Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: Mallinckrodt Medical B.V., Westerduinweg 3, 1755 LE Petten, Netherlands
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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 immediately available.
For each patient, the radiation exposure must be justifiable by the likely benefit. The activity administered should in any case be as low as reasonably achievable to obtain the required diagnostic information.
Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients. In patients with significant renal failure administration of 111In-pentetreotide is not advisable because the reduced or absent function of the principal route of excretion will lead to delivery of an increased radiation dose. Administration should be considered only when the possible damage from radiation is outweighed by the potential diagnostic information. Interpretable scintigrams may be obtained after haemodialysis during which the high background activity can at least partially be removed. Prior to dialysis images are non-diagnostic because of activity in the circulation. After dialysis a higher than usual uptake in liver, spleen and intestinal tract, and a higher than usual activity in circulation, were observed.
Because of the potential hazard of the ionizing radiation 111In-pentetreotide should not be used in children under 18 years of age, unless the value of the expected clinical information is considered to outweigh the possible damage from radiation.
For information on the use in the paediatric population see Section 4.2.
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.
Administration of a laxative is necessary in patients not suffering from diarrhoea, to differentiate stationary activity accumulations in lesions in, or adjacent to, the intestinal tract from moving accumulations in the bowel contents.
Indium(111In)-pentetreotide not bound to receptors, and non-peptide bound indium(111In), are rapidly eliminated through the kidneys. To enhance the process of excretion, in order to reduce background noise and to reduce the radiation dose to kidneys and bladder, a liberal fluid intake (at least 2 litres) is required for 2 or 3 days following administration.
Regarding patients on octreotide therapy it is recommended to withdraw this therapy temporarily to avoid a possible blockade of somatostatin receptors. This recommendation is given on empirical grounds, the absolute need for such measure has not been demonstrated. In some patients the withdrawal of therapy might be not tolerated and may cause rebound effects. This is notably the case in insulinoma patients, where the danger of sudden hypoglycaemia must be considered, and in patients suffering from the carcinoid syndrome. If the clinician responsible for the patients therapeutic management considers withdrawal of octreotide therapy tolerable a three days withdrawal period is recommended.
Positive scintigraphy with indium(111In)pentetreotide reflects the presence of an increased density of tissue somatostatin receptors rather than a malignant disease. Furthermore positive uptake is not specific for GEP and carcinoid-tumours. Positive scintigraphic results require evaluation of the possibility that another disease, characterised by high local somatostatin receptor concentrations, may be present. An increase in somatostatin receptor density can also occur in the following pathological conditions: tumours arising from tissue embryologically derived from the neural crest, (paragangliomas, medullary thyroid carcinomas, neuroblastomas, pheochromocytomas), tumours of the pituitary gland, endocrine neoplasms of the lungs (small-cell carcinoma), meningiomas, mammary carcinomas, lympho-proliferative disease (Hodgkin’s disease, non-Hodgkin lymphomas), and the possibility of uptake in areas of lymphocyte concentrations (subacute inflammations) must be considered.
Close contact with infants and pregnant women should be restricted during the first 36 hours after administration.
In diabetic patients, receiving high doses of insulin, the administration of pentetreotide may cause paradoxical hypoglycaemia via a temporary inhibition of glucagon secretion.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
Precautions with respect to environmental hazard, see section 6.6.
No interactions have been described to date.
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.
There is no experience with the use of Octreoscan in pregnant women.
Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus. The administration of the maximal diagnostic activity of 220 MBq to the patient results in an absorbed dose to the uterus of 8.6 mGy. In this dose range lethal effects and the induction of malformations, growth retardations and functional disorders are not to be expected; however the risk for the induction of cancer and hereditary defects may be increased. Only essential investigations should therefore be carried out during pregnancy, when the likely benefit exceeds the risk incurred by the mother and foetus.
Before administering radiopharmamaceuticals to a mother who is breast-feeding 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, it is not necessary to discontinue breast-feeding. However, close contact with infants should be restricted during the first 36 hours after administration.
Octreoscan has no or negligible influence on the ability to drive and use machines.
Adverse effects attributable to the administration of Octreoscan are uncommon (1/1000 to <1/100). Specific effects have not been observed. The symptoms reported are suggestive of vasovagal reactions or of anaphylactoid drug effects.
The withdrawal of octreotide therapy as a preparatory step to scintigraphy might provoke severe adverse effects, generally of the nature of a return of the symptoms seen before this therapy was started. Exposure to ionising radiation is linked with cancer induction and a potential for the development of hereditary defects. As the effective dose is 12 mSv, when the maximal recommended activity of 220 MBq is administered, these adverse events are expected to occur with a low probability.
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 12.
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