Enbrel

Enbrel

Enbrel Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 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.

1.2 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.

1.3 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 MTX.

1.4 Ankylosing Spondylitis

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

1.5 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.

History

There is currently no drug history available for this drug.

Other Information

Enbrel (etanercept) is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons.

The solution of Enbrel in the single-use prefilled syringe and the single-use prefilled SureClick autoinjector is clear and colorless, sterile, preservative-free, and is formulated at pH 6.3 ± 0.2.

Enbrel is also supplied in a multiple-use vial as a sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (containing 0.9% benzyl alcohol) yields a multiple-use, clear, and colorless solution with a pH of 7.4 ± 0.3.

Table 5. Contents of Enbrel
   Presentation    Active Ingredient Content    Inactive Ingredients Content
   Enbrel 50 mg prefilled syringe and SureClick autoinjector   0.98 mL of a 50 mg/mL solution of etanercept  1% sucrose

100 mM sodium chloride

25 mM L-arginine hydrochloride

25 mM sodium phosphate

   Enbrel 25 mg prefilled syringe   0.51 mL of a 50 mg/mL solution of etanercept  1% sucrose

100 mM sodium chloride

25 mM L-arginine hydrochloride

25 mM sodium phosphate

   Enbrel 25 mg multiple-use vial   25 mg etanercept  40 mg mannitol

10 mg sucrose

1.2 mg tromethamine

Enbrel Manufacturers


  • Immunex Corporation
    Enbrel (Etanercept) Solution Enbrel (Etanercept) Kit [Immunex Corporation]

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