Thyrogen^® (thyrotropin alfa for injection)

Bibliographical Information:

Drug Name	Generic Name	Studied Indications or Disease	Approved U.S. Drug Label
Thyrogen®	thyrotropin alfa for injection	thyroid cancer	Prescribing Info

Protocol TSH91-0601

Meier, Christoph A. et al. Diagnostic Use of Recombinant Human Thyrotropin in Patients with Thyroid Carcinoma (Phase I/II Study). Journal of Clinical Endocrinology and Metabolism 78:188-196,1994.

Protocol TSH92-0601

Ladensen PW, Braverman LE, Mazzaferri EL, et al. Comparison of Administration of Recombinant Human Thyrotropin with Withdrawal of Thyroid Hormone for Radioactive Iodine Scanning in Patients with Thyroid Carcinoma. N Engl J Med 1997;337:888-96.

Protocol TSH94-0301

Meier CA, Braverman LE, Ebner SE, et al. Diagnostic Use of Recombinant Human Thyrotropin in Patients with Thyroid Carcinoma (Phase I/II Study). J Clin Endocrinol Metab 1994;78:188-96.

Protocol TSH95-0101

Haugen BR, Pacini F, Reiners C, et al. A Comparison of Recombinant Human Thyrotropin and Thyroid Hormone Withdrawal for the Detection of Thyroid Remnant or Cancer. J Clin Endocrinol Metab 1999;84:3877-85.

Protocol THYR-007-00

Publication is pending and will be available in 2006.

Protocol THYR-008-00

Pacini F, Ladenson PW, Schlumberger M, et al. Radioiodine Ablation of Thyroid Remnants after Preparation with Recombinant Human Thyrotropin in Differentiated Thyroid Carcinoma: Results of an International, Randomized, Controlled Study. J Clin Endocrinol Metab. 2006;91:926-932.

Ladenson P, Pacini F, Schlumberger M, Driedger A, Kloos R, Sherman S, et al. Thyroid remnant ablation: a randomized comparison of thyrotropin alfa and thyroid hormone withdrawal [abstract]. Presented at the ENDO 2004: Endocrine Society 86th Annual Meeting; June 16-19, 2004; New Orleans, LA. p. S35-1.