CHALFONT ST. GILES, UK, 11 January 2018 - GE Healthcare announced today the approval in Canada of DaTscan™ (Ioflupane I 123 Injection), the first Health Canada approved radiopharmaceutical adjunct imaging agent to help physicians evaluate patients with a suspected parkinsonian syndrome (PS) such as Parkinson’s disease (PD), multiple system atrophy (MSA) and progressive supranuclear palsy (PSP). DaTscan is unable to discriminate between PD, MSA and PSP. Timely diagnosis can be instrumental in making the most of advances in therapeutic options that can help manage the disease’s progression.
PD is a neurodegenerative disease that today affects an estimated 100,000 people in Canada and more than five million people worldwide. It causes a progressive loss of dopamine in the brain, which can cause symptoms that include, among others, resting tremor, slowness of movement, stiffness or rigidity of muscles, difficulty with balance and walking, difficulty with fine motor movements.
Doctors primarily rely on clinical assessments to diagnose PD. However, clinical assessments, particularly early in the disease, can be inconclusive and may result in misdiagnosis [i]. DaTscan, when used as an adjunct to clinical assessment, can help physicians differentiate parkinsonian syndromes from essential tremor (ET), that may present with similar clinical symptoms. While the symptoms are similar, treatment and prognosis differ. Having another diagnostic tool for uncertain or challenging cases may help lead to a more timely and appropriate diagnosis and treatment.
“The timely and accurate diagnosis of PD is the first step toward optimal patient management and treatment”, said Marco Campione, Core Imaging General Manager of Americas at GE Healthcare. “We are glad to bring to physicians in Canada an additional tool that can help them address the challenges of PD diagnosis, and help patients get an earlier diagnosis”.
DaTscan is a radioactive drug that is injected into the bloodstream to image a specific area of the brain (the striatum) using a SPECT camera. For an adult with a suspected PS, a doctor may decide to conduct SPECT imaging using DaTscan to aid in establishing a diagnosis between PS and ET. PS include, but are not limited to, PD, MSA, and PSP. DaTscan was not designed to differentiate among different forms of PS.
DaTscan will be commercially available in Canada in early 2018.
About GE Healthcare
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Indication for Use:
DaTscan (Ioflupane (123I) Injection) is a radiopharmaceutical 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.
Important Risk and Safety Information About DaTscan™ (Ioflupane I 123 Injection)
CONTRAINDICATIONS: DaTscan is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. WARNINGS AND PRECAUTIONS - Radiopharmaceuticals should be used only by those health professionals who are appropriately qualified in the use of radioactive prescribed substances in or on humans. As in the use of any other radioactive material, care should be taken to minimize radiation exposure to patients consistent with proper patient management, and to minimize radiation exposure to occupational workers. Hypersensitivity Reactions: Hypersensitivity reactions have been reported following DaTscan administration. Prior to administration appropriate resuscitation equipment should be available. Thyroid Accumulation of I-123: The DaTscan injection may contain up to 6% of free iodide (iodine 123). Accumulation of radioiodine in the thyroid gland may result in long term risk for thyroid neoplasia. To decrease thyroid accumulation of iodine 123, administer a thyroid blocking agent at least 1 hour before administration of DaTscan. ADVERSE REACTIONS: In clinical trials, headache, nausea, and dizziness were commonly reported as adverse events. Less commonly reported adverse events included vertigo, increased appetite, dry mouth, formication, dysgeusia and injection site pain. In postmarketing experience, serious and nonserious hypersensitivity reactions as well as reports of injection-site pain, headache, dizziness, formication (paresthesia), dysgeusia, nausea and dry mouth have been reported. DRUG INTERACTIONS: Drugs that bind to the dopamine transporter with high affinity can interfere with DaTscan binding, therefore may affect the images obtained. The impact of dopamine agonists and antagonists has not been established. SPECIFIC POPULATIONS - Pregnancy: Since adequate reproduction studies have not been performed in animals to determine whether DaTscan affects fertility in males or females, has teratogenic potential, or has other adverse reactions on the fetus, this radiopharmaceutical preparation should not be administered to pregnant women unless it is considered that the benefits to be gained outweigh the potential hazards to the fetus. Nursing Mothers: It is not known whether ioflupane (123I) is secreted in human milk, therefore, if administration is considered necessary, breast-feeding should be interrupted for 3 days and substituted by formula feeding. During this time, breast milk should be expressed at regular intervals and the expressed feeds should be discarded. Pediatric Use: The safety and efficacy of DaTscan in children aged 0 to 18 years has not been established, therefore DaTscan is not recommended in children. Renal and Hepatic Impairment: Formal studies have not been carried out in patients with significant renal or hepatic impairment. DaTscan is not recommended in cases of moderate to severe renal or hepatic impairment. OVERDOSAGE: In cases of overdose of radioactivity, frequent micturition and defecation should be encouraged to minimise radiation dosage to the patient. Care should be taken to avoid contamination from the radioactivity eliminated by the patient using such methods. Reporting Side Effects: You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada.
• Online at MedEffect
• By calling 1-866-234-2345 (toll-free);
• By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program Health Canada, Postal Locator 0701E Ottawa, ON K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
For more information please consult the product monograph at http://www3.gehealthcare.com/~/media/Documents/MarketoPDFsnogating/ProductMonographCanadaControlNo201481December72017. The DaTscan product monograph is also available by calling 1-800-654-0118 (option 2, then option 3).
[i] National Parkinson Foundation Survey Results. March 2011.
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