April 17, 2014
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Drug Factsheets

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Enbrel

(etanercept)

DIN (Drug Identification Number)

02242903 ENBREL 25 MG POWDER FOR SOLUTION
02274728 ENBREL 50 MG/ML SUBCUTANEOUS SOLUTION

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How does Enbrel 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.

How should I use Enbrel?

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.





What form(s) does Enbrel 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 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.

Who should NOT take Enbrel?

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

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