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DaTscan for Your Patients Imaging Centers

A Suspected Parkinsonian Syndrome (PS) Is Not Always Straightforward

  • PS refers to a form of parkinsonism due to nigrostriatal degeneration1,2

Patients may present with a variety of symptoms3-6

Symptoms may not always tell the whole story

  • Tremors can be caused by medications such as antipsychotics
  • Not all patients with a PS present with tremor
    • Rest tremor has been shown to be absent in approximately 23%
      of patients with Parkinson’s disease (PD)7
  • Patients may present with mild or atypical symptoms that do not match either a PS or essential tremor (ET) diagnostic criteria
  • Symptoms can overlap or resemble the symptoms of many different movement disorders5,8
  • Lack of response to levodopa was observed in approximately 23% of patients with parkinsonian features who were diagnosed with a PS9

In one study, approximately 20% of patients with ET had rest tremor, characteristic of parkinsonism10

There is not definitive diagnostic confirmation currently available

  • Clinical examination and interpretation are primarily used to evaluate symptoms and rule out
    other conditions

Current clinical evaluation strategies are imperfect

Studies have demonstrated error rates in diagnostic accuracy4,11-14:

  • Trials evaluating response to medications and treatments: Adler et al, 201411; Meara et al, 199912
  • Study of levodopa response in early PD: Hauser et al, 20094
  • Studies demonstrating error rates of PD diagnosis and the misdiagnosis of ET: Schrag et al, 200213; Jain et al, 200614

PRODUCT INDICATIONS AND USE: DaTscan (Ioflupane I 123 Injection) is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single-photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected parkinsonian syndromes (PSs). DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson’s disease [PD], multiple system atrophy [MSA], and progressive supranuclear palsy [PSP]). DaTscan is an adjunct to other diagnostic evaluations. DaTscan was not designed to distinguish among PD, MSA, and PSP. The effectiveness of DaTscan as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established.

Important Risk and Safety Information About DaTscan

CONTRAINDICATIONS: DaTscan is contraindicated in patients with known hypersensitivity to the active substance, any of the excipients, or iodine. WARNINGS AND PRECAUTIONS — Hypersensitivity Reactions: Hypersensitivity reactions, generally consisting of skin erythema and pruritus, have been reported following DaTscan administration. Thyroid Accumulation: The DaTscan injection may contain up to 6% of free iodide (iodine 123 or I-123). To decrease thyroid accumulation of I-123, block the thyroid gland at least one hour before administration of DaTscan; failure to do so may increase the long-term risk for thyroid neoplasia. 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. SPECIFIC POPULATIONS — Pregnancy: It is unknown whether DaTscan can cause fetal harm or increase the risk of pregnancy loss in pregnant women. DaTscan should be given to pregnant women only if clearly needed. Like all radiopharmaceuticals, DaTscan may cause fetal harm, depending on the stage of fetal development and the magnitude of the radionuclide dose. Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Nursing Mothers: It is not known whether DaTscan is excreted into human milk; however, I-123 is excreted into human milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of DaTscan or not to administer DaTscan at all. Nursing women may consider interrupting nursing and pumping and discarding breast milk for six days after DaTscan administration to minimize risks to a nursing 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 the elderly and younger patients that would require a dose adjustment. Renal and Hepatic Impairment: The effect of renal or hepatic impairment on DaTscan imaging has not been established. The kidney excretes DaTscan; patients with severe renal impairment may have increased radiation exposure and altered DaTscan images. OVERDOSAGE: It is unknown whether or not ioflupane is dialyzable. The major risks of overdose relate to increased radiation exposure and long-term risk for neoplasia. In case of radioactivity overdosage, 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.

References: 1. parkinsonian+syndrome. Accessed March 11, 2016. 2. Tolosa E, Vander Borght T, Moreno E. Accuracy of DaTscan (123I-loflupane) SPECT in diagnosis of patients with clinically uncertain parkinsonism: 2-year follow-up of an open-label study. Mov Disord. 2007;22:2346-2351. 3. Benamer HTS, Oertel WH, Patterson J, et al. Prospective study of presynaptic dopaminergic imaging in patients with mild parkinsonism and tremor disorders: part 1. Baseline and 3-month observations. Mov Disord. 2003;18:977-984. 4. Hauser RA, Auinger P, Oakes D. Levodopa response in early Parkinson’s disease. Mov Disord. 2009;24:2328-2336. 5. Hauser RA, Grosset DG. [123I]FP-CIT (DaTscan) SPECT brain imaging in patients with suspected parkinsonian syndromes. J Neuroimaging. 2011; 22:225-230. 6. Bhidayasiri R. Differential diagnosis of common tremor syndromes. Postgrad Med J. 2005;81:756-762. 7. Hughes AJ, Daniel SE, Blankson S, Lees AJ. A clinicopathologic study of 100 cases of Parkinson’s disease. Arch Neurol. 1993;50:140-148. 8. Pahwa R, Lyons KE. Early diagnosis of Parkinson’s disease: recommendations from diagnostic clinical guidelines. Am J Manag Care. 2010;16:S94-S99. 9. D’Costa DF, Sheehan LJ, Phillips PA, Moore-Smith B. The levodopa test in Parkinson’s disease. Age Ageing. 1995;24:210-212. 10. Cohen O, Pullman S, Jurewicz E, Watner D, Louis ED. Rest tremor in patients with essential tremor: prevalence, clinical correlates, and electrophysiologic characteristics. Arch Neurol. 2003;60:405-410. 11. Adler CH, Beach TG, Hentz JG, et al. Low clinical diagnostic accuracy of early vs advanced Parkinson disease: clinicopathologic study. Neurology. 2014;83:406-412. 12. Meara J, Bhowmick BK, Hobson P. Accuracy of diagnosis in patients with presumed Parkinson’s disease. Age Ageing. 1999;28:99-102. 13. Schrag A, Ben-Shlomo Y, Quinn N. How valid is the clinical diagnosis of Parkinson’s disease in the community? J Neurol Neurosurg Psychiatry. 2002;73:529-534. 14. Jain S, Lo SE, Louis ED. Common misdiagnosis of a common neurological disorder. Arch Neurol. 2006;63:1100-1104.