Ioflupane I-123
Generic Name: ioflupane i-123
Brand Names:
Datscan
11 DESCRIPTION 11.1 Chemical Characteristics DATSCAN (ioflupane I 123 injection) is a sterile, pyrogen-free radioactive diagnostic agent for intravenous use. DATSCAN is a clear and colorless solution supplied in single-dose vials. Each milliliter contains 0.07 to 0.13 mcg ioflupane, 74 MBq (2 mCi) of iodine-123 (as ioflupane I 123) at calibration time, 5.8 mg acetic acid, 8.2 mg sodium acetate and 0.05 mL (5%) ethanol. The pH of the solution is between 4.2 and 5.2.
Overview
11 DESCRIPTION 11.1 Chemical Characteristics DATSCAN (ioflupane I 123 injection) is a sterile, pyrogen-free radioactive diagnostic agent for intravenous use. DATSCAN is a clear and colorless solution supplied in single-dose vials. Each milliliter contains 0.07 to 0.13 mcg ioflupane, 74 MBq (2 mCi) of iodine-123 (as ioflupane I 123) at calibration time, 5.8 mg acetic acid, 8.2 mg sodium acetate and 0.05 mL (5%) ethanol. The pH of the solution is between 4.2 and 5.2.
Uses
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
2 DOSAGE AND ADMINISTRATION Administer a thyroid-blocking agent at least one hour before the dose of DATSCAN. ( 2.2 ) 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. ( 2.3 ) 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 ) 2.1 Radiation Safety DATSCAN emits radiation and must be handled with safety measures to minimize radiation exposure to healthcare providers and patients [see Warnings and Precautions (5.3) ] .
Side Effects
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.
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 DATSCAN 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 DATSCAN administration may minimize the interference with a DATSCAN image is unknown.
Warnings
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity reactions including dyspnea, edema, rash, erythema, and pruritus have been reported. Have treatment measures available prior to DATSCAN administration. ( 5.1 ) Thyroid Accumulation of Iodine-123: Thyroid uptake of iodine-123 may result in an increased long-term risk for thyroid neoplasia. ( 2.2 , 5.2 ) Radiation Risk: Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration. 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 )
Pregnancy
8.1 Pregnancy Risk Summary Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Administration of an appropriate thyroid blocking agent is recommended before use of DATSCAN in a pregnant woman to protect the woman and fetus from accumulation of iodine-123 [see Dosage and Administration (2.2) ] . There are no available data on DATSCAN use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with ioflupane I 123.
Storage
Storage and Handling Store DATSCAN at 20° to 25°C (68° to 77°F). This product does not contain a preservative. Store DATSCAN within the original lead container or equivalent radiation shielding. Do not use DATSCAN preparations after the expiration date and time stated on the label.
Frequently Asked Questions
What is Ioflupane I-123 used for?▼
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 )
What are the side effects of Ioflupane I-123?▼
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.
Can I take Ioflupane I-123 during pregnancy?▼
8.1 Pregnancy Risk Summary Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Administration of an appropriate thyroid blocking agent is recommended before use of DATSCAN in a pregnant woman to protect the woman and fetus from accumulation of iodine-123 [see Dosage and Administration (2.2) ] . There are no available data on DATSCAN use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with ioflupane I 123.
What are the important warnings for Ioflupane I-123?▼
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity reactions including dyspnea, edema, rash, erythema, and pruritus have been reported. Have treatment measures available prior to DATSCAN administration. ( 5.1 ) Thyroid Accumulation of Iodine-123: Thyroid uptake of iodine-123 may result in an increased long-term risk for thyroid neoplasia. ( 2.2 , 5.2 ) Radiation Risk: Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration. 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.