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US Brand Names

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Description

Etanercept is injected under the skin 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.

Etanercept is used in children over the age of 2 years for juvenile rheumatoid 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:

• Reactive arthritis
• Inflammatory bowel disease arthritis

This product is available in the following dosage forms:

• Powder for Solution
• Solution

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Before Using

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 in children with juvenile rheumatoid arthritis below 2 years of age and in children with psoriasis. Safety and efficacy have not been established for children younger than 2 years old.

Geriatric

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

Pregnancy

Breastfeeding

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.

Drug Interactions

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
• Anakinra
• Bacillus of Calmette and Guerin Vaccine, Live
• Cyclophosphamide
• 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

Other Interactions

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:

• Blood disorder (e.g., aplastic anemia), history of or
• Congestive heart failure or
• Nervous system problems (e.g., multiple sclerosis, transverse myelitis) or
• Optic neuritis (inflammation of the eye nerve) or
• Seizures—Use with caution. May make these conditions worse.

• Cancer, history of or
• Diabetes mellitus (sugar diabetes) or
• Disease of the immune system, history of or
• Infections (e.g., hepatitis B, tuberculosis) or
• Wegener's granulomatosis (inflammation of the blood vessels that affects the lungs, kidneys, or other organs)—Etanercept may decrease the body's ability to fight infection.

• Sepsis (serious infection)—You should not use etanercept if you have this condition.

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Proper Use

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 will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.

This medicine comes with a patient medication guide. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

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 rheumatoid arthritis:
    • Children 2 to 17 years of age—0.8 milligram (mg) per kilogram (kg) of body weight up to 50 mg, injected under the skin once a week.
    • Children under 2 years of age—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.
  • For plaque psoriasis:
    • Adults—At first, 50 milligrams (mg) injected under the skin twice a week, given 3 or 4 days apart, for 3 months. Then the dose will be reduced to 50 mg 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

Store in the refrigerator. Do not freeze.

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.

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Precautions

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly and 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 (such as fever or chills; cough or hoarseness; lower back or side pain; or painful or difficult urination).

While you are being treated with etanercept, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccinations should not be given for 3 months before or while receiving etanercept.

This medicine may cause a serious allergic reaction. Check with your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you get the injection.

The needle cap of the prefilled syringe of this medicine contains dry natural rubber latex which may cause allergic reactions. Do not handle the cap if you are sensitive to latex.

This medicine may increase your risk of having a lupus-like syndrome or autoimmune hepatitis. Check with your doctor right away if you have fever or chills; general feeling of discomfort, illness, or weakness; light-colored stools; nausea and vomiting; upper right abdominal pain; or yellow eyes and skin.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking 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.

Do not take other medicines unless they have been discussed with your doctor. This includes anakinra (Kineret®) or cyclophosphamide (Cytoxan®). Using any of them together with this medicine may increase your risk of having serious side effects.

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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:

• Chills
• Cough
• Fever
• Sneezing
• Sore throat

• Congestion in 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 and/or pain

• Accumulation of pus
• Anxiety
• Bladder pain
• Blindness
• Blistering, peeling, loosening of skin
• Bloating
• Bloody, black, or tarry stools
• Blue-yellow color blindness
• Blurred vision
• Burning feeling in chest or stomach
• Change in personality
• Changes in skin color
• Chest discomfort or pain
• Cloudy or bloody urine
• Confusion
• Constipation
• Convulsions
• Cramping or burning
• Darkened urine
• Decreased urine output
• Decreased vision
• Diarrhea
• Difficult, irregular, troubled, or labored breathing (or difficulty in breathing gets worse)
• Difficult or burning urination
• Difficulty in moving
• Difficulty in speaking
• Difficulty in swallowing
• Dilated neck veins
• Discouragement
• Double vision
• Drowsiness
• Dry mouth
• Extreme fatigue
• Eye pain
• Feeling sad or empty
• Flushed, dry skin
• Frequent urge to urinate
• Fruit-like breath odor
• General feeling of discomfort, illness, or weakness
• Generalized pain
• Heartburn and/or indigestion
• High blood pressure
• Hives or welts
• Inability to move arms, legs, or facial muscles
• Increased hunger
• Increased thirst
• Irregular heartbeat
• Irritability
• Joint or muscle pain
• Lack of appetite
• Large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Lightheadedness
• Loss of consciousness
• Loss of interest or pleasure
• Lower back or side pain
• Muscle tenderness
• Nosebleeds
• Pain and inflammation at the joints
• Pain or discomfort in arms, jaw, back, or neck
• Pain, redness, or swelling in arm or leg
• Pains in stomach, side, or abdomen, possibly radiating to the back
• Pale skin
• Problems with bowel or bladder function
• Red skin lesions, often with a purple center
• Severe abdominal pain
• Severe and continuing nausea
• Severe numbness, especially on one side of the face or body
• Skin rash on face, scalp, or stomach
• Slow speech or inability to speak
• Sore throat
• Sores on the skin
• Sores, ulcers, or white spots on lips or in mouth
• Swelling of face, fingers, feet, or lower legs
• Swelling or redness in joints
• Swollen or painful glands
• Swollen, red, or tender area of infection
• Tenderness
• Tenderness in stomach area
• Tightness in chest
• Tiredness
• 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:

• Abdominal pain
• Loss of energy or weakness
• Nausea and vomiting
• Pain or burning in throat
• Redness and/or itching, pain, or swelling at the site of injection (under the skin)
• Runny or stuffy nose

• Bumps below the skin
• Depression
• Dry eyes
• Dry mouth
• Hair loss or thinning
• Heartburn
• Irritation or soreness of mouth
• Itching, redness, or tearing of eye
• Skin rash

• 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 skin, especially on 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.

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