Thyrogen 0.9 mg Powder for Solution for Injection

INJECTION, POWDER, FOR SOLUTION

**DOSAGE AND ADMINISTRATION** **Recommended Dosage** THYROGEN should be used by physicians knowledgeable in the management of patients with thyroid cancer. THYROGEN is indicated as a two-injection regimen. The recommended dosage of THYROGEN is a 0.9mg intramuscular injection to the buttock followed by a second 0.9 mg intramuscular injection to the buttock 24 hours later. THYROGEN should be administered intramuscularly only. THYROGEN should not be administered intravenously. Pretreatment with glucocorticoids should be considered for patients in whom tumor expansion may compromise vital anatomic structures \[see _Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. Routine measurement of serum TSH levels is not recommended after THYROGEN use. **Reconstitution, Preparation, and Administration of THYROGEN** The supplied lyophilized powder must be reconstituted with Sterile Water for Injection. THYROGEN should be prepared, and administered in the following manner: - Reconstitute each 0.9 mg vial of THYROGEN with 1.2 mL of Sterile Water for Injection to yield a single-dose solution containing the 0.9 mg/mL of thyrotropin alfa that delivers 1 mL (0.9 mg). - Gently swirl the contents of the vial until all the material is dissolved. Do not shake the solution. - Visually inspect the reconstituted solution for particulate matter and discoloration prior to administration. The reconstituted THYROGEN solution should be clear and colorless. Do not use if the solution has particulate matter or is cloudy or discolored. - Withdraw 1 mL of the reconstituted THYROGEN solution (0.9 mg of thyrotropin alfa) and inject intramuscularly in the buttocks. Discard any unused portions. - The reconstituted THYROGEN solution must be injected within 3 hours unless refrigerated; - If necessary, the reconstituted solution can be stored refrigerated at a temperature between 2°C and 8°C (36°F to 46°F) for up to 24 hours while avoiding microbial contamination. - Do not mix with other substances. **Timing of Serum Thyroglobulin Testing Following THYROGEN Administration** For serum thyroglobulin testing, the serum sample should be obtained 72 hours after the final injection of THYROGEN \[see _Clinical Studies_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. **Timing for Remnant Ablation and Diagnostic Scanning Following THYROGEN Administration** Oral radioiodine should be given 24 hours after the second injection of THYROGEN in both remnant ablation and diagnostic scanning. The activity of 131I is carefully selected at the discretion of the nuclear medicine physician. Diagnostic scanning should be performed 48 hours after the radioiodine administration.