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Label Changes for:

Thyrogen (thyrotropin alfa for injection)

July 2012

Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2012

 

 

PRECAUTIONS

Death in Patients Who are not Thyroidectomized or with Distant Metastatic Thyroid Cancer
  • There have been reports of death in which events leading to death occurred within 24 hours after administration of Thyrogen (see ADVERSE REACTIONS, Death in Patients Who are not Thyroidectomized or with Distant Metastatic Thyroid Cancer). For patients for whom Thyrogen-induced hyperthyroidism could have serious consequences, hospitalization for administration of Thyrogen and post-administration observation should be considered. Such patients might include those with known heart disease, extensive metastatic disease, or other known serious underlying illness
Stroke and Other Neurologic Events
  • There have been reports of neurologic events, including acute hemiplegia or hemiparesis, occurring one to three days after Thyrogen administration to patients with CNS metastases. These neurologic events appear to have been associated with sudden rapid tumor enlargement. There have also been postmarketing reports of stroke or unilateral weakness occurring within 72 hours (range 20 minutes to three days) of Thyrogen administration to women without known CNS metastases.
  • Prior to administration of Thyrogen, patients should be counseled to seek care immediately for any neurologic symptoms occurring after administration of the drug.
Sudden Rapid Tumor Enlargement in Distant Metastatic Thyroid Cancer
  • Sudden, rapid and painful enlargement of locally recurring papillary carcinoma has been reported within 12-48 hours of Thyrogen administration. The enlargement was accompanied by dyspnea, stridor or dysphonia. Rapid clinical improvement occurred following glucocorticoid therapy. It is recommended that pretreatment with glucocorticoids be considered for patients in whom local tumor expansion may compromise vital anatomic structures (such as trachea, central nervous system, or extensive macroscopic lung metastases)


ADVERSE REACTIONS

Death in Patients who are not Thyroidectomized or with Distant Metastatic Thyroid Cancer
  • There have been reports of death in which events leading to death occurred within 24 hours after administration of Thyrogen. A 77 year-old non-thyroidectomized patient with a history of heart disease and spinal metastases who received 4 Thyrogen injections over 6 days in a special treatment protocol experienced a fatal MI 24 hours after he received the last Thyrogen injection. ...
Stroke and Other Neurologic Events
  • Four patients out of 55 (7.3%) with CNS metastases who were followed in a special treatment protocol experienced acute hemiplegia, hemiparesis or pain one to three days after Thyrogen administration. The symptoms were attributed to local edema and/or focal hemorrhage at the site of the cerebral or spinal cord metastases. In addition, one case of acute visual loss with onset of symptoms within 24 hours after Thyrogen administration, has been reported in a patient with metastases to the optic nerve...
Sudden Rapid Tumor Enlargement in Distant Metastatic Thyroid Cancer
  • Sudden, rapid and painful enlargement of locally recurring papillary carcinoma has been reported within 12-48 hours of Thyrogen administration. The enlargement was accompanied by dyspnea, stridor or dysphonia. Rapid clinical improvement occurred following glucocorticoid therapy.
General
  • Adverse reaction data were derived from post-marketing surveillance and clinical trials. The percentages in Table 4 below represent adverse reactions experienced by 481 thyroid cancer patients who participated in the clinical trials for Thyrogen. Most patients received 2 intramuscular injections, 0.9 mg of thyrotropin alfa per injection, 24 hours apart...
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