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 for adults
• moderate-to-severe juvenile idiopathic arthritis (JIA) for 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 for adults
• psoriatic arthritis for adults
• chronic severe plaque psoriasis for children ages 4 to 17 who are able to undergo light therapy or take 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 for adults or 2 weeks for children with JIA. When used as treatment for plaque psoriasis, improvement is often seen within 4 weeks. 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.

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 psoriatic arthritis, the dose is based on body weight and should not exceed 50 mg per week.

This medication is available as single-use prefilled syringes or auto-injectors. Because the dose of etanercept in these syringes or auto-injectors cannot be adjusted, children receiving this medication must use the appropriate product based on their weight.

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, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not administer a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Etanercept is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in 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 or autoinjectors 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. Alternatively, syringes or autoinjectors may be stored at room temperature for up to 60 days. Protect from light, heat, and humidity.

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, water for injection, and sucrose. Preservative-free.

The syringes come in 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 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, sterile water, and sucrose. Preservative-free.

The autoinjectors come in 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.

Do not use etanercept if you:

• are allergic to etanercept or any ingredients of the medication
• 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.

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:

• nerve problems (e.g., vision changes, tingling and numbness, pains, muscle spasms, balance problems, difficulty thinking)
• symptoms of tuberculosis (e.g., persistent coughing, chest pain, weight loss, fatigue, night sweats, chills and fever, loss of appetite)
• 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:

• 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.

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.

Inflammatory bowel disease: In rare cases, children receiving this medication to treat JIA may be at risk of experiencing symptoms of inflammatory bowel disease, such as abdominal pain, cramping, weight loss, fatigue, and diarrhea. If your child experiences any of these symptoms, talk to their doctor as soon as possible.

Liver problems: Rarely, people using etanercept have developed liver problems. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

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:  Etanercept crosses the placenta and may affect the developing baby if it is used 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 breast-feeding and 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 have 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.

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other 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.

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.