DaTscan™

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) or suspected dementia with Lewy bodies (DLB).1
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Full Prescribing Information
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 diagnosis2-7

Diagnosis with purpose

DaTscan can significantly contribute to a more certain diagnosis, proving to be a useful adjunct in the work-up of PS and DLB16

Supply chain precision from dose to delivery

Backed by 11+ 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 (PSs) and suspected dementia with Lewy bodies (DLB). DaTscan does not replace the physician’s clinical diagnosis, but may help support clinical evaluation and improve diagnostic confidence.

Confidence in Numbers

11+

years in the US

>1.4 M

doses delivered worldwide

3.5 min

a patient is scanned every 3.5 min worldwide

>1 M

in the US 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 and dementia with Lewy bodies.

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.
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.15 Significant evidence base for the imaging results of DaTscan have contributed to its integration into key international guidelines.10,11
DLB diagnosis

The DaTscan difference in DLB diagnosis

Lewy body dementia (LBD) is the second most common neurodegenerative dementia after AD, estimated to affect 1.4 million adults in the US.12,13 LBD includes DLB (dementia with Lewy bodies) and PDD (Parkinson's disease dementia).12

A multicenter, randomized, open-label trial conducted by by Walker et al. in 2015 demonstrated the difference DaTscan can make in DLB diagnosis.14
In this study, only 25% of patients had parkinsonian features, but 43% had abnormal scans.14
  • • 170 people with a clinical diagnosis of possible DLB
  • • 114 received imaging with DaTscan, 56 were a control group
  • • Multicenter, randomized, open-label trial conducted in six European countries
  • • Patients who underwent imaging were far more likely to receive a change in diagnosis; 61% by week 8 and 71% by week 24 in comparison to 4% and 16% for the control group, respectively

Support to help your patients see the whole picture

DaTscan helps clinicians deliver the highest standard of patient care. Learn more about supporting resources available for DaTscan.

DaTscan locator tool

Find a facility using DaTscan in your area with our DaTscan facility locator tool.

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REFERENCES
  1. 1. DaTscan [Prescribing Information]; Arlington Heights, IL; 2022
  2. 2. 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.
  3. 3. 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.
  4. 4. 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.
  5. 5. 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.
  6. 6. 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.
  7. 7. 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.
  8. 8. 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.
  9. 9. 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.
  10. 10. 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
  11. 11. 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
  12. 12. Desai U, Chandler J, Kirson N, et al. Epidemiology and economic burden of Lewy body dementia in the United States. Curr Med Res Opin. 2022;38(7):1177-1188.
  13. 13. Barker WW, Luis CA, Kashuba A, et al. Relative frequencies of Alzheimer disease, Lewy body, vascular and frontotemporal dementia, and hippocampal sclerosis in the State of Florida Brain Bank. Alzheimer Dis Assoc Disord. 2002;16(4):203-212.
  14. 14. Walker Z, Moreno E, Thomas A, et al. Clinical usefulness of dopamine transporter SPECT imaging with 123I-FP-CIT in patients with possible dementia with Lewy bodies: randomised study. Br JPsychiatry. 2015;206(2):145-152.
  15. 15. Data on file. GE HealthCare
  16. 16. 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


JB07615US January 2023

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IMPORTANT SAFETY INFORMATION for DaTscan (Ioflupane I 123 injection)

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

  • • 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.

USE IN SPECIFIC POPULATIONS

  • • Pregnancy: Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Administration of a thyroid blocking agent is recommended before the use of DaTscan in a pregnant woman. All radiopharmaceuticals have potential to cause fetal harm. There are no available data on DaTscan use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Advise pregnant woman of the potential risks of fetal exposure to radiation with the administration of DaTscan.
  • • Lactation: Iodine 123 (I 123), the radionuclide in DaTscan, is present in human milk. There is no information on the effects on breastfed infants or on milk. Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for at least 6 days after DaTscan administration to minimize radiation exposure to a breastfeeding 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 elderly patients and younger patients that would require a dose adjustment 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.

OVERDOSAGE

  • • The risks of overdose relate predominantly to increased radiation exposure, with the long-term risks for neoplasia. In case of overdosage of radioactivity, 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 for additional Important Safety Information.

To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800 654 0118 (option 2, then option 1) or the FDA at 800 FDA 1088 or www.fda.gov/medwatch.

JB07615US