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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.
Thyrogen® (thyrotropin alfa for injection) 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 metastatic thyroid cancer.
Important Safety Information
- In post-marketing experience there have been rare reports of: events leading to death in patients with multiple serious medical problems; neurologic events, including stroke and unilateral weakness; and sudden, rapid and painful enlargement of locally recurring cancer.
- Prior to administration of Thyrogen, patients should be counseled to seek care immediately for any neurologic symptoms occurring after administration of Thyrogen. Also, it is recommended that pretreatment with glucocorticoids be considered for patients in whom local tumor expansion may comprise vital anatomic structures (such as trachea, central nervous system, or extensive macroscopic lung metastases).
- When Thyrogen-stimulated serum thyroglobulin (Tg) testing is performed in combination with radioiodine imaging, there remains a meaningful risk of missing a diagnosis of thyroid cancer or of underestimating the extent of disease.
- Although Thyrogen appeared non-inferior to thyroid hormone withdrawal in a study of postsurgical thyroid remnant ablation, long-term clinical outcome data are limited. Due to relatively small clinical experience with Thyrogen in remnant ablation, it is not possible to conclude whether long-term thyroid cancer outcomes would be equivalent after use of Thyrogen or hormone withdrawal for TSH elevation prior to remnant ablation.
- Caution should be exercised in patients with a known history of heart disease and with significant residual thyroid tissue. Careful evaluation of benefit risk should be assessed for high risk elderly patients with functioning thyroid tumors undergoing Thyrogen administration, to avoid palpitations or cardiac rhythm disorder.
- In clinical studies, the most common side effects reported were nausea, headache, fatigue, vomiting, dizziness, paraesthesia, asthenia, insomnia, and diarrhea.
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