Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 23 August 2018

Indication(s)

1 INDICATIONS AND USAGE DaTscan is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS).

In these patients, DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson 's disease, multiple system atrophy and progressive supranuclear palsy).

DaTscan is an adjunct to other diagnostic evaluations.

DaTscan (Ioflupane I 123 Injection) is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS).

In these patients, DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson 's disease, multiple system atrophy and progressive supranuclear palsy).

DaTscan is an adjunct to other diagnostic evaluations.

(1)

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

EPNS 2019 Congress Highlights

EPNS 2019 Congress Highlights

The epgonline.org team is creating daily reports from the 13th European Paediatric Neurology Society (EPNS) Congress, held in Athens, Greece from 17th to 21st September 2019, to bring you coverage of cutting-edge science and advances in clinical care across all fields of paediatric neurology. 

Hereditary ATTR amyloidosis

Hereditary ATTR amyloidosis

Explore the pathophysiology, epidemiology and multi-system symptoms associated with hereditary ATTR amyloidosis, as well as how to achieve an early and accurate diagnosis.

Migraine Knowledge Centre

Migraine Knowledge Centre

The Migraine Knowledge Centre features latest research on the prevalence and impact of migraine, the proposed neurological basis of the condition (and how this is being translated into new and exciting drug therapies), as well as current patient care strategies collated from headache organisations worldwide.

Load more

Related Content

Advisory information

contraindications
4 CONTRAINDICATIONS DaTscan is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients, or to iodine. Known hypersensitivity to the active substance or to any of the excipients, or to iodine. (4)
Adverse reactions

6 ADVERSE REACTIONS Hypersensitivity and injection site reactions have been reported following DaTscan administration.

(6.2) In clinical trials, the most common adverse reactions, headache, nausea, vertigo, dry mouth or dizziness occurred in < 1 % of subjects.

(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 Study Experience The data from clinical studies reflect exposure to DaTscan in 942 subjects with a mean age of 66 years (range 25 to 90 years).

Among these subjects, 42 % were women and 99 % Caucasian.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of DaTscan can not be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, no serious adverse reactions were reported.

Other adverse reactions occurred at a rate of 1 % or less and the reported events consisted of headache, nausea, vertigo, dry mouth or dizziness.

These reactions were of mild to moderate severity.

6.2 Postmarketing Experience Because postmarketing 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.

In the postmarketing experience, hypersensitivity reactions have been reported.

The reactions generally related to rash and pruritis within minutes of DaTscan administration.

The reactions either resolved spontaneously or following the administration of corticosteroids and antihistamines.

Injection site pain has also been reported.

Usage information

Dosing and administration

2 DOSAGE AND ADMINISTRATION DaTscan emits gamma radiation and must be handled with safety measures.

(2.1) Measure patient dose by a suitable radioactivity calibration system immediately prior to administration.

(2.1) Administer a thyroid-blocking agent at least one hour before the dose of DaTscan.

(2.2) The recommended DaTscan dose is 111 to 185 MBq (3 to 5 mCi).

(2.4) Begin SPECT imaging between 3 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 clinical personnel and patients.

Radiopharmaceuticals should be used by or under the control of physicians 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.

DaTscan dosing is based upon the radioactivity determined using a suitably calibrated instrument immediately prior to administration.

To minimize radiation dose to the bladder, 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 Dosage and Administration (2.5)].

2.2 Thyroid Blockade Before DaTscan Injection Before administration of DaTscan, administer Potassium Iodide Oral Solution or Lugol 's Solution (equivalent to 100 mg iodide) or potassium perchlorate (400 mg) to block uptake of iodine 123 by the patient 's thyroid.

Administer the blocking agent at least one hour before the dose of DaTscan [see Warnings and Precautions (5.2)].

2.3 Preparation and Administration Use aseptic procedures and radiation shielding during preparation and administration.

Inspect the DaTscan vial prior to administration and do not use it if the vial contains particulate matter or discoloration [see Description (11)].

Administer

DaTscan as a slow intravenous injection (administered over a period of not less than 15 to 20 seconds) via an arm vein.

2.4 Recommended Dose The recommended dose is 111 to 185 MBq (3 to 5 mCi) administered intravenously [see Clinical Studies (14)].

2.5 Radiation Dosimetry The estimated radiation absorbed doses to an average 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 230.0 Breasts 7.8 Esophagus 10.0 Gallbladder Wall 26.4 GI Tract 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 = 0.57 DULI + 0.43 DLLI [

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 42.0 Heart Wall 12.9 Kidneys 10.9 Liver 27.9 Lungs 41.2 Muscle 9.4 Osteogenic Cells 28.2 Ovaries 16.8 Pancreas 13.0 Red Marrow 9.2 Skin 6.0 Spleen 10.4 Testes 8.5 Thymus 10.0 Thyroid 9.0 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.

2.6 Imaging Guidelines Begin SPECT imaging 3 to 6 hours following DaTscan administration.

Acquire images using 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 not less than 120 views over 360 degrees.

Position the subject supine with the head on an off-the-table headrest, a flexible head restraint such as a strip of tape across the chin or forehead may be used to help avoid movement, and set a circular orbit for the detector heads with the radius as small as possible (typically 11 to 15 cm).

Experimental studies with a striatal phantom suggest that optimal images are obtained with matrix size and zoom factors selected to give a pixel size of 3.5 to 4.5 mm.

Collect a minimum of 1.5 million counts for optimal images.

2.7 Image Interpretation DaTscan images are interpreted visually, based upon the appearance of the striata.

Reconstructed pixel size should be between 3.5 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.

Determination of whether an image is normal or abnormal is made 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).

Use in special populations

8 USE IN SPECIFIC POPULATIONS Pregnancy: No human or animal data.

Any radiopharmaceutical, including DaTscan, may cause fetal harm.

Use only if clearly needed.

(8.1) Nursing Mothers: A decision should be made whether to interrupt nursing after DaTscan administration or not to administer DaTscan, taking into consideration the importance of the drug to the mother.

(8.3) Pediatric: Safety and effectiveness have not been established.

(8.4) 8.1 Pregnancy Pregnancy Category C: It is not known whether DaTscan can cause fetal harm or increase the risk of pregnancy loss when administered to a pregnant woman.

Animal reproductive and developmental toxicity studies have not been conducted with DaTscan.

Prior to the administration of DaTscan to women of childbearing potential, assess for the presence of pregnancy.

DaTscan should be given to a pregnant woman only if clearly needed.

Like all radiopharmaceuticals, DaTscan has a potential to cause fetal harm.

The likelihood of fetal harm depends on the stage of fetal development, and the magnitude of the radionuclide dose.

Administration of DaTscan 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.

Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function.

8.3 Nursing Mothers It is not known whether DaTscan is excreted into human milk.

However, iodine 123 is excreted into human milk.

Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of DaTscan or not to administer DaTscan, taking into account the importance of the drug to the mother.

Based on the physical half-life of iodine 123 (13.2 hours), nursing women may consider interrupting nursing and pumping and discarding breast milk for 6 days after DaTscan administration in order to minimize risks to a nursing infant.

8.4 Pediatric Use DaTscan is not indicated for use in children.

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

8.5 Geriatric Use In the two principal clinical studies, 45 % of the subjects were aged 65 and over.

There were no differences in response compared to younger subjects that would require a dose adjustment.

Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

8.6 Renal and Hepatic Impairment The effect of renal or hepatic impairment upon DaTscan imaging has not been established.

DaTscan is excreted by the kidney and patients with severe renal impairment may have increased radiation exposure and altered DaTscan images.

Pregnancy and lactation

8.3 Nursing Mothers It is not known whether DaTscan is excreted into human milk.

However, iodine 123 is excreted into human milk.

Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of DaTscan or not to administer DaTscan, taking into account the importance of the drug to the mother.

Based on the physical half-life of iodine 123 (13.2 hours), nursing women may consider interrupting nursing and pumping and discarding breast milk for 6 days after DaTscan administration in order to minimize risks to a nursing infant.

Interactions

7 DRUG INTERACTIONS The ioflupane within DaTscan binds to the dopamine transporter.

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, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, 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.

The impact of dopamine agonists and antagonists upon DaTscan imaging results has not been established.

Amoxapine, amphetamine, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, sertraline, citalopram and paroxetine may interfere with DaTscan imaging.

(7) The effects of dopamine agonists and antagonists on DaTscan imaging have not been established.

More information

Category Value
Authorisation number NDA022454
Agency product number 3MM99T8R5Q
Orphan designation No
Product NDC 17156-210
Date Last Revised 25-09-2015
Type HUMAN PRESCRIPTION DRUG
Storage and handling Storage 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 (Ioflupane I 123 Injection) preparations after the expiration date and time stated on the label.
Marketing authorisation holder Medi-Physics Inc. dba GE Healthcare.