Enbrel prefilled syringe now available
First posted Oct. 15, 2004
Updated Nov. 18, 2004
The prefilled 50 mg/ml syringe of Enbrel (generic name etanercept) approved by U.S. Food and Drug Administration on Sept. 27, 2004 is now available for patients.
The prefilled syringe, marketed by Amgen and Wyeth, eliminates the need to mix the drug prior to injecting. The prefilled syringe is the recommended dosing tool for treatment in all approved adult indications (plaque psoriasis, psoriatic arthritis, rheumatoid arthritis and ankylosing spondylitis).
The recommended dose of Enbrel for patients with plaque psoriasis is 50 mg twice weekly for three months, followed by a maintenance dose of 50 mg once weekly thereafter. Amgen expects the prefilled syringe to make dosing more convenient than the previous method of each 50 mg dose given as two 25 mg injections at two different sites.
The approval was based on a study showing the prefilled syringe to be biologically equivalent to two 25 mg vials. The 25 mg formulation will continue to be available for juvenile rheumatoid arthritis patients and those that prefer that dosing method.
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