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DaTSCAN (ioflupane (123l)) – Summary of product characteristics - V09AB03

Updated on site: 06-Oct-2017

Medication nameDaTSCAN
ATC CodeV09AB03
Substanceioflupane (123l)
ManufacturerGE Healthcare Limited

1.NAME OF THE MEDICINAL PRODUCT

DaTSCAN 74 MBq/ml solution for injection

2.QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of solution contains ioflupane (123I) 74 MBq at reference time (0.07 to 0.13 μg/ml of ioflupane).

Each 2.5 ml single dose vial contains 185 MBq ioflupane (123I) (specific activity range 2.5 to 4.5 x 1014 Bq/mmol) at reference time.

Each 5 ml single dose vial contains 370 MBq ioflupane (123I) (specific activity range 2.5 to 4.5 x 1014 Bq/mmol) at reference time.

Excipient(s) with known effect

This medicinal product contains 39.5 g/l ethanol.

For the full list of excipients see section 6.1.

3.PHARMACEUTICAL FORM

Solution for injection.

Clear colourless solution.

4.CLINICAL PARTICULARS

4.1Therapeutic indications

This medicinal product is for diagnostic use only.

DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:

In adult patients with clinically uncertain Parkinsonian Syndromes, for example those with early symptoms, in order to help differentiate Essential Tremor from Parkinsonian Syndromes related to idiopathic Parkinson’s Disease, Multiple System Atrophy and Progressive Supranuclear Palsy. DaTSCAN is unable to discriminate between Parkinson's Disease, Multiple System Atrophy and Progressive Supranuclear Palsy.

In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer’s disease.

DaTSCAN is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease dementia.

4.2Posology and method of administration

Prior to administration appropriate resuscitation equipment should be available.

DaTSCAN should only be used in adult patients referred by physicians experienced in the management of movement disorders and/or dementia. DaTSCAN should only be used by qualified personnel with the

appropriate government authorisation for the use and manipulation of radionuclides within a designated clinical setting.

Posology

Clinical efficacy has been demonstrated across the range 111 to 185 MBq. Do not exceed 185 MBq and do not use when the activity is below 110 MBq.

Patients must undergo appropriate thyroid blocking treatment prior to injection to minimise thyroid uptake of radioactive iodine, for example by oral administration of approximately 120 mg potassium iodide 1 to 4 hours prior to injection of DaTSCAN.

Special populations

Renal and hepatic impairment

Formal studies have not been carried out in patients with significant renal or hepatic impairment. No data are available (see section 4.4).

Paediatric population

The safety and efficacy of DaTSCAN in children aged 0 to 18 years has not been established. No data are available.

Method of Administration

For intravenous use.

DaTSCAN should be used without dilution. To minimise the potential for pain at the injection site

during administration, a slow intravenous injection (not less than 15 to 20 seconds) via an arm vein is recommended.

SPECT imaging should take place between three and six hours post-injection. Images should be

acquired using a gamma camera fitted with a high-resolution collimator and calibrated using the

159 keV photopeak and a ± 10% energy window. Angular sampling should preferably be not less than 120 views over 360 degrees. For high resolution collimators the radius of rotation should be consistent and set as small as possible (typically 11-15cm). 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

3.5-4.5 mm for those systems currently in use. A minimum of 500k counts should be collected for optimal images. Normal images are characterised by two symmetrical crescent-shaped areas of equal

intensity. Abnormal images are either asymmetric or symmetric with unequal intensity and/or loss of crescent.

4.3

Contraindications

-

Hypersensitivity to the active substance or to any of the excipients listed in section 6,1.

-

Pregnancy (see section 4.6).

4.4

Special warnings and precautions for use

If hypersensitivity reactions occur, the administration of the medicinal product must be discontinued immediately and, if necessary, intravenous treatment initiated. Resuscitative medicinal products and equipment (e.g. endotracheal tube and ventilator) have to be readily available.

This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations and the appropriate licences of the local competent official organisations.

For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit. The activity administered must be such that the resulting dose is as low as reasonably achievable bearing in

mind the need to obtain the intended diagnostic result.

Formal studies have not been carried out in patients with significant renal or hepatic impairment. In the

absence of data, DaTSCAN is not recommended in cases of moderate to severe renal or hepatic impairment.

This medicinal product contains 39.5 g/l (5% volume) ethanol (alcohol), up to 197 mg per dose, equivalent to 5 ml beer or 2 ml wine. Harmful for those suffering from alcoholism. To be taken into account in high-risk groups such as patients with liver disease or epilepsy.

4.5Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed in humans.

Ioflupane binds to the dopamine transporter. Medicines that bind to the dopamine transporter with high affinity may therefore interfere with DaTSCAN diagnosis. These include amfetamine, benzatropine, buproprion, cocaine, mazindol, methylphenidate, phentermine and sertraline.

Medicines shown during clinical trials not to interfere with DaTSCAN imaging include amantadine, trihexyphenidyl, budipine, levodopa, metoprolol, primidone, propranolol and selegiline. Dopamine

agonists and antagonists acting on the postsynaptic dopamine receptors are not expected to interfere with DaTSCAN imaging and can therefore be continued if desired. Medicinal products shown in animal studies not to interfere with DaTSCAN imaging include pergolide.

4.6Fertility, pregnancy and lactation

Women of childbearing potential

Where it is necessary to administer radioactive medicinal products to women of childbearing potential,

information should always be sought about pregnancy. Any woman who has missed a period should be assumed pregnant until proven otherwise. Where uncertainty exists, it is important that radiation

exposure should be the minimum consistent with achieving satisfactory imaging. Alternative techniques which do not involve ionising radiation should be considered.

Pregnancy

Animal reproductive toxicity studies have not been performed with this product. Radionuclide

procedures carried out on pregnant women also involve radiation doses to the foetus. Administration of 185 MBq of ioflupane (123I) results in an absorbed dose to the uterus of 3.0 mGy. DaTSCAN is

contraindicated in pregnancy (see section 4.3).

Breastfeeding

It is not known whether ioflupane (123I) is excreted in human milk. Before administering a radioactive medicinal product to a breast-feeding mother, consideration should be given as to whether the investigation could be reasonably delayed until the mother has ceased breast-feeding and as to whether

the most appropriate choice of radiopharmaceutical has been made, bearing in mind the secretion of radioactivity in breast milk. If administration is considered necessary, breast-feeding should be interrupted for 3 days and substituted by formula feeding. During this time, breast milk should be expressed at regular intervals and the expressed feeds should be discarded.

Fertility

No fertility studies have been performed. No data are available.

4.7Effects on ability to drive and use machines

DaTSCAN has no known influence on the ability to drive and use machines.

4.8Undesirable effects

Summary of the safety profile

No serious adverse reactions related to DaTSCAN administration have been reported.

Tabulated summary of adverse reactions

The frequencies of adverse reactions are defined as follows:

Very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (

1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Immune system disorders

Not known: Hypersensitivity

Metabolism and nutrition disorders

Uncommon: Appetite increased

Nervous system disorders

Common: Headache

Uncommon: Dizziness, formication (paraesthesia), dysgeusia

Ear and labyrinth disorders

Uncommon: Vertigo

Gastrointestinal disorders

Uncommon: Nausea, dry mouth

General disorders and administration site conditions

Uncommon: Injection site pain (intense pain following administration into small veins)

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 4.35 mSv when the maximal recommended activity of

185 MBq is administered these adverse events are expected to occur with a low probability.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

4.9Overdose

In cases of overdose of radioactivity, frequent micturition and defaecation should be encouraged in order to minimise radiation dose to the patient. Care should be taken to avoid contamination from the radioactivity eliminated by the patient using such methods.

5.PHARMACOLOGICAL PROPERTIES

5.1Pharmacodynamic properties

Pharmacotherapeutic group: Diagnostic radiopharmaceutical central nervous system, ATC code: V09AB03.

Due to the low quantities of ioflupane injected, pharmacological effects are not expected following intravenous administration of DaTSCAN at the recommended dosage.

Mechanism of action

Ioflupane is a cocaine analogue. Studies in animals have shown that ioflupane binds with high affinity to

the presynaptic dopamine transporter and so radiolabelled ioflupane (123I) can be used as a surrogate marker to examine the integrity of the dopaminergic nigrostriatal neurons. Ioflupane also binds to the

serotonin transporter on 5-HT neurons but with lower (approximately 10-fold) binding affinity.

There is no experience in types of tremor other than essential tremor.

Clinical efficacy

Clinical studies in patients with dementia with Lewy bodies

In a pivotal clinical trial including evaluation of 288 subjects with dementia with Lewy bodies (DLB) (144 subjects), Alzheimer’s disease (124 subjects), vascular dementia (9 subjects) or other (11 subjects), the results of an independent, blinded visual assessment of the DaTSCAN images were compared to the

clinical diagnosis as determined by physicians experienced in the management and diagnosis of dementias. Clinical categorisation into the respective dementia group was based on a standardised and

comprehensive clinical and neuropsychiatric evaluation. The values for the sensitivity of DaTSCAN in determining probable DLB from non-DLB ranged from 75.0% to 80.2% and specificity from 88.6% to 91.4%. The positive predictive value ranged from 78.9% to 84.4% and the negative predictive value

from 86.1% to 88.7%. Analyses in which both possible and probable DLB patients were compared with non-DLB dementia patients demonstrated values for the sensitivity of DaTSCAN ranging from 75.0%

to 80.2% and specificity from 81.3% to 83.9% when the possible DLB patients were included as non-DLB patients. The sensitivity ranged from 60.6% to 63.4% and specificity from 88.6% to 91.4% when the possible DLB patients were included as DLB patients.

5.2Pharmacokinetic properties

Distribution

Ioflupane (123I) is cleared rapidly from the blood after intravenous injection; only 5% of the administered activity remains in whole blood at 5 minutes post-injection.

Organ uptake

Uptake in the brain is rapid, reaching about 7% of injected activity at 10 minutes post-injection and decreasing to 3% after 5 hours. About 30% of the whole brain activity is attributed to striatal uptake.

Elimination

At 48 hours post-injection, approximately 60% of the injected radioactivity is excreted in the urine, with faecal excretion calculated at approximately 14%.

5.3Preclinical safety data

Non-clinical data for ioflupane reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and genotoxicity.

Studies on reproductive toxicity and to assess the carcinogenic potential of ioflupane have not been performed.

6.PHARMACEUTICAL PARTICULARS

6.1List of excipients

Acetic acid

Sodium acetate

Ethanol

Water for injections

6.2Incompatibilities

Not applicable

6.3Shelf-life

2.5 ml vial: 7 hours from the activity reference time stated on the label. 5 ml vial: 20 hours from the activity reference time stated on the label.

6.4Special precautions for storage

Do not store above 25oC. Do not freeze.

6.5Nature and contents of container

2.5 or 5 ml solution in a single colourless 10 ml glass vial sealed with a rubber closure and metal overseal.

Pack size of 1.

Not all pack sizes may be marketed.

6.6Special precautions for disposal and other handling

General warning

Normal safety precautions for handling radioactive materials should be observed.

Disposal

After use, all materials associated with the preparation and administration of radiopharmaceuticals, including any unused product and its container, should be decontaminated or treated as radioactive waste and disposed of in accordance with the conditions specified by the local competent authority. Contaminated material must be disposed of as radioactive waste via an authorised route.

7.MARKETING AUTHORISATION HOLDER

GE Healthcare Limited

Little Chalfont

Bucks HP7 9NA

United Kingdom

8.MARKETING AUTHORISATION NUMBERS

EU/1/00/135/001 (2.5 ml)

EU/1/00/135/002 (5 ml)

9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 27 July 2000

Date of latest renewal: 28 July 2010

10.DATE OF REVISION OF THE TEXT

11 DOSIMETRY

Iodine-123 has a physical half-life of 13.2 hours. It decays emitting gamma radiation with a predominant energy of 159 keV and X-rays of 27 keV.

The estimated absorbed radiation doses to an average adult patient (70 kg) from intravenous injection of ioflupane (123I) are listed below. 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). Frequent bladder emptying should be encouraged after dosing to minimise radiation exposure.

 

 

Target Organ

Absorbed radiation dose

Gy/MBq

 

Adrenals

13.1

Brain

18.1

Breasts

8.0

Gallbladder wall

25.7

Lower large intestine wall

42.4

Small intestine

20.6

Stomach

11.4

Upper large intestine wall

38.1

Heart wall

13.1

Kidneys

11.1

Liver

28.3

Lungs

42.5

Muscle

9.6

Ovaries

17.0

Pancreas

13.2

Bone marrow

9.8

Bone surfaces

17.4

Skin

6.3

Spleen

10.6

Testes

8.8

Thymus

10.3

Thyroid

9.2

Urinary bladder wall

53.5

Uterus

16.3

Total body

11.5

Effective Dose

23.5 Sv/MBq

 

 

The effective dose (E) resulting from administration of 185 MBq of DaTSCAN injection is 4.35 mSv (per 70 kg individual). The above data are valid in normal pharmacokinetic behaviour. When renal or

hepatic function is impaired, the effective dose and the radiation dose delivered to organs might be increased.

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. See also section 6.6.

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu

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