Thyrotropin alfa
Also known as: Thyrogen
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In short
In the European Union, Thyrogen is indicated for use with serum thyroglobulin testing to detect thyroid remnants and well-differentiated thyroid cancer after a thyroidectomy. It is also indicated in the European Union for pre-therapeutic stimulation with radioiodine to ablate thyroid tissue remnants in patients without distant metastatic thyroid cancer. In the United States, Thyrogen is indicated as an adjunctive diagnostic tool for serum thyroglobulin testing in the follow-up of well-differentiated thyroid cancer. It is also used in the United States as an adjunct for radioiodine ablation of thyroid tissue remnants after a near-total or total thyroidectomy. Thyrotropin alfa is listed by the cited source as having an approved use for malignant neoplasm of the thyroid gland.
From: Source: European Medicines Agency (EMA), Thyrogen — EPAR, 19/02/2025. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.
Codes
- RxNorm
- 4952 thyrotropin alfa
- EMA
- EMEA/H/C/000220
Official indications
Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.
EMA (EU) Thyrogen
Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post thyroidectomy patients maintained on hormone suppression therapy (THST). Low risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and no rh (recombinant human) TSH-stimulated increase of Tg levels may be followed-up by assaying rh TSH-stimulated Tg levels. Thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mCi (1.1 GBq) to 100 mCi (3.7 GBq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.4).
Source: European Medicines Agency (EMA), Thyrogen — EPAR, 19/02/2025. © European Medicines Agency.
Document date: 19/02/2025 · Official document →
FDA (USA) Thyrogen
1 INDICATIONS AND USAGE THYROGEN ® is a thyroid stimulating hormone indicated for: Adjunctive Diagnostic Tool for Well-Differentiated Thyroid Cancer: 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 who have previously undergone thyroidectomy. ( 1.1 ) Limitations of Use : THYROGEN-stimulated Tg levels are generally lower than, and do not correlate with Tg levels after thyroid hormone withdrawal. Even when THYROGEN-Tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or underestimating the extent of the disease. Anti-Tg Antibodies may confound the Tg assay and render Tg levels uninterpretable. Adjunct for Thyroid Remnant Ablation in Well-Differentiated Thyroid Cancer: Use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer. ( 1.2 ) Limitations of Use : The effect of THYROGEN on thyroid cancer recurrence greater than 5 years post-remnant ablation has not been evaluated. 1.1 Adjunctive Diagnostic Tool for Well-Differentiated Thyroid Cancer THYROGEN ® 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 who have previously undergone thyroidectomy. Limitations of Use : THYROGEN-stimulated Tg levels are generally lower than, and do not correlate with, Tg levels after thyroid hormone withdrawal [see Clinical Studies (14.1) ] . Even when THYROGEN-stimulated Tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or of underestimating the extent of disease. Anti-Tg antibodies may confound the Tg assay and render Tg levels uninterpretable [see Clinical Studies (14.1) ] . Therefore, in such cases, even with a negative or low-stage THYROGEN radioiodine scan, consideration should be given to further evaluating patients. 1.2 Adjunct for Thyroid Remnant Ablation in Well-Differentiated Thyroid Cancer THYROGEN is indicated for use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer. Limitations of Use : The effect of THYROGEN on thyroid cancer recurrence greater than five years post-remnant ablation has not been evaluated [see Clinical Studies (14.2) ] .
Data provided by the U.S. Food and Drug Administration.
Document date: 20230224 · Official document →
Related terms in the cited sources
Has an official indication for
- Thyroid cancer Condition
In alphabetical order.
Other treatments A–Z
What people report
Not enough data yet. Anonymous counts appear here only for groups of at least 20 people who agreed to share them.
External resources
Questions
What is Thyrotropin alfa approved for in the European Union?
Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post thyroidectomy patients maintained on hormone suppression therapy (THST). Low risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and no rh (recombinant human) TSH-stimulated increase of Tg levels may be followed-up by assaying rh TSH-stimulated Tg levels. Thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mCi (1.1 GBq) to 100 mCi (3.7 GBq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.4). (Source: European Medicines Agency (EMA), Thyrogen — EPAR, 19/02/2025. © European Medicines Agency.)
Sources and attribution
- Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
- Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
- Data provided by the U.S. Food and Drug Administration.
- This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
- Source: European Medicines Agency (EMA), Thyrogen — EPAR, 19/02/2025. © European Medicines Agency.
Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →
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Treatments. Indications are quoted unchanged from official product information (European Medicines Agency, U.S. Food and Drug Administration). They describe what a medicine is approved for, not whether it is right for you. Approved uses can differ between countries. Always read the package leaflet and follow your doctor's or pharmacist's advice.
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