DATSCAN

The pharmacokinetics of ioflupane I 123 were studied by monitoring radioactivity following intravenous injection; only 5% of the administered radioactivity remained in whole blood at 5 minutes post-injection. Uptake in the brain reached approximately 7% of injected radioactivity at 10 minutes post-injection and decreased to 3% after 5 hours; striata to background ratios were relatively constant between 3 hours and 6 hours post-injection. About 30% of the whole brain radioactivity was attributed ...

14.1 Suspected Parkinsonian Syndromes The safety and efficacy of DATSCAN were evaluated in two multicenter, single-arm, open-label studies (Study 1 and Study 2) that enrolled 284 adult patients with suspected PS. In these studies, DATSCAN image interpretation was compared to a reference clinical diagnostic standard of "PS" or "non-PS". PS consisted of Parkinson's disease (PD), multiple system atrophy (MSA), and progressive supranuclear palsy (PSP). These conditions have been associated with dopaminergic neurodegeneration and DATSCAN imaging was not designed to distinguish among the conditions....

The following clinically significant adverse reaction is described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] The following adverse reactions were reported at ≤1%: headache, nausea, vertigo, dry mouth and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditio...

DATSCAN is contraindicated in patients with known serious hypersensitivity to ioflupane I 123 [see Warnings and Precautions (5.1) ] . Known serious hypersensitivity to ioflupane I 123 ( 4 )

Hypersensitivity Reactions: Hypersensitivity reactions including dyspnea, edema, rash, erythema, and pruritus have been reported. Have treatment measures available prior to DATSCAN administration. ( 5.1 ) Thyroid Accumulation of Iodine-123: Thyroid uptake of iodine-123 may result in an increased long-term risk for thyroid neoplasia. ( 2.2 , 5.2 ) Radiation Risk: Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and afte...

7 DRUG INTERACTIONS Ioflupane I 123 binds to the dopamine transporter [see Clinical Pharmacology (12.1) ] . Drugs that bind to the dopamine transporter with high affinity may interfere with the image obtained following DATSCAN administration. These potentially interfering drugs consist of: amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, m...