Datscan

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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
• Brain
• Striata 230 Breasts
• Gallbladder Wall
• GI Tract Esophagus 10 Stomach Wall
• 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]
• Upper Large Intestine Wall
• Lower Large Intestine Wall 42 Heart Wall
• Kidneys
• Liver
• Lungs
• Muscle
• Osteogenic Cells
• Ovaries
• Pancreas 13 Red Marrow
• Skin 6 Spleen
• Testes
• Thymus 10 Thyroid 9 Urinary Bladder Wall
• Uterus
• Total Body
• 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

The safety and efficacy of DATSCAN have not been established in pediatric patients.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• In the two principal clinical studies of DATSCAN 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

• 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

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Hypersensitivity Reactions Inform the patient that hypersensitivity reactions, including dyspnea, edema, rash, erythema and pruritus, have been reported following DATSCAN administration [see Warnings and Precautions (5.1) ].
• Adequate Hydration Instruct patients to drink a sufficient amount of water prior to and after receiving DATSCAN and to void frequently for the first 48 hours following DATSCAN administration [see Dosage and Administration (2.3) ] .
• Lactation Advise a lactating woman to interrupt breastfeeding and pump and discard breastmilk for at least 6 days (>10 physical half-lives) after DATSCAN 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 DATSCAN [see Use in Specific Populations (8.1) ].

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• 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 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• How Supplied DATSCAN (ioflupane I 123 injection) is a clear, colorless solution supplied in single-dose glass vials 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.
• Each vial is enclosed in a lead container of appropriate thickness.
• NDC 17156-210-01 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.
• This preparation is approved for use by persons licensed by the Illinois Emergency Management Agency pursuant to 32 IL.
• Adm.
• Code Section 330.260(a) and 335.4010 or equivalent licenses of the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

Quoted from the official label, section “How Supplied”.

How to store it

• 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.
• This preparation is approved for use by persons licensed by the Illinois Emergency Management Agency pursuant to 32 IL.
• Adm.
• Code Section 330.260(a) and 335.4010 or equivalent licenses of the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

Quoted from the official label, section “Storage and Handling”.

What is in it

• 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.
• 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:
• Chemical Structure
• 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
• External Radiation The specific gamma-ray constant for iodine-123 is
• 1.6 R/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 Calculation based on attenuation and energy-transfer coefficients obtained from National Institute of Standards & Technology Internal Report NISTIR 5632.
• 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

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Same active substance

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