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Generic Name: etanercept (Subcutaneous route)

ee-TAN-er-sept

Subcutaneous route(Solution;Powder for Solution)

Patients treated with etanercept are at increased risk for infections, some progressing to serious infections leading to hospitalization or death. These infections have included bacterial sepsis, tuberculosis, invasive fungal and other opportunistic infections, including Legionella and Listeria. Evaluate for latent tuberculosis and treat if necessary prior to initiation of therapy. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including etanercept .

Commonly used brand name(s)

In the U.S.

  • Enbrel

Available Dosage Forms:

  • Powder for Solution
  • Solution

Therapeutic Class: Immune Suppressant

Pharmacologic Class: Tumor Necrosis Factor Inhibitor

Uses For Enbrel

Etanercept injection is used to reduce signs and symptoms of active arthritis, rheumatoid arthritis, or psoriatic arthritis, such as joint swelling, pain, tiredness, and duration of morning stiffness. This medicine may also slow the progression of damage to the body from active arthritis or rheumatoid arthritis. It may also be used to treat plaque psoriasis or a condition known as ankylosing spondylitis.

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Etanercept is also used in children 2 years of age and older for juvenile idiopathic arthritis.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in the product labeling, etanercept is used in certain patients with the following medical condition:

  • Inflammatory bowel disease arthritis.
  • Reactive arthritis.

Before Using Enbrel

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of etanercept injection in children with juvenile idiopathic arthritis younger than 2 years of age and in children with psoriasis. Safety and efficacy have not been established for children younger than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of etanercept injection in the elderly. However, elderly patients are more likely to have infections, which may require caution in patients receiving etanercept.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abatacept
  • Adenovirus Vaccine Type 4, Live
  • Adenovirus Vaccine Type 7, Live
  • Anakinra
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Cyclophosphamide
  • Influenza Virus Vaccine, Live
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Poliovirus Vaccine, Live
  • Rilonacept
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcoholic hepatitis, moderate to severe or
  • Blood or bone marrow problems (e.g., aplastic anemia, low white blood cells), history of or
  • Congestive heart failure, history of or
  • Nervous system problems (e.g., Guillain-Barré syndrome, multiple sclerosis, demyelinating disease) or
  • Optic neuritis (inflammation of the eye nerve) or
  • Psoriasis (skin disease) or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Cancer, history of or
  • Diabetes or
  • Disease of the immune system, history of or
  • Infections (e.g., hepatitis B, bacteria, fungus, virus), active or history of or
  • Tuberculosis, active or history of or
  • Wegener's granulomatosis (inflammation of the blood vessels that affects the lungs, kidneys, or other organs)—Patients with these conditions may have an increased chance for side effects.
  • Sepsis (serious infection in the blood)—Should not be used in patients with this condition.

Proper Use of Enbrel

This medicine is given as a shot under your skin. Etanercept may sometimes be given at home to patients who do not need to be in the hospital. If you or your child are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand exactly how to use the medicine.

This medicine comes with a Medication Guide and a Patient Instructions for Use leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself or your child a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.

This medicine is available in 3 forms. You may use a prefilled syringe, a prefilled SureClick™ autoinjector, or a vial (glass container).

The needle cap on the prefilled syringe and SureClick™ autoinjector contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child have a latex allergy before you start using this medicine.

To use the autoinjector or syringe:

  • Wash your hands with soap and water before and after using this medicine.
  • Remove the carton with the syringe or autoinjector from the refrigerator and place it on a clean cloth.
  • Allow 30 minutes for the syringe or autoinjector to warm up to room temperature.
  • Do not remove the needle cover on the prefilled syringe or the autoinjector cap while allowing the medicine to reach room temperature. Remove these immediately before use.
  • Check the liquid in the syringe or autoinjector. It should be clear and colorless, and may have small white particles. If it is cloudy, discolored, or has large particles, do not use it.
  • Check that the amount of liquid in the prefilled syringe falls between the two purple fill level indicator lines on the syringe. If the syringe does not have the right amount of liquid, do not use it.
  • If the liquid is clear, place it on a clean, flat surface. Do not shake the medicine.
  • Choose an injection site on your body (e.g., thigh, abdomen or stomach area, or upper arm). Clean the injection site with a fresh alcohol wipe and let it dry.
  • Remove the cap or needle cover when you are ready to inject.
  • Do not inject into skin areas that are red, bruised, tender, or hard.
  • Throw away used needles in a hard, closed container (puncture-resistant) that the needles cannot poke through. Keep this container away from children and pets.

To use the vial:

  • Wash your hands with soap and water before and after using this medicine.
  • The vial of powder must be mixed with the liquid provided in your dose kit. Mix the medicine only when you are ready to use it. Do not shake the medicine after it has been mixed.
  • Do not use the mixture if it is cloudy or has particles floating in it.
  • If the liquid is clear, prepare your dose by filling the syringe with the proper amount from the vial. Attach a new needle to the syringe before you inject.
  • Choose an injection site on your body (e.g., thigh, abdomen or stomach area, or upper arm). Clean the injection site with a fresh alcohol wipe and let it dry.
  • Do not inject into skin areas that are red, bruised, tender, or hard.
  • Throw away used needles in a hard, closed container (puncture-resistant) that the needles cannot poke through. Keep this container away from children and pets.
  • If you are using one vial (container) for more than one dose, use the "Mixing Date" stickers from the dose kit to write the date you mixed the medicine. Attach the sticker to the vial.
  • Put the unused mixture in the refrigerator right away. Do not mix the contents of one vial with another vial.
  • Throw away any unused medicine after 14 days.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

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 form (prefilled syringe, prefilled autoinjector, or vial):
    • For juvenile idiopathic arthritis:
      • Children 2 years of age and older weighing 63 kilograms (kg) or more—50 milligrams (mg) injected under the skin once a week.
      • Children 2 years of age and older weighing less than 63 kilograms (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 two 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—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.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Protect the medicine from direct light. Keep your medicine in the original package until you are ready to use it.

Precautions While Using Enbrel

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

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. Stop using this medicine and 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. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and check with your doctor right away if you or your child have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain 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. Stop using this medicine and check with your doctor right away if you or your child have fever or chills; a general feeling of discomfort, illness, or weakness; light-colored stools; nausea and 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 (e.g., 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: shortness of breath; 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.

Enbrel Side Effects

Along with its needed effects, a medicine 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:

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 in 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
  • wheezing
  • yellow eyes or skin

Some side effects 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 site of injection (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
  • weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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