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Ioflupane I 123 Pregnancy and Breastfeeding Warnings

Ioflupane I 123 is also known as: DaTscan

Ioflupane I 123 Pregnancy Warnings

Ioflupane I-123 has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Ioflupane I-123 is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk. Like all radiopharmaceuticals, ioflupane I-123 has a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development, and the magnitude of the radionuclide dose. Administration of ioflupane I-123 at a dose of 185 MBq (5 mCi) results in an absorbed radiation dose to the uterus of 0.3 rad (3.0 mGy). Radiation doses greater than 15 rad (150 mGy) have been associated with congenital anomalies but doses under 5 rad (50 mGy) generally have not. Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function.

Ioflupane I 123 Breastfeeding Warnings

There are no data on the excretion of ioflupane into human milk. However, iodine 123 is excreted into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of ioflupane I-123 or not to administer ioflupane I-123, taking into account the importance of the drug to the mother. Based on the physical half-life of iodine 123 (13.2 hours), nursing women may consider interrupting nursing and pumping and discarding breast milk for 6 days after ioflupane I-123 administration in order to minimize risks to a nursing infant.

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