Enbrel is a tumor necrosis factor (TNF) blocker. The boxed warning also advises that lymphoma and other malignancies have been reported in children and adolescents using TNF blockers.
In autoimmune diseases, the immune system attacks itself and causes symptoms such as pain and swelling. As a TNF inhibitor, Enbrel affects the immune system by binding to TNF alpha and TNF beta, rendering TNF inactive. TNF is a substance in the body that causes inflammation.
Enbrel is available as a subcutaneous (under the skin) injection.
What Is Enbrel Used For?
The Food and Drug Administration (FDA) approved Enbrel to treat:
Brand Name(s): Enbrel, Erelzi, Eticovo
Drug Availability: Prescription
Administration Route: Subcutaneous
Therapeutic Classification: Immunosuppressants
Available Generically: No
Controlled Substance: N/A
Active Ingredient: Etanercept
Dosage Form(s): Solution
Rheumatoid arthritis Polyarticular juvenile idiopathic arthritis in people age 2 years and older Psoriatic arthritis Ankylosing spondylitis Plaque psoriasis in people age 4 years and older
How to Take Enbrel
Enbrel is administered by yourself or a caregiver via subcutaneous injection into the fatty layer of the abdomen, the outer area of the upper arm, or the front of the middle thigh. Before using Enbrel, be sure to read the medication guide provided to you with your prescription.
For the first injection, a healthcare provider will instruct you on how to administer Enbrel.
Storage
Enbrel vials and syringes should be stored in their original packaging to protect from light. They should be kept in the refrigerator at 36 degrees to 46 degrees Fahrenheit. Do not shake or freeze the medication. If needed, you can store Enbrel at room temperature (68 degrees to 77 degrees) for 14 days. However, do not put it back in the refrigerator once kept at room temperature.
The AutoTouch reusable autoinjector should be stored at room temperature.
Off-Label Uses
Healthcare providers may prescribe Enbrel for off-label uses, meaning for conditions not specifically indicated by the FDA.
Enbrel has been studied for the following off-label uses:
Juvenile spondyloarthropathy (a type of childhood arthritis of the lower back and sacroiliac joints) in children age 2 years and olderGraft-versus-host disease (a potentially serious complication of stem cell transplantation)Sarcoidosis (a disease characterized by tiny collections of inflammatory cells affecting multiple organs of the body)
What Are the Side Effects of Enbrel?
This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 800-FDA-1088.
Common Side Effects
The most common side effects of Enbrel are:
Injection site reactions such as redness, itching, pain, swelling, bleeding, or bruisingUpper respiratory infections
Severe Side Effects
Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:
Infections: Enbrel can lower your body’s immune system’s ability to fight infections. In clinical trials, serious infections included pneumonia (lung infection), cellulitis (bacterial skin infection), septic arthritis (infection of the joint fluid), bronchitis (inflammation of the lining of the bronchial tubes), gastroenteritis (short-term inflammation of the digestive tract), pyelonephritis (a type of urinary tract infection), sepsis (an extreme response to an infection), abscess (accumulation of pus), tuberculosis (bacterial infection of the lungs), and osteomyelitis (infection in the bones). Neurological events: TNF blockers, including Enbrel, have been associated with rare cases of new-onset or worsening central or peripheral nervous system demyelinating disorders (causing destruction of the protective myelin layer of nerves), and new or worsening seizure disorders. Congestive heart failure: Post-marketing reports have shown worsening or new-onset heart failure, sometimes without precipitating factors or in those without known heart disease, in Enbrel use. Blood problems: Rare cases of pancytopenia (lower than normal blood cells and platelets), aplastic anemia (halted production of new blood cells), and neutropenia (having too few neutrophils, a type of white blood cell) have occurred in people treated with Enbrel. People taking Enbrel should be aware of signs and symptoms of blood abnormalities like persistent fever, bruising, bleeding, and pale appearance. Seek immediate medical attention if these occur. Cancers: Clinical trials of TNF blockers, including Enbrel, showed incidences of lymphoma (cancer of lymph system cells), leukemia (blood cancer), and skin cancer related to the use of these medications.
Long-Term Side Effects
There is a chance of developing autoantibodies with Enbrel. Rarely, treatment with Enbrel can result in a lupus-like syndrome or autoimmune hepatitis.
Dosage: How Much Enbrel Should I Take?
Modifications
There are no adequate studies of Enbrel in pregnancy. This drug should only be used in pregnancy if the benefits to the pregnant person outweigh the risks to the fetus. Studies in animals did not show fetal harm due to Enbrel. If you are pregnant while taking Enbrel, your healthcare provider may encourage you to register in a pregnancy registry to monitor outcomes.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For injection dosage forms (prefilled autoinjector, prefilled cartridge, prefilled syringe, or vial): For juvenile idiopathic arthritis: Children 2 years of age and older weighing 63 kilograms (kg) or more—The dose is 50 milligrams (mg) injected under the skin once a week. Children 2 years of age and older weighing less than 63 kg—Dose is based on body weight and must be determined by your doctor. The dose is 0. 8 milligram (mg) per kilogram (kg) of body weight up to 50 mg, injected under the skin once a week. Children younger than 2 years of age—Use and dose must be determined by your doctor. For plaque psoriasis: Adults—At first, 50 milligrams (mg) injected under the skin 2 times per week, given 3 or 4 days apart, for 3 months. Then, your dose will be reduced to 50 mg once a week. Children 4 years of age and older weighing 63 kilograms (kg) or more—The dose is 50 milligrams (mg) injected under the skin once a week. Children 4 years of age and older weighing less than 63 kg—Dose is based on body weight and must be determined by your doctor. The dose is 0. 8 milligram (mg) per kilogram (kg) of body weight up to 50 mg, injected under the skin once a week. Children younger than 4 years of age—Use and dose must be determined by your doctor. For rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis: Adults—50 milligrams (mg) injected under the skin once a week. Children—Use and dose must be determined by your doctor.
Enbrel is excreted in breast milk in small quantities and is poorly absorbed by infants. However, there is no long-term follow-up data on infants who breastfed while the lactating person used Enbrel. Most experts and professional consensus guidelines view the use of Enbrel during breastfeeding as low risk to a nursing infant.
Clinical trials of Enbrel included a small number of people age 65 and older. This number is too small to determine whether people in this age group respond differently to Enbrel than younger individuals. Use Enbrel cautiously if you are older than 65, as you may be at a higher risk of infections in general.
Missed Dose
If you miss an injection of Enbrel, call your healthcare provider regarding when to take your next dose of Enbrel.
Overdose: What Happens If I Take Too Much Enbrel?
Overdose effects are expected to be similar to side effects experienced with normal doses. Treatment of an overdose is supportive. Monitor for signs and symptoms of infection. A healthcare provider may monitor your blood for decreased counts of cells important for fighting infections and preventing bleeding.
Precautions
What Are Reasons I Shouldn’t Take Enbrel?
You should not continue taking Enbrel if you develop a serious infection or sepsis.
If someone collapses or isn’t breathing after taking Enbrel, call 911 immediately.
Your body’s ability to fight infection may be reduced while you are being treated with etanercept. It is very important that you call your doctor at the first signs of any infection. Check with your doctor right away if you or your child have any of the following symptoms while using this medicine: fever, chills, cough or hoarseness, flu-like symptoms, lower back or side pain, painful or difficult urination, or unusual tiredness or weakness.
While you are being treated with etanercept, do not have any immunizations (vaccines) without your doctor’s approval. Your child’s vaccines need to be current before he or she begins using etanercept. Be sure to ask your child’s doctor if you have any questions about this.
This medicine may cause serious allergic reactions including anaphylaxis. This can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine.
You or your child will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.
This medicine may increase your risk of having a lupus-like syndrome or autoimmune hepatitis. Check with your doctor right away if you or your child have a fever or chills, a general feeling of discomfort, illness, or weakness, light-colored stools, nausea, vomiting, upper right-sided abdominal or stomach pain, or yellow eyes and skin.
Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you or your child have any of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, or white spots in your mouth or lips, or unusual tiredness or weakness.
Serious nervous system problems, including Guillain-Barré syndrome, multiple sclerosis, demyelinating disease, and seizures have occurred rarely in people using this medicine. Talk with your doctor if you have concerns about this.
A small number of people (including children and teenagers) who have used this medicine have developed certain types of cancer (eg, leukemia). Some patients also developed a rare type of cancer called lymphoma. Talk with your doctor if you or your child have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.
Check with your doctor right away if you have more than one of these symptoms: trouble breathing, swelling of the face, fingers, feet, or lower legs, or sudden weight gain. These may be signs of a heart condition called congestive heart failure (CHF).
Do not take other medicines unless they have been discussed with your doctor. This includes abatacept (Orencia®), anakinra (Kineret®), or cyclophosphamide (Cytoxan®). Using any of them together with this medicine may increase your risk of having serious side effects.
What Other Medications Interact With Enbrel?
Some medications may interact with Enbrel if taken together, requiring closer monitoring or dosage adjustments.
These medications include:
The immune-modulating biologics Kineret (anakinra) and Orencia (abatacept): Using Enbrel with these medications can increase the incidence of infections. Cytoxan (cyclophosphamide): Adding Enbrel to cyclophosphamide for Wegener’s granulomatosis was associated with an increase in non-cutaneous solid cancers and did not improve clinical outcomes when compared with standard therapy alone. Azulfidine (sulfasalazine): Taking Enbrel with sulfasalazine can decrease neutrophils (white blood cells important for fighting infections).
Additionally, do not receive any live vaccines while taking Enbrel. You may get other, non-live vaccines.
Live vaccines include immunizations for:
Mumps, measles, rubella (MMR)RotavirusChicken poxSmallpox
What Medications Are Similar?
Other TNF blockers include:
Humira (adalimumab) Remicade (infliximab) Simponi (golimumab) Cimzia (certolizumab pegol)
These medications should be used together with Enbrel.
How Can I Stay Healthy While Taking Enbrel?
Before starting treatment with Enbrel, be sure that you are up to date on all immunizations according to current immunization guidelines, since Enbrel may result in a less robust response to certain vaccines. Once you start Enbrel, you may continue to receive vaccines that are not live vaccines.
Your healthcare provider should test you for tuberculosis before starting treatment with Enbrel. If latent (dormant) TB is diagnosed, you should be treated with antibiotics. Monitor for signs and symptoms of TB and other infections while taking Enbrel. These signs and symptoms include:
FeverSweats or chillsCough or flu-like symptomsShortness of breathMuscle achesWarm, red, or painful areas of skinSores on your bodyBurning when urinatingTiredness
