DATSCAN (Ioflupane I 123 Injection) indication expanded to include use in patients with suspected Dementia with Lewy Bodies (DLB) - Seite 2

Earlier this year, GE Healthcare announced plans to bolster its Molecular Imaging neurology portfolio by complementing DaTscan with two pipeline radiopharmaceuticals, one for Positron Emission Tomography (PET) and another for SPECT, aiming to offer customers, in both clinical and research settings, a wider choice of diagnostic tracers to help evaluate adult patients with suspected Parkinsonian syndromes.

GE Healthcare’s Pharmaceutical Diagnostics unit is a global leader in imaging agents used to support around 100 million procedures per year globally, equivalent to three patient procedures every second. Its Molecular Imaging portfolio combines established proprietary products across cardiology, neurology and oncology, with an innovative pipeline, all aimed at enabling better diagnosis and monitoring for improved therapy decision-making and clinical outcomes.

References:

ⁱ Barker, Warren W et al. “Relative frequencies of Alzheimer disease, Lewy body, vascular and frontotemporal dementia, and hippocampal sclerosis in the State of Florida Brain Bank.” Alzheimer disease and associated disorders vol. 16,4 (2002): 203-12. doi:10.1097/00002093-200210000-00001

ⁱⁱ Warr et al. Q J Nucl Med Mol Imaging; 2012; 56: 39-54

ⁱⁱⁱ Zweig and Galvin Alzheimer’s Research & Therapy 2014, 6.21; http://alzres.com/content/6/2/21

Product Indications and Important Safety Information – DaTscan

PRODUCT INDICATION AND USE

DATSCAN is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with:

• suspected Parkinsonian syndromes (PS) or
• suspected dementia with Lewy bodies (DLB).

Important Safety Information About DaTscan (ioflupane I 123 injection)

CONTRAINDICATIONS

• DaTscan is contraindicated in patients with known serious hypersensitivity to ioflupane I 123.

WARNINGS AND PRECAUTIONS

• Hypersensitivity Reactions: Hypersensitivity reactions, including dyspnea, edema, rash, erythema, and pruritus, have been reported following DATSCAN administration.

• Thyroid Accumulation: DaTscan may contain up to 6% of free iodide (iodine-123). Thyroid uptake of iodine-123 may result in an increased long-term risk for thyroid neoplasia. To decrease thyroid accumulation of iodine-123, block the thyroid gland before administration of DaTscan.

ADVERSE REACTIONS