Thyrogen 0.9 mg Powder for Solution for Injection

INDICATIONS AND USAGE

• Adjunctive Diagnostic Tool for Serum Thyroglobulin Testing in Well Differentiated Thyroid Cancer

  THYROGEN® 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 who have previously undergone thyroidectomy.

  Limitations of Use:

  • THYROGEN-stimulated Tg levels are generally lower than, and do not correlate with, Tg levels after thyroid hormone withdrawal [see Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].
  • Even when THYROGEN-stimulated Tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or of underestimating the extent of disease.
  • Anti-Tg antibodies may confound the Tg assay and render Tg levels uninterpretable [see Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Therefore, in such cases, even with a negative or low-stage THYROGEN radioiodine scan, consideration should be given to further evaluating patients.

• Adjunct to Treatment for Ablation in Well Differentiated Thyroid Cancer

  THYROGEN 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 distant metastatic thyroid cancer.

CONTRAINDICATIONS

If THYROGEN is administered with radioiodine, the contraindications to radioiodine also apply to this combination regimen. Refer to the radioiodine prescribing information for a list of contraindications for radioiodine.

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.