Pancreatic, thyroid, and other endocrine cancers:

Indications for: THYROGEN

Adjunctive diagnostic tool for serum thyroglobin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy. 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.

Adult Dosage:

Give by IM inj into the buttock. 0.9mg, followed by a second 0.9mg injection 24 hours later. For radioiodine imaging or remnant ablation, give radioiodine 24 hours after the second Thyrogen injection.

Children Dosage:

Not established.

THYROGEN Warnings/Precautions:

See full labeling. Reports of death in patients who are non-thyroidectomized or with distant metastatic thyroid cancer wthin 24hrs after administration. Heart disease, metastatic disease: increased risk of Thyrogen-induced hyperthyroidism, consider hospitalization for administration and post-administration observation. Caution patients regarding possible neurologic symptoms. Consider pretreatment with glucocorticoids in those whose tumor expansion may compromise vital anatomic structures (eg, trachea, lung metastases). Anti-thyroglobulin (Tg) antibodies may render Tg levels uninterpretable; consider further evaluation with thyroid hormone withdrawal scan. Residual thyroid tissue. End-stage renal disease. Elderly. Pregnancy, nursing mothers: contraindicated if concomitant with radioiodine.

THYROGEN Classification:

Thyroid stimulating hormone (recombinant).

Adverse Reactions:

Nausea, headache, fatigue, influenza-like symptoms; death (in non-thyroidectomized or with distant metastatic thyroid cancer), stroke and other neurologic events, sudden rapid tumor enlargement in distant metastatic thyroid cancer.

Metabolism:

Hepatic.

Drug Elimination:

Renal.

Generic Drug Availability:

NO

How Supplied:

Single-dose vials—2