Generic name: THYROTROPIN ALFA 0.9mg in 1mL
Dosage form: injection, powder, for solution
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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 0.9 mg 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 (5.3)].
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:
- Add 1.2 mL of Sterile Water for Injection to the vial containing the THYROGEN lyophilized powder.
- Swirl the contents of the vial until all the material is dissolved. Do not shake the solution. The reconstituted THYROGEN solution has a concentration of 0.9 mg of thyrotropin alfa per mL.
- 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.
- The reconstituted THYROGEN solution must be injected within 3 hours unless refrigerated; if refrigerated, the reconstituted solution may be kept for up to 24 hours.
- Discard unused portions. 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 (14.1)].
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.