IOFLUPANE I-123

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 Ioflupane I 123 Injection 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, Ioflupane I 123 Injection 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 Ioflupane I 123 Injection imaging...

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 CURIUM US LLC at 1-866-789-2211 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 con...

Ioflupane I 123 Injection 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 Ioflupane I 123 Injection 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 hydra...

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 Ioflupane I 123 Injection administration. These potentially interfering drugs consist of: amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol...