INDICATIONS AND USAGE（适应症）

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 with or without methotrexate.

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 patients 4 years or older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

DOSAGE（服用剂量）

Administration of one 50 mg Enbrel single-dose prefilled syringe, one single-dose prefilled Enbrel SureClick autoinjector, or one Enbrel Mini single-dose prefilled cartridge (for use with the AutoTouch reusable autoinjector only), provides a dose equivalent to two 25 mg Enbrel single-dose prefilled syringes, two 25 mg single-dose vials, or two multiple-dose vials of lyophilized Enbrel, when multiple-dose vials are reconstituted and administered as recommended.

Adult Patients

Enbrel is administered by subcutaneous injection.

Dosage Strength and Frequency were recommended as follows:

50 mg weekly for adult RA, AS, and PsA,

Starting Dose with 50 mg twice weekly for 3 months and maintenance Dose with 50 mg once weekly for adult PsO

Adult Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis Patients

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 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.

Pediatric Patients

Enbrel is administered by subcutaneous injection.

Dosage Strength and Frequency were recommended as follows:

50 mg weekly for 63 kg (138 pounds) or more,

0.8 mg/kg weekly for less than 63 kg (138 pounds).

To achieve pediatric doses other than 25 mg or 50 mg, use Enbrel solution in a single-dose vial or reconstituted lyophilized powder in a multiple-dose vial.

In JIA patients, glucocorticoids, NSAIDs, or analgesics may be continued during treatment with Enbrel.

ADVERSE REACTIONS（不良反应）

Serious Infections

Neurologic Reactions

Malignancies

Patients with Heart Failure

Hematologic Reactions

Hepatitis B Reactivation

Allergic Reactions

Autoimmunity

Immunosuppression

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/74bead6e-b746-4134-817f-0c053ef9e451/spl-doc?hl=Etanercept

Enbrelinformation