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(see INDICATIONS AND USAGE, Considerations in the Use of Thyrogen (thyrotropin alfa for injection) )

General

The use of Thyrogen (thyrotropin alfa for injection) (thyrotropin alfa for injection) should be directed by physicians knowledgeable in the management of patients with thyroid cancer.

There have been reports of deaths in which events leading to death occurred within 24 hours after administration of Thyrogen (thyrotropin alfa for injection) . A 77 year-old non-thyroidectomized patient with a history of heart disease and spinal metastases who received 4 Thyrogen (thyrotropin alfa for injection) injections over 6 days in a special treatment protocol experienced a fatal MI 24 hours after he received the last Thyrogen (thyrotropin alfa for injection) injection. The event was likely related to Thyrogen (thyrotropin alfa for injection) -induced hyperthyroidism. In post-marketing experience, there have been rare reports of events leading to death that occurred within 24 hours of administration of Thyrogen (thyrotropin alfa for injection) in patients with multiple serious medical problems. For patients for whom Thyrogen (thyrotropin alfa for injection) -induced hyperthyroidism could have serious consequences, hospitalization for administration of Thyrogen (thyrotropin alfa for injection) 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.

Thyroglobulin (Tg) antibodies may confound the Tg assay and render Tg levels uninterpretable. Therefore, in such cases, even with a negative or low-stage Thyrogen (thyrotropin alfa for injection) radioiodine scan, consideration should be given to evaluating patients further with, for example, a confirmatory thyroid hormone withdrawal scan to determine the location and extent of thyroid cancer.

Thyrogen (thyrotropin alfa for injection) should be administered intramuscularly only. It should not be administered intravenously.

TSH antibodies have not been reported in patients treated with Thyrogen (thyrotropin alfa for injection) in the clinical trials, although only 27 patients received Thyrogen (thyrotropin alfa for injection) on more than one occasion.

Caution should be exercised when Thyrogen (thyrotropin alfa for injection) is administered to patients who have been previously treated with bovine TSH and, in particular, to those patients who have experienced hypersensitivity reactions to bovine TSH.

Thyrogen (thyrotropin alfa for injection) is known to cause a transient but significant rise in serum thyroid hormone concentration when given to patients who have substantial thyroid tissue still in situ. Therefore, caution should be exercised in patients with a known history of heart disease and with significant residual thyroid tissue (see ADVERSE REACTIONS).

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) (see ADVERSE REACTIONS).

Careful evaluation of benefit risk relationships should be assessed for high risk elderly patients with functioning thyroid tumors undergoing Thyrogen (thyrotropin alfa for injection) administration. This may result in palpitations or cardiac rhythm disorder (see ADVERSE REACTIONS).

Elimination of Thyrogen (thyrotropin alfa for injection) is significantly slower in dialysis-dependent end stage renal disease (ESRD) patients, resulting in prolonged elevation of TSH levels (see ADVERSE REACTIONS).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term toxicity studies in animals have not been performed with Thyrogen (thyrotropin alfa for injection) to evaluate the carcinogenic potential of the drug. Thyrogen (thyrotropin alfa for injection) was not mutagenic in the bacterial reverse mutation assay. Studies have not been performed with Thyrogen (thyrotropin alfa for injection) to evaluate the effects on fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with Thyrogen (thyrotropin alfa for injection) .

It is also not known whether Thyrogen (thyrotropin alfa for injection) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Thyrogen (thyrotropin alfa for injection) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Thyrogen (thyrotropin alfa for injection) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 16 years have not been established. Geriatric Use Results from controlled trials indicate no difference in the safety and efficacy of Thyrogen (thyrotropin alfa for injection) between adult patients less than 65 years and those greater than 65 years of age.

Last reviewed on RxList: 9/22/2008
This monograph has been modified to include the generic and brand name in many instances.