Thyrotropin alfa
Thyrogen is an injected version of thyroid-stimulating hormone that lets people with thyroid cancer have radioiodine treatment and follow-up blood tests without stopping their thyroid hormone tablets and suffering weeks of hypothyroidism.
Overview
Thyrotropin alfa was approved by the FDA in November 1998 as an adjunctive diagnostic tool for serum thyroglobulin testing with or without radioiodine imaging in the follow-up of well-differentiated thyroid cancer, and in 2007 for pre-therapeutic stimulation before radioiodine remnant ablation after thyroidectomy in patients without distant metastases; the EU authorised Thyrogen in 2000 with the same uses. The HiLo and ESTIMABL trials showed that rhTSH-stimulated low-dose (1.1 GBq) radioiodine ablation is as effective as high-dose ablation after thyroid hormone withdrawal, sparing patients hypothyroid symptoms and reducing radiation exposure. Nausea and headache are the main adverse effects; transient tumour swelling can occur with CNS or spinal metastases. Marketed by Sanofi (Genzyme).
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 1998 | Adjunctive diagnostic tool for thyroglobulin testing in well-differentiated thyroid cancer; pre-therapeutic stimulation for radioiodine remnant ablation added 2007 |
| EU | 2000 | Thyroglobulin testing and radioiodine imaging in thyroid cancer follow-up; pre-therapeutic stimulation for radioiodine ablation |
Trials
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Latest papers
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