Enbrel

DRUG DESCRIPTION

Enbrel (etanercept) is a dimeric fusion protein consisting of the extracellular
ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor
receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of
etanercept contains the CH2 domain, the CH3 domain and hinge region, but not
the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology
in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists
of 934 amino acids and has an apparent molecular weight of approximately 150
kilodaltons.

The solution of Enbrel in the single-use prefilled syringe and the single-use
prefilled SureClick autoinjector is clear and colorless, sterile, preservative-free,
and is formulated at pH 6.3 ± 0.2.

Table 5: Contents of Enbrel

Enbrel is also supplied in a multiple-use vial as a sterile, white, preservative-free,
lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic
Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-use,
clear, and colorless solution with a pH of 7.4 ± 0.3.

Presentation	Active Ingredient Content	Inactive Ingredients Content
Enbrel 50 mg prefilled syringe and SureClick autoinjector	0.98 mL of a 50 mg/mL solution of etanercept	1% sucrose 100 mM sodium chloride 25 mM L-arginine hydrochloride 25 mM sodium phosphate
Enbrel 25 mg refilled syringe	0.51 mL of a 50 mg/mL solution of etanercept	1% sucrose 100 mM sodium chloride 25 mM L-arginine hydrochloride 25 mM sodium phosphate
Enbrel 25 mg multiple-use vial	25 mg etanercept	40 mg mannitol 10 mg sucrose 1.2 mg tromethamine

What are the possible side effects of etanercept (Enbrel, Enbrel Prefilled Syringe, Enbrel SureClick)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with etanercept. Stop using etanercept and call your doctor right away if you have signs of infection such as:

• fever, sweating, chills, tired feeling;


• feeling short of breath;


• cough, sore throat; or


• flu symptoms, weight...

Read All Potential Side Effects and See Pictures of Enbrel »

What are the precautions when taking etanercept (Enbrel)?

Before using etanercept, tell your doctor or pharmacist if you are allergic to it; or to latex or natural dry rubber (found in the prefilled syringes or autoinjectors); 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...

Read All Potential Precautions of Enbrel »

Enbrel Consumer (continued)

SIDE EFFECTS: 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 persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 develop signs of infection while using this drug, such as: fever, chills, persistent sore throat, persistent cough, night sweats, trouble breathing, painful/frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).

Tell your doctor right away if you have any serious side effects, including: a rash on nose and cheeks (butterfly rash), dizziness, extreme fatigue, 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, severe stomach/abdominal pain, persistent nausea/vomiting, dark urine, yellowing eyes/skin.

An allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of an allergic reaction include: 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.

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

PRECAUTIONS: Before using etanercept, tell your doctor or pharmacist if you are allergic to it; or to latex or natural dry rubber (found in the prefilled syringes or autoinjectors); 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).

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine. Consult your doctor about risks of exposure to chickenpox and other infections.

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

Caution is advised when using this drug in the elderly because they may be more prone to infections.

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. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.

Enbrel Patient Information Including Side Effects

Brand Names: Enbrel, Enbrel Prefilled Syringe, Enbrel SureClick

Generic Name: etanercept (Pronunciation: ee TAN er sept)

• What is etanercept (Enbrel)?


• What are the possible side effects of etanercept (Enbrel)?


• What is the most important information I should know about etanercept (Enbrel)?


• What should I discuss with my healthcare provider before using etanercept (Enbrel)?


• How should I use etanercept (Enbrel)?


• What happens if I miss a dose (Enbrel)?


• What happens if I overdose (Enbrel)?


• What should I avoid while using etanercept (Enbrel)?


• What other drugs will affect etanercept (Enbrel)?


• Where can I get more information?

What is etanercept (Enbrel)?

Etanercept works by decreasing a certain protein produced by the immune system. The immune system helps the body fight infections. In people with autoimmune disorders, the immune system mistakes the body's own cells for invaders and attacks them.

Etanercept is used to treat the symptoms of rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, and to prevent joint damage caused by these conditions. It is also used to treat plaque psoriasis in adults and polyarticular juvenile idiopathic arthritis in children who are at least 2 years old.

Etanercept is not a cure for any autoimmune disorder and will only treat the symptoms of your condition.

Etanercept may also be used for other purposes not listed in this medication guide.

What are the possible side effects of etanercept (Enbrel)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with etanercept. Stop using etanercept and call your doctor right away if you have signs of infection such as:

• fever, sweating, chills, tired feeling;


• feeling short of breath;


• cough, sore throat; or


• flu symptoms, weight loss.

Call your doctor at once if you have any of these other serious side effects:

• shortness of breath with swelling, rapid weight gain;


• chest pain, ongoing cough, coughing up blood;


• easy bruising or bleeding, pale skin, unusual weakness;


• signs of skin infection such as itching, swelling, warmth, redness, or oozing;


• black, bloody, or tarry stools;


• changes in mood or personality (in children);


• numbness, burning, pain, or tingly feeling;


• joint pain or swelling with fever, swollen glands, muscle aches, chest pain, unusual thoughts or behavior, and/or seizure (convulsions); or


• patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).

Less serious side effects may include:

• nausea, vomiting, diarrhea, stomach pain;


• runny or stuffy nose, cold symptoms; or


• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about etanercept (Enbrel)?

You should not use this medication if you are allergic to etanercept, or if you have a severe infection such as sepsis (infection of the blood).

Before using etanercept, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

Children using this medication should be current on all childhood immunizations before starting treatment with etanercept.

You may have pain, redness, swelling, or warmth where the medicine was injected. Call your doctor if these symptoms continue for longer than 5 days.

Serious and sometimes fatal infections may occur during treatment with etanercept. Contact your doctor right away if you have signs of infection such as: fever, cough, sweating, tired feeling, or if you feel short of breath.

Related Drug Centers

• Enbrel