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Thyrogen

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Thyrogen

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

THYROGEN-induced Hyperthyroidism

When given to patients who have substantial thyroid tissue still in situ or functional thyroid cancer metastases, THYROGEN is known to cause a transient (over 7 to 14 days) but significant rise in serum thyroid hormone concentration. There have been reports of death in non-thyroidectomized patients and in patients with distant metastatic thyroid cancer in which events leading to death occurred within 24 hours after administration of THYROGEN. Patients with residual thyroid tissue at risk for THYROGEN-induced hyperthyroidism include the elderly and those with a known history of heart disease. Hospitalization for administration of THYROGEN and post-administration observation in patients at risk should be considered.

Stroke

There are postmarketing reports of radiologically-confirmed stroke and neurological findings suggestive of stroke unconfirmed radiologically (e.g., unilateral weakness) occurring within 72 hours (range 20 minutes to three days) of THYROGEN administration in patients without known central nervous system metastases. The majority of such patients were young women taking oral contraceptives at the time of their event or had other risk factors for stroke, such as smoking or a history of migraine headaches. The relationship between THYROGEN administration and stroke is unknown. Patients should be well-hydrated prior to treatment with THYROGEN.

Sudden Rapid Tumor Enlargement

Sudden, rapid and painful enlargement of residual thyroid tissue or distant metastases can occur following treatment with THYROGEN. This may lead to acute symptoms, which depend on the anatomical location of the tissue. Such symptoms include acute hemiplegia, hemiparesis, and loss of vision one to three days after THYROGEN administration. Laryngeal edema, pain at the site of distant metastasis, and respiratory distress requiring tracheotomy have also been reported after THYROGEN administration.

Pretreatment with glucocorticoids should be considered for patients in whom tumor expansion may compromise vital anatomic structures.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term toxicity studies in animals have not been performed with THYROGEN to evaluate the carcinogenic potential of the drug. THYROGEN was not mutagenic in the bacterial reverse mutation assay. Studies have not been performed with THYROGEN to evaluate the effects on fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with THYROGEN.

It is also not known whether THYROGEN can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. THYROGEN 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 is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

In pooled clinical studies of THYROGEN, 60 patients (12%) were > 65 years, and 421 (88%) were ≤ 65 years of age. Results from controlled trials do not indicate a difference in the safety and efficacy of THYROGEN between adult patients less than 65 years and those over 65 years of age [see WARNINGS AND PRECAUTIONS].

Renal Impairment

Elimination of THYROGEN is significantly slower in dialysis-dependent end stage renal disease (ESRD) patients, resulting in prolonged elevation of TSH levels.

Last reviewed on RxList: 4/10/2014
This monograph has been modified to include the generic and brand name in many instances.

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