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Data From a Pooled Analysis Presented at American Academy of Neurology's 66th Annual Meeting Shows Diagnostic Effectiveness of DaTscanTM (Ioflupane I123 Injection)

April 29, 2014

Philadelphia, PA, April 29, 2014 -- Data from a pooled analysis of four clinical trials, presented today at the American Academy of Neurology's 66th Annual Meeting in Philadelphia, showed that using DaTscan™ (Ioflupane I 123 Injection) with single-photon emission computed tomography (SPECT) brain imaging was associated with a high level of diagnostic effectiveness.[i]

The analysis showed high overall sensitivity and specificity of DaTscan images to detect a striatal dopaminergic deficit, which is associated with several conditions, including Parkinsonian syndromes (PS). Across all four studies, when images were assessed by on-site readers, the overall sensitivity was 91.9% and specificity was 83.6%. When images were assessed blindly by a panel of independent experts, the overall sensitivity was 88.7% and specificity was 91.2%.

DaTscan is a radiopharmaceutical approved in the United States for striatal dopamine transporter visualization, using SPECT brain imaging to assist in the evaluation of adult patients with suspected PS to help differentiate PS from essential tremor (ET). In Europe, where DaTscan is marketed as DaTSCAN, it is indicated for detecting loss of functional dopaminergic neuron terminals in the striata of adult patients with clinically uncertain PS to help differentiate PS from ET, or to help differentiate probable dementia with Lewy bodies (DLB) from Alzheimer's disease. DaTscan (DaTSCAN in the EU) are adjuncts to other diagnostic evaluations. 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.

The results of this pooled analysis were presented by Dr. Grosset during Session S8: Aging, Dementia, and Cognitive and Behavioral Neurology: PET Imaging on Tuesday, April 29, at 1:45 PM. The study was sponsored by GE Healthcare.

A Commitment to Understanding Neurodegenerative Disease

GE Healthcare takes a comprehensive approach to understanding a variety of neurological disorders, such as Alzheimer's disease, Parkinson's disease, posttraumatic stress disorder, concussion, traumatic brain injury, and multiple sclerosis, through its ongoing research to uncover the causes, risks, and physical effects of these conditions. By collaborating with the pharmaceutical industry to assist in the development of the next generation of therapies to treat these disorders and working with potential partners in the industry, GE Healthcare can provide imaging support for clinical trials of therapeutic agents.

Important Risk and Safety Information About DaTscan™ (Ioflupane I 123 Injection)

INDICATIONS AND USE: DaTscan is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single-photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected parkinsonian syndromes (PSs). DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson's disease [PD], multiple system atrophy [MSA], and progressive supranuclear palsy [PSP]). DaTscan is an adjunct to other diagnostic evaluations. DaTscan was not designed to distinguish among PD, MSA, and PSP. The effectiveness of DaTscan as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established. CONTRAINDICATIONS: DaTscan is contraindicated in patients with known hypersensitivity to the active substance, any of the excipients, or iodine. WARNINGS AND PRECAUTIONS --- Hypersensitivity Reactions: Hypersensitivity reactions, generally consisting of skin erythema and pruritus, have been reported following DaTscan administration. Thyroid Accumulation: The DaTscan injection may contain up to 6% of free iodide (iodine 123 or I-123). To decrease thyroid accumulation of I-123, block the thyroid gland at least one hour before administration of DaTscan; failure to do so may increase the long-term risk for thyroid neoplasia. ADVERSE REACTIONS: 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. DRUG INTERACTIONS: Drugs that bind to the dopamine transporter with high affinity may interfere with the DaTscan image. The impact of dopamine agonists and antagonists on DaTscan imaging results has not been established. SPECIFIC POPULATIONS --- Pregnancy: It is unknown whether DaTscan can cause fetal harm or increase the risk of pregnancy loss in pregnant women. DaTscan should be given to pregnant women only if clearly needed. Like all radiopharmaceuticals, DaTscan may cause fetal harm, depending on the stage of fetal development and the magnitude of the radionuclide dose. Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Nursing Mothers: It is not known whether DaTscan is excreted into human milk; however, I-123 is excreted into human milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of DaTscan or not to administer DaTscan at all. Nursing women may consider interrupting nursing and pump and discard breast milk for six days after DaTscan administration to minimize risks to a nursing infant. Pediatric Use: The safety and efficacy of DaTscan have not been established in pediatric patients. Geriatric Use: There were no differences in responses between the elderly and younger patients that would require a dose adjustment. Renal and Hepatic Impairment: The effect of renal or hepatic impairment on DaTscan imaging has not been established. The kidney excretes DaTscan; patients with severe renal impairment may have increased radiation exposure and altered DaTscan images. DRUG ABUSE AND DEPENDENCE: Ioflupane I 123 Injection is a DEA Schedule II controlled substance. A DEA license is required for handling or administering this controlled substance. OVERDOSAGE: It is unknown whether or not ioflupane is dialyzable. The major risks of overdose relate to increased radiation exposure and long-term risk for neoplasia. In case of radioactivity overdosage, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient. PROCEDURE --- Radiation Safety: DaTscan emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients.

Prior to DaTscan administration, please read the Full Prescribing Information.


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[i] Grosset D, Grachev I, O'Brien J, et al. Integrated analysis of [123I]FP-CIT (DaTscan; Ioflupane I123 Injection) SPECT brain imaging - diagnostic effectiveness in patients with movement disorders and/or dementia. Data presented at: 66th Annual Meeting of the American Academy of Neurology, April 29, 2014, Philadelphia, PA.

Aleisia Gibson
[email protected]

Scott Lerman
[email protected]

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