DaTscan is the first radiopharmaceutical diagnostic tracer approved by
Builds on DaTscan’s global market leadership with over one million doses already used worldwide in the clinical evaluation of Parkinson’s syndromes
One in five dementia patients suffer from DLB, the second most common form of degenerative dementia after Alzheimer’s disease
The clinical signs and symptoms of DLB can be atypical and may overlap with other forms of dementia, leading to up to 70% of DLB patients being misdiagnosed, often with Alzheimer’s diseaseii. This new indication allows clinicians to use DaTscan to help differentiate DLB from other forms of dementia. Early and accurate diagnosis of DLB can help ensure appropriate specific treatment and specialized care for patients, while allowing them and their caregivers to more effectively manage the disease and plan for the futureiii.
About one in five dementia patients suffer from DLB, making it the second most common form of degenerative dementia after Alzheimer’s disease.
Approval of DaTscan for use in DLB is the culmination of significant work, including clinical trials, data collection and analysis, and evidence collation for submission to the
At the beginning of this year,
i Barker, Warren W et al. ‘Relative frequencies of Alzheimer’s disease, Lewy bodies, vascular and frontotemporal dementia and hippocampal sclerosis in the State of
ii Warr et al. QJ Nucl Med Mol Images; 2012; 56: 39-54
iii Zweig and
Product Indications and Important Safety Information – DaTscan
INDICATION AND USE OF THE PRODUCT
DATSCAN is indicated as an adjunct to other diagnostic evaluations for visualization of the striatal dopamine transporter using single photon emission computed tomography (SPECT) brain imaging in adult patients with:
suspected parkinsonian syndrome (PS) or suspected dementia with Lewy bodies (DLB).
Important Safety Information for DaTscan (Ioflupan I 123 Injection)
DaTscan is contraindicated in patients with known severe hypersensitivity to ioflupane I 123.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Hypersensitivity reactions, including dyspnea, edema, rash, erythema, and pruritus, have been reported following administration of DATSCAN.
Thyroid Accumulation: DaTscan may contain up to 6% free iodide (iodine-123). Thyroid uptake of iodine-123 may result in an increased long-term risk of thyroid neoplasia. To decrease iodine-123 accumulation in the thyroid, block the thyroid gland prior to administration of DaTscan.
Mild to moderate headache, nausea, vertigo, dry mouth, or dizziness were reported in clinical trials. In post-marketing experience, hypersensitivity reactions and pain at the injection site have been reported.
Drugs that bind to the dopamine transporter with high affinity can interfere with DaTscan imaging. The impact of dopamine agonists and antagonists on DaTscan imaging results has not been established.
USE IN SPECIFIC POPULATIONS
Pregnancy: Radioactive iodine products cross the placenta and may permanently affect fetal thyroid function. Administration of a thyroid-blocking agent is recommended prior to the use of DaTscan in a pregnant woman. All radiopharmaceuticals have the potential to cause fetal harm. There are no data available on the use of DaTscan in pregnant women to assess the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Inform the pregnant woman of the potential risks of fetal radiation exposure with DaTscan administration
Lactation: Iodine 123 (I 123), the radionuclide in DaTscan, is present in human milk. There is no information on the effects on infants or on milk. Advise a lactating woman to discontinue nursing and express and discard breast milk for at least 6 days after administration of DaTscan to minimize radiation exposure to a nursing infant.
Pediatric Use: The safety and efficacy of DaTscan in pediatric patients have not been established.
Geriatric Use: No differences in responses between elderly and younger patients requiring dose adjustment were observed in the Parkinsonian syndrome studies.
Renal Impairment: DaTscan is excreted by the kidney and patients with severe renal impairment may have increased radiation exposure and altered DaTscan images.
The risks of overdose are predominantly related to increased radiation exposure, with long-term risks of neoplasia. In case of radioactivity overdose, frequent urination and defecation should be recommended to minimize the patient’s exposure to radiation.
PROCEDURE – Radiological Safety
DaTscan emits radiation and must be handled safely to minimize radiation exposure to clinical staff and patients.
Prior to DaTscan administration, please read the full Prescribing Information for additional information.
Important Security Information.
To report SUSPECTED ADVERSE REACTIONS, contact
DaTscan is a radiopharmaceutical imaging agent that works by binding to dopamine transporters (DaT) in the brain. A specific marker for DaT, DaTscan produces images that provide visual evidence based on the density of dopamine transporters.
DaTscan was the first FDA-approved complementary radiopharmaceutical imaging agent to help clinicians evaluate patients with suspected parkinsonian syndromes (PS), such as Parkinson’s disease (PD).
DaTscan has been available in the US since 2011 and has been used in more than 1 million patients in 40 countries.
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