Indium ¹¹¹In pentetreotide

There is no experience with the use of indium ¹¹¹In pentetreotide 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.

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.

Indium ¹¹¹In pentetreotide has no or negligible influence on the ability to drive and use machines.

Adverse effects attributable to the administration of indium ¹¹¹In pentetreotide 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.