Genzyme announced that the FDA has approved the revised prescribing information for Thyrogen (thyrotropin alfa for injection) to expand the dose range of radioiodine (RAI) when used for thyroid remnant ablation.
Thyrogen is a recombinant thyroid stimulating hormone currently indicated as adjunctive diagnostic tool for serum thyroglobin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer, and as 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.
Previously the amount of radioiodine was fixed at 100mCi but physicians may now select a dose from the range of 30–100mCi. The revision approval is based on the results of the 2 large prospective studies that compared ablation success among patients receiving recombinant human thyrotropin (rhTSH) and patients undergoing thyroid hormone withdrawal (THW) at both low and high doses of radioiodine. Patients receiving Thyrogen vs. THW had fewer hypothyroid symptoms and preserved quality of life across both studies.
These findings are reflected in the clinical studies section in the updated prescribing information.
For more information call (800) 745-4447 or visit Thyrogen.com.