Generic Name
Ioflupane I-123
Brand Names
Ioflupane, DaTscan
FDA approval date: March 01, 2011
Classification: Radioactive Diagnostic Agent
Form: Injection
What is Ioflupane (Ioflupane I-123)?
DaTscan is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes . In these patients, DaTscan may be used to help differentiate essential tremor from tremor due to PS . DaTscan is an adjunct to other diagnostic evaluations. DaTscan is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes . In these patients, DaTscan may be used to help differentiate essential tremor from tremor due to PS . DaTscan is an adjunct to other diagnostic evaluations.
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Brand Information
Ioflupane I 123 (IOFLUPANE I-123)
1INDICATIONS 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).
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
Ioflupane I 123 Injection 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 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) [
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 Ioflupane I 123 Injection. 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 [
The impact of dopamine agonists and antagonists upon Ioflupane I 123 Injection 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.
7HOW SUPPLIED/STORAGE AND HANDLING
Ioflupane I 123 Injection is a sterile, clear, colorless solution supplied in a 10 mL single-dose vial containing a total volume of 2.5 mL with a total radioactivity of 185 MBq (5 mCi) of Ioflupane I 123 at calibration time and date. Each mL contains 74 MBq (2 mCi) of Ioflupane I 123 at calibration time and date. Each vial is enclosed in a lead container of appropriate thickness for radiation protection.
Catalog No.166
185 megabecquerels (5 mCi)
NDC 69945-166-05
Storage
Store Ioflupane I 123 Injection upright at 20° to 25°C (68° to 77°F). This product does not contain a preservative. Store Ioflupane I 123 Injection within the original lead container or equivalent radiation shielding.
Do not use Ioflupane I 123 Injection preparations after the expiration date and time stated on the label. Discard unused portion.
Handling
This preparation is approved for use by persons licensed by the Nuclear Regulatory Commission or an Agreement State.
8PATIENT COUNSELING INFORMATION
Hypersensitivity Reactions
Inform the patient that hypersensitivity reactions, including dyspnea, edema, rash, erythema and pruritus, have been reported following Ioflupane I 123 Injection administration [
Adequate Hydration
Instruct patients to drink a sufficient amount of water prior to and after receiving Ioflupane I 123 Injection and to void frequently for the first 48 hours following Ioflupane I 123 Injection administration [
Lactation
Advise a lactating woman to interrupt breastfeeding and pump and discard breastmilk for at least 6 days (>10 physical half-lives) after Ioflupane I 123 Injection administration in order to minimize radiation exposure to a breastfed infant [
Pregnancy
Advise a pregnant woman of the potential risks of fetal exposure to radiation doses with Ioflupane I 123 Injection [
Manufactured and Distributed by Curium US LLC, 2703 Wagner Pl, Maryland Heights, MO 63043 U.S.A.
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© 2022 Curium US LLC – All rights reserved.
9PRINCIPAL DISPLAY PANEL
NDC 69945-166-05
Ioflupane I 123 Injection
185 MBq (5 mCi) per 2.5 mL at calibration
74 MBq (2 mCi) per 1 mL
Ioflupane I 123 Injection
185 MBq (5 mCi) per 2.5 mL at calibration
74 MBq (2 mCi) per 1 mL
Radiopharmaceutical For Intravenous Use Only
Single-Dose Vial – Discard Unused Portion.
Recommended dosage: See Prescribing Information.
Each mL contains: 74 MBq (2 mCi) of Ioflupane I 123 at calibration date and time, 0.07 - 0.13 mcg ioflupane, 5.7 mg acetic acid, 7.8 mg sodium acetate, 0.05 ml of dehydrated alcohol (ethanol).
Store upright at controlled room temperature 20°C to 25°C (68°F to 77°F) in a shielded container.
Rx only
Total Activity: 185 MBq (5 mCi) at calibration
Radioactivity Concentration: 74 MBq/mL (2 mCi/mL)
Total Volume: 2.5 mL
Cal. time: 1200 ET (1100 CT)
Expires 7 hours after calibration time.
Cal. date:
Lot #:
CAUTION
RADIOACTIVE MATERIAL
CURIUM™ Logo
Manufactured by:
Curium US LLC, 2703 Wagner Place, Maryland Heights, MO 63043
R10/2021 A166C0
10PRINCIPAL DISPLAY PANEL
NDC 69945-166-05
Ioflupane I 123 Injection
185 MBq (5 mCi) per 2.5 mL at calibration
[74 MBq (2 mCi) per 1 mL]
Ioflupane I 123 Injection
185 MBq (5 mCi) per 2.5 mL at calibration
[74 MBq (2 mCi) per 1 mL]
Radiopharmaceutical - For Intravenous Use Only
Single-Dose Vial – Discard Unused Portion.
Cal. time:
1200 ET (1100 CT)
Cal. date:
Lot #:
Volume: 2.5 mL
Radioactive Concentration:
74 MBq/mL (2 mCi/mL)
Total Activity:
185 MBq (5 mCi)
Recommended Dosage:
See Prescribing Information
Rx only
Store upright at controlled
room temperature 20°C to
25°C (68°F to 77°F) in a
shielded container.
7 hours after calibration time.
Each mL contains 74 MBq
(2 mCi) of Ioflupane I 123 at
calibration, 0.07 - 0.13 mcg
ioflupane, 5.7 mg acetic acid,
7.8 mg sodium acetate,
0.05 mL ethanol.
CAUTION
RADIOACTIVE MATERIAL
Manufactured by:
Curium US LLC
2703 Wagner Place
Maryland Heights, MO
63043
A166V0 R12/2021
![PRINCIPAL DISPLAY PANEL
NDC 69945-166-05
Ioflupane I 123 Injection
185 MBq (5 mCi) per 2.5 mL at calibration
[74 MBq (2 mCi) per 1 mL]
Radiopharmaceutical - For Intravenous Use Only
Single-Dose Vial – Discard Unused Portion.
Cal. time:
1200 ET (1100 CT)
Cal. date:
Lot #:
Volume: 2.5 mL
Radioactive Concentration:
74 MBq/mL (2 mCi/mL)
Total Activity:
185 MBq (5 mCi)
Recommended Dosage:
See Prescribing Information
Rx only
Store upright at controlled
room temperature 20°C to
25°C (68°F to 77°F) in a
shielded container. Expires
7 hours after calibration time.
Each mL contains 74 MBq
(2 mCi) of Ioflupane I 123 at
calibration, 0.07 - 0.13 mcg
ioflupane, 5.7 mg acetic acid,
7.8 mg sodium acetate,
0.05 mL ethanol.
CAUTION
RADIOACTIVE MATERIAL
Manufactured by:
Curium US LLC
2703 Wagner Place
Maryland Heights, MO
63043
A166V0 R12/2021](https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ioflupane-i-123-04.jpg&setid=66d20aee-4530-48dd-a483-ed7604b36d97)