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Enbrel

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Enbrel

Enbrel

INDICATIONS

Rheumatoid Arthritis

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 (RA). Enbrel can be initiated in combination with methotrexate (MTX) or used alone.

Polyarticular Juvenile Idiopathic Arthritis

Enbrel is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older.

Psoriatic Arthritis

Enbrel is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). Enbrel can be used in combination with methotrexate (MTX) in patients who do not respond adequately to MTX alone.

Ankylosing Spondylitis

Enbrel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).

Plaque Psoriasis

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

DOSAGE AND ADMINISTRATION

Table 1: Dosing and Administration for Adult Patients

Patient Population Recommended Dosage Strength and Frequency
Adult RA, AS, and PsA Patients 50 mg weekly
Adult PsO Patients Starting Dose: 50 mg twice weekly for 3 months
Maintenance Dose: 50 mg once weekly

See the Enbrel (etanercept) “Instructions for Use” insert for detailed information on injection site selection and dose administration.

Adult Rheumatoid Arthritis, Ankylosing Spondylitis, And Psoriatic Arthritis Patients

MTX, 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 American College of Rheumatology (ACR) response rates, doses higher than 50 mg per week are not recommended.

Adult Plaque Psoriasis Patients

In addition to the 50 mg twice weekly recommended starting dose, starting doses of 25 mg or 50 mg per week were shown to be efficacious. The proportion of responders was related to Enbrel dosage [see Clinical Studies].

JIA Patients

Table 2: Dosing and Administration for Juvenile Idiopathic Arthritis

Pediatric Patients Weight Recommended Dose
63 kg (138 pounds) or more 50 mg weekly
Less than 63 kg (138 pounds) 0.8 mg/kg weekly

In JIA patients, glucocorticoids, NSAIDs, or analgesics may be continued during treatment with Enbrel. Higher doses of Enbrel have not been studied in pediatric patients.

Preparation Of Enbrel

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) “Instructions for Use” insert for each presentation contains more detailed instructions on the preparation of Enbrel.

Preparation of Enbrel Using the Single-use Prefilled Syringe or Single-use Prefilled SureClick Autoinjector

For a more comfortable injection, leave Enbrel at room temperature for about 15 to 30 minutes before injecting. DO NOT remove the needle cover while allowing the prefilled syringe to reach room temperature.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. There may be small white particles of protein in the solution. This is not unusual for proteinaceous solutions. The solution should not be used if discolored or cloudy, or if foreign particulate matter is present.

When using the Enbrel single-use prefilled syringe, check to see if the amount of liquid in the prefilled syringe falls between the two purple fill level indicator lines on the syringe. If the syringe does not have the right amount of liquid, DO NOT USE THAT SYRINGE.

Preparation of Enbrel Using the Multiple-use Vial

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. Reconstituted solution must be refrigerated at 36°F to 46°F (2°C to 8°C) and used within 14 days. Discard reconstituted solution after 14 days because product stability and sterility cannot be assured after 14 days. DO NOT store reconstituted Enbrel solution at room temperature.

For a more comfortable injection, leave the Enbrel dose tray at room temperature for about 15 to 30 minutes before injecting.

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. 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. Keeping the diluent syringe in place, gently swirl the contents of the Enbrel vial during dissolution. To avoid excessive foaming, do not shake or vigorously agitate.

Generally, dissolution of Enbrel takes less than 10 minutes. Do not use the solution 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.

Monitoring To Assess Safety

Prior to initiating Enbrel and periodically during therapy, patients should be evaluated for active tuberculosis and tested for latent infection [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

50 mg Single-use Prefilled Syringe

0.98 mL of a 50 mg/mL solution of etanercept

50 mg Single-use Prefilled SureClick Autoinjector

0.98 mL of a 50 mg/mL solution of etanercept

25 mg Single-use Prefilled Syringe

0.51 mL of a 50 mg/mL solution of etanercept

25 mg Multiple-use Vial

25 mg of etanercept

Storage And Handling

Administration of one 50 mg Enbrel prefilled syringe or one Enbrel SureClick autoinjector provides a dose equivalent to two 25 mg Enbrel prefilled syringes or two multiple-use vials of lyophilized Enbrel, when vials are reconstituted and administered as recommended.

Enbrel Single-Use Prefilled Syringe And Enbrel Single-Use Prefilled Sureclick Autoinjector

Each Enbrel single-use prefilled syringe and Enbrel single-use prefilled SureClick autoinjector contains 50 mg/mL of etanercept in a single-dose syringe with a 27-gauge, ½-inch needle.

50 mg single-use prefilled syringe Carton of 4 NDC 58406-435-04
50 mg single-use prefilled SureClick autoinjector Carton of 4 NDC 58406-445-04
25 mg single-use prefilled syringe Carton of 4 NDC 58406-455-04

Enbrel should be refrigerated at 36°F to 46°F (2°C to 8°C). Do not use Enbrel beyond the expiration date stamped on the carton or barrel label. DO NOT SHAKE. Store Enbrel in the original carton to protect from light or physical damage.

For convenience, storage of individual syringes or autoinjectors at room temperature for a maximum single period of 14 days is permissible, with protection from light and sources of heat. Once a syringe or autoinjector has been stored at room temperature, it should not be placed back into the refrigerator. If not used within 14 days at room temperature, the syringe or autoinjector should be discarded. Do not store Enbrel in extreme heat or cold. DO NOT FREEZE. Keep out of the reach of children.

Enbrel Multiple-Use Vial (Recommended For Weight-Based Dosing)

Enbrel multiple-use vial is supplied in a carton containing four 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 ½-inch needle, one vial adapter, and one plunger. Each carton contains four “Mixing Date:” stickers.

25 mg multiple-use vial Carton of 4 NDC 58406-425-34

Enbrel should be refrigerated at 36°F to 46°F (2°C to 8°C). Do not use Enbrel beyond the expiration date stamped on the dose tray. DO NOT SHAKE. Store Enbrel in the original carton to protect from light or physical damage.

For convenience, storage of an individual dose tray containing Enbrel multi-use vial and diluent syringe at room temperature for a maximum single period of 14 days is permissible, with protection from light, sources of heat, and humidity. Once the dose tray has been stored at room temperature, it should not be placed back into the refrigerator. If not used within 14 days at room temperature, the dose tray should be discarded. Once a vial has been reconstituted, the solution must be used immediately or may be refrigerated for up to 14 days. Do not store Enbrel in extreme heat or cold. DO NOT FREEZE. Keep out of the reach of children.

Manufactured by: Immunex Corporation Thousand Oaks, CA 91320-1799. Marketed by Amgen Inc. and Pfizer Inc. Revised: 11/2013

Last reviewed on RxList: 1/14/2014
This monograph has been modified to include the generic and brand name in many instances.

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Enbrel - User Reviews

Enbrel User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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