IMPORTANT SAFETY CONSIDERATIONS (continued)
• Sudden, rapid and painful enlargement of residual thyroid tissue or
distant metastases can occur following treatment with Thyrogen.
• Pretreatment with glucocorticoids should be considered for patients in
whom tumor expansion may compromise vital anatomic structures.
• Patients should be well-hydrated prior to treatment with Thyrogen.
• Caution should be exercised in patients who have substantial thyroid
tissue still in situ or functional thyroid cancer metastases, specifically
in 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.
ADVERSE REACTIONS
• The most common adverse reactions reported in clinical trials were
nausea and headache.
USE IN SPECIFIC POPULATIONS
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: 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.
Renal Impairment: Elimination of Thyrogen is significantly slower
in dialysis-dependent end stage renal disease patients, resulting in
prolonged elevation of TSH levels.
See full Prescribing Information for more details.
www.thyrogen.com/~/media/Thyrogen/Files/PDFs/pi.pdf
