INDICATIONS AND USAGE（适应症）

Adjunctive Diagnostic Tool for 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.

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. Therefore, in such cases, even with a negative or low-stage THYROGEN radioiodine scan, consideration should be given to further evaluating patients.

Adjunct for Thyroid Remnant 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.

Limitations of Use:

The effect of THYROGEN on thyroid cancer recurrence greater than five years post-remnant ablation has not been evaluated.

DOSAGE（服用剂量）

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.

Routine measurement of serum TSH levels is not recommended after THYROGEN use.

ADVERSE REACTIONS（不良反应）

Transient (<48 hours) influenza-like symptoms, including fever (>100°F/38°C), chills/shivering, myalgia/arthralgia, fatigue/asthenia/malaise, headache, and chills.

Hypersensitivity including urticaria, rash, pruritus, flushing, and respiratory signs and symptoms.

Injection site reactions, including pain, erythema, bruising, and pruritus.

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/b52dfa36-f90b-4e19-9b5e-26db9d04df2b/spl-doc?hl=Thyrogen

Thyrogeninformation