DaTscan 2 mCi/mL
Ioflupane I-123 · INJECTION, SOLUTION · Medi-Physics Inc. dba GE Healthcare.
DaTscan is a injection, solution containing ioflupane i-123 at 2 mCi/mL, taken intravenous. Manufactured by Medi-Physics Inc. dba GE Healthcare..
Key Facts
- Brand Name
- DaTscan
- Generic Name
- Ioflupane I-123
- NDC Code (Product)
17156-210- Manufacturer
- Medi-Physics Inc. dba GE Healthcare.
- Strength
- 2 mCi/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA022454
- Drug Class
- Radioactive Diagnostic Agent [EPC]
- Marketing Start
- 03/01/2011
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS 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). 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 (SPECT) brain imaging in adult patients with: suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dose of DATSCAN in adult patients is 111 MBq to 185 MBq (3 mCi to 5 mCi) administered intravenously over at least 20 seconds. ( 2.2 ) Administer a thyroid blocking agent at least one hour before the dose of DATSCAN. ( 2.3 ) Begin SPECT imaging between 3 hours and 6 hours post injection. ( 2.4 ) See full prescribing information for image interpretation and radiation dosimetry. ( 2.5 , 2.6 ) 2.1 Radiation Safety - Drug Handling Handle DATSCAN with safety measures to minimize radiation exposure to healthcare providers and patients [see Warnings and Precautions (5.3) ] . Use waterproof gloves and effective radiation shielding, including lead-glass syringe shields when handling and administering DATSCAN. Radiopharmaceuticals should be used by or under the control of healthcare providers who are qualified by specific training and experienced in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. 2.2 Recommended Dosage The recommended dose of DATSCAN in adult patients is 111 MBq to 185 MBq (3 mCi to 5 mCi), administer…
Contraindications
4 CONTRAINDICATIONS DATSCAN is contraindicated in patients with known serious hypersensitivity to ioflupane I 123 [see Warnings and Precautions (5.1) ] . Known serious hypersensitivity to ioflupane I 123 ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Ioflupane I 123 binds to the dopamine transporter [see Clinical Pharmacology (12.1) ] . Drugs that bind to the dopamine transporter with high affinity have the potential to impact DATSCAN image interpretation. These potentially interfering drugs include: amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil, norephedrine, phentermine, selegiline, and sertraline. 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 [see Dosage and Administration (2.3) ]. The impact of dop…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reaction is described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] The following adverse reactions were reported at ≤1%: headache, nausea, vertigo, dry mouth and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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) [see Dosage and Administration (2.2) ]. The following adverse reactions were reported at a rate of 1% or less: hea…
Frequently Asked Questions
What is DaTscan used for?
DaTscan contains Ioflupane I-123. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is DaTscan a controlled substance?
DaTscan is not classified as a controlled substance by the DEA.
What is the generic name for DaTscan?
The generic name for DaTscan is Ioflupane I-123. There are 1 other brand versions of Ioflupane I-123.
What is the NDC code for DaTscan 2 mCi/mL?
The NDC (National Drug Code) for DaTscan 2 mCi/mL is 17156-210, listed by Medi-Physics Inc. dba GE Healthcare..