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Thyrogen Generic Name & Formulations
Legal Class
Rx
General Description
Thyrotropin alfa 0.9mg/vial; lyophilized pwd for IM inj after reconstitution; contains mannitol.
Pharmacological Class
Thyroid stimulating hormone (recombinant).
How Supplied
Single-dose vials—2
Manufacturer
Generic Availability
NO
Thyrogen Indications
Indications
Adjunctive diagnostic tool for serum thyroglobin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy. 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 metastatic thyroid cancer.
Thyrogen Dosage and Administration
Adult
Give by IM inj into the buttock. 0.9mg, followed by a second 0.9mg injection 24 hours later. For radioiodine imaging or remnant ablation, give radioiodine 24 hours after the second Thyrogen injection.
Children
Not established.
Thyrogen Contraindications
Not Applicable
Thyrogen Boxed Warnings
Not Applicable
Thyrogen Warnings/Precautions
Warnings/Precautions
See full labeling. Reports of death in patients who are non-thyroidectomized or with distant metastatic thyroid cancer wthin 24hrs after administration. Heart disease, metastatic disease: increased risk of Thyrogen-induced hyperthyroidism, consider hospitalization for administration and post-administration observation. Caution patients regarding possible neurologic symptoms. Consider pretreatment with glucocorticoids in those whose tumor expansion may compromise vital anatomic structures (eg, trachea, lung metastases). Anti-thyroglobulin (Tg) antibodies may render Tg levels uninterpretable; consider further evaluation with thyroid hormone withdrawal scan. Residual thyroid tissue. End-stage renal disease. Elderly. Pregnancy, nursing mothers: contraindicated if concomitant with radioiodine.
Thyrogen Pharmacokinetics
See Literature
Thyrogen Interactions
Not Applicable
Thyrogen Adverse Reactions
Adverse Reactions
Nausea, headache, fatigue, influenza-like symptoms; death (in non-thyroidectomized or with distant metastatic thyroid cancer), stroke and other neurologic events, sudden rapid tumor enlargement in distant metastatic thyroid cancer.
Thyrogen Clinical Trials
See Literature
Thyrogen Note
Not Applicable
Thyrogen Patient Counseling
See Literature
