What is Enbrel?(etanercept)

Enbrel (etanercept) is a tumor necrosis factor (TNF) blocker. It works by decreasing TNF, a protein produced by the immune system to helps the body fight infections. In people with autoimmune disorders, the immune system produces too much TNF and mistakenly attacks healthy cells.

ENBREL was the first TNF biologic treatment to be FDA approved for moderate to severe RA in 1998. ENBREL is used to treat five long-term inflammatory conditions. Enbrel is used to treat rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, and to prevent joint damage caused by these conditions.

Enbrel is also used to treat polyarticular juvenile idiopathic arthritis in children who are at least 2 years old. Enbrel is also used to treat plaque psoriasis in adults and children who are at least 4 years old

Etanercept (trade name Enbrel) is a biopharmaceutical that treats autoimmune diseases by interfering with tumor necrosis factor (TNF, a soluble inflammatory cytokine) by acting as a TNF inhibitor. It has U.S. F.D.A.

Approval to treat rheumatoid arthritis, juvenile rheumatoid arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. TNF-alpha is the “master regulator” of the inflammatory (immune) response in many organ systems. Autoimmune diseases are caused by an overactive immune response. Etanercept has the potential to treat these diseases by inhibiting TNF-alpha.

Etanercept is a fusion protein produced by recombinant DNA. It fuses the TNF receptor to the constant end of the IgG1 antibody. First, the developers isolated the DNA sequence that codes the human gene for soluble TNF receptor 2, which is a receptor that binds to tumor necrosis factor-alpha. Second, they isolated the DNA sequence that codes the human gene for the Fc end of immunoglobulin G1(IgG1).

Third, they linked the DNA for TNF receptor 2 to the DNA for IgG1 Fc. Finally, they expressed the linked DNA to produce a protein that links the protein for TNF receptor 2 to the protein for IgG1 Fc. The prototypic fusion protein was first synthesized and shown to be highly active and unusually stable as a modality for blockade of TNF in vivo in the early 1990s by Bruce A. Beutler, an academic researcher then at the University of Texas Southwestern Medical Center at Dallas, and his colleagues. These investigators also patented the protein, selling all rights to its use to Immunex, a biotechnology company that was acquired by Amgen in 2002

Uses

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), as well as 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.

How to use Enbrel Syringe

Read the Medication Guide and the Patient Information Leaflet provided by your pharmacist before you start using this drug and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Etanercept is injected under the skin of the thigh, abdomen, or upper arm, usually once or twice weekly exactly as prescribed by your doctor.

The dosage is based on your medical condition and response to treatment. For children, the dosage is also based on weight. Do not change your dose without first consulting your doctor. Use this medication regularly in order to get the most benefit from it. You should start to see an improvement in 1 to 2 weeks. It may take up to 3 months to receive the full benefit of this medication.

If you will be giving yourself the injection, your doctor may want you to have the first injection in the medical office. Make sure you learn the proper way to inject this medication from your health care professional, as described in the Patient Information Leaflet from the manufacturer.

If you are removing the medication from the refrigerator, allow it to warm to room temperature before injecting. This takes about 15 to 30 minutes. Do not shake the product. The prefilled syringe or pen injector may have small white particles in the liquid which is normal. Before using, check this product visually for other particles, cloudiness, or discoloration. If you see any of these things, do not use the liquid.

Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site each time you use this drug to prevent problems under the skin. New injections should be given at least 1 inch (2.5 centimeters) from an old injection site. Do not inject into areas of the skin that are sore, bruised, red, or hard.

Learn how to store and discard needles and medical supplies safely. Consult your pharmacist. Never reuse needles or syringes.

Tell your doctor if your condition persists or worsens.

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.

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.

Along with its needed effects, etanercept (the active ingredient contained in Enbrel) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking etanercept:

More common

• Chills
• cough
• fever
• sneezing
• sore throat

Less common

• Congestion in the chest
• depression
• fast heartbeat
• frequent or painful urination
• itching, pain, redness, or swelling on the skin
• joint or muscle stiffness, tightness, or rigidity
• shortness of breath
• stomach discomfort or pain

Incidence not known

• Bladder pain
• blistering, peeling, or loosening of the skin
• bloody, black, or tarry stools
• blue-yellow color blindness
• blurred vision
• chest discomfort or pain
• cloudy or bloody urine
• confusion
• convulsions
• darkened urine
• decreased urine output
• decreased vision
• diarrhea
• difficult, irregular, troubled, or labored breathing (or difficulty with breathing gets worse)
• difficulty with moving
• dilated neck veins
• double vision
• extreme fatigue
• eye pain
• feeling sad or empty
• fruit-like breath odor
• general feeling of discomfort, illness, or weakness
• generalized pain
• heartburn or indigestion
• high blood pressure
• inability to move the arms, legs, or facial muscles
• irregular heartbeat
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lightheadedness
• loss of consciousness
• muscle tenderness
• pain or discomfort in the arms, jaw, back, or neck
• pain, redness, or swelling in the arm or leg
• problems with bowel or bladder function
• red skin lesions, often with a purple center
• red, scaling, or crusted skin
• severe and continuing nausea
• severe numbness, especially on one side of the face or body
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the face, fingers, feet, or lower legs
• tenderness
• tightness in the chest
• trouble concentrating
• trouble sleeping
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• weight loss
• yellow eyes or skin

Some side effects of etanercept may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain
• loss of energy or weakness
• nausea and vomiting
• pain or burning in the throat
• redness or itching, pain, or swelling at the injection site (under the skin)
• runny or stuffy nose

Less common

• Bumps below the skin
• depression
• dry eyes
• dry mouth
• hair loss or thinning
• heartburn
• irritation or soreness of the mouth
• itching, redness, or tearing of the eye
• skin rash

Incidence not known

• Altered sense of taste
• burning, crawling, itching, numb, prickling, “pins and needles”, or tingling feelings
• feeling faint, dizzy, or lightheaded
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• loss of appetite
• sweating

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 pen injectors); 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.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

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), live vaccines (such as measles, mumps, polio, rubella, typhoid, varicella, yellow fever), other medications for autoimmune disease (such as azathioprine, cyclophosphamide).

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