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

 
 



DRUG INTERACTIONS

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).

OVERDOSAGE

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.

CONTRAINDICATIONS

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

REFERENCES

  1. Ramey DR, Fries JF, Singh G. The Health Assessment Questionnaire 1995 - Status and Review. In: Spilker B, ed. "Quality of Life and Pharmacoeconomics in Clinical Trials." 2nd ed. Philadelphia, PA. Lippincott-Raven 1996;227.
  2. Ware JE Jr, Gandek B. Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project. J. Clin Epidemiol 1998;51(11):903.
  3. Giannini EH, Ruperto N, Ravelli A, et al. Preliminary definition of improvement of juvenile arthritis. Arthritis Rheum 1997;40(7):1202.
  4. Fredriksson T, Petersson U. Severe psoriasis-oral therapy with a new retinoid. Dermatologica 1978;157:238.
  5. van der Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis: a proposal for modification of the New York criteria. Arthritis Rheum 1984;27(4):361-8.
  6. Anderson JJ, Baron G, van der Heijde D, Felson DT, Dougados M. Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum 2001;44(8):1876-86.
  7. Van Oosten BW, Barkhof F, Truyen L, et al. Increased MRI activity and immune activation in two multiple sclerosis patients treated with the monoclonal anti-tumor necrosis factor antibody cA2. Neurology 1996;47:1531.
  8. Arnason BGW, et al. (Lenercept Multiple Sclerosis Study Group). TNF neutralization in MS: Results of a randomized, placebo-controlled multicenter study. Neurology 1999;53:457.
  9. Fisher CJ Jr, Agosti JM, Opal SM, et al. Treatment of septic shock with the tumor necrosis factor receptor: Fc fusion protein. The Soluble TNF Receptor Sepsis Study Group. N Engl J Med 1996;334(26):1697.
  10. National Cancer Institute. Surveillance, Epidemiology, and End Results Database (SEER) Program. SEERIncidence Crude Rates, 11 Registries, 1992-1999.
  11. Mellemkjaer L, Linet MS, Gridley G, et al. Rheumatoid Arthritis and Cancer Risk. European Journal of Cancer 1996;32A(10):1753-1757.
  12. Baecklund E, Ekbom A, Sparen P, et al. Disease Activity and Risk of Lymphoma in Patients With Rheumatoid Arthritis: Nested Case-Control Study. BMJ 1998;317:180-181.

AMGEN®

Wyeth®

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.

3XXXXXX-v20

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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