Generic Name: Etanercept Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: B

Uses

What is Etanercept used for?

Etanercept 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). Some brands of this medication are also used to treat 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 should I take Etanercept?

Inject this medication under the skin of the thigh, abdomen, or upper arm as directed by your doctor, usually once or twice a week.

The dosage is based on your medical condition and response to treatment. Children’s dosage is also based on weight. Do not change your dose without consulting your doctor.

Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day(s) each week.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Your doctor may give your first injection in the medical office.

If your medication has been refrigerated, leave it at room temperature for at least 15 to 30 minutes before injecting. Do not warm up this medication any other way. For example, do not heat it in the microwave or place it in hot water. Do not shake this medication. Before using, check this product visually for particles, cloudiness, or discoloration. The prefilled syringe, cartridge, or pen injector may have small white particles in the liquid. This is normal. If you see other particles, cloudiness, or discoloration, do not use the liquid.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into areas that are sore, bruised, red, or hard.

Learn how to store and discard medical supplies safely.

You may notice improvement in your condition after 1 to 2 weeks, but it may take a few months to get the full benefit of this medication. Tell your doctor if your condition does not get better or if it gets worse.

How do I store Etanercept?

Store etanercept in its original carton in the refrigerator. Do not freeze. Do not use after the expiration date on the label has passed. After mixing etanercept with a diluent, store in the refrigerator and use within 14 days. If you need to store etanercept at room temperature, protect the medicine from light and from extreme hot or cold temperatures. Once the medicine has reached room temperature, you should not put it back into the refrigerator. Throw away any Enbrel not used within 14 days. Throw away any Erelzi not used within 28 days.

There may be different brands of Etanercept that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Etanercept down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Etanercept?

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.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Etanercept during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Etanercept. Etanercept is pregnancy risk category B according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Etanercept?

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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Etanercept?

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.

Etanercept may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Etanercept?

Etanercept may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Etanercept?

Etanercept may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Etanercept.

What is the dose of Etanercept for an adult?

Usual Adult Dose for Ankylosing Spondylitis

50 mg subcutaneously once a week

Comments:

-Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with this drug.

-Doses higher than 50 mg per week are not recommended.

Uses:

-Rheumatoid Arthritis: To reduce symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). This drug can be used alone or in combination with methotrexate (MTX).

-Ankylosing Spondylitis: To reduce symptoms in patients with active ankylosing spondylitis (AS).

-Psoriatic Arthritis: To reduce symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). This drug can be used alone or in combination with methotrexate (MTX).

Usual Adult Dose for Rheumatoid Arthritis

50 mg subcutaneously once a week

Comments:

-Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with this drug.

-Doses higher than 50 mg per week are not recommended.

Uses:

-Rheumatoid Arthritis: To reduce symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). This drug can be used alone or in combination with methotrexate (MTX).

-Ankylosing Spondylitis: To reduce symptoms in patients with active ankylosing spondylitis (AS).

-Psoriatic Arthritis: To reduce symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). This drug can be used alone or in combination with methotrexate (MTX).

Usual Adult Dose for Psoriatic Arthritis

50 mg subcutaneously once a week

Comments:

-Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with this drug.

-Doses higher than 50 mg per week are not recommended.

Uses:

-Rheumatoid Arthritis: To reduce symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). This drug can be used alone or in combination with methotrexate (MTX).

-Ankylosing Spondylitis: To reduce symptoms in patients with active ankylosing spondylitis (AS).

-Psoriatic Arthritis: To reduce symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). This drug can be used alone or in combination with methotrexate (MTX).

Usual Adult Dose for Plaque Psoriasis

Initial dose: 50 mg subcutaneously 2 times a week (administered 3 to 4 days apart) for 3 months; alternatively, starting doses of 25 to 50 mg once a week have been shown to be effective

Maintenance dose: 50 mg subcutaneously once a week

Use: For the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

Dose Adjustments

In plaque psoriasis, starting doses of 25 mg or 50 mg per week were also shown to be efficacious.

What is the dose of Etanercept for a child?

Usual Pediatric Dose for Juvenile Idiopathic Arthritis

2 years and older:

-Less than 63 kg: 0.8 mg/kg subcutaneously once a week

-Greater than or equal to 63 kg: 50 mg subcutaneously once a week

-Maximum dose: 50 mg subcutaneously once a week

Comments:

-Glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with this drug.

Use:

-For reducing symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients 2 years and older

Usual Pediatric Dose for Plaque Psoriasis

4 years and older:

-Less than 63 kg: 0.8 mg/kg subcutaneously once a week

-Greater than or equal to 63 kg: 50 mg subcutaneously once a week

-Maximum: 50 mg subcutaneously once a week

Comments:

-Glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with this drug.

Use: For the treatment of patients 4 years and older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

Precautions

-Safety and efficacy for use in polyarticular juvenile idiopathic arthritis has not been established in pediatric patients less than 2 years of age.

-Safety and efficacy for use in all other indications has not been established in pediatric patients less than 18 years of age.

How is Etanercept available?

Etanercept is available in the following dosage forms and strengths:

  • Subcutaneous kit,
  • Subcutaneous solution.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Etanercept, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: September 1, 2018 | Last Modified: September 1, 2018

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