WARNINGS
What is the most important information I should know about Enbrel?
Enbrel may cause serious side effects, including:
1. Risk of Infection
2. Risk of Cancer
3. 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. 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 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 Guillain-Barré syndrome. . have or had heart failure. . are scheduled to have surgery. . have recently received or are scheduled to receive a vaccine. All vaccines should be brought up-to-date before starting Enbrel. People taking Enbrel should not receive live vaccines. Ask your healthcare provider if you are not sure if you received a live vaccine. . 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 healthcare provider prior to administration of live vaccines to your infant. are breastfeeding or plan to breastfeed. Enbrel can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Enbrel. See the section “What are the possible side effects of Enbrel?” below for more information.
Who should not use Enbrel? Do not use Enbrel if you: . have an infection that has spread through your body (sepsis).
USES
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. See the section WARNINGS and PRECAUTIONS, and the section SIDE EFFECTS, below.
HOW TO USE
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: . See the sections WARNINGS and PRECAUTIONS above.
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, seizures, or inflammation of the nerves of the eyes. Tell your healthcare provider 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.
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 healthcare provider 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 healthcare provider if you develop red scaly patches or raised bumps that may be filled with pus. Your healthcare provider may decide to stop your treatment with Enbrel.
Allergic reactions. Allergic reactions can happen to people who use TNF-blocker medicines. Call your healthcare provider 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 healthcare provider 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 healthcare provider 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, itching, pain, swelling, bleeding or bruising. These symptoms 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, call your healthcare provider.
Upper respiratory infections (sinus infections). These are not all the possible side effects with Enbrel.
Tell your healthcare provider 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.
General information about the safe and effective use of Enbrel. Medicines are sometimes prescribed for purposes other than those listed 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 symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about Enbrel. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Enbrel that is written for health professionals.
What are the ingredients in Enbrel?
Single-dose Prefilled Syringe, Single-dose Prefilled SureClick Autoinjector, Single-dose Vial and Enbrel Mini single-dose cartridge: Active Ingredient: etanercept Inactive Ingredients: L-arginine hydrochloride, sodium chloride, and sucrose Multiple-dose Vial:
Active Ingredient: etanercept
Inactive Ingredients: mannitol, sucrose, tromethamine
OVERDOSE
Do not use Enbrel more often than as directed by your healthcare provider.
MISSED DOSE
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.
STORAGE
How should I store Enbrel?
Store Enbrel in the refrigerator between 36-degrees F to 46-degrees F (2-degrees C to 8-degrees 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-degrees F to 77-degrees F (20-degrees C to 25-degrees 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-degrees F to 46-degrees F (2-degrees C to 8-degrees 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-degrees F to 77-degrees F (20-degrees C to 25-degrees 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.
NOTES
Medication Guide: revision date 09/2024
Prescribing Information: revision date 10/2024
Specific drug interaction studies have not been conducted with Enbrel.
1. Vaccines
Most PsA patients receiving Enbrel were able to mount effective B-cell immune responses to pneumococcal polysaccharide vaccine, but titers in aggregate were moderately lower and fewer patients had 2-fold rises in titers compared to patients not receiving Enbrel. The clinical significance of this is unknown. Patients receiving Enbrel may receive concurrent vaccinations, except for live vaccines. No data are available on the secondary transmission of infection by live vaccines in patients receiving Enbrel.
Patients with a significant exposure to varicella virus should temporarily discontinue Enbrel therapy and be considered for prophylactic treatment with varicella zoster immune globulin [see the sections WARNINGS and PRECAUTIONS above].
2. Immune-Modulating Biologic Products
In a study in which patients with active RA were treated for up to 24 weeks with concurrent Enbrel and anakinra therapy, a 7% rate of serious infections was observed, which was higher than that observed with Enbrel alone (0%) [see the sections WARNINGS and PRECAUTIONS above.] and did not result in higher ACR response rates compared to Enbrel alone. The most common infections consisted of bacterial pneumonia (4 cases) and cellulitis (4 cases). One patient with pulmonary fibrosis and pneumonia died due to respiratory failure. Two percent of patients treated concurrently with Enbrel and anakinra developed neutropenia (ANC < 1 × 109/L).
In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events, including infections, and did not demonstrate increased clinical benefit [see the sections WARNINGS and PRECAUTIONS above].
3. Cyclophosphamide
The use of Enbrel in patients receiving concurrent cyclophosphamide therapy is not recommended [see the sections WARNINGS and PRECAUTIONS above].
4.) Sulfasalazine
Patients in a clinical study who were on established therapy with sulfasalazine, to which Enbrel was added, were noted to develop a mild decrease in mean neutrophil counts in comparison to groups treated with either Enbrel or sulfasalazine alone. The clinical significance of this observation is unknown.
See the section WARNINGS above.
