Safety profile of DaTscan™ (Ioflupane I 123 Injection), a radiopharmaceutical indicated for visualization of the striatal dopamine transporter using SPECT

Objectives To assess DaTscan ([123I]Ioflupane) safety data from 11 clinical trials in GE Healthcare’s clinical development and post-marketing experience.

Methods In GE-sponsored clinical trials, DaTscan was administered intravenously to 1236 subjects (1171 patients and 65 healthy volunteers). Clinical trials collected information on adverse events (AEs), and collected data on laboratory parameters (e.g., serum biochemistry, hematology and urinalysis), vital signs and electrocardiograms (ECG). Administered activity of [123I]ioflupane ranged from 3 to 5 mCi (111 to 185 MBq; a maximum mass dose of 0.325 microgram), comparable to administered activities for other commercially available 123I-labeled imaging products. The calculated whole body effective dose was 4 to 6 mSv, comparable to 1 year of natural background radiation in the USA (3 to 4 mSv).

Results Review of clinical trial data on non-serious AEs, vital signs, laboratory parameters, and ECG identified no safety issues. There were mild and infrequently reported AEs and no SAEs or deaths that were considered related to DaTscan administration. The most common AE ascribed to DaTscan by the investigator was headache (1%), followed by nausea, and vertigo, dry mouth, hunger, dizziness, and formication (<1 % each). Most of these AEs were mild. The safety profile established in clinical trials is supported by limited AE reports (including hypersensitivity reported as rash and pruritis shortly after dosing) from post-marketing exposure in over 300,000 patients who have been imaged with DaTscan.

Conclusions Comprehensive review of the safety data from clinical trials and 12 years of post-marketing use shows that adverse events associated with diagnostic radiopharmaceutical DaTscan are mild and infrequently reported, and DaTscan is a safe product to use. DaTscan is also considered to be low risk from a radiation dosimetry perspective.

Research Support This study was sponsored and conducted by GE Healthcare, Princeton, NJ, USA.