MIBG (123I)

Posology Adults The recommended activity range is 110-400 MBq based on a patient of average weight (70 kg). Elderly population No special dosage-scheme is required for the elderly patient. Renal impairment Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.

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. 00 In very young children (up to 1 year), a minimum dose of 37 MBq is necessary in order to obtain images of sufficient quality.

The safety and efficacy of MIBG (123I) in paediatric patients < 1 month have not been established. No data are available. Method of administration Multidose vial. 8). If desired, the volume to be administered can be increased by dilution.

8). Saline flush is recommended following MIBG (123I) administration. For instructions on dilution of the medicinal product before administration, see section 12. For patient preparation, see section

Tabulated list of adverse reactions The following table includes the adverse reactions sorted by system organ classes according to MedDRA. The frequencies are defined as follows: very common ≥ 1/10; common from ≥ 1/100 to <1/10; uncommon from ≥ 1/1,000 to <1/100, rare from ≥ 1/10,000 to <1/1,000; very rare <1/10,000; frequency not known (cannot be estimated from the available data).

System Organ Class (SOCs) Adverse reactions* Frequency Immune system disorders Hypersensitivity Anaphylactoid reactions Not known Nervous System disorders Dizziness Headache Paraesthesia Not known Cardiac disorders Tachycardia Palpitations Not known Respiratory, thoracic and mediastinal disorders Dyspnoea.

Not known Vascular disorders Transient hypertension. Flushing Not known Gastrointestinal disorders Abdominal cramps, abdominal pain Nausea Vomiting Not known Skin and subcutaneous tissue disorders Urticaria Rash Erythema Not known General disorders and administration site conditions Injection site pain Localised oedema Injection site reaction Feeling hot Cold chills Not known Injury, poisoning and procedural complications Radiation necrosis after paravenous drug administration.

4). Within one hour these symptoms disappear. g. 4). 4). General advice Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. 2 mSv when the maximal recommended activity of 400 MBq is administered these adverse reactions 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. uk/yellowcard

4. Image acquisition • Neuroendocrine tumours imaging: whole body anterior and posterior scintigraphy images and/or relevant spot images and/or SPECT images may be performed 24 hours after the MIBG (123I) administration. These scans are eventually repeated after 48 hours.

• Myocardial imaging: anterior planar imaging of the chest at 15 min (early image) and 4 hours (late image) following administration of MIBG (123I) eventually followed by a single photon emission computed tomography (SPECT). 1. 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. Patients with sympathetic nervous system impairment In patients suffering from clinical conditions that influence the nervous or sympathetic system functioning, such as Parkinsonian syndromes, a decrease in MIBG (123I) cardiac uptake can be observed regardless of cardiac pathology.

Renal impairment Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible. Severe renal insufficiency may cause impaired imaging results since iobenguane (123I) is excreted mainly via the kidneys.

2. Careful consideration of the indication is required since the effective dose per MBq is higher than in adults (see section 11). 5). - To minimize radiation dose to the thyroid gland, thyroid uptake of free iodide should be prevented using stable iodine administered orally: • In adults, thyroid blockade should be performed approximatively 1 hour before MIBG (123I) injection, by a single administration of potassium iodide (130 mg) or potassium iodate (170 mg) (see Table 1 below).

1.