Generic Name and Formulations:
Thyrotropin alfa 1.1mg/vial; lyophilized pwd for IM inj after reconstitution; contains mannitol.
Sanofi Genzyme Company
Indications for THYROGEN:
Adjunctive diagnostic tool for serum thyroglobin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer. 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.
≥16yrs: Give by IM inj into the buttock. 0.9mg, followed by a second 0.9mg injection 24 hours later. For radioiodine imaging or remnant ablation, give radioiodine 24 hours after the second Thyrogen injection.
<16yrs: not established.
See full labeling. Reports of death in patients who are not thyroidectomized or with distant metastatic thyroid cancer wthin 24hrs after administration. Heart disease, extensive metastatic disease, or other serious underlying illnesses; increased risk of Thyrogen-induced hyperthyroidism, consider hospitalization for administration and post-administration observation. Caution patients regarding possible neurologic symptoms. Consider pretreatment with glucocorticoids in those whose tumor expansion may compromise vital anatomic structures (eg, trachea, CNS, lung metastases). Thyroglobulin (Tg) antibodies may render Tg levels uninterpretable; consider further evaluation with thyroid hormone withdrawal scan. Previous bovine TSH treatment. Residual thyroid tissue. End-stage renal disease. Elderly (increased risk of cardiac effects). Pregnancy (Cat.C). Nursing mothers.
Thyroid stimulating hormone (recombinant).
Nausea, headache, fatigue, influenza-like symptoms; death (in non-thyroidectomized or with distant metastatic thyroid cancer), stroke and other neurologic events, sudden rapid tumor enlargement in distant metastatic thyroid cancer.
2-vial kit—2 vials of Thyrogen; 4-vial kit—2 vials of Thyrogen + 2 vials of diluent