Etanercept, Injection

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KEY POINTS

• This medicine is given by injection to treat certain kinds of arthritis and psoriasis. Use it exactly as directed.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause lupus-like syndrome, or cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: tumor necrosis factor (TNF) blocker; disease-modifying antirheumatic drug (DMARD)

Generic and brand names: etanercept, injection; Enbrel; Erelzi

What is this medicine used for?

This medicine is used to treat:

• Rheumatoid or psoriatic arthritis when other medicines have not been effective
• Ankylosing spondylitis
• Juvenile idiopathic arthritis
• Plaque psoriasis

This medicine is given as a shot just under the skin. This medicine may be given with another medicine.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to latex
• A blood disorder
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Diabetes
• Heart failure
• Hepatitis B or other liver problems
• Multiple sclerosis, optic neuritis, Guillain-Barré syndrome, or any other nerve disorder
• Seizures
• Tuberculosis (TB), a positive skin test for TB, or close contact with someone who has TB (your healthcare provider may give you a skin test to check for this).

You should NOT receive shots of this medicine if you have any kind of infection. Tell your healthcare provider if you:

• Currently have an infection
• Have been around someone with chickenpox
• Have any open cuts or sores
• Often have infections or infections come back
• Are scheduled to receive any vaccines

Some infections are more likely in certain parts of the country. Tell your healthcare provider where you have lived or recently traveled or where you plan to travel to during treatment.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check with your healthcare provider before using this medicine in children under age 2.

This medicine is available as a single-use prefilled syringe, a single-use autoinjector, and a multiple-use vial. Your healthcare provider will decide which type is best for you.

Sometimes you can give yourself these shots or have someone at home give them to you. Check the label on the medicine for directions about your specific dose. Be sure you know when to take the medicine and how much medicine you should take. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

If your healthcare provider is giving you the injections, keep all appointments.

What if I miss a dose?

If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. If you develop ANY signs of infection (fever, pain, or swelling) while receiving this medicine, stop using the medicine and contact your healthcare provider right away. Also, do not have any vaccines without getting your healthcare provider's approval first.

Your healthcare provider will check you regularly to see how this medicine affects you. Keep all appointments.

This medicine may increase your risk for certain kinds of cancer. Talk to your healthcare provider about this.

Rarely, this medicine causes a condition called lupus-like syndrome. Its symptoms include a rash on your face or other parts of your body, chest pain or discomfort that doesn’t go away, new joint pain, shortness of breath, and sensitivity to sunlight. Talk to your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Lupus-like syndrome (new joint pain, rash, sensitivity to sunlight, chest pain); seizures; fever; cough; sore throat; trouble breathing; pain while urinating or urinating more often than usual; unexplained bleeding or bruising; unusually pale skin; yellowing of the skin, dark urine, severe nausea or vomiting, severe stomach pain, light-colored bowel movements; unexplained loss of appetite; numbness or tingling in any part of your body; trouble walking; vision changes; severe dizziness; blood in vomit, bowel movement, or urine; unexplained swelling in your ankles or feet; increased shortness of breath; unusual tiredness or weakness; new or worsening skin sores, red scaly patches, raised bumps that may be filled with pus, or other skin changes; pain, redness, or swelling around the injection site that doesn’t go away or gets worse.

Other: Headache; runny nose; mild dizziness; itching, redness, or pain at the injection site.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Cyclophosphamide (Cytoxan)
• Diabetes medicines such as glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• Fingolimod (Gilenya)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as abatacept (Orencia), adalimumab (Humira), anakinra (Kineret), belimumab (Benlysta), canakinumab (Ilaris), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), leflunomide (Arava), tocilizumab (Actemra), and tofacitinib (Xeljanz)
• Natalizumab (Tysabri)
• Natural remedies such as curcumin, echinacea, and green tea
• Rilonacept (Arcalyst)
• Sulfasalazine (Azulfidine)
• Vaccines
• Vedolizumab (Entyvio)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in its original container in the refrigerator. Keep the container tightly closed. Protect from heat, high humidity, and bright light. Do not freeze. Do not shake the medicine. Do not use this medicine after the expiration date on the package.

Autoinjector or prefilled syringes: You may store at room temperature for up to 14 days. Once this medicine has reached room temperature, do not put it back in the refrigerator. Discard any unused medicine that has been stored at room temperature after 14 days.

Multi-use vial: Once the powder has been mixed, use the medicine right away or refrigerate. Discard any unused mixed solution after 14 days.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.