The safety profile of Thyrogen as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants following thyroidectomy for well-differentiated thyroid cancer did not differ from that of Thyrogen for diagnostic purposes.
Summary of adverse reactions with Thyrogen and thyroid hormone withdrawal in pooled clinical trials (≥ 1% of patients in any phase)
Post-marketing experience indicates that Thyrogen administration may cause transient (<48 hours) influenza-like symptoms, also called flu-like symptoms (FLS), which may include fever (>100°F/38°C), chills/shivering, myalgia/arthralgia, fatigue/asthenia/malaise, headache (nonfocal), and chills.
Manifestations of hypersensitivity to Thyrogen have been reported in the post-marketing settings, and include urticaria, rash, pruritus, flushing, and respiratory signs and symptoms. Injection site reactions, including pain, erythema, bruising, and pruritus have also been reported in the post-marketing setting.
Information from post-marketing surveillance and from the literature suggests that elimination of Thyrogen is slower in patients with end-stage renal disease who are dialysis-dependent, resulting in prolonged elevation of TSH levels. Patients with end-stage renal disease who receive Thyrogen may have prolonged elevation of TSH levels.
Thyrogen is given as a 0.9 mg injection into the muscle of the buttock for two consecutive days.
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