Publisher: ROTOP Pharmaka GmbH, Bautzner Landstrasse 400, 01328 Dresden, Germany, Phone: +49 351 26 31 02 10, Fax: +49 351 26 31 03 13, e-mail: service@rotop-pharmaka.de
Hypersensitivity to HYNIC-[D-Phe1, Tyr3-octreotide]TFA salt, to EDDA (Etylenediamine-N,N'-diacetic acid) or to any of the excipients or sodium pertechnetate (99mTc) solution for injection.
The radiolabelled preparation is intended for single use only.
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.
Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.
Dosage reductions in hepatic impairment are not necessary, see 5.2.
For information on the use in paediatric population, see 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.
Optimal imaging of the abdominal cavity is obtained after the application of liquid diet starting two days before the examination as well as administration of laxatives on the day before the examination. The method of patient preparation may depend on the applied examination protocol and the localization of imaged lesions.
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 not be 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 (for proposals for withdrawal refer to section 4.5).
Positive scintigraphy with 99mTc-EDDA/HYNIC-TOC reflects the presence of an increased density of tissue somatostatin receptors rather than a malignant disease.
Furthermore positive uptake is not specific for gastro-entero-pancreatic 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, lymphoproliferative disease (Hodgkin’s disease, non-Hodgkin lymphomas), and the possibility of uptake in areas of lymphocyte concentrations (subacute inflammations) must be considered.
If the patient is not prepared properly to the examination, bowel uptake might influence the quality of images. Significant nonspecific accumulation occurring within digestive tract could be misinterpreted and misreported as pathologic or could impair the proper images evaluation.
Tumours which do not bear receptors will not be visualised.
In some patients suffering from GEP-NET the receptor density may be insufficient to allow visualisation with 99mTc-EDDA/HYNIC-TOC. This has to be considered for patients with insulinoma.
The efficacy of 99mTc-EDDA/HYNIC-TOC for monitoring the effect of treatment (follow-up) and patient selection for peptide receptor radionuclide therapy has not been established (see section 5.1). For the limitations of use for staging or re-staging of GEP-NET see section 5.1.
Close contact with infants and pregnant women should be avoided during the first 24 hours after administration of the radiopharmaceutical.
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
In patients subjected to diagnostic examinations with the use of 99mTcEDDA/HYNIC-TOC, it is recommended on an empirical basis to withdraw the treatment with somatostatin analogues temporarily (both “cold” as well as labelled with radioactive isotopes) to avoid a potential blockage of somatostatin receptors:
The withdrawal of therapy with somatostatin analogues 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.
No interaction studies have been performed. There are limited data concerning possible interactions
When an administration of a radiopharmaceutical 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.
Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus. Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus.
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 24 hours and the expressed feeds discarded.
Effects on the ability to drive or use machines have not to be expected after use of this product.
During the evaluation of adverse reactions the following frequency data are taken as a basis: 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), not known (cannot be estimated form the available data).
Very rarely transient headache or epigastric pain may occur directly after administration of 99mTc-EDDA/HYNIC-TOC.
Exposure to ionisation radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is about 3.7mSv when the maximal recommended activity of 740MBq 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 the national reporting system listed in <Appendix V>.
After radiolabelling a dilution with up to 5 mL physiological saline is possible. 99mTc-EDDA/HYNIC-TOCmust not be mixed with other medicinal products.
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