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Evaluating Results About PS

DaTscan Adds the Clarity of Dopamine Transporter (DaT) Visualization to
Symptom Presentation

Visualizing DaT status helps determine diagnosis

Conditions associated with a loss of dopaminergic neurons1,2

  • Parkinson’s disease (PD)
  • Multiple system atrophy (MSA)
  • Progressive supranuclear palsy (PSP)
  • Dementia with Lewy bodies (DLB)
  • Corticobasal degeneration (CBD)

Conditions associated with no loss of dopaminergic neurons

  • Drug-induced parkinsonism
  • Vascular parkinsonism
  • Psychogenic parkinsonism
  • Essential tremor (ET)
  • Dystonic tremor
  • Alzheimer’s disease (AD)

DaT visualization helps assess nigrostriatal dopaminergic integrity

DaTscan binds presynaptically to striatal DaT3,4

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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.

In NDA clinical trials, DaTscan demonstrated agreement among readers1

  • DaTscan images were evaluated by readers blinded to clinical information at the time of the read1

Positive and negative percent agreements for NDA studies 1 and 21

Referrer_Reader Chart2

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.

Study Design1: Two multicenter, single-arm studies (Study 1 and Study 2) evaluated 284 adult patients with tremor. DaTscan image outcomes were compared to a reference clinical diagnostic standard of “PS” or “non-PS.” The reference clinical diagnostic standard for PS was diagnoses for PD, MSA, and PSP. The reference clinical diagnostic standard for non-PS was an essential tremor (ET) diagnosis or other non-PS diagnosis. Study 1 consisted of patients with early features of PS; patients with features suggestive of MSA or PSP were excluded. Study 2 consisted of patients with clinically established diagnosis of PS (PD, MSA, PSP) or ET.

DaTscan images were evaluated by readers blinded to clinical information. Study 1 readers had no other role in patient assessment; Study 2 readers included site investigators. The reference clinical diagnostic standards were the clinical diagnoses established by a consensus panel of movement disorder specialists that evaluated data inclusive through 36 months of follow-up (Study 1) or the investigator-determined baseline clinical diagnosis (Study 2).

Among the 99 patients in Study 1, 44% were female, 42% were 65 years of age and older, and all were Caucasian. Among the 185 patients in Study 2, 35% were female, 48% were 65 years of age and older, and 99% were Caucasian. Among the patients in Study 1, the baseline clinical diagnoses consisted of: Probable PD (44%), possible PD (31%), “benign” PD (6%), possible ET (11%), and other diagnoses (7%). Among the patients in Study 2, the baseline clinical diagnoses consisted of: PD (70%), ET (15%), MSA (10%), and PSP (5%).

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. DaTscan [prescribing information]. Arlington Heights, IL: GE Healthcare; 2015. 2. Kägi G, Bhatia KP, Tolosa E. The role of DAT-SPECT in movement disorders. J Neurol Neurosurg Psychiatry. 2010; 81:5-12. 3. Dodel RC, Höffken H, Möller JC, et al. Dopamine transporter imaging and SPECT in diagnostic work-up of Parkinson’s disease: a decision-analytic approach. Mov Disord. 2003;18:S52-S62. 4. Antonini A, Berto P, Lopatriello S, Tamma F, Annemans L, Chambers M. Cost-effectiveness of 123I-FP-CIT SPECT in the differential diagnosis of essential tremor and Parkinson’s disease in Italy. Mov Disord. 2008;23:2202-2209. 5. Colloby SJ, Williams ED, Burn DJ, Lloyd JJ, McKeith IG, O’Brien JT. Progression of dopaminergic degeneration in dementia with Lewy bodies and Parkinson’s disease with and without dementia assessed using 123I-FP-CIT SPECT. Eur J Nucl Med Mol Imaging. 2005;32:1176-1185.