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Indication

Thyrogen® (thyrotropin alfa for injection) is indicated for use as an additional tool to identify thyroid disease (by testing the blood for a hormone called thyroglobulin), with or without a radiology test using a form of iodine, in the follow up of patients with a certain type of thyroid cancer (known as well differentiated thyroid cancer).

Thyrogen® (thyrotropin alfa for injection) is also indicated for use as a preparation for treatment with a form of iodine to remove left over thyroid tissue in patients who have had surgery to take out the entire thyroid gland for a certain type of thyroid cancer (known as well differentiated thyroid cancer) and who do not have signs of thyroid cancer which has spread to other parts of the body.

Important Safety Information

  • Since Thyrogen was first approved for use, there have been rare reports of events that led to death in patients with several serious health problems; rare reports of central nervous system problems such as stroke and weakness on one side of the body; and rare reports of a quick and painful growth of cancer tumors that have returned to different sites in the body.
  • Before getting Thyrogen, your doctor should talk to you about finding medical help immediately if you have any central nervous system problems after you get Thyrogen. Your doctor may need to treat you with a glucocorticoid (a medication to help prevent an increase in the size of the cancer tumor) if you may have cancer tumors near your windpipe, in your central nervous system, or in your lungs.
  • When Thyrogen is used to help detect thyroid cancer, there is still a chance all—or parts of—your cancer could be missed.
  • In a study of people being prepared for treatment with a form of iodine after thyroid surgery, results were similar between those who received Thyrogen and those who stopped taking their thyroid hormone. Researchers do not know if results would be similar over a longer period of time.
  • Your doctor may take extra steps to care for you during Thyrogen treatment if you have heart disease and large amounts of remaining thyroid tissue after surgery.
  • If you are over 65 years old and did not have your entire thyroid removed during treatment of your cancer, you may be at risk for abnormal heartbeat while receiving Thyrogen. Because of this, you and your doctor will need to carefully consider the risks and benefits of Thyrogen before starting it.
  • In clinical studies, the most common side effects reported were upset stomach, headache, tiredness, throwing up, dizziness, prickling and tingling sensation, weakness, difficulty sleeping, and diarrhea.

Please see full Prescribing Information.