|
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) ] .
|