Health Guide
Drug Guide

Etanercept (Subcutaneous route)

Pronunciation:

ee-TAN-er-sept

Brand Names:

Dosage Forms:

Warnings:

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. Discontinue etanercept if a serious infection or sepsis occurs during treatment. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including etanercept .

Subcutaneous route(Solution)

Patients treated with etanercept products 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. Discontinue etanercept-szzs if a serious infection or sepsis occurs during treatment. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including etanercept products .

Classifications:

Therapeutic

Immune Suppressant

Pharmacologic

Tumor Necrosis Factor Inhibitor

Uses of This Medicine:

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.

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:

Before Using This Medicine:

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.

Children

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.

Older adults

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 CategoryExplanation
All TrimestersBAnimal 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.

Other 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.

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:

Proper Use of This Medicine:

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:

To use the vial:

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.

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 This Medicine:

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.

Side Effects of This Medicine:

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.


Last Updated: 10/12/2016

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