DaTscan

DaTscan is an FDA-registered drug product whose active ingredient is IOFLUPANE I-123. It is labelled by Medi-Physics Inc. dba GE Healthcare. taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 17156-210, application NDA022454, label effective 20260424. It is one of 2 FDA drug label records sharing the active ingredient IOFLUPANE I-123. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing IOFLUPANE I-123 are most often described in connection with: indicated adjunct, diagnostic evaluations, striatal dopamine, transporter visualization, single photon, emission computed, tomography spect, brain imaging. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 )

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), administered intravenously over at least 20 seconds, 3 hours to 6 hours before imaging. 2.3 Patient Preparation and Administration Thyroid Blockade Before DATSCAN 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 DATSCAN [see Warnings and Precautions (5.2) ] . Assessment of Drug Interactions Consider discontinuing drugs that have the potential to impact DATSCAN image interpretation for at least 5 biological half-lives before administration of DATSCAN if use of these drugs can be safely suspended [see Drug Interactions (7) ] . Patient Hydration and Voiding To minimize radiation exposure, encourage hydration prior to and following DATSCAN administration in order to permit frequent voiding. Encourage the patient to void frequently for the first 48 hours following DATSCAN administration [see Warnings and Precautions (5.3) ] . Pregnancy Status Assess pregnancy status before administering DATSCAN to a female of reproductive potential [see Use in Specific Populations (8.1) ]. Administration Use aseptic procedures and radiation shielding during preparation and administration. Inspect the DATSCAN 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. 2.4 Imaging Instructions Begin SPECT imaging 3 hours to 6 hours following DATSCAN administration. Use a gamma camera fitted with high-resolution collimators and set to a photopeak of 159 keV with a ± 10% energy window. Angular sampling should be at least 120 views over 360 degrees. Position the patient supine with the head on an off-the-table headrest, use a flexible head restraint such as a strip of tape across the chin or forehead if necessary to help avoid movement, and set a circular orbit for the detector heads with the radius as small as possible (typically 11 cm to 15 cm). Obtain images with matrix size and zoom factors selected to give a pixel size of 3.5 mm to 4.5 mm. Collect a minimum of 1.5 million counts for optimal images. 2.5 Image Interpretation Interpret DATSCAN images visually, based upon the appearance of the striata. Reconstructed pixel size should be between 3.5 mm and 4.5 mm with slices 1 pixel thick. Optimum presentation of the reconstructed images for visual interpretation is transaxial slices parallel to the anterior commissure-posterior commissure (AC-PC) line. Determine whether an image is normal or abnormal by assessing the extent (as indicated by shape) and intensity of the striatal signal. Image interpretation does not involve integration of the striatal image appearance with clinical signs and/or symptoms. Normal: In transaxial images, normal images are characterized by two symmetric comma- or crescent-shaped focal regions of activity mirrored about the median plane. Striatal activity is distinct, relative to surrounding brain tissue (Figure 1). Abnormal: Abnormal DATSCAN images fall into at least one of the following three categories (all are considered abnormal). Activity is asymmetric, e.g., activity in the region of the putamen of one hemisphere is absent or greatly reduced with respect to the other. Activity is still visible in the caudate nuclei of both hemispheres resulting in a comma or crescent shape in one and a circular or oval focus in the other. There may be reduced activity between at least one striatum and surrounding tissues (Figure 2). Activity is absent in the putamen of both hemispheres and confined to the caudate nuclei. Activity is relatively symmetric and forms two roughly circular or oval foci. Activity of one or both is generally reduced (Figure 3). Activity is absent in the putamen of both hemispheres and greatly reduced in one or both caudate nuclei. Activity of the striata with respect to the background is reduced (Figure 4). Figures 1-4 2.6 Radiation Dosimetry The estimated radiation absorbed doses to an adult from intravenous injection of DATSCAN 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 DATSCAN 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 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 colon = 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] 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 11.3 EFFECTIVE DOSE PER UNIT ADMINISTERED ACTIVITY (µSv/MBq) 21.3 The Effective Dose resulting from a DATSCAN administration with an administered activity of 185 MBq (5 mCi) is 3.94 mSv in an adult.

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 )

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: headache, nausea, vertigo, dry mouth, and dizziness. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of DATSCAN. 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

FDA lists 2 drug label records with IOFLUPANE I-123 as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is DaTscan 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 …

Who makes DaTscan?
Medi-Physics Inc. dba GE Healthcare. is the labeler of record for DaTscan. 2 FDA label records share the active ingredient IOFLUPANE I-123, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does DaTscan come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is DaTscan prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing IOFLUPANE I-123?
Yes. 2 FDA drug label records list IOFLUPANE I-123 as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has DaTscan been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.