How does this medication work? What will it do for me?
Etanercept belongs to the class of medications called biological response modifiers ("biologics") or 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
People with these conditions produce extra amounts of proteins called tumour necrosis factor (TNF), which causes 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.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. 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?
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 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 Prefilled Syringes
Each single-use prefilled 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 prefilled 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 Prefilled SureClick Autoinjector
Each single-use use prefilled 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, 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.
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?
You should not use etanercept if you:
- are allergic to etanercept or any ingredients of the medication
- are allergic to latex (needle cap on the prefilled syringe contains a derivative of latex. If you know you are allergic to latex, talk to your health care provider before using the prefilled SureClick autoinjector.
- have or are at risk of sepsis syndrome (an infection that spreads through your body), such as people with weakened immune systems (e.g., receiving chemotherapy) and people with HIV
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.
- abdominal pain
- dry mouth
- pain, itching, redness, or swelling at the site of injection
- upper respiratory infections (such as colds, sore throats, or sinus infections)
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:
- fever, sweats, chills, or other signs of infection
- leg cramps
- skin rash
- sores in the mouth
Stop taking the medication and seek immediate medical attention if any of the following occur:
- 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.
HEALTH CANADA ADVISORY
August 20, 2009
Health Canada has issued new information concerning the use of Enbrel® (etanercept). To read the full report, visit Health Canada's website at www.hc-sc.gc.ca.
Previous advisories on Enbrel® were issued on April 21, 2009.To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
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.
Blood disorders: Rarely, people taking this medication have become deficient in certain types of blood cells. If you notice easy bruising, blood in the stools, black tarry stools, blood or material that looks like coffee grounds in the vomit, or if you look pale or feel faint, seek immediate medical attention.
Cancer: Very rarely, people taking etanercept and similar medications have developed lymphoma, a type 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. Contact your doctor if you develop symptoms of lymphoma (such as fatigue, weight loss, fever, swollen glands, night sweats, and itching). (Note though that these may also be symptoms of other conditions.)
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, 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, as this 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 experience numbness or tingling, weakness in your arms or legs, dizziness, or vision changes while taking this medication, contact your doctor immediately.
Vaccines: Live vaccines (e.g., yellow fever, BCG, cholera, typhoid, varicella) should not be given when 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. 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: It is not known if etanercept passes into breast milk. If you are a breast-feeding mother and are taking this medication, 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.
What other drugs could interact with this medication?
There may be an interaction between etancercept and any of the following:
- live vaccines (e.g., yellow fever, BCG, cholera, typhoid, varicella)
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.