Trade Names:Thyrogen- Injection, lyophilized powder for solution 1.1 mg
Thyrotropin alfa has comparable biochemical properties to human pituitary thyroid-stimulating hormone (TSH). Binding to TSH receptors on normal thyroid epithelial cells or on well-differentiated thyroid cancer tissue stimulates iodine uptake and organification, and synthesis and secretion of thyroglobulin, triiodothyronine, and thyroxine.
C max is 116 mU/L. T max is 3 to 24 h.
Mean elimination t ½ is 25 ± 10 h.
Adjunctive diagnostic tool for serum thyroglobulin testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer; adjunctive treatment of radioiodine ablation of thyroid tissue remnants in patients who have undergone a near-total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of metastatic cancer; may be used in patients with an undetectable thyroglobulin upon thyroid hormone suppressive therapy to exclude residual or recurrent thyroid cancer; may be used in combination with radioiodine to ablate thyroid remnants following near-total thyroidectomy in patients without evidence of metastatic disease; may be used in patients requiring serum thyroglobulin testing and radioiodine imaging who are unwilling to undergo thyroid hormone withdrawal testing and whose treating health care provider believes that the use of a less sensitive test is justified; may be used in patients who are either unable to mount an adequate endogenous TSH response to thyroid hormone withdrawal or in whom withdrawal is medically contraindicated.
IM 0.9 mg initially, followed by 0.9 mg 24 h later.
Store at 36° to 46°F. The reconstituted solution may be stored for up to 24 h at 36° to 46°F. Protect from light.
None well documented.
Thyroglobulin antibodies may confound the thyroglobulin assay, making levels uninterpretable. In this case, patients should be further evaluated.
Atrial arrhythmias (postmarketing).
Headache (7%); dizziness, fatigue (3%); asthenia, insomnia, paresthesia (2%).
Nasopharyngitis (1%); laryngeal edema with respiratory distress, visual loss (postmarketing).
Nausea (12%); vomiting (3%); diarrhea (1%).
Hypersensitivity reactions, including flushing, pruritus, rash, respiratory signs and symptoms, and urticaria (postmarketing).
Hemiparesis, hemiplegia (7%).
Thyroglobulin present (1%); death, rapid and painful enlargement of locally recurring papillary carcinoma accompanied by dyspnea, dysphonia, and stridor; transient flu-like symptoms (postmarketing).
Category C .
Safety and efficacy not established in children younger than 16 yr of age.
Palpitations or cardiac rhythm disorder may occur in high-risk elderly patients with functioning thyroid tumors undergoing thyrotropin administration.
Thyrotropin elimination is slower in dialysis-dependent end-stage renal disease patients, resulting in prolonged TSH levels.
Patients with known heart disease, extensive metastatic disease, or other known serious underlying illness should be hospitalized for administration of thyrotropin because thyrotropin-induced hyperthyroidism could have serious consequences.
There have been reports of death in which events leading to death occurred within 24 h of thyrotropin alfa administration.
Transient but important increases in serum thyroid hormone concentration have occurred when thyrotropin was given to patients with substantial thyroid tissue present in situ. Use with caution in patients with a known history of heart disease and residual thyroid tissue.
Use with caution in patients who have been previously treated with bovine TSH, particularly patients who have experienced hypersensitivity to bovine TSH.
Dizziness, headache, hot flashes, nausea, vomiting, and weakness have been reported with doses that were higher than recommended.
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