Thyrogen

/ Sanofi

THYROGEN should be used by physicians knowledgeable in the management of patients with thyroid cancer.
THYROGEN is indicated as a two-injection regimen. The recommended dosage of THYROGEN is a 0.9 mg intramuscular injection to the buttock followed by a second 0.9 mg intramuscular injection to the buttock 24 hours later.
THYROGEN should be administered intramuscularly only. THYROGEN should not be administered intravenously.
Pretreatment with glucocorticoids should be considered for patients in whom tumor expansion may compromise vital anatomic structures.
Routine measurement of serum TSH levels is not recommended after THYROGEN use.

Radioiodine imaging, serum Tg testing.

I.V. administration.

Pregnancy and lactation. Risk of missing diagnosis of thyroid cancer. Thyroid hormone withdrawal Tg testing remains standard diagnostic modality.

Nausea, headache.

Non reported.

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.

In clinical trials of THYROGEN, three patients experienced symptoms after receiving THYROGEN doses higher than those recommended. Two patients had nausea after a 2.7 mg IM dose (3 times the recommended dose), and in one of these patients, the event was accompanied by weakness, dizziness and headache. Another patient experienced nausea, vomiting and hot flashes after a 3.6 mg IM dose (4 times the recommended dose). There is no specific therapy for THYROGEN overdose. Supportive care is recommended.
In addition, one patient experienced symptoms after receiving Thyrogen intravenously. This patient received 0.3 mg Thyrogen as a single intravenous bolus and, 15 minutes later experienced severe nausea, vomiting, diaphoresis, hypotension (BP decreased from 115/66 mm Hg to 81/44 mm Hg) and tachycardia (pulse increased from 75 to 117 bpm).