Ioflupane I 123

What is Ioflupane I 123

Ioflupane I 123 is an intravenous, radioactive, diagnostic agent used to assist in the evaluation of adults with suspected Parkinsonian syndrome (PS) by helping to differentiate essential tremor from tremor due to PS (idiopathic Parkinson’s disease, multiple system atrophy, and progressive supranuclear palsy).

Ioflupane I 123 is administered in conjunction with single photon emission computed tomography (SPECT) to produce images of the brain, with abnormal scans being suggestive of PS-related tremors; however, these images are intended to be used only as an adjunct to other diagnostic tests.

Compared to normal SPECT images, which are characterized by 2 symmetrical regions of activity that are comma- or crescent-shaped, abnormal images will show 1 of the following: asymmetrical activity (i.e., activity in the putamen of 1 hemisphere while absent or reduced in the other); absent activity in the putamen of both hemispheres; or absent activity in the putamen of both hemispheres and greatly reduced activity in 1 or both caudate nuclei. Data from 2 studies, involving a total of 284 adults with tremor, were used to determine drug safety and efficacy. In the first study, 3 blinded readers evaluated scans from 99 patients with early signs or symptoms of PS.

The readers were able to correctly identify abnormal scans in 77%, 78%, and 79% of patients with PS (i.e., positive percent agreement); whereas normal scans among non-PS patients (i.e., negative percent agreement) were correctly identified in 96% of patients by each reader.

In the second study, scans from 185 patients with established diagnoses of PS or essential tremor were evaluated by 5 readers. In this study, readers had a positive percent agreement that ranged from 92% to 97% in patients with PS and a negative percent agreement that ranged from 74% to 96% in patients with essential tremor.

To block uptake of I 123 by the thyroid, premedication with potassium iodide oral solution or potassium perchlorate is necessary; failure to block thyroid uptake of iodine I 123 may result in increased long-term risk for thyroid cancer.

Ioflupane I 123 was FDA-approved in January 2011.

Indications

  • radiographic examination

For use during radiographic examination (single photon emission computed tomography [SPECT]) of the brain to differentiate essential tremor from tremor due to Parkinsonian syndromes

Side Effects

  • Dizziness
  • headache
  • nausea
  • vertigo

xerostomia occurred in < 1% of patients receiving ioflupane I 123 during clinical trials. All adverse reactions were deemed mild to moderate in severity

Monitoring Parameters

  • pregnancy testing

Contraindications

  • accidental exposure
  • breast-feeding
  • iodine hypersensitivity
  • pregnancy
  • pregnancy testing
  • radiation exposure
  • renal disease
  • renal impairment
  • reproductive risk
  • thyroid cancer

Interactions

No information is available regarding drug interactions associated with Ioflupane I 123 

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