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Web-Ordering Full Prescribing Information

Overview

Details

Resources

Support

Web-Ordering Full Prescribing Information

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) or suspected dementia with Lewy bodies (DLB).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 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 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.

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.¹⁵ 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

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

datscan-new-graph-hero-sticky-scrolling-st-en

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.

Find a facility

References

DaTscan [Prescribing Information]; Arlington Heights, IL; 2022
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
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.
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.
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.
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 I 123 injection)

Product Indications and Important Safety Information – DaTscan

PRODUCT INDICATION AND USAGE

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).

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 of Iodine-123: 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.

• Radiation Risk: DaTscan contributes to patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to patients and healthcare providers.

ADVERSE REACTIONS

• In clinical trials, headache, nausea, vertigo, dry mouth, or dizziness were reported at a rate of 1% or less. In postmarketing experience, hypersensitivity reactions and injection-site pain have been reported.

DRUG INTERACTIONS

• Drugs that bind to the dopamine transporter with high affinity have the potential to impact DaTscan image interpretation. The impact of dopamine agonists and antagonists upon DaTscan imaging results has not been established.

• In patients taking venlafaxine or desvenlafaxine prior to DaTscan administration, there have been cases of altered DaTscan uptake that impacted image interpretation. The mechanism of interference of these drugs with DaTscan imaging is not known.

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 production. 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 overall differences in safety and effectiveness between elderly patients, aged 65 and older, and younger patients.

• 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.

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