Adult Dosing
Serum thyroglobulin testing
- After reconstitution with 1.2 mL sterile Water for Injection, administer 1 mL (0.9 mg) IM q24 hrs x2 doses
Notes:- Use with or without radioiodine imaging for follow-up of patients with well-differentiated thyroid cancer
- Indicated for IM injection to the buttock; do not administer intravenously
- Consider pretreatment with glucocorticoids in patients with local tumor expansion which may compromise vital anatomic structures (such as trachea, CNS, or extensive macroscopic lung metastases)
- For radioiodine imaging, administer radioiodine 24 hrs after the final injection of thyrotropin alfa
- Perform diagnostic scanning 48 hrs after radioiodine administration and delay post-therapy scanning additional days to allow background activity to decline
- For serum Tg testing, obtain the serum sample 72 hrs after the final thyrotropin alfa injection
Adjunctive therapy for radioiodine ablation of thyroid tissue
- After reconstitution with 1.2 mL sterile Water for Injection, administer 1 mL (0.9 mg) IM q24 hrs x2 doses
Notes:- Use after near-total or total thyroidectomy for well-differentiated thyroid cancer without metastases
- Indicated for IM injection to the buttock; do not administer intravenously
- For remnant ablation, administer radioiodine 24 hrs after the final injection of thyrotropin alfa
- Perform diagnostic scanning 48 hrs after radioiodine administration and delay post-therapy scanning additional days to allow background activity to decline
Pediatric Dosing
- Safety and efficacy in pediatric patients <16 yrs of age have not been established
Serum thyroglobulin testing
Children >16 yrs
- After reconstitution with 1.2 mL sterile Water for Injection, administer 1 mL (0.9 mg) IM q24 hrs x2 doses
Notes:- Use with or without radioiodine imaging for follow-up of patients with well-differentiated thyroid cancer
- Indicated for IM injection to the buttock; do not administer intravenously
- Consider pretreatment with glucocorticoids in patients with local tumor expansion which may compromise vital anatomic structures (such as trachea, CNS, or extensive macroscopic lung metastases)
- For radioiodine imaging, administer radioiodine 24 hrs after the final injection of thyrotropin alfa
- Perform diagnostic scanning 48 hrs after radioiodine administration and delay post-therapy scanning additional days to allow background activity to decline
- For serum Tg testing, obtain the serum sample 72 hrs after the final thyrotropin alfa injection
Adjunctive therapy for radioiodine ablation of thyroid tissue
Children >16 yrs
- After reconstitution with 1.2 mL sterile Water for Injection, administer 1 mL (0.9 mg) IM q24 hrs x2 doses
Notes:- Use after near-total or total thyroidectomy for well-differentiated thyroid cancer without metastases
- Indicated for IM injection to the buttock; do not administer intravenously
- For remnant ablation, administer radioiodine 24 hrs after the final injection of thyrotropin alfa
- Perform diagnostic scanning 48 hrs after radioiodine administration and delay post-therapy scanning additional days to allow background activity to decline
- Therapy should only be administered intramuscularly; avoid IV administration
- Administration of thyrotropin alfa should be guided by physicians who are well trained and experienced in the management of patients with thyroid cancer
- Deaths have been reported in which events leading to death occurred within 24 hours after thyrotropin alfa injection; these events may be likely related to thyrotropin alfa-induced hyperthyroidism. Hospitalize patients for whom therapy-induced hyperthyroidism could have serious consequences and consider post-administration monitoring. Patients with known heart disease, extensive metastatic disease, or other known serious underlying illness are at risk
- Neurologic events associated with sudden rapid tumor enlargement, including acute hemiplegia or hemiparesis may occur 1-3 days after administration of thyrotropin alfa in patients with CNS metastases. Instruct patient to seek care immediately for any neurologic symptoms occurring after administration of the drug
- Sudden, rapid and painful enlargement of locally recurring papillary carcinoma followed by dyspnea, stridor or dysphonia has been reported within 12-48 hours of initiation of therapy
- Thyroglobulin (Tg) antibodies may confound the Tg assay and render Tg levels uninterpretable. In such cases, even with a negative or low-stage thyrotropin alfa radioiodine scan, consider further evaluation with a confirmatory thyroid hormone withdrawal scan to determine the location and extent of thyroid cancer
- Exercise caution when administering therapy to patients previously treated with bovine TSH, especially to those with a hx of hypersensitivity reactions to bovine TSH
- Exercise caution in patients with a hx of cardiac disease and with significant residual thyroid tissue due to the potential risk of rise (transient but marked) in serum thyroid hormone concentration in patients with substantial thyroid tissue still in situ
- Consider pre-treatment with glucocorticoids for patients in whom local tumor expansion may compromise vital anatomic structures such as trachea, CNS, or extensive macroscopic lung metastases
- Carefully assess risks and benefits in high risk elderly patients with functioning thyroid tumors receiving thyrotropin alfa administration, as it may result in palpitations or cardiac rhythm disorder
- Thyrotropin alfa excretion is significantly slower in dialysis-dependent end stage renal disease (ESRD) patients leading to prolonged elevation of TSH levels
Cautions: Use cautiously in
- Cardiac disease
- Metastatic disease
- Serious illness
- Dialysis
- Residual thyroid tissue
- Elderly patients
Pregnancy Category:C
Breastfeeding: It is unknown whether thyrotropin alfa is excreted in human milk. However, the manufacturer advises to use caution when administering thyrotropin alfa to a nursing woman.
