Enbrel Indications, Dosage, Storage, Stability - Etanercept

Enbrel Indications, Dosage, Storage, Stability - Etanercept

INDICATIONS AND USAGE

ENBREL^® is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ENBREL^® can be initiated in combination with methotrexate (MTX) or used alone.

ENBREL^® is indicated for reducing signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more DMARDs.

ENBREL^® is indicated for reducing signs and symptoms and inhibiting the progression of structural damage of active arthritis in patients with psoriatic arthritis.

ENBREL^® can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.

ENBREL^® is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

ENBREL^® is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The recommended dose of ENBREL^® for adult patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis is 50 mg per week given as one subcutaneous (SC) injection using a 50 mg/mL single-use prefilled syringe. Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with ENBREL^®. Based on a study of 50 mg ENBREL^® twice weekly in patients with RA that suggested higher incidence of adverse reactions but similar ACR response rates, doses higher than 50 mg per week are not recommended (see ADVERSE REACTIONS).

The recommended starting dose of ENBREL^® for adult patients is a 50 mg dose given twice weekly (administered 3 or 4 days apart) for 3 months followed by a reduction to a maintenance dose of 50 mg per week (see CLINICAL STUDIES). The recommended dose should be administered subcutaneously, using 50 mg/mL single-use prefilled syringes.

Starting doses of ENBREL^Rof 25 mg or 50 mg per week were also shown to be efficacious. The proportion of responders were related to ENBREL^® dosage (see CLINICAL STUDIES).

The recommended dose of ENBREL^® for pediatric patients ages 4 to 17 years with active polyarticular-course JRA is 0.8 mg/kg per week (up to a maximum of 50 mg per week). For pediatric patients weighing 63 kg (138 pounds) or more, the weekly dose of 50 mg may be administered using the prefilled syringe. For pediatric patients weighing 31 to 62 kg (68 to136 pounds), the total weekly dose should be administered as two subcutaneous (SC) injections, either on the same day or 3 or 4 days apart using the multiple-use vial. The dose for pediatric patients weighing less than 31 kg (68 pounds) should be administered as a single SC injection once weekly using the correct volume from the multiple-use vial. Glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with ENBREL^®. Concurrent use with methotrexate and higher doses of ENBREL^® have not been studied in pediatric patients.

ENBREL^® is intended for use under the guidance and supervision of a physician. Patients may self-inject when deemed appropriate and if they receive medical follow-up, as necessary. Patients should not self-administer until they receive proper training in how to prepare and administer the correct dose.

The ENBREL^® (etanercept) "Patient Information" insert contains more detailed instructions on the preparation of ENBREL^®.

Before injection, ENBREL^® single-use prefilled syringe may be allowed to reach room temperature (approximately 15 to 30 minutes). DO NOT remove the needle shield while allowing the prefilled syringe to reach room temperature.

ENBREL^® should be reconstituted aseptically with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) giving a solution of 1.0 mL containing 25 mg of ENBREL^®.

A vial adapter is supplied for use when reconstituting the lyophilized powder. However, the vial adapter should not be used if multiple doses are going to be withdrawn from the vial. If the vial will be used for multiple doses, a 25-gauge needle should be used for reconstituting and withdrawing ENBREL^®, and the supplied "Mixing Date:" sticker should be attached to the vial and the date of reconstitution entered. Reconstitution with the supplied BWFI, using a 25-gauge needle, yields a preserved, multiple-use solution that must be used within 14 days.

If using the vial adapter, twist the vial adapter onto the diluent syringe. Then, place the vial adapter over the ENBREL^® vial and insert the vial adapter into the vial stopper. Push down on the plunger to inject the diluent into the ENBREL^® vial. It is normal for some foaming to occur. Keeping the diluent syringe in place, gently swirl the contents of the ENBREL^Rvial during dissolution. To avoid excessive foaming, do not shake or vigorously agitate.

If using a 25-gauge needle to reconstitute and withdraw ENBREL^®, the diluent should be injected very slowly into the ENBREL^® vial. It is normal for some foaming to occur. The contents should be swirled gently during dissolution. To avoid excessive foaming, do not shake or vigorously agitate.

Generally, dissolution of ENBREL^® takes less than 10 minutes. Visually inspect the solution for particulate matter and discoloration prior to administration. The solution should not be used if discolored or cloudy, or if particulate matter remains.

Withdraw the correct dose of reconstituted solution into the syringe. Some foam or bubbles may remain in the vial. Remove the syringe from the vial adapter or remove the 25-gauge needle from the syringe. Attach a 27-gauge needle to inject ENBREL^®.

The contents of one vial of ENBREL^® solution should not be mixed with, or transferred into, the contents of another vial of ENBREL^®. No other medications should be added to solutions containing ENBREL^®, and do not reconstitute ENBREL^® with other diluents. Do not filter reconstituted solution during preparation or administration.

Reconstitution with the supplied BWFI, using a 25-gauge needle, yields a preserved, multiple-use solution that must be used within 14 days. Discard reconstituted solution after 14 days. PRODUCT STABILITY AND STERILITY CANNOT BE ASSURED AFTER 14 DAYS.

A 50 mg dose should be given as one SC injection using a 50 mg/mL single-use prefilled syringe or as two 25 mg SC injections using the multiple-use vial. The two 25 mg injections should be given either on the same day or 3 or 4 days apart (see CLINICAL STUDIES).

Rotate sites for injection (thigh, abdomen, or upper arm). Never inject into areas where the skin is tender, bruised, red, or hard. See the ENBREL^® (etanercept) "Patient Information" insert for detailed information on injection site selection and dose administration.

ENBREL^® single-use prefilled syringe: Do not use a prefilled syringe beyond the expiration date stamped on the carton or syringe barrel label. The prefilled syringes must be refrigerated at 2° to 8°C (36° to 46°F). DO NOT FREEZE. Keep the ENBREL^® prefilled syringes in the original carton to protect from light until the time of use. Do not shake.

ENBREL^® multiple-use vial: Do not use a dose tray beyond the expiration date stamped on the carton, dose tray label, vial label, or diluent syringe label. The dose tray containing ENBREL^® (sterile powder) must be refrigerated at 2°-8°C (36°-46°F). DO NOT FREEZE.

Reconstituted solutions of ENBREL^® prepared with the supplied Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol), using a 25-gauge needle, may be stored for up to 14 days if refrigerated at 2°-8°C (36°-46°F). Discard reconstituted solution after 14 days. PRODUCT STABILITY AND STERILITY CANNOT BE ASSURED AFTER 14 DAYS.

ENBREL^® single-use prefilled syringe is supplied in a carton containing four prefilled syringes (NDC 58406-435-04). Each prefilled syringe contains 0.98 mL of 50 mg/mL of etanercept in a single-dose syringe with a 27 gauge, ½ inch needle. Administration of one 50 mg/mL prefilled syringe of ENBREL^® provides a dose equivalent to two 25 mg vials of lyophilized ENBREL^®, when vials are reconstituted and administered as recommended.

ENBREL^® multiple-use vial is supplied in a carton containing four dose trays (NDC 58406-425-34). 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 ½ inch needle, one vial adapter, one plunger, and two alcohol swabs. Each carton contains four "Mixing Date:" stickers.

Manufactured by: Immunex Corporation, Thousand Oaks, CA 91320-1799 U.S. License Number 1132 , Marketed by Amgen and Wyeth Pharmaceuticals © 2004 Immunex Corporation. All rights reserved., 3XXXXXX- v22 Issue Date: 09/27/2004 Immunex U.S. Patent Numbers: 5,395,760; 5,605,690; 5,945,397; 6,201,105; 6,572,852; Re. 36,755