New Data Show Benefit of DaTSCAN? (Ioflupane I 123 Injection) in the Diagnosis of Patients with Clinically Uncertain Dementia with Lewy Bodies

Data presented at the XXI World Congress of Neurology in Vienna this week suggest that DaTSCAN™ (Ioflupane I 123 Injection) SPECT imaging could add value to current diagnostic tools used by physicians to diagnose patients with dementia with Lewy bodies (DLB) by improving physician’s ability to definitively diagnose the disorder and increase their confidence in so doing. DaTSCAN is GE Healthcare’s radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging.

Data presented in two abstracts from a multicenter (21 centers in 6 European countries), randomized, open-label, comparative clinical trial evaluated the impact of DaTSCAN SPECT imaging on the clinical diagnosis of dementia and physician confidence of that diagnosis in patients with possible DLB who underwent DaTSCAN imaging (N=114) compared with those in the control group who did not (N=56). Specifically:

• A higher proportion of patients who underwent DaTSCAN SPECT imaging had a change in diagnostic category after 8 weeks (61% vs 4%; P< 0.0001) and 24 weeks (71% versus 16%, P<0.0001). Significantly more patients in the imaging group were given more confident diagnoses during follow-up. Clinicians also reported that they were more likely to change the diagnostic category if the DaTSCAN image was abnormal (82%) than if the result was normal (48%).¹
• In subjects with possible DLB who did not receive imaging, the clinical evolution of symptoms over 6-months did not impact the diagnosis. However, the result of a DaTSCAN image, in combination with the clinical features, contributed significantly to a change in dementia diagnostic category.²

“The diagnosis of a patient with DLB can be challenging, particularly in patients with clinically uncertain DLB,” said Igor Grachev, MD, Medical Director, GE Healthcare Life Sciences. “While the diagnosis often becomes clearer over time, particularly as signs and symptoms progress, in many cases true DLB can be missed. This study shows that DaTSCAN SPECT imaging, when used in combination with other core and suggestive features, has the ability to facilitate a more certain confident diagnosis.”

DLB is one of the most common types of degenerative dementia, and is a common form of dementia in old age, accounting for nearly 15-20 percent of cases.³ The central feature of DLB is progressive cognitive decline, combined with three additional defining features: (1) pronounced “fluctuations” in alertness and attention, such as frequent drowsiness, lethargy, lengthy periods of time spent staring into space, or disorganized speech; (2) recurrent visual hallucinations, and (3) parkinsonian motor symptoms, such as rigidity and the loss of spontaneous movement.⁴

About DaTSCAN™ (Ioflupane I 123 Injection)

DaTSCAN is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging. DaTSCAN 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.

In July 2000, the European Commission granted a Marketing Authorization under the trade name DaTSCAN for use in detecting loss of functional dopaminergic neurons (nerve cells in the brain) in patients with clinically uncertain Parkinsonian syndrome (PS). In July 2006, the European indication was expanded to include differentiation of probable DLB from Alzheimer’s Disease (AD). DaTSCAN is currently licensed and distributed in 34 countries, and has been in clinical use for ten years in more than 300,000 patients worldwide.

GE’S COMMITMENT TO IMAGING RESEARCH

DaTSCAN is one component of a broad portfolio of marketed and investigational diagnostic solutions that GE Healthcare is currently developing in the neurological disease field. GE Healthcare takes a comprehensive approach to understanding a variety of neurological disorders such as Alzheimer’s disease, Parkinson’s disease, post-traumatic stress disorder, concussion, traumatic brain injury and Multiple Sclerosis through its ongoing research to uncover the causes, risks, and physical effects of these conditions. By collaborating with the pharmaceutical industry to assist in their development of the next generation of therapies to treat these disorders and working with potential partners in the industry, GE Healthcare can provide imaging support for clinical trials of therapeutic agents.

About GE Healthcare

GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.

For our latest news, please visit http://newsroom.gehealthcare.com

PRESCRIBING INFORMATION DaTSCAN™ ioflupane (¹²³I) 74 MBq/ml solution for injection

Please refer to full Summary of Product Characteristics (SPC) before prescribing. Further information available on request.

PRESENTATION

Single dose vials containing 185 MBq or 370 MBq ioflupane (¹²³I) at reference time.

INDICATIONS

Detecting loss of functional dopaminergic neuron terminals in the striatum.

i) in adult patients with clinically uncertain Parkinsonian Syndromes, for example those with early symptoms, in order to help differentiate Essential Tremor from Parkinsonian Syndromes 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.

ii)in adult patients to help differentiate probable dementia with Lewy bodies (DLB) from Alzheimer’s disease. DaTSCAN is unable to discriminate between DLB and Parkinson’s Disease dementia.

DOSAGE AND METHOD OF ADMINISTRATION

Prior to administration appropriate resuscitation equipment should be available. For use in patients referred by physicians experienced in the management of movement disorders/dementia. Clinical efficiency has been demonstrated across the range of 111-185 MBq; do not use outside this range. Appropriate thyroid blocking treatment must be given prior to injection of DaTSCAN. The safety and efficacy of DaTSCAN in children 0 to 18 years has not been established. No data are available in patients with significant renal or hepatic impairment. DaTSCAN should be used without dilution. Slow intravenous injection (15-20 seconds) via an arm vein is recommended. SPECT imaging should take place 3-6 hours after injection of DaTSCAN.

CONTRAINDICATIONS

Pregnancy and hypersensitivity to the active substance or any of the excipients.

WARNINGS AND PRECAUTIONS

If hypersensitivity reactions occur, the administration of the medicinal product must be discontinued immediately and, if necessary, intravenous treatment initiated. Resuscitative medicinal products and equipment (e.g. endotracheal tube and ventilator) have to be readily available. Radiopharmaceuticals should only be used by qualified personnel with appropriate government authorisation and should be prepared using aseptic and radiological precautions. For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit. The activity administered must be such that the resulting dose is as low as reasonably achievable bearing in mind the need to obtain the intended diagnostic result. DaTSCAN is not recommended in cases of moderate to severe renal or hepatic impairment. Contains 39.5 g/l (5% volume) ethanol, up to 197mg per dose, harmful for those suffering from alcoholism. To be taken into account in high-risk groups such as patients with liver disease or epilepsy.

INTERACTIONS

Consider current medication. Medicines that bind to the dopamine transporter with high affinity may interfere with diagnosis; these include amfetamine, benzatropine, buproprion, cocaine, mazindol, methylphenidate, phentermine and sertraline. Medicines shown during clinical trials not to interfere with DaTSCAN imaging include amantadine, trihexyphenidyl, budipine, levodopa, metoprolol, primidone, propranolol and selegiline. Dopamine agonists and antagonists acting on the postsynaptic dopamine receptors are not expected to interfere with DaTSCAN imaging and can therefore be continued if desired. In animal studies pergolide does not interfere with DaTSCAN imaging.

PREGNANCY AND LACTATION

Contraindicated in pregnancy. Information should be sought about pregnancy from women of child bearing potential. A woman who has missed her period should be assumed to be pregnant. If uncertain, radiation exposure should be the minimum needed for satisfactory imaging. Consider alternative techniques. If administration to a breast feeding woman is necessary, substitute formula feeding for breast feeding for 3 days.

UNDESIRABLE EFFECTS

No serious adverse effects have been reported. Common side effects include headache. Uncommon side effects include vertigo, increased appetite, formication, dizziness, dysgeusia, nausea and dry mouth. Intense pain on injection has been reported uncommonly following administration into small veins. Hypersensitivity occurs with unknown frequency. Exposure to ionising radiation is linked with cancer induction and a potential for hereditary defects. Because of the low radiation dose incurred these adverse events are expected to occur with a low probability.

DOSIMETRY

Effective dose from 185 MBq is 4.35 mSv.

OVERDOSE

Encourage frequent micturition and defecation.

MARKETING AUTHORISATION HOLDER

GE Healthcare Limited, Amersham Place, Little Chalfont, Buckinghamshire, HP7 9NA, UK.

CLASSIFICATION FOR SUPPLY

Subject to medical prescription.

MARKETING AUTHORISATION NUMBERS

EU/1/00/135/001 (2.5ml) and EU/1/00/135/002 (5.0ml).

DATE OF REVISION OF TEXT

22 March 2013.

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