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Administration

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 diluents, if provided, is intended for single use. Discard unused portion of the diluents.

Thyrogen should be stored at 2-8 ºC (36-46 ºF). 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 ºC and 8 ºC, while avoiding microbial contamination.

DO NOT USE Thyrogen after the expiration date on the vial. Protect from light.

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 are recommended for diagnostic radioiodine scanning with Thyrogen:

Ø A diagnostic activity of 4mCi (148 MBq) ¹³¹I should be used.

Ø Whole images should be acquired for a minimum of 30 minutes and/or should contain a minimum of 140,000 counts.

Ø Scanning times for single (spot) images of body regions should be 10-15 minutes or less of 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 of 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.

Indication
Thyrogen (thyrotropin alfa for injection) is indicated for use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer.

Thyrogen (thyrotropin alfa for injection) is indicated for use as an 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.

Important Safety Information

When Thyrogen-stimulated serum thyroglobulin (Tg) testing is performed in combination with radioiodine imaging, there remains a meaningful risk of missing a diagnosis of thyroid cancer or of underestimating the extent of disease.
Although Thyrogen appeared non-inferior to thyroid hormone withdrawal in a study of postsurgical thyroid remnant ablation, long-term clinical outcome data are limited. Due to relatively small clinical experience with Thyrogen in remnant ablation, it is not possible to conclude whether long-term thyroid cancer outcomes would be equivalent after use of Thyrogen or hormone withdrawal for TSH elevation prior to remnant ablation.
Caution should be exercised in patients with a known history of heart disease and with significant residual thyroid tissue. Careful evaluation of benefit risk should be assessed for high risk elderly patients with functioning thyroid tumors undergoing Thyrogen administration, to avoid palpitations or cardiac rhythm disorder.
It is recommended that pretreatment with glucocorticoids be considered for patients in whom local tumor expansion may comprise vital anatomic structures (such as trachea, central nervous system, or extensive macroscopic lung metastases).
In clinical studies, the most common side effects reported were nausea, headache, fatigue, vomiting, dizziness, paraesthesia, asthenia, insomnia, and diarrhea.

Please see accompanying full Prescribing Information.