Ioflupane I 123 2 mCi/mL Injection, Solution, 2.5 mL
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🧪 Inactive Ingredients / Excipients
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5.7 mg / 1 mL
UNII Q40Q9N063P
Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
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0.05 mL / 1 mL
UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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7.8 mg / 1 mL
UNII 4550K0SC9B
Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
3 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ioflupane I 123 2 mCi/mLthis 69945-0166-05 | Curium | 2.5 ml | — | AP | FDA listed | — |
| DaTscan 2 mCi/mL 17156-0210-01 | Medi-Physics | 1 vial | — | AP | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69945-0166-05 You're viewing this | 2.5 mL in 1 VIAL, SINGLE-DOSE (69945-166-05) | 2022-03-31 | Active |
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| NDC identity (package / product / labeler codes) | ✓ Available |
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| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and 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 and 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
2.1Radiation 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 void frequently for the first 48 hours following Ioflupane I 123 Injection administration [ see Dosage and Administration ( 2.5 ) ].
2.2Thyroid Blockade Before Ioflupan e I 123 Injection Administration Administer Potassium Iodide Oral Solution or Strong Iodine Solution (e.g., Lugol's Solution) equivalent to 100 mg iodide to block uptake of iodine-123 by the patient's thyroid at least one hour before the dose of Ioflupane I 123 Injection [ see Warnings and Precautions ( 5.2 ) ].
2.3Recommended Dos age 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. 4 Preparation and Administration Assess pregnancy status before administering Ioflupane I 123 Injection to a female of reproductive potential [ see Use in Specific Populations ( 8.1 ) ].
Use aseptic procedures and radiation shielding during preparation and administration. Inspect the Ioflupane I 123 Injection vial for particulate matter and discoloration prior to administration and do not use it if the vial contains particulate matter or discoloration. Measure patient dose using a dose calibrator immediately prior to administration.
Discard unused portion.
2.5Radiation Dosimetry The estimated radiation absorbed doses to an adult from intravenous injection of Ioflupane I 123 Injection are shown in Table 1. The values are calculated assuming urinary bladder emptying at 4.8-hour intervals and appropriate thyroid blocking (iodine-123 is a known Auger electron emitter). Table 1 Estimated Radiation Absorbed Doses from Ioflupane I 123 Injection ORGAN / TISSUE ABSORBED DOSE PER UNIT ADMINISTERED ACTIVITY (μGy / MBq) Adrenals
12.9 Brain
17.8 Striata 230 Breasts
7.8 Gallbladder Wall
26.4 GI Tract Esophagus 10 Stomach Wall
11.2 Small Intestine Wall
21.2 Colon Wall a
39.8 Upper Large Intestine Wall
38.1 Lower Large Intestine Wall 42 Heart Wall
12.9 Kidneys
10.9 Liver
27.9 Lungs
41.2 Muscle
9.4 Osteogenic Cells
28.2 Ovaries
16.8 Pancreas 13 Red Marrow
9.2 Skin 6 Spleen
10.4 Testes
8.5 Thymus 10 Thyroid 9 Urinary Bladder Wall
53.1 Uterus
16.1 Total Body
11.3EFFECTIVE DOSE PER UNIT ADMINISTERED ACTIVITY (µSv/MBq) 21.3 a The absorbed dose to the colon wall is the mass-weighted sum of the absorbed doses to the upper and lower large intestine walls, D c olon = 0.57D ULI + 0.43D LLI [Publication 80 of the ICRP (International Commission on Radiological Protection); Annals of the ICRP 28 (3). Oxford: Pergamon Press; 1998] The Effective Dose resulting from a Ioflupane I 123 Injection administration with an administered activity of 185 MBq (5 mCi) is 3.94 mSv in an adult.
2.6Imaging Instructions Begin SPECT imaging 3 hours to 6 hours following Ioflupane I 123 Injection administration. Use a gamma camera fitted with…
💊 Dosage Forms and Strengths ▾
3 DOSAGE 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. Injection: 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. ( 3 )
⛔ 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 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity reactions including dyspnea, edema, rash, erythema, and pruritus have been reported. Have treatment measures available prior to Ioflupane I 123 Injection 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. ( 2.1 , 5.3 ) 5.
1 Hypersensitivity Reactions Hypersensitivity reactions, including dyspnea, edema, rash, erythema, and pruritus, have been reported following Ioflupane I 123 Injection administration [ see Adverse Reactions ( 6.2 ) ]. The reactions have generally occurred within minutes of Ioflupane I 123 Injection administration and have either resolved spontaneously or following the administration of corticosteroids and antihistamines. Ioflupane I 123 Injection is contraindicated in patients with known serious hypersensitivity to ioflupane I-123 [ see Contraindications ( 4 ) ].
Have treatment measures available and monitor patients for symptoms or signs of a hypersensitivity reaction.
5.2Thyroid Accumulation of Iodine-123 Ioflupane I 123 Injection may contain up to 6% of free iodide (iodine-123). Thyroid uptake of iodine-123 may result in an increased long-term risk for thyroid neoplasia. To decrease thyroid accumulation of iodine-123, block the thyroid gland before administration of Ioflupane I 123 Injection [ see Dosage and Administration ( 2.2 ) ].
5.3Radiation Risk Ioflupane I 123 Injection contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to patients and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration ( 2.1 )].
🤒 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.
6.1Clinical 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) [ see Dosage and Administration ( 2.3 ) ]. The following adverse reactions were reported at a rate of 1% or less: headache, nausea, vertigo, dry mouth, and dizziness.
6.2Postmarketing 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
🔄 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 with Ioflupane I 123 Injection imaging. The effects of dopamine agonists and antagonists on Ioflupane I 123 Injection imaging have not been established. ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. ( 8.1 ) Lactation: Advise a lactating woman to interrupt breastfeeding and pump and discard breastmilk for at least 6 days after Ioflupane I 123 Injection administration. ( 8.2 ) 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 Ioflupane I 123 Injection 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 Ioflupane I 123 Injection 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. All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. Administration of Ioflupane I 123 Injection at a dose of 185 MBq (5 mCi) results in an absorbed radiation dose to the uterus of 0.3 rad (3.0 mGy).
Radiation doses greater than 15 rad (150 mGy) have been associated with congenital anomalies but doses under 5 rad (50 mGy) generally have not. Advise pregnant women of the potential risks of fetal exposure to radiation doses with administration of Ioflupane I 123 Injection. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
8.2Lactation Risk Summary Iodine-123, the radionuclide in Ioflupane I 123 Injection, is present in human milk. There is no information on the effects on the breastfed infant or on milk production. 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.
8.4Pediatric Use The safety and efficacy of Ioflupane I 123 Injection have not been established in pediatric patients.
8.5Geriatric Use In the two principal clinical studies of Ioflupane I 123 Injection for suspected Parkinsonian syndromes, 45% of the subjects were aged 65 and over, while 10% were 75 and over [ see Clinical Studies ( 14.1 ) ]. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
8.6Renal Impairment Ioflupane I 123 Injection is excreted by the kidney and patients with severe renal impairment may have increased radiation exposure and altered Ioflupane I 123 Injection images.
🤰 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 Ioflupane I 123 Injection 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 Ioflupane I 123 Injection 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. All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
Administration of Ioflupane I 123 Injection at a dose of 185 MBq (5 mCi) results in an absorbed radiation dose to the uterus of 0.3 rad (3.0 mGy). Radiation doses greater than 15 rad (150 mGy) have been associated with congenital anomalies but doses under 5 rad (50 mGy) generally have not. Advise pregnant women of the potential risks of fetal exposure to radiation doses with administration of Ioflupane I 123 Injection.
The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of Ioflupane I 123 Injection have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use In the two principal clinical studies of Ioflupane I 123 Injection for suspected Parkinsonian syndromes, 45% of the subjects were aged 65 and over, while 10% were 75 and over [ see Clinical Studies ( 14.1 ) ]. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
🆘 Overdosage ▾
10 OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The active drug substance in Ioflupane I 123 Injection is N-ω-fluoropropyl-2β-carbomethoxy-3β-(4-[ 123 I]iodophenyl)nortropane or ioflupane I-123. In vitro , ioflupane binds reversibly to the human dopamine transporter (DaT) (Ki = 0.62 nM; IC 50 = 0.71 nM). Autoradiography of post-mortem human brain slices exposed to radiolabeled ioflupane shows concentration of the radiolabel in striatum (caudate nucleus and putamen).
The specificity of the binding of ioflupane I-125 to dopamine transporter was demonstrated by competition studies with the DaT inhibitor GBR 12909 (a dopamine reuptake inhibitor), the serotonin reuptake inhibitor citalopram, and the norepinephrine reuptake inhibitor desipramine in post-mortem human brain slices exposed to radiolabeled ioflupane. Citalopram reduced binding in the neocortex and thalamus with only minor effects in the striatum. This indicated that the binding in the cortex and thalamus is mainly to the serotonin reuptake sites.
Desipramine showed no effect on the level of striatal binding of ioflupane I- 125, but reduced extrastriatal binding by 60 to 85%. The binding of ioflupane I-125 to the striatum was abolished in the presence of high concentrations of GBR 12909, indicating selectivity of ioflupane binding for the pre-synaptic DaT. Following administration of Ioflupane I 123 Injection to humans, radioactive decay of the iodine-123 emits gamma radiation which can be detected externally using gamma detectors, allowing visualization of the brain striata through SPECT imaging [ see Clinical Pharmacology ( 12.3 ) ].
12.2Pharmacodynamics As Ioflupane I 123 Injection contains a very small quantity of ioflupane, no ioflupane pharmacologic effects are expected [ see Description ( 11 ) ].
12.3Pharmacokinetics The pharmacokinetics of ioflupane I-123 were studied by monitoring radioactivity following intravenous injection; only 5% of the administered radioactivity remained in whole blood at 5 minutes post-injection. Uptake in the brain reached approximately 7% of injected radioactivity at 10 minutes post-injection and decreased to 3% after 5 hours; striata to background ratios were relatively constant between 3 hours and 6 hours post-injection. About 30% of the whole brain radioactivity was attributed to striatal uptake.
By 48 hours post-injection, approximately 60% of the injected radioactivity has been excreted in the urine, with fecal excretion estimated to be approximately 14%.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The active drug substance in Ioflupane I 123 Injection is N-ω-fluoropropyl-2β-carbomethoxy-3β-(4-[ 123 I]iodophenyl)nortropane or ioflupane I-123. In vitro , ioflupane binds reversibly to the human dopamine transporter (DaT) (Ki = 0.62 nM; IC 50 = 0.71 nM). Autoradiography of post-mortem human brain slices exposed to radiolabeled ioflupane shows concentration of the radiolabel in striatum (caudate nucleus and putamen).
The specificity of the binding of ioflupane I-125 to dopamine transporter was demonstrated by competition studies with the DaT inhibitor GBR 12909 (a dopamine reuptake inhibitor), the serotonin reuptake inhibitor citalopram, and the norepinephrine reuptake inhibitor desipramine in post-mortem human brain slices exposed to radiolabeled ioflupane. Citalopram reduced binding in the neocortex and thalamus with only minor effects in the striatum. This indicated that the binding in the cortex and thalamus is mainly to the serotonin reuptake sites.
Desipramine showed no effect on the level of striatal binding of ioflupane I- 125, but reduced extrastriatal binding by 60 to 85%. The binding of ioflupane I-125 to the striatum was abolished in the presence of high concentrations of GBR 12909, indicating selectivity of ioflupane binding for the pre-synaptic DaT. Following administration of Ioflupane I 123 Injection to humans, radioactive decay of the iodine-123 emits gamma radiation which can be detected externally using gamma detectors, allowing visualization of the brain striata through SPECT imaging [ see Clinical Pharmacology ( 12.3 ) ].
📦 How Supplied / Storage and Handling ▾
16 HOW 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.
📋 Description ▾
11 DESCRIPTION The chemical name for ioflupane I-123 is N-ω-fluoropropyl-2β-carbomethoxy-3β-(4- [123I]iodophenyl)nortropane and it has the following structural formula:
11.1Chemical Characteristics Ioflupane I 123 Injection is a sterile, pyrogen-free radioactive diagnostic agent for intravenous use. Ioflupane I 123 Injection is a clear and colorless solution is 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, 5.7 mg acetic acid, 7.8 mg sodium acetate and 0.05 mL (5%) ethanol.
The pH of the solution is between 4.2 and 5.2. The chemical name for ioflupane I-123 is N-ω-fluoropropyl-2β-carbomethoxy-3β-(4- [ 123 I]iodophenyl)nortropane and it has the following structural formula: 11. 2 Physical Characteristics Iodine-123 is a cyclotron-produced radionuclide that decays to tellurium-123 by electron capture and has a physical half-life of 13.2 hours.
The photon that is useful for detection and imaging studies is listed in Table 2. Table 2 Principal Radiation Emission Data – Iodine-123 Radiation Energy Level (keV) Abundance (%) Gamma 159 83 11. 3 External Radiation The specific gamma-ray constant for iodine-123 is
1.6R/mCi-hr at 1 cm. The first half-value thickness of lead (Pb) for iodine-123 is 0.04 cm. The relative transmission of radiation emitted by the radionuclide that results from interposition of various thicknesses of Pb is shown in Table 3 (e.g., the use of 2.16 cm Pb will decrease the external radiation exposure by a factor of about 1,000).
Table 3 Reduction in In-air Collision Kerma Caused by Lead Shielding a Shield Thickness cm of lead (Pb) Reduction in In-air Collision Kerma 0.04 0.5 0.13 10 -1 0.77 10 -2 2.16 10 -3 3.67 10 -4 a Calculation based on attenuation and energy-transfer coefficients obtained from National Institute of Standards & Technology Internal Report NISTIR 5632.
💬 Information for Patients ▾
17 PATIENT 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 [ see Warnings and Precautions ( 5.1 ) ]. 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 [ see Dosage and Administration ( 2.1 ) ].
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 [ see Use in Specific Populations ( 8.2 ) ]. Pregnancy Advise a pregnant woman of the potential risks of fetal exposure to radiation doses with Ioflupane I 123 Injection [ see Use in Specific Populatio ns ( 8.1 ) ]. Manufactured and Distributed by Curium US LLC, 2703 Wagner Pl, Maryland Heights, MO 63043 U.S.A.
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