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.
|Adverse Event||Thyrogen(N=481)n (%)||Thyroid Hormone Withdrawal(N=418)n (%)|
|Nausea||53 (11)||2 (<1)|
|Fatigue||11 (2)||2 (<1)|
|Asthenia||5 (1)||1 (<1)|
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.
In 1 of the diagnostic clinical trials, antibodies to thyrotropin alfa did not develop in any patient, after single or repeated (127 patients) use of the product. In a second study of 229 patients, 35 had Tg antibodies.
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 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:
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:
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.
Caution should be exercised in patients who have substantial thyroid tissue still in situ or functional thyroid cancer metastases, specifically in the elderly and those with a known history of heart disease.
Hospitalization for administration of Thyrogen and post-administration observation in patients at risk should be considered.
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.
Patients should be well-hydrated prior to treatment with Thyrogen.
Sudden, rapid and painful enlargement of residual thyroid tissue or distant metastases can occur following treatment with Thyrogen.
Pretreatment with glucocorticoids should be considered for patients in whom tumor expansion may compromise vital anatomic structures.
The most common adverse reactions reported in clinical trials were nausea and headache.
Pregnancy Category C: Animal reproduction studies have not been conducted with Thyrogen. It is also not known whether Thyrogen can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Thyrogen should be given to a pregnant woman only if clearly needed.
Nursing Mothers: It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Thyrogen is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Results from controlled trials do not indicate a difference in the safety and efficacy of Thyrogen between adult patients less than 65 years and those over 65 years of age.
Renal Impairment: Elimination of Thyrogen is significantly slower in dialysis-dependent end stage renal disease patients, resulting in prolonged elevation of TSH levels.