Ioflupane I 123 2 mCi/mL
IOFLUPANE I-123 · INJECTION, SOLUTION · Curium US LLC
Ioflupane I 123 is a injection, solution containing ioflupane i-123 at 2 mCi/mL, taken intravenous. Manufactured by Curium US LLC.
Key Facts
- Brand Name
- Ioflupane I 123
- Generic Name
- IOFLUPANE I-123
- NDC Code (Product)
69945-166- Manufacturer
- Curium US LLC
- Strength
- 2 mCi/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA213792
- Drug Class
- Radioactive Diagnostic Agent [EPC]
- Marketing Start
- 03/31/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Ioflupane I 123 Injection 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). Ioflupane I 123 Injection 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 Administer a thyroid-blocking agent at least one hour before the dose of Ioflupane I 123 Injection. ( 2.2 ) The recommended dose of Ioflupane I 123 Injection in adult patients is 111 MBq to 185 MBq (3 mCi to 5 mCi) administered intravenously over at least 20 seconds. ( 2.3 ) Measure patient dose using a dose calibrator immediately prior to administration. ( 2.4 ) Begin SPECT imaging between 3 hours and 6 hours post-injection. ( 2.6 ) Figure 1,2,3,4 2.1 Radiation Safety Ioflupane I 123 Injection emits radiation and must be handled with safety measures to minimize radiation exposure to healthcare providers and patients [ see Warnings and Precautions ( 5.3 ) ]. 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. To minimize radiation exposure, encourage hydration prior to and following Ioflupane I 123 Injection administration in order to permit frequent voiding. Encourage the patient to voi…
Contraindications
4 CONTRAINDICATIONS Ioflupane I 123 Injection 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 may interfere with the image obtained following Ioflupane I 123 Injection administration. These potentially interfering drugs consist of: amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil, norephedrine, phentermine, phenylpropanolamine, selegiline, and sertraline. Selective serotonin reuptake inhibitors (paroxetine and citalopram) may increase or decrease ioflupane binding to the dopamine transporter. Whether discontinuation of these drugs prior to Ioflupane I 123 Injection administration may minimize the interference with a Ioflupane I 123 Injection image is unknown. The impact of dopamine agonists and antagonists upon Ioflupane I 123 Injection imaging results has not been established. Amoxapine, amphetamine, armodafinil, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, modafinil norephedrine, phentermine, phenylpropanolamine, selegiline, sertraline, citalopram and paroxetine may interfere…
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 CURIUM US LLC at 1-866-789-2211 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 Ioflupane I 123 Injection 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 Ioflupane I 123 Injection 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 Ioflupane I 123 Injection is 111 MBq to 185 MBq (3 mCi to 5 mCi) [ see Dosage and Administration ( 2.3 ) ]. The followin…
Frequently Asked Questions
What is Ioflupane I 123 used for?
Ioflupane I 123 contains IOFLUPANE I-123. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Ioflupane I 123 a controlled substance?
Ioflupane I 123 is not classified as a controlled substance by the DEA.
What is the generic name for Ioflupane I 123?
The generic name for Ioflupane I 123 is IOFLUPANE I-123. There are 1 other brand versions of IOFLUPANE I-123.
What is the NDC code for Ioflupane I 123 2 mCi/mL?
The NDC (National Drug Code) for Ioflupane I 123 2 mCi/mL is 69945-166, listed by Curium US LLC.