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Enbrel (Etanercept) - Drug Interactions, Contraindications, Overdosage, etc



Specific drug interaction studies have not been conducted with ENBREL®. However, it was observed that the pharmacokinetics of ENBREL® was unaltered by concomitant methotrexate in rheumatoid arthritis patients.

In a study in which patients with active RA were treated for up to 24 weeks with concurrent ENBREL® and anakinra therapy, a 7% rate of serious infections was observed, which was higher than that observed with ENBREL® alone (0%) (see also WARNINGS). Two percent of patients treated concurrently with ENBREL® and anakinra developed neutropenia (ANC < 1 × 109/L).


The maximum tolerated dose of ENBREL® has not been established in humans. Toxicology studies have been performed in monkeys at doses up to 30 times the human dose with no evidence of dose-limiting toxicities. No dose-limiting toxicities have been observed during clinical trials of ENBREL®. Single IV doses up to 60 mg/m2 have been administered to healthy volunteers in an endotoxemia study without evidence of dose-limiting toxicities.


ENBREL® should not be administered to patients with sepsis or with known hypersensitivity to ENBREL® or any of its components.


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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.


Issue Date: 4/30/2004

Immunex U.S. Patent Numbers:

5,395,760; 5,605,690; 5,945,397; 6,201,105; 6,572,852; Re. 36,755

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