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Overview

Details

Resources

Support

Patient Education

Web ordering Product monograph

DaTscan™ (Ioflupane I123 Injection)

DaTscan™ (Ioflupane I 123 injection) 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).¹

At a glance

Confidence inside the vial and far beyond

A pioneer and leader in DaT SPECT imaging, supported by more than a decade of data demonstrating clinical value that may aid in diagnosis^2-7

Diagnosis with purpose

DaTscan can significantly contribute to a more certain diagnosis, proving to be a useful adjunct in the work-up of PS¹³

Supply chain precision from dose to delivery

Backed by 8+ years of supply chain excellence, our state-of-the-art manufacturing facility meticulously works to deliver every dose on-time

More than a manufacturer

Expertise included with every vial includes a dedicated account manager, medical affairs including clinical applications, and reimbursement support

Confidence in the vial and far beyond

DaTscan is a radiopharmaceutical used in a brain scan (SPECT) to visualize striatal dopamine transporters assisting in the evaluation of patients with suspected Parkinsonian syndromes (PS). DaTscan does not replace the physician’s clinical diagnosis, but may help support clinical evaluation and improve diagnostic confidence.

Confidence in numbers

years in Canada

>1.4 M

doses delivered worldwide

3.5 Min

a patient is scanned every 3.5 min worldwide

100k

in the Canada are currently living with Parkinson’s disease, one of the world’s fastest growing neurological disorders⁸

Features

DaTscan is a proven diagnostic tool for the evaluation of Parkinsonian syndromes.

While early detection can result in reduced treatment cost and improved clinical outcomes, providing an early and accurate diagnosis can be challenging.

Diagnostic clarity

Diagnosis through dopamine transporter (DaT) imaging

Combining clinical assessment with DaT SPECT imaging in the early part of the diagnostic process could reduce overdiagnosis, helping to avoid inappropriate therapy.⁹
Multiple studies have reported similarly high rates of change in diagnosis with DaTscan imaging.^2,4,7 Patients with an abnormal DaTscan were more likely to receive a final diagnosis of PS, while patients with a normal DaTscan were more likely to receive a final diagnosis of non-PS.

datscan-brain-scan-hero-sticky-scrolling-st-en

Confidence inside the vial and far beyond

Reassurance of clinical value and diagnostic assistance established through multiple clinical trials

1,300+ publications on DaTscan are available, supporting effectiveness, utility and potential impact on patient management.¹² Significant evidence base for the imaging results of DaTscan have contributed to its integration into key international guidelines.^10,11

confidence-in-vial-hero-sticky-scrolling-st-en

References

DaTscan [Product Monograph]; Mississauga, ON; 2026
Catafau AM, et al. Impact of dopamine transporter SPECT using 123I-ioflupane on diagnosis and management of patients with clinically uncertain parkinsonian syndromes. Mov Disord. 2004 Apr 22; 19(10): 1175-1182.
Hauser RA, Grosset DG. [123I]FP-CIT (DaTscan) SPECT brain imaging in patients with suspected parkinsonian syndromes. J Neuroimaging. 2011 Mar 16; 22(3): 225-230.
Kupsch AR, et al. Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study. J Neurol Neurosurg Psychiatry. 2012 Apr 6; 83(6): 620-628.
Hauser RA, et al. Sensitivity, specificity, positive and negative predictive values and diagnostic accuracy of DaTscan™ (ioflupane I123 injection): predicting clinical diagnosis in early clinically uncertain parkinsonian syndrome. J Neurol Stroke. 2014 May 11; 1(1): 7-20.
Bajaj N, et al. Association between Hoehn and Yahr, mini-mental state examination, age, and clinical syndrome predominance and diagnostic effectiveness of ioflupane I 123 injection (DaTSCAN™) in subjects with clinically uncertain parkinsonian syndromes. Alzheimers Res Ther. 2014 Oct 8; 6(5-8): 67.
Isaacson JR, et al. Impact of DaTScan imaging on clinical decision making in clinically uncertain Parkinson’s disease. J Parkinson’s Dis. 2021 Apr 13; 11(2): 885-889.
Yang W, et al. Current and projected future economic burden of Parkinson’s disease in the U.S. NPJ Parkinsons Dis. 2020 Jul 9; 6:15.
Marshall VL, Patterson J, Hadley DM, Grosset KA, Grosset DG. Two-year follow-up in 150 consecutive cases with normal dopamine transporter imaging. Nucl Med Commun. 2006;27:933-937.
Berardelli A, Wenning GK, Antonini A, et al. EFNS/MDS-ES/ENS recommendations for the diagnosis of Parkinson’s disease. Eur J Neurol. 2013;20(1):16-34. doi:10.1111/ene.12022
Postuma RB, Berg D, Stern M, et al. MDS clinical diagnostic criteria for Parkinson’s disease. Mov Disord. 2015;30(12):1591-1601. doi:10.1002/mds.26424
Data on file. GE HealthCare
Hauser RA, Bajaj N, Marek K, et al. Sensitivity, specificity, positive and negative predictive values and diagnostic accuracy of DaTscan™ (Ioflupane I123 injection): predicting clinical diagnosis in early clinically uncertain parkinsonian syndrome. J Neurol Stroke. 2014;1(1):7‒20. DOI: 10.15406/jnsk.2014.01.00003

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IMPORTANT SAFETY INFORMATION for DaTscan™ (Ioflupane [123I] Injection)

PRODUCT INDICATION AND CLINICAL USE

DaTscan is indicated for visualization of functional striatal dopamine transporter using single photon emission computed tomography (SPECT) brain imaging in adult patients with suspected Parkinsonian Syndromes (PS). DaTscan SPECT imaging may be used as an adjunct to other established evaluations to help differentiate essential tremor from tremor due to PS related to idiopathic Parkinson's Disease (PD), multiple system atrophy (MSA), and progressive supranuclear palsy (PSP). DaTscan is unable to discriminate between PD, MSA, and PSP.

CONTRAINDICATIONS

DaTscan is contraindicated in patients who are hypersensitive to ioflupane or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container.

WARNINGS AND PRECAUTIONS

Radiopharmaceutical Use: DaTscan should be used only by healthcare professionals qualified in the use of radioactive prescribed substances. Appropriate management facilities should be readily available, and radiation exposure should be minimized for patients and healthcare workers.

Hypersensitivity Reactions: Hypersensitivity reactions have been reported following DaTscan administration. Appropriate resuscitation equipment should be available prior to administration.

Thyroid Accumulation of Iodine-123: DaTscan may contain free iodide (iodine-123). Accumulation of radioiodine in the thyroid gland may increase long-term risk for thyroid neoplasia. Administration of a thyroid blocking agent is recommended prior to DaTscan administration.

Radiation Risk: As with any radiopharmaceutical, exposure to ionizing radiation is associated with a potential risk of cancer induction and hereditary defects. Radiation exposure should be kept as low as reasonably achievable while obtaining the intended diagnostic information.

ADVERSE REACTIONS

In clinical studies, the most commonly reported adverse events were headache, nausea, and dizziness.

Less common adverse events included vertigo, increased appetite, dry mouth, formication (paresthesia), dysgeusia, and injection-site pain.

Post-marketing reports include hypersensitivity reactions and injection-site pain.

DRUG INTERACTIONS

Drugs that bind to the dopamine transporter with high affinity may interfere with DaTscan image interpretation and may affect imaging results.

Examples include amphetamine, benzatropine, bupropion, cocaine, mazindol, methylphenidate, phentermine, sertraline, and venlafaxine. Temporary discontinuation should be considered when clinically appropriate.

USE IN SPECIFIC POPULATIONS

Pregnancy: DaTscan should not be administered during pregnancy unless the expected benefit outweighs the potential risk to the fetus.

Lactation: If administration is necessary, breastfeeding should be interrupted for 3 days after DaTscan administration and expressed milk should be discarded.

Pediatrics: Safety and efficacy in patients under 18 years of age have not been established. DaTscan is not authorized for pediatric use in Canada.

Renal and Hepatic Impairment: DaTscan is not recommended in patients with moderate to severe renal or hepatic impairment due to limited clinical data.

OVERDOSAGE

The risks of overdose relate primarily to radiation exposure. In cases of radioactive overdose, frequent urination and bowel movements should be encouraged to minimize radiation dose to the patient. Care should be taken to avoid contamination from excreted radioactivity.

Prior to administration, please read the Product Monograph for DaTscan for complete prescribing information and important safety information.

Reporting Side Effects

To report suspected adverse reactions, contact GE HealthCare Canada at 1-800-654-0118 (option 2, then option 1) or email canadainfo@ge.com.

Adverse reactions can also be reported to Health Canada by visiting canada.ca/drug-device-reporting or by calling toll-free 1-866-234-2345.