Generic Name
Ioflupane I-123
Brand Names
DaTscan, Ioflupane
FDA approval date: March 01, 2011
Classification: Radioactive Diagnostic Agent
Form: Injection
What is DaTscan (Ioflupane I-123)?
DATSCAN is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography brain imaging in adult patients with: suspected Parkinsonian syndromes or suspected dementia with Lewy bodies . DATSCAN is a radioactive diagnostic agent indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography brain imaging in adult patients with: suspected Parkinsonian syndromes or suspected dementia with Lewy bodies .
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Brand Information
DaTscan (Ioflupane I-123)
1INDICATIONS 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).
2DOSAGE FORMS AND STRENGTHS
Injection: clear, colorless solution containing 185 MBq (5 mCi) in 2.5 mL at a concentration of 74 MBq/mL (2 mCi/mL) of ioflupane I 123 at calibration date and time supplied in single-dose vials.
3CONTRAINDICATIONS
DATSCAN is contraindicated in patients with known serious hypersensitivity to ioflupane I 123
4ADVERSE REACTIONS
The following clinically significant adverse reaction is described elsewhere in the labeling:
- Hypersensitivity Reactions
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of DATSCAN cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data from clinical trials reflect exposure to DATSCAN in 942 subjects with a mean age of 66 years (range 25 years to 90 years). Among these subjects, 42% were female and 99% White. Subjects received 88 MBq to 287 MBq (2 mCi to 8 mCi) [median 173 MBq (4.7 mCi)] intravenously as a single dose. The recommended dose of DATSCAN is 111 MBq to 185 MBq (3 mCi to 5 mCi)
The following adverse reactions were reported at a rate of 1% or less: headache, nausea, vertigo, dry mouth, and dizziness.
4.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of DATSCAN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune system disorders: Hypersensitivity, including dyspnea, edema, rash, erythema, and pruritus
General disorders and administration site conditions: Injection site pain
5DRUG INTERACTIONS
Ioflupane I 123 binds to the dopamine transporter
Selective serotonin reuptake inhibitors (paroxetine and citalopram) may increase or decrease ioflupane binding to the dopamine transporter.
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.
Whether discontinuation of any of the above drugs prior to DATSCAN administration may minimize the impact on image interpretation is unknown; however, if use of these drugs can be safely suspended, consider discontinuing for at least 5 biological half-lives before administration of DATSCAN
The impact of dopamine agonists and antagonists upon DATSCAN imaging results has not been established.
6OVERDOSAGE
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.
7PRINCIPAL DISPLAY PANEL - 2.5 mL Vial Label
GE Healthcare
DaTscan™
Ioflupane I 123 185 MBq (5 mCi) in 2.5 mL
Radiopharmaceutical for Intravenous Injection
Single-Dose Vial. Discard unused portion.
R
VOLUME: 2.5 mL
RADIOACTIVE
CALIB.
CALIB.
