the color or size of a mole.
• Rarely, bone marrow and blood problems have happened with Enbrel (etanercept vials). This includes a severe health problem called aplastic anemia. Sometimes, this has been deadly. Call your doctor right away if you have any signs of infection like fever, chills, or sore throat; any unexplained bruising or bleeding; purple "splotches" on your skin; or feeling very tired or weak.
• If you have had hepatitis B before or carry the virus, talk with your doctor. Drugs like this one can cause the virus to become active. This can lead to very bad and sometimes deadly liver problems.
• Hepatitis B testing needs to be done as you were told by the doctor. Talk with the doctor.
• If you are 65 or older, use Enbrel (etanercept vials) with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• If giving Enbrel (etanercept vials) to your child and your child's weight changes, talk with the doctor. The dose of Enbrel (etanercept vials) may need to be changed.
• Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn or infant. Talk with the doctor to see if this product has benzyl alcohol in it.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
• If you used Enbrel (etanercept vials) when you were pregnant, tell your baby's doctor.

How is this medicine (Enbrel) best taken?

Use Enbrel (etanercept vials) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Wash your hands before and after use.
• Do not shake.
• Move the site where you give the shot with each shot.
• Do not give into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
• Do not give into skin within 2 inches of the belly button.
• Do not give if the solution is not clear and colorless.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
• This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
• To make the injection feel better, take Enbrel (etanercept vials) out of the refrigerator and allow it to sit at room temperature for up to 30 minutes before use. Do not remove the cap or cover. Do not heat Enbrel (etanercept vials).
• Do not use if the solution is cloudy, leaking, or has particles.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
• Pale skin.
• Red scaly patches or bumps that are pus filled.
• A skin lump or growth.
• Call your doctor right away if you have a swollen gland, night sweats, shortness of breath, or weight loss without trying.
• Very bad and sometimes deadly liver problems have happened with Enbrel (etanercept vials). Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Rarely, people using drugs like this one have had nervous system problems. Sometimes, these problems have not gone away. Call your doctor right away if you have a burning, numbness, or tingling feeling that is not normal; change in eyesight; dizziness; seizures; or weakness in your arms or legs.
• Heart failure has happened with Enbrel (etanercept vials), as well as heart failure that has gotten worse in people who already have it. Tell your doctor if you have heart disease. Call your doctor right away if you have shortness of breath, a big weight gain, a heartbeat that is not normal, or swelling in the arms or legs that is new or worse.

What are some other side effects of Enbrel?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where the shot is given.
• Diarrhea.
• Headache.
• Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Enbrel?

• Store in a refrigerator. Do not freeze.
• Unmixed vials may be stored at room temperature for up to 2 weeks. If stored at room temperature, do not put it back in the refrigerator.
• Use right away after mixing or you may store in a refrigerator for up to 2 weeks.
• Store in the original container to protect from light.
• Protect from very hot or very cold temperatures.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Enbrel (etanercept vials) is refilled. If you have any questions about Enbrel (etanercept vials), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

• What are the new drugs for the treatment of rheumatoid arthritis (RA)?
• What are biosimilar drugs?
• Can Enbrel be taken with antibiotics?
• Can you take it with a cold?
• What are the new drugs for the treatment of plaque psoriasis?
• Does perispinal etanercept work for stroke recovery?
• How many biosimilars have been approved in the United States?

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