Thyrogen® (thyrotropin alfa for injection) 0.9 mg/mL
INDICATIONS AND USAGE
• Thyrogen ® is a thyroid stimulating hormone indicated for:
Diagnostic: 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.
• 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.
Ablation: 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 long term thyroid cancer outcomes has not
been determined.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
• There have been reports of death in non-thyroidectomized patients
and in patients with distant metastatic thyroid cancer in which events
leading to death occurred within 24 hours after administration of
Thyrogen.
• There are post marketing reports of stroke in young women with risk
factors for stroke, and neurological findings suggestive of stroke
(e.g., unilateral weakness) occurring within 72 hours of Thyrogen
administration in patients without known central nervous system
metastases.
