Safety

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)

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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.

Choose how to get Thyrogen (Thyrotropin alfa) for your patients

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The ThyrogenONE portal provides your office online access to help you and your patients :

  • Submit and track benefit verifications
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Option 2: Call ThyrogenONE at 1-88-THYROGEN
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Dedicated ThyrogenONE Case Managers can assist you and your patients with the following.

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