Thyrogen (Thyrotropin Alfa Recombinant) - Summary

THYROGEN SUMMARY

Thyrogen^® (thyrotropin alfa for injection) contains a highly purified recombinant form of human thyroid stimulating hormone (TSH), a glycoprotein which is produced by recombinant DNA technology. Thyrotropin alfa is synthesized in a genetically modified Chinese hamster ovary cell line.

Thyrogen (thyrotropin alfa for injection) is indicated for use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer.

POTENTIAL CLINICAL USES:

1. Thyrogen Tg testing may be used in patients with an undetectable Tg on thyroid hormone suppressive therapy to exclude the diagnosis of residual or recurrent thyroid cancer (see CLINICAL PHARMACOLOGY, Clinical Trials, Thyroglobulin (Tg) Results).
2. Thyrogen testing may be used in patients requiring serum Tg testing and radioiodine imaging who are unwilling to undergo thyroid hormone withdrawal testing and whose treating physician believes that use of a less sensitive test is justified.
3. Thyrogen testing may be used in patients who are either unable to mount an adequate endogenous TSH response to thyroid hormone withdrawal or in whom withdrawal is medically contraindicated.

THYROGEN NEWS HIGHLIGHTS

Published Studies Related to Thyrogen (Thyrotropin)

Improvement of goiter volume reduction after 0.3 mg recombinant human thyrotropin-stimulated radioiodine therapy in patients with a very large goiter: a double-blinded, randomized trial. [2007.09]

Peripheral blood levels of thyroglobulin mRNA and serum thyroglobulin concentrations after radioiodine ablation of multinodular goiter with or without pre-treatment with recombinant human thyrotropin. [2007.07]

Single-dose rexinoid rapidly and specifically suppresses serum thyrotropin in normal subjects. [2007.01]

[Stimulation with 0,3 mg recombinant human thyrotropin (rhTSH) increases the effect of 131I therapy in patients with nontoxic nodular goiter. A prospective, randomized, double-blind trial--secondary publication] [2006.11.20]

Single-Dose Rexinoid Rapidly and Specifically Suppresses Serum Thyrotropin in Normal Subjectsa. [2006.10.24]

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Clinical Trials Related to Thyrogen (Thyrotropin)

Comparison of the Safety and Successful Ablation of Thyroid Remnant in Post-Thyroidectomized Euthyroid Patients (i.e. Patients Administered Thyrogen) Versus Hypothyroid Patients (no Thyrogen) Following 131I Administration [Completed]

A New Study to Follow-up Thyroid Cancer Patients Who Participated in a Previous Study, Which Compared the Success of Destruction of the Thyroid Remnant Using Standard Treatment or Thyrogen. [Completed]

Study of Radioiodine (131-I) Uptake Following Administration of Thyrogen and Hypothyroid States During Thyroid Hormone Withdrawal. [Completed]

Study Comparing Thyrogen Versus a Modified Release of Recombinant Human Thyroid Stimulating Hormone [Completed]

Quality of Life, Recombinant TSH (Thyrogen) and Thyroid Cancer [Recruiting]

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