"Nov. 9, 2010 (Atlanta) -- People who take drugs called TNF blockers for rheumatoid arthritis may potentially reduce their odds of developing Alzheimer's disease, preliminary research suggests.
The use of TNF blockers was associated with"...
Read the Medication Guide that comes with Enbrel before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. It is important to remain under your doctor's care while using Enbrel.
What is the most important information I should know about Enbrel?
Enbrel may cause serious side effects, including:
- Risk of Infection
- 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 doctor should test you for TB before starting Enbrel.
- Your doctor should monitor you closely for symptoms of TB during treatment with Enbrel even if you tested negative for TB.
- Your doctor 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 doctor says it is okay.
2. Risk of cancer
- There have been cases of unusual cancers in children and teenage patients 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 or psoriasis, especially those with very active disease, may be more likely to get lymphoma.
Before starting Enbrel, be sure to talk to your doctor:
Enbrel may not be right for you. Before starting Enbrel, tell your doctor about all of your medical conditions, including:
Infections – tell your doctor if you:
- have an infection. (See “What is the most important information I should know about Enbrel?”)
- 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 doctor 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 doctor 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 doctor:
- About all the medicines you take including
prescription and nonprescription medicines, vitamins and herbal supplements
- 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 medication to control your diabetes, your doctor may decide you need less anti-diabetic medicine while taking Enbrel.
Keep a list of all your medications with you to show your doctor and pharmacist each time you get a new medicine. Ask your doctor if you are not sure if your medicine is one listed above.
Other important medical information you should tell your doctor BEFORE starting Enbrel, includes if you:
- have or had a nervous system problem such as multiple sclerosis or Guillain-Barré syndrome.
- have or had heart failure.
- are scheduled to have surgery.
- have recently received or are scheduled to receive a
- All vaccines should be brought up-to-date before starting Enbrel.
- People taking Enbrel should not receive live vaccines.
- Ask your doctor if you are not sure if you received a live vaccine.
- are allergic to rubber or latex.
- The needle covers on the single-use prefilled syringes and the needle covers within the needle caps on the single-use prefilled SureClick® autoinjectors contain dry natural rubber.
- have been around someone with varicella zoster (chicken pox).
- are pregnant or plan to become pregnant. It is not known
if Enbrel will harm your unborn baby. If you took Enbrel during pregnancy, talk
to your doctor prior to administration of live vaccines to your infant.
- If you become pregnant while taking Enbrel, you are encouraged to enroll in Amgen's Pregnancy Surveillance Program. You can enroll by calling 1-80077-AMGEN (1-800-772-6436).
- are breastfeeding or plan to breastfeed. Enbrel can pass
into breast milk. You and your doctor should decide if you will take Enbrel or
breastfeed. You should not do both.
- If you choose to breastfeed while taking Enbrel, you are encouraged to enroll in Amgen's Lactation Surveillance Program. You can enroll by calling 1-80077-AMGEN (1-800-772-6436).
See the section “What are the possible side effects of Enbrel?” 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.
- psoriatic arthritis. Enbrel can be used alone or with methotrexate.
- ankylosing spondylitis (AS).
- chronic moderate to severe plaque psoriasis in adults ages 18 years and older.
- moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in children ages 2 years and older.
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 doctor.
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. See “What is the most important information I should know about Enbrel?” 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 doctor 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 doctor or nurse.
- Enbrel is available in the forms listed below. Your
doctor will prescribe the type that is best for you.
- Single-use Prefilled Syringe
- Single-use Prefilled SureClick Autoinjector
- Multiple-use Vial
- 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 doctor 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 doctor or pharmacist. Do not use Enbrel more often than as directed by your doctor.
- Your child's dose of Enbrel depends on his or her weight. Your child's doctor will tell you which form of Enbrel to use and how much to give your child.
What are the possible side effects of Enbrel?
See “What is the most important information I should know about 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 doctor right away if you have any symptoms of an infection. See “Before starting Enbrel, be sure to talk to your doctor” 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 doctor 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, seizures, or inflammation of the nerves of the eyes. Tell your doctor right away if you get any of these symptoms: numbness or tingling in any part of your body, vision changes, weakness in your arms and legs, and dizziness.
- Blood problems. Low blood counts have been seen with other TNF-blocker medicines. Your body may not make enough of the blood cells that help fight infections or help stop bleeding. Symptoms include fever, bruising or bleeding very easily, or looking pale.
- Heart failure including new heart failure or worsening of heart failure you already have. New or worse heart failure can happen in people who use TNF-blocker medicines like Enbrel. If you have heart failure your condition should be watched closely while you take Enbrel. Call your doctor right away if you get new or worsening symptoms of heart failure while taking Enbrel, such as shortness of breath or swelling of your lower legs or feet.
- Psoriasis. Some people using Enbrel developed new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that may be filled with pus. Your doctor may decide to stop your treatment with Enbrel.
- Allergic reactions. Allergic reactions can happen to people who use TNF-blocker medicines. Call your doctor right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction include a severe rash, a swollen face, or trouble breathing.
- Autoimmune reactions, including:
- Lupus-like syndrome. Symptoms include a rash on your face and arms that gets worse in the sun. Tell your doctor if you have this symptom. Symptoms may go away when you stop using Enbrel.
- Autoimmune hepatitis. Liver problems can happen in people who use TNF-blocker medicines, including Enbrel. These problems can lead to liver failure and death. Call your doctor right away if you have any of these symptoms: feel very tired, skin or eyes look yellow, poor appetite or vomiting, pain on the right side of your stomach (abdomen).
Common side effects of Enbrel include:
- Injection site reactions such as redness, swelling, itching, or pain. These symptoms usually go away within 3 to 5 days. If you have pain, redness, or swelling around the injection site that doesn't go away or gets worse, call your doctor.
- Upper respiratory infections (sinus infections).
These are not all the side effects with Enbrel. Tell your doctor about any side effect that bothers you or does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Enbrel?
- Store Enbrel in the refrigerator at 36° to 46°F (2° to 8°C).
- If needed, you may store the Enbrel syringe,
autoinjector, or the dose tray for the multi-use vial at room temperature
between 68°F to 77°F (20°C to 25°C) for up to 14 days.
- Once Enbrel has reached room temperature, do not put it back in the refrigerator.
- Throw away Enbrel that has been stored at room temperature after 14 days.
- Mixed Enbrel powder 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 Enbrel in extreme heat or cold. For example, avoid storing Enbrel in your vehicle's glove box or trunk.
- Do not freeze.
- Do not shake.
- Store Enbrel in the original carton to protect from light or physical damage.
- Keep Enbrel and all medicines out of the reach of children.
General Information about Enbrel
Medicines are sometimes prescribed for purposes not mentioned in a Medication Guide. Do not use Enbrel for a condition for which it was not prescribed. Do not give Enbrel to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about Enbrel. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Enbrel that was written for healthcare professionals. For more information, call 1-888-4ENBREL (1-888-436-2735).
What are the ingredients in Enbrel?
Single-use Prefilled Syringe and the Single-use Prefilled SureClick Autoinjector:
Active Ingredient: etanercept
Inactive Ingredients: sucrose, sodium chloride, L-arginine hydrochloride and sodium phosphate
Active Ingredient: etanercept
Inactive Ingredients: mannitol, sucrose, tromethamine
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Instructions for Use
Single-use Prefilled SureClick® Autoinjector
How do I prepare and give an injection with Enbrel Single-use Prefilled SureClick Autoinjector?
This section contains information on how to properly use the Enbrel SureClick autoinjector. It is important that you do NOT try to give yourself the injection unless you have received special training from your doctor, nurse, or pharmacist.
A single-use prefilled SureClick autoinjector contains one 50 mg dose of Enbrel.
Children must weigh at least 138 pounds to use Enbrel single-use prefilled SureClick autoinjector. Children who weigh less than 138 pounds should use a different form of Enbrel.
IMPORTANT: The needle cap on the single-use prefilled SureClick autoinjector contains a needle cover that is composed of dry natural rubber, which is made from latex. Tell your doctor if you are allergic to latex.
- A new Enbrel SureClick autoinjector, and
- Alcohol wipes or similar
- Cotton ball or gauze
- Sharps disposal container
Storage of Enbrel
- Enbrel should be refrigerated 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 your Enbrel SureClick
autoinjector at room temperature at 68°F to 77°F (20°C to 25°C) for up to 14
- Once Enbrel has reached room temperature, do not put it back in the refrigerator.
- Throw away Enbrel that has been stored at room temperature after 14 days.
- Do NOT store Enbrel in extreme heat or cold. For example, avoid storing Enbrel in your vehicle's glove box or trunk. Do NOT freeze.
- Keep Enbrel and all medicines out of the reach of children. If you have any questions about storage, contact your doctor, nurse, or pharmacist, or call 1-888-4ENBREL (1-888-436-2735) for further instructions.
Preparing for an Enbrel Injection
- Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
- Remove one single-use prefilled Enbrel SureClick autoinjector from the carton. Carefully lift the autoinjector straight up out of the box. Do NOT shake the autoinjector. Place the carton containing any remaining autoinjectors back into the refrigerator (36° to 46°F [2° to 8°C]).
- Check the expiration date on the autoinjector label. If the expiration date has passed, do NOT use the autoinjector and contact your pharmacist or call 1-8884ENBREL (1-888-436-2735) for assistance.
- The syringe in your Enbrel autoinjector may break if you drop it onto a hard surface. You may not be able to see that the syringe in your Enbrel autoinjector is cracked or broken. If you drop it onto a hard surface, do NOT use the autoinjector. Use a new autoinjector for your injection.
- Do NOT use the autoinjector if the white needle cap is missing or not securely attached. Call 1-888-4ENBREL (1-888-436-2735).
- Look at Enbrel through the inspection window. It should be clear and colorless, or may have small white particles. Do NOT inject Enbrel if it looks cloudy, discolored, or has large lumps, flakes, or colored particles. Call 1-888-4ENBREL (1-888-436-2735). Use a new autoinjector for your injection.
- For a more comfortable injection, leave the autoinjector at room temperature for about 15 to 30 minutes before injecting. Do NOT remove the white needle cap while allowing it to reach room temperature. Do NOT warm Enbrel in any other way (for example, do NOT warm it in a microwave or in hot water).
- Wash your hands thoroughly.
- Do NOT remove the white needle cap from the autoinjector until you are ready to inject.
Choosing and Preparing an Injection Site
Choose an Injection Site
The injection site must be firm for the autoinjector to work properly. The preferred injection site for Enbrel using a prefilled SureClick autoinjector is the front of the thigh.
- Rotate Injection Location
Rotate the site for each injection. Do NOT inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with stretch marks.
- Patients with Psoriasis
If you have psoriasis, you should NOT inject directly into any raised, thick, red, or scaly skin patches or lesions.
Instructions for Preferred Injection Site
The front of the thigh is the preferred injection site.
Instructions for Alternate Injection Sites
When using alternate injection sites, it is particularly important to create enough firmness on the site to be able to successfully complete the injection.
Stretch technique Make sure the skin under and around the prefilled autoinjector is firm and taut to provide enough resistance to fully retract the safety guard and unlock the prefilled autoinjector.
You can use the abdomen, except for the two-inch area right around the navel. Stretch the skin at the injection site to create a firm and taut surface.
If someone else is giving you the injection, they can also use the outer area of the upper arms. For the upper arms, it is recommended to stretch the skin at the injection site to create a firm and taut surface.
Prepare the Site
To prepare the area of skin where Enbrel is to be injected, wipe the injection site with an alcohol swab. Do NOT touch this area again before giving the injection.
Injecting Enbrel Using a Single-use Prefilled SureClick Autoinjector
Do NOT remove the white needle cap from the autoinjector until you are ready to inject.
1. Pull the white needle cap straight off. To avoid damaging the needle inside the autoinjector, do NOT twist or bend the white needle cap while you are removing it, and do NOT try to put the white needle cap back onto the autoinjector.
When you remove the white needle cap, there may be a drop of liquid at the end of the needle or safety guard; this is normal.
Do NOT twist or bend the white needle cap.
Do NOT re-attach the white needle cap onto the prefilled autoinjector.
Do pull the white needle cap straight off.
2. Do NOT touch the purple button. Press prefilled autoinjector onto skin to unlock safety guard.
Do NOT press the purple button until the safety guard is fully retracted.
Do keep enough downward pressure to fully retract the purple safety guard and to keep the purple button unlocked.
Do hold the prefilled autoinjector at a right angle (90°) at the injection site.
3. Briefly press and release purple button.
Do maintain pressure on the skin during the injection.
4. Count slowly to 15 seconds for injection to end and check window to confirm delivery of full dose.
Do NOT move the prefilled autoinjector during the injection.
Do wait for the injection to finish before releasing pressure.
You might hear a second click as the purple button pops back up.
After the Injection
- There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site.
- Do NOT rub the injection site. If needed, you may cover the injection site with a bandage.
Do check the inspection window to confirm it has turned purple.
If the inspection window is not purple, call your healthcare provider.
If you have any problems, please call 1-888-4ENBREL (1-888-436-2735) for assistance.
Disposing of Supplies
The SureClick autoinjector should NEVER be reused.
Dispose of the used autoinjector as instructed by your healthcare provider, or by following these steps:
- Do NOT throw the used autoinjector in the household trash or recycle.
- Place the used autoinjector in a hard plastic disposal container with a screw-on cap or a metal container with a plastic lid, such as a coffee can, labeled “used syringes.” If a metal container is used, cut a small hole in the plastic lid and tape the lid to the metal container. If a hard plastic container is used, always screw the cap on tightly after each use. Do NOT use glass or clear plastic containers. Sharps disposal containers may also be purchased at your local pharmacy.
- When the container is full, tape around the cap or lid to make sure the cap or lid does not come off.
- You should always check first with your healthcare provider for instructions on how to properly dispose of a filled disposal container. There may be special state and local laws for disposing of used needles and syringes, including autoinjectors. Do NOT throw the disposal container in household trash. Do NOT recycle.
- Always keep the container out of the reach of children.
A healthcare provider familiar with Enbrel should answer all questions. Call 1-8884ENBREL (1-888-436-2735) or visit www.enbrel.com for more information about Enbrel.
These Instructions for Use have been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 1/14/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Enbrel Information
Enbrel - User Reviews
Enbrel User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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