DaTscan imaging contributes to a more certain diagnosis when used as an adjunct in the work-up of patients with possible DLB.
Important Safety Information
PRODUCT INDICATION AND USE
DATSCAN is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with:
suspected Parkinsonian syndromes (PS) or
suspected dementia with Lewy bodies (DLB).
DaTscan is contraindicated in patients with known serious hypersensitivity to ioflupane I 123.
In clinical trials, headache, nausea, vertigo, dry mouth, or dizziness of mild to moderate severity were reported. In postmarketing experience, hypersensitivity reactions and injection-site pain have been reported
Please read the full Prescribing Information here
, for additional Important Safety Information.
To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2, then option 1) or the FDA at 800 FDA 1088 or www.fda.gov/medwatch