Diagnostic
PREGNANCY RECOMMENDATION: Contraindicated
BREASTFEEDING RECOMMENDATION: Contraindicated
PREGNANCY SUMMARY
No reports describing the use ioflupane iodine123 in human pregnancy have been located. Reproduction studies in animals have not been performed. In 2012, the Society of Nuclear Medicine stated that the drug was contraindicated in pregnancy (1).
FETAL RISK SUMMARY
Ioflupane iodine123 is a radiopharmaceutical for IV injection. It is indicated for striatal dopamine transporter visualization using single photon emission computed tomography brain imaging to assist in the evaluation of adult patients with suspected parkinsonian syndromes. The recommended dose is 111–185 MBq (3–5 mCi). Only about 5% of the administered radioactivity remained in whole blood 5 minutes after injection. By 48 hours, about 60% of the radioactivity had been excreted in the urine and about 14% in the feces. The physical half-life of iodine123 is 13.2 hours (2).
Reproduction studies in animals have not been conducted. Studies for carcinogenic potential and reproductive toxicity of ioflupane have not been conducted, but there was no evidence of mutagenesis in multiple assays (2).
In humans, a dose of 185 MBq results in an absorbed radiation dose to the uterus of 0.3 rad, Radiation doses >15 rad have been associated with congenital anomalies but doses <5 rad generally have not. However, radioactive iodine products cross the placenta and, depending on the stage of fetal development, can permanently impair fetal thyroid function (2).
BREASTFEEDING SUMMARY
Although no specific reports describing the use of ioflupane iodine123 during lactation have been located, it is known that iodine123 is excreted into breast milk. The manufacturer recommends that breastfeeding should not be started before the radiopharmaceutical is administered, or if breastfeeding is already underway, it should be interrupted. Based on the physical half-life of iodine123 (13.2 hours), nursing women should pump and discard breast milk for 6 days to minimize risks to a nursing infant (2). The breasts should be emptied regularly and completely. Milk that has been pumped during this period should either be discarded or stored in a refrigerator. The stored milk can be given to infant after 10 physical half-lifes, or about 5.5 days have elapsed since pumping (3).
References
1.Djang DSW, Janssen MJR, Bohnen N, Booij J, Henderson TA, Herholz K, Minoshima S, Rowe CC, Sabri O, Seibyl J, Van Berckel BNM, Wanner M. SNM practice guideline for dopamine transporter imaging with 123I-ioflupane SPECT 1.0. J Nucl Med 2012;53:154–63.
2.Product information. DaTscan. GE Healthcare, Medi-Physics, 2011.
3.Ioflupane I 123. National Library of Medicine LactMed Database. Available at http://toxnet.nlm.gov/cgi-bin/sis/htmlgen?LACT. Accessed May 29, 2013.