DOSAGE AND ADMINISTRATION
A two-injection regimen is recommended for Thyrogen administration.
The two-injection regimen is Thyrogen 0.9 mg intramuscularly (IM), followed by a second 0.9 mg IM injection 24 hours later.
After reconstitution with 1.2 mL Sterile Water for Injection, a 1.0 mL solution (0.9 mg thyrotropin alfa) is administered by intramuscular injection to the buttock.
For radioiodine imaging or remnant ablation, radioiodine administration should be given 24 hours following the final Thyrogen injection. Diagnostic scanning should be performed 48 hours after radioiodine administration, whereas post-therapy scanning may be delayed additional days to allow background activity to decline.
The following parameters utilized in the second Phase 3 study are recommended for diagnostic radioiodine scanning with Thyrogen:
- A diagnostic activity of 4 mCi (148 MBq) 131I should be used.
- Whole body images should be acquired for a minimum of 30 minutes and/or should contain a minimum of 140,000 counts.
- Scanning times for single (spot) images of body regions should be 10-15 minutes or less if the minimum number of counts is reached sooner (i.e. 60,000 for a large field of view camera, 35,000 counts for a small field of view).
For radioiodine ablation of thyroid tissue remnants, the activity of 131I is carefully selected at the discretion of the nuclear medicine physician. Studies with Thyrogen were conducted using 100 mCi ± 10% of 131I. Data are inadequate to determine if a lower dose of radioiodine would be effective when Thyrogen is used as an adjunct to radioiodine in postsurgical thyroid remnant ablation.
For serum Tg testing, the serum sample should be obtained 72 hours after the final injection of Thyrogen.
INSTRUCTIONS FOR USE
Thyrogen (thyrotropin alfa for injection) is for intramuscular injection to the buttock. The powder should be reconstituted immediately prior to use with 1.2 mL of sterile Water for Injection, USP. Each vial of Thyrogen and each vial of diluent, if provided, is intended for single use. Discard unused portion of the diluent.
Thyrogen should be stored at 2-8°C (36-46°F). Each vial, after reconstitution with 1.2 mL of the accompanying Sterile Water for Injection, USP, should be inspected visually for particulate matter or discoloration before use. Any vials exhibiting particulate matter or discoloration should not be used.
If necessary, the reconstituted solution can be stored for up to 24 hours at a temperature between 2°C and 8°C, while avoiding microbial contamination.
DO NOT USE Thyrogen after the expiration date on the vial. Protect from light.
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