etanercept 50 mg/mL (1 mL) subcutaneous pen injector

Generic name:
Etanercept - injection

Pronunciation
(ee-TAN-er-sept)

Brand name(s)
Enbrel

Because etanercept works by blocking the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection (such as fungal infections, bacterial infections including tuberculosis) or make any infection you have worse. Tell your doctor your medical history, especially of past/recent/current infections. Also, tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States. You should be tested for tuberculosis (TB skin test or chest X-ray) before and during treatment with etanercept. Tell your doctor right away if you have any signs of infection (such as sore throat or cough that doesn't go away, fever, chills, night sweats, painful/frequent urination, unusual vaginal discharge, white patches in the mouth).

The immune system is also important in preventing and controlling cancer. Though it is very unlikely to happen, there is a risk (especially in children/teens/young adults) of developing cancer (such as lymphoma, skin) due to this medication or due to your medical condition. Discuss the risks and benefits of treatment with your doctor. Tell your doctor right away if you develop symptoms such as fever that doesn't go away, unusual lumps/growths, swollen or painful abdomen, unexplained weight loss, or night sweats.

This medication is used alone or in combination with an immunosuppressant (such as methotrexate) to treat certain types of arthritis (such as rheumatoid, psoriatic, juvenile idiopathic, and ankylosing spondylitis). Some brands of this medication are also used to treat a skin condition called psoriasis. These conditions are caused by an overactive immune system (autoimmune disease). The immune system attacks the body's own healthy cells, causing inflammation in the joints and skin.

Etanercept controls your body's defensive response by blocking the action of a certain natural substance (TNF) that is used by the immune system. Treatment decreases redness, itching and scaly patches in psoriasis as well as the pain, swelling and stiffness of joints in arthritis. This medication can stop the progression of disease and joint damage, resulting in improved daily functioning and quality of life.

This medication treats but does not cure autoimmune diseases. Symptoms usually return within 1 month of stopping the medication.

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using this drug and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually once or twice a week. The injection is given in the thigh, abdomen, or upper arm. The dosage is based on your medical condition and response to treatment. Children's dosage is also based on weight.

Take the medication out of the refrigerator at least 15 to 30 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication any other way (for example, do not heat it in the microwave or place it in hot water). Do not shake the medication. Before using, check this product for particles, cloudiness, or discoloration. The prefilled syringe, cartridge, or pen injector may have small white particles in the liquid. This is normal. If you see other particles, cloudiness, or discoloration, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is sore, bruised, red, or hard. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day(s) each week.

You may notice improvement in your condition after 1 to 2 weeks, but it may take a few months to get the full benefit of this medication. Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Redness, itching, pain, or swelling at the injection site may occur. This usually starts 1-2 days after the injection and clears up in 3-5 days. Injection site reactions usually lessen after the first month. Headache may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of liver disease (such as nausea/vomiting that doesn't stop, dark urine, stomach/abdominal pain, yellowing eyes/skin)
• a rash on nose and cheeks (butterfly rash)
• dizziness
• extreme tiredness
• looking pale
• hair loss
• swelling of the arms/legs
• unusual bruising/bleeding
• severe headache
• mental/mood changes
• seizures
• unexplained muscle weakness
• numbness/tingling of the hands/feet
• unsteadiness
• vision changes

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using etanercept, tell your doctor or pharmacist if you are allergic to it; or to latex or natural dry rubber (found in some forms of etanercept); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• active or recurrent infection (such as hepatitis B, HIV, tuberculosis)
• blood disorders (such as leukemia, anemia)
• weakened bone marrow
• history of cancer (such as lymphoma)
• diabetes
• heart failure
• seizures
• nervous system problems (such as multiple sclerosis)
• a certain liver problem (alcoholic hepatitis)
• blood vessel disorders (such as vasculitis)

Etanercept can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using etanercept before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be at greater risk for infections while using this drug.

It is recommended that children be up to date on all their childhood vaccinations before starting etanercept.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. Mothers who have used this medication during pregnancy should ask a doctor about immunizations/vaccinations for their newborn babies.

This medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• abatacept
• interleukin-1 blockers (such as anakinra, canakinumab, rilonacept)
• other medications for autoimmune disease (such as azathioprine, cyclophosphamide)

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, liver function, TB test) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

This medication may interfere with certain lab tests. Be sure to tell the lab personnel that you are on this medication.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Store in the refrigerator. Do not freeze. Keep the medication in the original packaging to protect from light. This medication may also be stored at room temperature if needed. If the medication is stored at room temperature, do not put it back in the refrigerator and discard after 14 or 30 days (depending on your product). Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.