Diagnostic Agent

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

1. Patients with an undetectable Tg on thyroid hormone suppressive therapy to exclude the diagnosis of residual or recurrent thyroid cancer

2. Patients requiring serum Tg testing and radioiodine imaging who are unwilling to undergo thyroid hormone withdrawal testing and whose treating physician believes that use of a less sensitive test is justified

3. Patients who are either unable to mount an adequate endogenous TSH response to thyroid hormone withdrawal or in whom withdrawal is medically contraindicated

C

Hypersensitivity to any component

Caution should be exercised when administered to patients who have been previously treated with bovine TSH and, in particular, to those patients who have experienced hypersensitivity reactions to bovine TSH

1. There remains a meaningful risk of a diagnosis of thyroid cancer or of an underestimating the extent of disease when Thyrogen®-stimulated Tg testing is performed and in combination with radioiodine imaging

2. Thyrogen® Tg levels are generally lower than, and do not correlate with, Tg levels after thyroid hormone withdrawal

3. Newly detectable Tg level or a Tg level rising over time after Thyrogen® or a high index of suspicion of metastatic disease, even in the setting of a negative or low-stage Thyrogen® radioiodine scan, should prompt further evaluation such as thyroid hormone withdrawal to definitively establish the location and extent of thyroid cancer.

4. Decision to perform a Thyrogen® radioiodine scan in conjunction with a Thyrogen® serum Tg test and whether or when to withdraw a patient from thyroid hormones are complex. Pertinent factors in this decision include the sensitivity of the Tg assay used, the Thyrogen® Tg level obtained, and the index of suspicion of recurrent or persistent local or metastatic disease.

5. Thyrogen® is not recommended to stimulate radioiodine uptake for the purposes of ablative radiotherapy of thyroid cancer

6. The signs and symptoms of hypothyroidism which accompany thyroid hormone withdrawal are avoided with Thyrogen® use

1% to 10%:

Gastrointestinal: Nausea, vomiting

Neuromuscular & skeletal: Weakness, paresthesia

There has been no reported experience of overdose in humans

Store intact vials at 2°C to 8°C/36°F to 46°F; reconstitute each vial with 1.0 mL of sterile water for injection - each vial should be reconstituted immediately prior to use with diluent provided. If necessary, the reconstituted solution can be stored for up to 24 hours at 2°C to 8°C

An exogenous source of human TSH that offers an additional diagnostic tool in the follow-up of patients with a history of well-differentiated thyroid cancer. Binding of thyrotropin alpha to TSH receptors on normal thyroid epithelial cells or on well-differentiated thyroid cancer tissue stimulates iodine uptake and organification and synthesis and secretion of thyroglobulin, triiodothyronine, and thyroxine.

Mean peak concentrations: 3-24 hours after injection

Half-life, elimination: 25 ± 10 hours

Children >16 years and Adults: I.M.: 0.9 mg every 24 hours for 2 doses or every 72 hours for 3 doses. For radioiodine imaging, radioiodine administration should be given 24 hours following the final Thyrogen® injection. Scanning should be performed 48 hours after radioiodine administration (72 hours after the final injection of Thyrogen®).

I.M. injection into the buttock

No information available to require special precautions

No effects or complications reported

Kits containing two 1.1 mg vials (>4 int. units) of Thyrogen® and two 10 mL vials of sterile water for injection