etanercept (Rx)

Rheumatoid/psoriatic arthritis, ankylosing spondylitis

Adult: SUBCUT 50 mg qwk or 25 mg 2-3/wk, 3-4 days apart Child 2-17 yr: SUBCUT 0.8 mg/kg/wk, max 50 mg/wk Plaque psoriasis

Adult: SUBCUT 50 mg 2-3/wk x 3 mo Adolescent and child 4-17 yr (unlabeled): SUBCUT 0.8 mg/kg/wk, max 50 mg/wk Juvenile rheumatoid arthritis (JRA) Adolescent and child 2-17 yr: SUBCUT 0.8 mg/kg/wk, max 50 mg/wk

Available forms: Powder for inj 25 mg; inj 50 mg/ml; auto injector, single use

Implementation - If appropriate, may be administered by the patient or a caregiver after thorough instruction of proper injection preparation and administration. Assess the patient’s or caregiver’s ability to inject subcut and observe the first injection - Administration of one 50 mg/ml prefilled syringe or autoinjector provides a dose equivalent to two, 25 mg prefilled syringes or two, 25 mg vials of lyophilized when vials are reconstituted and administered as recommended - The needle cap on the prefilled syringe and on the SureClick autoinjector contain dry natural rubber (latex) and should not be handled by persons sensitive to this product Inj route - Visually inspect parenteral products for particulate matter and discoloration prior to use, solution should be clear and colorless, although small white particles in solution may be noted in the autoinjector or prefilled syringe Subcut route - Injection sites include front of the thigh; abdomen except the 2 inches around the navel; or outer area of the upper arm. Rotate injection sites. Do not administer where skin is tender, bruised, red, or hard. Also, do not inject directly into any raised, thick, red, or scaly skin patches or lesions related to psoriasis Reconstitution and administration of the vial - Do not mix or transfer the contents of one vial into another vial. Also, do not filter reconstituted product during preparation or administration. Do not add other medications to solutions containing etanercept. ONLY use the supplied diluent - A vial adaptor is supplied for use when reconstituting the powder; however, the adaptor should not be used if multiple doses are going to be withdrawn from the vial. To reconstitute using the vial adaptor, slide the plunger into the flange end of the syringe. Attach the plunger to the gray rubber stopper in the syringe by turning the plunger clockwise until a slight resistance is felt. Remove the twist-off cap from the prefilled diluent syringe by turning counterclockwise. Once the twist-off cap is removed, twist the vial adapter onto the syringe clockwise until a slight resistance is felt. Place the vial adapter over the top of the vial being careful not to bump or touch the plunger; the plastic spike inside the vial adapter should puncture the gray stopper. Push the plunger down until all the liquid from the syringe is in the vial and gently swirl to dissolve the powder. After the diluent is added, some foaming may occur. Do not shake. Generally, dissolution takes less than 10 min; the solution should be clear and colorless. Each reconstituted vial contains 25 mg/ml of etanercept. Turn the vial upside down and slowly pull the plunger down to the unit markings on the side of the syringe that correspond with the needed dose. Gently tap the syringe to make any air bubbles rise to the top of the syringe, and slowly push the plunger up to remove them. Remove the syringe from the vial adapter by turning the syringe counterclockwise and attach the 27 gauge needle - If the vial will be used for multiple doses, use a 25-gauge needle for reconstituting and withdrawing the solution. Insert the 25 gauge needle or the vial adapter straight into the center of the gray stopper. A “pop” will be felt. Inject the diluent very slowly. After the diluent is added, some foaming may occur. Do not shake. Swirl contents gently during dissolution. Generally, dissolution takes less than 10 minutes; the solution should be clear and colorless. Write the mixing date on the supplied sticker and attach to the vial. Each reconstituted vial contains 25 mg/ml of etanercept. Withdraw the correct dose of the solution into the syringe; remove any air bubbles. Remove the 25-gauge needle from the syringe. Attach a 27-gauge needle - Hold the barrel of the syringe with one hand and pull the needle cover straight off. Hold the syringe in one hand like a pencil and use the other hand to gently pinch a fold of skin at the cleaned injection site. Insert the needle at a 45° angle to the skin. Let go of the skin, and hold the syringe near its base to stabilize it. Push the plunger to inject all of the solution at a slow, steady rate. Withdraw the needle at the same angle as insertion. Do NOT rub the site - Use as soon as possible after reconstitution. Place reconstituted vials for multiple doses in the refrigerator at 2-8° C (36°-46° F) within 4 hr of reconstitution and may be stored up up to 14 days. DO NOT FREEZE Use of the SureClick autoinjector - Allow to reach room temperature, do not shake. Immediately before use, remove the needle shield by pulling it straight off - Stretch the skin under and around the prefilled autoinjector, place the open end against the injection site at a 90° angle. Without pushing the purple button on top, push the autoinjector firmly against the skin to unlock. Press the purple button on top once and release the button. Listen for the first click. Wait for the second click or wait 15 seconds, and remove the autoinjector from injection site. Do NOT rub the site - Look at the inspection window. If it is not purple, call 1-888-436-2735; do not try to reuse the autoinjector Use of the prefilled syringe -

Single-use: allow to come to room temperature, do not shake. Immediately before use, remove the needle shield by pulling it straight off; do not twist off or recap. Check to see if the amount of liquid in the prefilled syringe falls between the two purple fill level indicator lines on the syringe. Hold the prefilled syringe with the covered needle pointing down. If bubbles are seen in the syringe, very gently tap the prefilled syringe to allow any bubbles to rise to the top of the syringe. Turn the syringe so that the purple horizontal lines on the barrel are directly facing you. Do not use if the syringe does not have the right amount of liquid - Hold the barrel of the prefilled syringe with one hand and pull the needle cover straight off. Holding the syringe with the needle pointing up, check the syringe for air bubbles. If there are bubbles, gently tap until the air bubbles rise to the top of the syringe. Slowly push the plunger up to force the air bubbles out of the syringe - Hold the syringe in one hand like a pencil and use the other hand to gently pinch a fold of skin at the cleaned injection site. Insert the needle at a 45° angle to the skin. Let go of the skin, and hold the syringe near its base to stabilize it. Push the plunger to inject all of the solution at a slow, steady rate. Withdraw the needle at the same angle as insertion. Do NOT rub the site