Side effects of enbrel

Etanercept, Injectable Solution

Keep these considerations in mind if your doctor prescribes etanercept for you.

General

  • Take this drug once a week.

Self-management

If your healthcare provider decides that you or a caregiver can give your injections at home, you or your caregiver should receive training on the right way to do the injection. Don’t try to inject this drug until you’ve been shown the right way to give the injections by your healthcare provider.

There are five ways to administer this drug. Your doctor or nurse will tell you which one you’re using and show you how to give it. Here are some tips for preparing to use the different types of injections:

Single-use prefilled syringe

For Enbrel:

  • Gather your alcohol swab, a cotton ball or gauze, an adhesive bandage, and a safe needle disposal container.
  • Carefully take the prefilled syringe out of the box. Be sure to avoid shaking it.
  • Don’t use the syringe if the needle cover is missing. If it’s missing, return the syringe to your pharmacy.
  • Leave the syringe at room temperature for about 15–30 minutes before injecting. Don’t warm it up any other way.
  • Wash your hands with soap and warm water.
  • Hold the syringe with the covered needle pointing down. If you see bubbles in it, very gently tap the syringe so the bubbles rise to the top.
  • Turn the syringe so the purple horizontal lines on the barrel are facing you. Check to see if the amount of liquid in the syringe falls between the purple lines. The top of the liquid might be curved. If the liquid isn’t in that range, don’t use the syringe.
  • Make sure the solution in the syringe is clear and colorless. White particles are okay. Don’t use the solution if it’s cloudy or discolored.
  • Follow the instructions for injecting that your doctor gave you, or that came with your Enbrel syringe.

For Erelzi:

Warning: The needle cap on the prefilled syringe contains latex. Don’t handle the syringe if you’re sensitive to latex.

  • Gather your alcohol swab, a cotton ball or gauze, an adhesive bandage, and a safe needle disposal container.
  • Carefully take the prefilled syringe out of the box. Be sure to avoid shaking it.
  • Don’t remove the needle cap until just before you give the injection.
  • The syringe has a needle guard that will be activated to cover the needle after the injection is given. Don’t touch the “wings” on the needle guard before use. Touching them may cause the needle guard to be activated too early.
  • Don’t use the syringe if the blister tray is broken. Also, don’t use the syringe if it’s broken or the needle guard is activated. In case of these problems, return the syringe to your pharmacy.
  • Leave the syringe at room temperature for about 15–30 minutes before injecting. Don’t warm it up any other way.
  • Wash your hands with soap and warm water.
  • Make sure the solution in the syringe is clear, and colorless to slightly yellow. Small white particles are okay. Don’t use the solution if it’s cloudy or discolored, or contains large lumps or flakes. In case of these problems, return the syringe to your pharmacy.
  • Follow the instructions for injecting that your doctor gave you, or that came with your Erelzi syringe.

Single-use prefilled pen:

Warning: The needle cover inside the cap of the pen contains latex. Don’t handle the pen if you’re sensitive to latex.

  • Carefully take the prefilled pen out of the box. Be sure to avoid shaking it.
  • Don’t use the pen if you drop it with the cap removed, or if the pen looks damaged after you drop it.
  • Leave the pen at room temperature for about 15–30 minutes before injecting. Don’t warm it up any other way.
  • Gather your alcohol swab, a cotton ball or gauze, an adhesive bandage, and a safe needle disposal container.
  • Wash your hands with soap and warm water.
  • Make sure the solution in the prefilled pen is clear and colorless to slightly yellow. White particles are okay. Don’t use the solution if it’s cloudy, discolored, or has large lumps, flakes, or particles in it.
  • Follow the instructions for injecting that your doctor gave you, or that came with your Erelzi pen.
  • When you’ve finished your injection, the window in the pen will turn green. If the window has not turned green after you remove the pen, or if it looks like the medication is still injecting, you have not received a full dose. Call your doctor right away.

SureClick auto-injector:

  • Remove one auto-injector from the carton. Be sure to avoid shaking it.
  • If you drop it onto a hard surface, don’t use it. Use a new one instead.
  • Do NOTuse the auto-injector if the white needle cap is missing or not securely attached.
  • Look at this drug through the inspection window. It should be clear and colorless, or it may have small white particles. Don’t use it if it looks cloudy, discolored, or has large lumps, flakes, or colored particles.
  • Leave the auto-injector at room temperature for at least 30 minutes before injecting. Don’t warm it up any other way. Leave the white cap on during this time.
  • Wash your hands well.
  • Don’t remove the white needle cap from the auto-injector until you’re ready to inject.
  • Follow the instructions for injecting that your doctor gave you, or that came with your SureClick auto-injector.
  • When you’ve finished your injection, the window in the auto-injector will turn yellow. After you remove the auto-injector, if the window has not turned yellow or if it looks like the drug is still injecting, you have not received a full dose. If this happens, you should call your doctor right away.

Enbrel Mini single-dose prefilled cartridge for use with reusable AutoTouch auto-injector

  • If you drop your auto-injector onto a hard surface, don’t use it. Don’t use it if any part appears cracked or broken. Call your doctor to find out how to get a new auto-injector.
  • Don’t remove the purple cap from the cartridge before inserting it into the auto-injector. Don’t use the cartridge if the purple needle cap is missing or not securely attached, and don’t re-use or recap a cartridge.
  • Leave the cartridge at room temperature for at least 30 minutes before injecting. Don’t warm it up any other way. Leave the purple cap on during this time.
  • Wash your hands well.
  • Hold the cartridge with the labeled side facing out and slide it into the door of the auto-injector. Close the door and remove the purple cap.
  • Look at this drug through the inspection window. It should be clear and colorless, or it may have small white particles. Don’t use it if it looks cloudy, discolored, or has large lumps, flakes, or colored particles.
  • Follow the instructions for injecting that your doctor gave you, or that came with your auto-injector.

Multiple-use vials:

  • Check to make sure the dose tray has these five items:
    • one prefilled diluent syringe containing 1 mL of diluent (liquid) with attached adapter and twist-off cap
    • one plunger
    • one 27-gauge 1/2-inch needle in a hard plastic cover
    • one vial adapter
    • one etanercept vial
  • Leave the dose tray at room temperature for about 15–30 minutes before injecting.
  • Wash your hands with soap and warm water.
  • Peel the paper seal off the dose tray and remove all the items.
  • Inspect the volume of liquid in the syringe with the twist-off cap pointing down. Use the unit markings on the side of the syringe to make sure there’s at least 1 mL of liquid in the syringe. If the level of liquid is below the 1 mL mark, don’t use it.
  • Don’t use it if the twist-off cap is missing or not securely attached.
  • Follow the instructions for injecting that your doctor gave you, or that came with your multiple-use vials.

Storage

For Enbrel products:

  • Store this drug in the refrigerator. Keep it at a temperature between 36°F and 46°F (2°C and 8°C). If you can’t refrigerate it, you can store it at temperatures up to 77°F (25°C) for up to 14 days.
  • Once you’ve stored this drug at room temperature, don’t put it back into the refrigerator. If you don’t use an Enbrel product within 14 days at room temperature, throw it away properly. Mixed powder should be used right away or kept in the refrigerator for up to 14 days.
  • Don’t freeze this drug. Don’t use it if it was frozen and then thawed.
  • Be sure to avoid shaking the medication.
  • Keep this drug in its original carton until you use it to protect it from light. Keep it away from extreme heat or cold. Don’t use it after the expiration date printed on the label.
    • Store the AutoTouch reusable auto-injector at room temperature. Don’t refrigerate it.

For Erelzi products:

  • Store this drug in the refrigerator. Keep it at a temperature between 36°F and 46°F (2°C and 8°C). If you can’t refrigerate it, you can store it at a temperature between 68°F to 77°F (20°C to 25°C) for up to 28 days.
  • Once you’ve stored this drug at room temperature, don’t put it back into the refrigerator. If you don’t use an Erelzi product within 28 days at room temperature, throw it away properly.
  • Don’t freeze this drug. Don’t use it if it was frozen and then thawed.
  • Be sure to avoid shaking the medication.
  • Keep this drug in its original carton until you use it to protect it from light. Keep it away from extreme heat or cold. Don’t use it after the expiration date printed on the label.
  • Don’t throw used needles, syringes, pens, or cartridges away in your household trash. Don’t flush them down the toilet either.
  • Ask your pharmacist for a needle clipper and an FDA-approved disposal container for throwing away used needles, syringes, pens, and cartridges.
  • When the container is almost full, follow your community guidelines for the right way to throw it away. Your community may have a program for disposing of needles, syringes, pens, and cartridges. Be sure to follow any local laws your state may have on how to throw away these items.
  • Don’t throw the container in your household trash or recycle it. (If you need to put the container in the trash, label it “Do not recycle.”)

Clinical monitoring

During your treatment with this drug, your doctor may do certain tests. These will help keep you safe while you take etanercept. These tests may include:

  • Tuberculosis (TB) test: Your doctor may test you for TB before starting this drug and check you closely for TB symptoms during treatment.
  • Hepatitis B virus test: If you carry the hepatitis B virus, your doctor may do blood tests before you start treatment, while you’re using this drug, and for several months after you stop using the drug.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

  • Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
  • Don’t worry about airport X-ray machines. They can’t harm your medication.
  • You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
  • This medication normally needs to be refrigerated. When traveling, you can store it at temperatures up to 77°F (25°C) for up to 14 days.
  • Needles and syringes need to be used to take this medication. Check for special rules about traveling with needles and syringes.
  • Be sure you have enough medication before you start your trip. It may be difficult to get this medication at a pharmacy while you’re traveling.
  • Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Availability

Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it.

Hidden costs

In addition to this drug, you’ll need to buy sterile alcohol wipes, gauze, and a container for safe disposal of needles, syringes, pens, and cartridges.

Prior authorization

Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

Enbrel

How does this medication work? What will it do for me?

Etanercept belongs to the class of medications called biological response modifiers (“biologics”) or tumour necrosis factor inhibitors (TNF blockers). It is used to treat:

  • active ankylosing spondylitis
  • chronic moderate-to-severe plaque psoriasis in adults
  • moderate-to-severe juvenile idiopathic arthritis (JIA) in children and adolescents 4 to 17 years of age who have not responded to another class of medications called disease modifying antirheumatic drugs (DMARDs)
  • moderate-to-severe rheumatoid arthritis in adults
  • psoriatic arthritis in adults
  • chronic severe psoriatic arthritis in children ages 4 to 17 who are candidates for light therapy or other medications

People with these conditions produce extra amounts of proteins called tumour necrosis factor (TNF), causing pain, inflammation, and damage. Etanercept works by blocking the production of TNF and reducing inflammation in the joints and on the skin. The benefits of using this medication may be seen as early as one week after the start of treatment in adults or 2 weeks in children, with the full effect usually achieved by 3 months.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Multiple-use Vials

Each vial contains a sterile, white, preservative-free lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection (BWFI), USP (containing 0.9% benzyl alcohol) yields a multiple-use, clear, and colourless solution with a pH of 7.4±0.3 containing 25 mg of etanercept. Nonmedicinal ingredients: mannitol, sucrose, and tromethamine.

Cartons of 4 dose trays. Each dose tray contains one 25 mg vial of etanercept, one diluent syringe (1 mL Sterile Bacteriostatic Water for Injection, USP, containing 0.9% benzyl alcohol), one 27-gauge needle, one vial adapter, and one plunger. Each carton contains 4 “Mixing Date:” stickers. A single-dose replacement tray is available, if needed.

Single-use Pre-filled Syringes

Each single-use pre-filled syringe contains 0.98 mL (minimum deliverable volume of 0.94 mL) of a 50 mg/mL clear and colourless, formulated at pH 6.3±0.2 solution of etanercept. There may be small white particles of protein in the solution. Nonmedicinal ingredients: L-arginine hydrochloride, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, and sucrose. Preservative-free.

Cartons of 4 single-dose pre-filled syringes with a 27-gauge needle. A single syringe replacement carton is available if needed. Administration of one 50 mg/mL prefilled syringe of etanercept provides a dose equivalent to two 25 mg vials of lyophilized etanercept, when vials are reconstituted and administered as recommended.

Single-use Pre-filled SureClick Autoinjector

Each single-use use pre-filled SureClick autoinjector contains 0.98 mL (minimum deliverable volume of 0.94 mL) of a 50 mg/mL clear and colourless, formulated at pH 6.3±0.2 solution of etanercept. There may be small white particles of protein in the solution. Nonmedicinal ingredients: L-arginine hydrochloride, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, and sucrose. Preservative-free.

Cartons of 4 SureClick autoinjectors. A single autoinjector replacement carton is available if needed. Administration of one 50 mg/mL etanercept SureClick autoinjector provides a dose equivalent to two 25 mg vials of lyophilized etanercept, when vials are reconstituted and administered as recommended.

How should I use this medication?

This medication is given by subcutaneous (under the skin) injection, usually in the front of the thigh, upper arm, or abdomen. The recommended dose depends on the condition being treated.

  • For adults with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, the recommended dose is 50 mg once a week injected under the skin.
  • For adults with plaque psoriasis, the initial recommended dose is 50 mg twice weekly (3 or 4 days apart) injected under the skin. After the first 3 months of treatment, the dose can be reduced to 50 mg once weekly.
  • For children aged 4 to 17 with juvenile idiopathic arthritis or psoriatric arthritis, the dose is based on body weight and should not exceed 50 mg per week.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose of this medication, contact your doctor to find out when to take the next dose. Do not administer a double dose to make up for a missed one.

Etanercept is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparing and injecting your first dose (or first few doses). Do not attempt to prepare or inject this medication on your own until you completely understand how to mix and inject a dose. If you are having difficulty giving yourself injections, talk to your health care provider.

Single-use prefilled syringes should be stored in the refrigerator at 2°C to 8°C, protected from light, and kept out of the reach of children. Do not freeze or shake. Remove the medication from the refrigerator and allow it to warm to room temperature before injecting it. This takes approximately 15 to 30 minutes.

Vials should be should be stored in the refrigerator at 2°C to 8°C and kept out of the reach of children. Do not freeze. Once mixed, vials should be stored in the refrigerator at 2°C to 8°C for up to 14 days.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use etanercept if you:

  • are allergic to etanercept or any ingredients of the medication
  • are allergic to latex (the needle cap on the pre-filled syringe contains a derivative of latex; if you know you are allergic to latex, talk to your health care provider before using the pre-filled SureClick autoinjector)
  • have or are at risk of sepsis syndrome (an infection that spreads through your body), for example if you have a weakened immune system (e.g., are receiving chemotherapy) or HIV

Do not give this medication to children less than 4 years of age.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • headache
  • pain, itching, redness, or swelling at the site of injection

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • sores in the mouth, upper respiratory infections (such as colds, sore throats, or sinus infections)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • seizures
  • signs of an allergic reaction (such as difficulty breathing, hives, swelling of the face or throat)
  • symptoms of a severe infection (such as fever, shaking or chills, fast heartbeat, quick breathing, confusion, or skin rash)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: In rare cases, some people may develop an allergic reaction to this medication. Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, contact your doctor immediately. The needle cover on the prefilled syringe contains dry natural rubber. Before you start injections, tell your doctor if you have an allergy to rubber or latex.

Anemia: Etanercept may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Bleeding: Etanercept can cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, or blood or material that looks like coffee grounds in vomit, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Cancer: Very rarely, people taking etanercept and similar medications have developed leukemia or lymphoma, types of blood cancer. In general, people with rheumatoid arthritis or psoriasis who take medications that suppress the immune system over long periods of time may also have a higher risk of developing lymphoma, even if they don’t take etanercept. Discuss any concerns you have with your doctor.

There may be a slightly increased risk of developing melanoma (a type of skin cancer). Report any unusual growths on your skin to your doctor as soon as possible. Your doctor will monitor you for skin cancer while you are taking this medication. Talk to your doctor if you have any concerns.

Diabetes: Etanercept may cause a decrease in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart failure: Etanercept may worsen congestive heart failure. If you have heart failure, talk to your doctor about the risks and benefits of using this medication. Symptoms to watch out for include swelling of the feet and ankles and shortness of breath. If you notice these symptoms, contact your doctor immediately.

Hepatitis B: People infected with hepatitis B virus (an infection that can damage the liver) may have a relapse of their condition while taking this medication. If you are at risk for hepatitis B, your doctor may test you for this infection before starting treatment with etanercept and will follow your condition closely while you are taking the medication. If you notice symptoms of liver problems, such as abdominal pain, yellow eyes or skin, loss of appetite, fatigue, or dark urine, contact your doctor immediately.

Infections: This medication can increase the risk of developing an infection, including serious infections such as sepsis, chicken pox, fungal infections, and tuberculosis. Before starting etanercept treatment, your doctor may test to see if you have tuberculosis. If you notice signs of an infection such as fever, chills, pain, swelling, coughing, or pus, contact your doctor as soon as possible. This medication should also not be started while you have an active infection. This medication should not be used in combination with anakinra or abatacept, as these medications can increase the risk of severe infection.

Tell your doctor if you have a history of infections that keep coming back, or other conditions that might increase your risk of infections (e.g., diabetes) or have visited or lived in areas where there is a greater risk of certain kinds of fungal infection (e.g. blastomycosis). While you are taking etanercept, your doctor will monitor you for signs of infection.

Nervous system: This medication may cause or worsen nervous system disorders. If you have a history of nervous system disorders, such as multiple sclerosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience numbness or tingling, weakness in your arms or legs, dizziness, or vision changes while taking this medication, contact your doctor immediately.

Vaccines: Vaccines (e.g., yellow fever, BCG, cholera, typhoid, varicella, meningococcal, diphtheria) should not be given while you are taking etanercept. Children with JIA should complete the recommended vaccination schedule before receiving their first dose of etanercept.

Pregnancy: There have been no studies on the use of etanercept by pregnant women. Etanercept crosses the placenta and may affect the developing baby if it is used by the mother during pregnancy. For this reason, this medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking etanercept, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication has not been established for children younger than 4 years old. It can be used to treat children aged 4 to 17 years who have moderate-to-severe juvenile idiopathic arthritis or chronic severe psoriatic arthritis.

Seniors: People over the age of 65 may be more at risk of side effects from this medication.

What other drugs could interact with this medication?

There may be an interaction between etanercept and any of the following:

  • abatacept
  • anakinra
  • bacillus Calmette-Guérin (BCG)
  • belimumab
  • canakinumab
  • certolizumab pegol
  • cyclophosphamide
  • denosumab
  • echinacea
  • fingolimod
  • infliximab
  • leflunomide
  • nivolumab
  • natalizumab
  • pimecrolimus
  • roflumilast
  • sulfasalazine
  • tacrolimus
  • tocilizumab
  • tofacitinib
  • trastuzumab
  • vaccines (e.g., yellow fever, BCG, cholera, typhoid, varicella, meningococcal, diphtheria)
  • vedolizumab

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Enbrel

Enbrel is the brand name of the injectable drug etanercept, used to relieve symptoms of certain autoimmune disorders (conditions where the immune system attacks parts of the body).

The drug can treat rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, and chronic plaque psoriasis.

Enbrel is in a class of drugs known as tumor-necrosis factor (TNF) inhibitors. It works by blocking TNF, a substance in the body that causes inflammation, among other functions.

The medication was approved by the Food and Drug Administration (FDA) in 1998 and is manufactured by Amgen, Inc.

Enbrel Warnings

Enbrel can affect the way your body’s immune system fights infections.

People who take Enbrel are at an increased risk of developing serious infections including viral, bacterial, or fungal infections.

You should tell your doctor if you are prone to infections of any kind before taking Enbrel.

Also, tell your physician if you have or have ever had diabetes, human immunodeficiency virus (HIV), acquired immunodeficiency virus (AIDS), tuberculosis (TB), hepatitis B, or any other condition that affects your immune system, or if you’ve ever had a malignant tumor.

Alert your healthcare provider if you live or have ever lived in areas where severe fungal infections are more common (such as the Ohio and Mississippi river valleys) or areas where TB is common.

Tell your doctor if you are taking any drugs that decrease your immune system activity such as abatacept (Orencia); anakinra (Kineret); azathioprine (Imuran); steroids including dexamethasone, methylprednisolone (Medrol), prednisolone (Prelone) and prednisone; or methotrexate (Rheumatrex).

While taking Enbrel, you should call your doctor immediately if you experience any of the following symptoms of infection:

  • Weakness
  • Sweating
  • Breathing difficulties
  • Sore throat
  • Cough
  • Coughing up bloody mucus
  • Fever
  • Weight loss
  • Extreme fatigue
  • Diarrhea
  • Stomach pain
  • Flu-like symptoms
  • Red, warm, or painful skin

Some children and teenagers who took Enbrel (or similar medicines) developed cancers, including lymphoma.

You should call your doctor immediately if your child experiences any of the following symptoms while taking Enbrel:

  • Swollen glands in the neck, underarms, or groin
  • Unexplained weight loss
  • Easy bruising or bleeding

Adults who take Enbrel may also be more likely to develop certain cancers such as lymphoma, leukemia, and skin cancer. You should talk to your physician about these risks.

Tell your doctor you are taking Enbrel before having any type of surgery, including dental procedures.

Don’t have any vaccinations while taking Enbrel without first talking with your physician. If your child is on this medicine, talk to your healthcare provider about how vaccines should be given.

Before taking Enbrel, you should tell your doctor if you have or have ever had the following:

  • Seizures
  • Any cuts or open sores
  • Any disease that affects the nervous system such as multiple sclerosis (MS) or Guillain-Barre syndrome
  • Transverse myelitis (inflammation of the spinal cord that can cause unusual sensations)
  • Optic neuritis (inflammation of the nerve that sends messages from the eye to the brain)
  • Bleeding problems
  • Liver disease
  • Heart failure

Call your physician immediately if you are exposed to chickenpox while taking Enbrel.

Pregnancy and Enbrel

Enbrel is not expected to harm an unborn baby. You should talk to your doctor if you are pregnant or might become pregnant while taking this medicine.

It’s not known whether using Enbrel while breastfeeding will harm a nursing infant.

The manufacturer recommends that women do not breastfeed while taking this medication.

Mar. 23 —

TUESDAY, June 19 (HealthDay News) — Patients who used the psoriasis drug Enbrel for more than a year had no more adverse effects than patients taking a placebo, a new study found.

And most patients showed an improvement in their psoriasis, according to the study. Enbrel had previously been shown to be safe and effective when used over a short period of time, but the question remained whether long-term use of the drug would be safe.

“This drug is safe for long-term use,” said lead author Dr. Stephen Tyring, a clinical professor of dermatology at the University of Texas Health Science Center at Houston. “During 96 weeks of follow-up, both the safety and efficacy of the drug were very good.”

Enbrel (etanercept) is a drug that blocks tumor necrosis factor, a pro-inflammatory cytokine. People with an immune disease, such as psoriasis, have too much tumor necrosis factor (TNF) in their bodies. Enbrel reduces the amount of TNF to normal levels, but it can also lower the ability of the immune system to fight infections.

In the trial, Tyring’s team randomly assigned 618 people with psoriasis to 12 weeks of treatment with Enbrel or a placebo. The patents received 50 milligrams of Enbrel twice a week. After the initial 12 weeks of treatment, 591 patients from both groups continued to receive Enbrel for 84 weeks.

The study researchers found that people receiving Enbrel or a placebo had a similar number of adverse reactions, including serious infections. “There was not a problem with increased infections or any other adverse events in using the drug for the long term, and this is at the higher dosage of 100 milligrams a week,” Trying said.

What’s more, by the end of the trial, the psoriasis had improved at least 75 percent for 51.1 percent of the original Enbrel group and 51.6 percent of the original placebo group.

The findings are published in the June issue of the Archives of Dermatology.

Tyring noted that Enbrel is not usually used alone, as it was in this trial, but in combination with other drugs, such as creams, as well as with light therapy. “So, in real life, we see better results,” he said.

The main drawback to long-term Enbrel treatment is cost, Tyring said. “Like all five biological treatments for psoriasis, Enbrel is expensive, and if the patient doesn’t have insurance, it is difficult to keep using this dosage and perhaps even a lower dosage,” he said.

According to the National Psoriasis Foundation, Enbrel can cost $10,000 to $25,000 a year or more, depending on the dose and how often it is taken.

One skin disease expert agreed that long-term use of Enbrel is safe and effective, even at the higher dose.

“Physicians would love to use the drug this way,” said Dr. Jeffrey M. Weinberg, director of the clinical research center in the department of dermatology at St. Luke’s-Roosevelt Hospital Center, in New York City. “The limiting factor is cost,” he added.

Some patients do well on 50 milligrams a week, Weinberg said. “But many people do better at the higher dose, especially those who weigh more,” he said. “About 40 percent of patients would benefit from the higher dose.”

More information

For more information on psoriasis, visit the National Psoriasis Foundation.

SOURCES: Stephen Tyring, M.D., Ph.D., clinical professor of dermatology, University of Texas Health Science Center at Houston; Jeffrey M. Weinberg, M.D., director, clinical research center, department of dermatology, St. Luke’s-Roosevelt Hospital Center, New York City; June 2007, Archives of Dermatology

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

  • Serious Infections
  • Neurologic Reactions
  • Malignancies
  • Patients with Heart Failure
  • Hematologic Reactions
  • Hepatitis B Reactivation
  • Allergic Reactions
  • Autoimmunity
  • Immunosuppression

Clinical Trials Experience

Across clinical studies and postmarketing experience, the most serious adverse reactions with Enbrel were infections, neurologic events, CHF, and hematologic events . The most common adverse reactions with Enbrel were infections and injection site reactions.

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not predict the rates observed in clinical practice.

Adverse Reactions In Adult Patients With Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Or Plaque Psoriasis

The data described below reflect exposure to Enbrel in 2219 adult patients with RA followed for up to 80 months, in 182 patients with PsA for up to 24 months, in 138 patients with AS for up to 6 months, and in 1204 adult patients with PsO for up to 18 months.

In controlled trials, the proportion of Enbrel-treated patients who discontinued treatment due to adverse events was approximately 4% in the indications studied.

Adverse Reactions In Pediatric Patients

In general, the adverse reactions in pediatric patients were similar in frequency and type as those seen in adult patients .

In a 48-week clinical study in 211 children aged 4 to 17 years with pediatric PsO, the adverse reactions reported were similar to those seen in previous studies in adults with PsO. Long-term safety profile for up to 264 additional weeks was assessed in an open-label extension study and no new safety signals were identified.

In open-label clinical studies of children with JIA, adverse reactions reported in those ages 2 to 4 years were similar to adverse reactions reported in older children.

Infections

Infections, including viral, bacterial, and fungal infections, have been observed in adult and pediatric patients. Infections have been noted in all body systems and have been reported in patients receiving Enbrel alone or in combination with other immunosuppressive agents.

In controlled portions of trials, the types and severity of infection were similar between Enbrel and the respective control group (placebo or MTX for RA and PsA patients) in RA, PsA, AS and PsO patients. Rates of infections in RA and adult PsO patients are provided in Table 3 and Table 4, respectively. Infections consisted primarily of upper respiratory tract infection, sinusitis and influenza.

In controlled portions of trials in RA, PsA, AS and PsO, the rates of serious infection were similar (0.8% in placebo, 3.6% in MTX, and 1.4% in Enbrel/Enbrel + MTX-treated groups). In clinical trials in rheumatologic indications, serious infections experienced by patients have included, but are not limited to, pneumonia, cellulitis, septic arthritis, bronchitis, gastroenteritis, pyelonephritis, sepsis, abscess and osteomyelitis. In clinical trials in adult PsO patients, serious infections experienced by patients have included, but are not limited to, pneumonia, cellulitis, gastroenteritis, abscess and osteomyelitis. The rate of serious infections was not increased in open-label extension trials and was similar to that observed in Enbrel-and placebo-treated patients from controlled trials.

In 66 global clinical trials of 17,505 patients (21,015 patient-years of therapy), tuberculosis was observed in approximately 0.02% of patients. In 17,696 patients (27,169 patient-years of therapy) from 38 clinical trials and 4 cohort studies in the U.S. and Canada, tuberculosis was observed in approximately 0.006% of patients. These studies include reports of pulmonary and extrapulmonary tuberculosis .

The types of infections reported in pediatric patients with PsO and JIA were generally mild and consistent with those commonly seen in the general pediatric population. Two JIA patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae.

Injection Site

Reactions In placebo-controlled trials in rheumatologic indications, approximately 37% of patients treated with Enbrel developed injection site reactions. In controlled trials in patients with PsO, 15% of adult patients and 7% of pediatric patients treated with Enbrel developed injection site reactions during the first 3 months of treatment. All injection site reactions were described as mild to moderate (erythema, itching, pain, swelling, bleeding, bruising) and generally did not necessitate drug discontinuation. Injection site reactions generally occurred in the first month and subsequently decreased in frequency. The mean duration of injection site reactions was 3 to 5 days. Seven percent of patients experienced redness at a previous injection site when subsequent injections were given.

Other Adverse Reactions

Table 3 summarizes adverse reactions reported in adult RA patients. The types of adverse reactions seen in patients with PsA or AS were similar to the types of adverse reactions seen in patients with RA.

Table 3. Percent of Adult RA Patients Experiencing Adverse Reactions in Controlled Clinical Trials

Reaction Placebo Controlleda
(Studies I, II, and a Phase 2 Study)
Active Controlledb
(Study III)
Placebo
(N = 152)
Enbrelc
(N = 349)
MTX
(N = 217)
Enbrelc
(N = 415)
Percent of Patients Percent of Patients
Infectiond (total) 39 50 86 81
Upper Respiratory Infectionse 30 38 70 65
Non-upper Respiratory Infections 15 21 59 54
Injection Site Reactions 11 37 18 43
Diarrhea 9 8 16 16
Rash 2 3 19 13
Pruritus 1 2 5 5
Pyrexia 3 4 2
Urticaria 1 4 2
Hypersensitivity 1 1
a Includes data from the 6-month study in which patients received concurrent MTX therapy in both arms.
b Study duration of 2 years.
c Any dose.
d Includes bacterial, viral and fungal infections.
e Most frequent Upper Respiratory Infections were upper respiratory tract infection, sinusitis and influenza.

In placebo-controlled adult PsO trials, the percentages of patients reporting adverse reactions in the 50 mg twice a week dose group were similar to those observed in the 25 mg twice a week dose group or placebo group.

Table 4 summarizes adverse reactions reported in adult PsO patients from Studies I and II.

Table 4. Percent of Adult PsO Patients Experiencing Adverse Reactions in Placebo-Controlled Portions of Clinical Trials (Studies I & II)

Reaction Placebo
(N = 359)
Enbrela
(N = 876)
Percent of Patients
Infectionb (total) 28 27
Non-upper Respiratory Infections 14 12
Upper Respiratory Infectionsc 17 17
Injection Site Reactions 6 15
Diarrhea 2 3
Rash 1 1
Pruritus 2 1
Urticaria 1
Hypersensitivity 1
Pyrexia 1
a Includes 25 mg subcutaneous (SC) once weekly (QW), 25 mg SC twice weekly (BIW), 50 mg SC QW, and 50 mg SC BIW doses.
b Includes bacterial, viral and fungal infections.
c Most frequent Upper Respiratory Infections were upper respiratory tract infection, nasopharyngitis and sinusitis.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to etanercept in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

Patients with RA, PsA, AS or PsO were tested at multiple time points for antibodies to etanercept. Antibodies to the TNF receptor portion or other protein components of the Enbrel drug product were detected at least once in sera of approximately 6% of adult patients with RA, PsA, AS or PsO. These antibodies were all non-neutralizing. Results from JIA patients were similar to those seen in adult RA patients treated with Enbrel.

In adult PsO studies that evaluated the exposure of etanercept for up to 120 weeks, the percentage of patients testing positive at the assessed time points of 24, 48, 72 and 96 weeks ranged from 3.6%-8.7% and were all non-neutralizing. The percentage of patients testing positive increased with an increase in the duration of study; however, the clinical significance of this finding is unknown. No apparent correlation of antibody development to clinical response or adverse events was observed. The immunogenicity data of Enbrel beyond 120 weeks of exposure are unknown.

In pediatric PsO studies, approximately 10% of subjects developed antibodies to etanercept by Week 48 and approximately 16% of subjects developed antibodies to etanercept by Week 264. All of these antibodies were non-neutralizing. However, because of the limitations of the immunogenicity assays, the incidence of binding and neutralizing antibodies may not have been reliably determined.

The data reflect the percentage of patients whose test results were considered positive for antibodies to etanercept in an ELISA assay, and are highly dependent on the sensitivity and specificity of the assay.

Autoantibodies

Patients with RA had serum samples tested for autoantibodies at multiple time points. In RA Studies I and II, the percentage of patients evaluated for antinuclear antibodies (ANA) who developed new positive ANA (titer ≥ 1:40) was higher in patients treated with Enbrel (11%) than in placebo-treated patients (5%). The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with Enbrel compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with Enbrel compared to none of placebo-treated patients). The proportion of patients treated with Enbrel who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients. In RA Study III, no pattern of increased autoantibody development was seen in Enbrel patients compared to MTX patients .

Postmarketing Experience

Adverse reactions have been reported during post approval use of Enbrel in adults and pediatric patients. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Enbrel exposure.

Adverse reactions are listed by body system below:

Blood and lymphatic system disorders: pancytopenia, anemia, leukopenia, neutropenia, thrombocytopenia, lymphadenopathy, aplastic anemia

Cardiac disorders: congestive heart failure

Gastrointestinal disorders: inflammatory bowel disease (IBD)

General disorders: angioedema, chest pain

Hepatobiliary disorders: autoimmune hepatitis, elevated transaminases, hepatitis B reactivation

Immune disorders: macrophage activation syndrome, systemic vasculitis, sarcoidosis

Musculoskeletal and connective tissue disorders: lupus-like syndrome

Neoplasms benign, malignant, and unspecified: melanoma and non-melanoma skin cancers, Merkel cell carcinoma

Nervous system disorders: convulsions, multiple sclerosis, demyelination, optic neuritis, transverse myelitis, paresthesias

Ocular disorders: uveitis, scleritis

Respiratory, thoracic and mediastinal disorders: interstitial lung disease

Skin and subcutaneous tissue disorders: cutaneous lupus erythematosus, cutaneous vasculitis (including leukocytoclastic vasculitis), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, subcutaneous nodule, new or worsening psoriasis (all sub-types including pustular and palmoplantar)

Opportunistic infections, including atypical mycobacterial infection, herpes zoster, aspergillosis and Pneumocystis jiroveci pneumonia, and protozoal infections have also been reported in postmarketing use.

Rare (< 0.1%) cases of IBD have been reported in JIA patients receiving Enbrel, which is not effective for the treatment of IBD.

Read the entire FDA prescribing information for Enbrel (Etanercept)

Generic Name: etanercept (ee TAN er sept)
Brand Names: Enbrel, Enbrel Prefilled Syringe, Enbrel SureClick, Erelzi Prefilled Syringe, Erelzi Sensoready Pen

Medically reviewed by Sanjai Sinha, MD Last updated on Mar 15, 2019.

  • Overview
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What is Enbrel?

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 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.

Important information

Using Enbrel may increase your risk of developing certain types of cancer, including a rare type of lymphoma. Ask your doctor about your specific risk. This has occurred mainly in teenagers and young adults using Enbrel or similar medicines to treat Crohn’s disease or ulcerative colitis. Call your doctor at once if you have any of the following symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a small amount, pain in your upper stomach that may spread to your shoulder, nausea, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Enbrel can weaken your immune system. Serious and sometimes fatal infections may occur. Call your doctor right away if you have signs of infection such as: fever, chills, cough, sweating, body aches, skin sores or redness, diarrhea, burning when you urinate, or feeling very tired or short of breath.

Before taking this medicine

You should not use Enbrel if you are allergic to etanercept, or if you have a severe infection such as sepsis (infection of the blood).

To make sure Enbrel is safe for you, tell your doctor if you have:

  • a weak immune system, HIV or AIDS, tuberculosis, or any type of recurring infection;

  • symptoms of an active infection such as fever, flu symptoms, diarrhea, or painful urination;

  • an open cut or skin sores;

  • diabetes;

  • congestive heart failure;

  • a history of nerve disorders such as multiple sclerosis, Guillain-Barré syndrome, myelitis, or optic neuritis;

  • epilepsy or other seizure disorder;

  • asthma or other breathing disorder;

  • if you have ever had hepatitis B;

  • if you are allergic to latex rubber; or

  • if you are scheduled to receive any vaccines, or if you have recently been vaccinated with BCG (Bacille Calmette-Guerin).

Tell your doctor if you have ever had tuberculosis, were exposed to tuberculosis indicated by a positive PPD test, if anyone in your household has tuberculosis, or if you have recently traveled to an area where certain infections are common (Ohio River Valley, Mississippi River Valley, and the Southwest).

Children using this medication should be current on all childhood immunizations before starting treatment with Enbrel.

Using Enbrel may increase your risk of developing certain types of cancer, including a fast-growing lymphoma that can be fatal. This rare lymphoma has occurred in male teenagers and young men using a combination of immunosuppressant medicines to treat Crohn’s disease or ulcerative colitis. However, people with autoimmune disorders (including rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma. Talk to your doctor about your individual risk.

Tell your doctor if you are pregnant or plan to become pregnant while using this medicine. If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Enbrel on the baby.

Etanercept can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

How should I use Enbrel?

Before you start treatment with Enbrel, your doctor may perform tests to make sure you do not have an infection.

Enbrel is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

You may need to mix Enbrel with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

A child who weighs less than 138 pounds may not be able to use certain forms of Enbrel. If a child is using this medicine, tell your doctor if the child has any changes in weight.

Your care provider will show you the best places on your body to inject Enbrel. Do not inject into the same place two times in a row. Avoid injecting into skin that is bruised, tender, red, or hard.

You may have pain, redness, swelling, or warmth where the medicine was injected. Call your doctor if these symptoms continue for longer than 5 days.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

A single-use prefilled syringe or injection pen is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Do not shake this medicine. Prepare your dose only when you are ready to give an injection. Do not use the medicine if it looks cloudy or has changed colors. Call your pharmacist for new medicine.

Enbrel can weaken your immune system. Your blood may need to be tested often.

If you have ever had hepatitis B, Enbrel can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

If you need surgery, tell the surgeon ahead of time that you are using Enbrel.

Store Enbrel in its original carton in the refrigerator. Do not freeze. Do not use after the expiration date on the label has passed. After mixing Enbrel with a diluent, store in the refrigerator and use within 14 days.

If you need to store Enbrel 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.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of Enbrel.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Enbrel?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox.

Do not receive a “live” vaccine while using Enbrel. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, one form of typhoid, yellow fever, varicella (chickenpox), the older form of the shingles vaccine, and nasal flu (influenza) vaccine.

Enbrel side effects

Get emergency medical help if you have signs of an allergic reaction to Enbrel: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur. Call your doctor right away if you have signs of infection such as: fever, chills, cough, sweating, body aches, skin sores or redness, diarrhea, weight loss, burning when you urinate, coughing up blood, or feeling very tired or short of breath.

Also call your doctor at once if you have:

  • blood problems – fever, pale skin, easy bruising or bleeding;

  • liver problems – upper stomach pain, vomiting, tiredness, loss of appetite, jaundice (yellowing of the skin or eyes);

  • lupus-like syndrome – joint pain or swelling, chest discomfort, feeling short of breath, skin rash on your cheeks or arms (worsens in sunlight);

  • nerve problems – numbness or tingling, problems with vision, or weak feeling in your arms or legs;

  • new or worsening psoriasis – skin redness or scaly patches, raised bumps filled with pus;

  • signs of heart failure – shortness of breath with swelling of your ankles or feet, rapid weight gain;

  • signs of lymphoma – fever, night sweats, weight loss, stomach pain or swelling, chest pain, cough, trouble breathing, swollen glands (in your neck, armpits, or groin); or

  • signs of tuberculosis – fever, cough, night sweats, loss of appetite, weight loss, feeling constantly tired.

Common Enbrel side effects may include:

  • pain, swelling, itching, or redness where the medicine was injected;

  • headache; or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Enbrel?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • abatacept (Orencia);

  • anakinra (Kineret);

  • cyclophosphamide (Cytoxan); or

  • insulin or oral diabetes medicine.

This list is not complete. Other drugs may interact with etanercept, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Enbrel only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 15.02.

Related questions

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  • What are the new drugs for the treatment of plaque psoriasis?
  • What are the new drugs for the treatment of rheumatoid arthritis (RA)?

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Related treatment guides

  • Psoriatic Arthritis
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  • Juvenile Idiopathic Arthritis
  • Juvenile Rheumatoid Arthritis
  • Plaque Psoriasis

Enbrel Side Effects

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

dark 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

high blood pressure

inability to move the arms, legs, or facial muscles

indigestion

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

seizures

severe and continuing nausea

severe numbness, especially on one side of the face or body

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

Etanercept

Most people don’t have any side effects, and for those who do, they aren’t usually serious. However, if you do have severe side effects, or are concerned about your symptoms, contact one of the healthcare professionals in charge of your care.

Some of the most common side effects include:

  • a blocked or runny nose
  • a sore throat
  • feeling sick or vomiting
  • a mild fever
  • headaches
  • dizziness
  • a rash
  • stomach pain.

Some people may have reactions at the spot of the injection, such as redness, swelling or pain. These reactions should stop appearing after a month of treatment. Regularly changing the injection spot will help reduce the chances of this happening.

In rare cases, people experience allergic reactions. This could be in the form of swelling, a rash or you may feel short of breath. If you do develop these symptoms, or any other severe symptoms, during or soon after a dose of etanercept you should seek medical advice straight away.

Because etanercept affects the immune system, it can make you more likely to develop the symptoms of a cold or to pick up infections. Tell your doctor or rheumatology nurse straight away if you develop any of the following symptoms:

  • a cough that won’t go away
  • unexpected weight loss
  • fever.

Also make them aware if you notice any unexplained bruising or bleeding. Your rheumatology team might advise you to pause or stop treatment.

You should contact your rheumatology team if you get chickenpox or shingles, or if you come into come into contact with someone who has them and you have never had chickenpox before. These illnesses can be worse than usual if you’re on etanercept. You may need treatment for them and your etanercept may be stopped until you’re better.

Anti-TNF drugs have been associated with some types of skin cancer. However, the link between the two is unclear. Skin cancers can often be treated successfully when diagnosed early. To be on the safe side, make sure to wear sunscreen and regularly check your skin for any new spots or changes to your freckles or moles.

Very rarely, etanercept may cause a condition called drug-induced lupus. Symptoms include a rash, fever and increased joint pain. If you have any of these symptoms, you should tell your rheumatology team. This condition usually clears up if etanercept is stopped.

Tips to reduce your risk of infection

  • Try to avoid close contact with people you know have an infection.
  • Wash your hands regularly and carry around a small bottle of antibacterial hand gel.
  • Keep your mouth clean by brushing your teeth regularly.
  • Stop smoking if you’re a smoker.
  • Make sure your food is stored and prepared properly.
  • Try to keep your house clean and hygienic, especially the kitchen, bathrooms and toilets.

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