COMPETENCE IN NUCLEAR MEDICINE
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CLINICAL PARTICULARS

4.2 Posology and method of Administration

Posology

Adults and elderly Population

In oncology, the radioactivity usually recommended for adults is 2-4 MBq/kg of body mass depending on the PET(/CT) machine in use and acquisition mode, administered by direct slow intravenous injection over approximately one minute. One half of this activity may be administered for neurological indications not requiring whole body images.

Renal / Hepatic impairment

Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.

Paediatric Population

The use in children and adolescents has to be considered carefully, based upon clinical needs and assessing the risk/benefit ratio in this patient group.

The activities to be administered to children and adolescents may be calculated according to the recommendations of the EANM paediatric task group Dosage Card; the activity administered to children and to adolescents may be calculated by multiplying a baseline activity (for calculation purposes) by the body-mass-dependent coefficients given in the table below.

 

A[MBq]Administered = Baseline Activity × Coefficient

 

The Baseline Activity for 2D imaging is 25.9 MBq and for 3D imaging 14.0 MBq (recommended in children).

3kg=1

22kg=5.29

42kg=9.14

4kg=1.14

24kg=5.71

44kg=9.57

6kg=1.71

26kg=6.14

46kg=10.0

8kg=2.14

28kg=6.43

48kg=10.29

10kg=2.71

30kg=6.86

50kg=10.71

12kg=3.14

32kg=7.29

52-54kg=11.29

14kg=3.57

34kg=7.72

56-58kg=12.0

16kg=4.00

36kg=8.00

60-62kg=12.71

18kg=4.43

38kg=8.43

64-66kg=13.43

20kg=4.86

40kg=8.86

68kg=14.0

 

Method of Administration

For patient preparation, see section 4.4.

The activity of IASOdopa has to be measured with activimeter immediately prior to injection.

The injection of IASOdopa must be intravenous in order to avoid irradiation as a result of local extravasation, as well as imaging artefacts. It should be administered by direct intravenous injection. For instructions for preparation, see section 12.

Image acquisition

Neurology

  • “dynamic” acquisition of PET images of the brain during 90 to 120 minutes right after injection
  • or one “static” PET acquisition starting 90 minutes after the injection.

Oncology

To detect foci in the liver, pancreas or brain area, early “static” images can be acquired starting 5 minutes after injection, or a “dynamic” acquisition starting right after the injection during 10 minutes.

  • Brain tumours: “static” acquisition 10 to 30 minutes after injection.
  • Whole-body: images are usually acquired 60 minutes after injection.

4.3 Contraindications

  • Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to any of the components of the labelled radiopharmaceutical.
  • Pregnancy.

4.4 Special warnings and precautions for use

Potential for hypersensitivity or anaphylactic reactions

If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary. To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.

Individual benefit/risk justification

For each patient, the radiation exposure must be justifiable by the likely benefit. The activity administered should in every case be as low as reasonably achievable to obtain the required diagnostic information.

Renal / hepatic impairment

Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.

Paediatric Population

For information on the use in paediatric population, see section 4.2 or 5.1.

Careful consideration of the indication is required since the effective dose per MBq is higher than in adults (see section 11).

Patient preparation

The patient should be well hydrated before the start of the examination and urged to void as often as possible during the first hours after the examination in order to reduce radiation

Interpretation of IASOdopa Images

Neurology

The interpretation of IASOdopa uptake values in the different parts of the brain requires the comparison to age and sex matched controls. Recent publications refer to data base of normal cases and voxel-based Statistical Parametric Mapping (SPM) and automated region of interest (ROI) analysis.

Oncology

False positive results in inflammatory lesions seem to be very rare with IASOdopa PET. Nevertheless, the possibility of an inflammatory lesion should be kept in mind when an unexpected IASOdopa focus is detected. The physiologic biodistribution must be taken into account in the interpretation; in particular uptake in the basal ganglia, diffuse uptake in the pancreas, uptake in the gallbladder leading to subsequent activity in the gut, and uptake in the kidney leading to “hot spots” aspect in the ureters and a high activity in the bladder.

After the procedure

Close contact with infants and pregnant women should be restricted during12 hours.

Specific warnings

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.

Depending on the time when you administer the injection, the content of sodium given to the patient may in some cases be greater than 1 mmol. This should be taken into account in patient on low sodium diet

Precautions with respect to environmental hazard see section 6.6.

4.5 Interaction with other medicinal products and other forms of interaction

Carbidopa: prior to IASOdopa administration, use of carbidopa may increase IASOdopa bioavailability to the brain by inhibiting peripheral decarboxylase activity and restricting peripheral 6-fluoro-(18F)-L-dopa metabolism with 3- O-methyl-6-fluoro-(18F)-L-dopa formation.

Haloperidol: increased intracerebral dopamine turnover caused by haloperidol may result in increased accumulation of IASOdopa.

Monoamine oxidase (MAO) inhibitors: concurrent use with MAO inhibitors may result in increased accumulation of IASOdopa in the brain.

Reserpine: reserpine-induced depletion of the contents of intraneuronal vesicles may prevent retention of IASOdopa in the brain.

Paediatric Population

Interaction studies have only been performed in adults.

4.6 Fertility, pregnancy and lactation

Women of childbearing potential

When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient.

Pregnancy

The use of IASOdopa is contraindicated in pregnant women due to preventive radiation protection of the fetus (see section 4.3).

Breastfeeding

Before administering radiopharmaceuticals to a mother who is breastfeeding consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breastfeeding, and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk. If the administration is considered necessary, breastfeeding should be interrupted for the initial 12 hours following injection and the expressed feeds discarded.

Close contact with infants should be restricted during this period of 12 hours.

Fertility

Not applicable

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 7 mSv when the maximal recommended activity of 280 MBq is administered these adverse reactions are expected to occur with a low probability.

No undesirable effects have been observed to date.

Pain at injection has been reported in rare cases which resolved within minutes without corrective measures.

Paediatric population: Not reported

4.9 Overdose

Adult, ederly and paediatric population: An overdose in the pharmacological sense is unlikely given with the doses used for diagnostic purposes.

In the event of administration of a radiation overdose with IASOdopa the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by forced diuresis and frequent bladder voiding. It might be helpful to estimate the effective dose that was applied.

Paediatric population: Not reported

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