Technetium ⁹⁹ᵐTc antigranulocyte antibody Other names: Technetium TC-99M antigranulocyte antibody

The use of besilesomab as an anti-granulocyte monoclonal antibody is contraindicated in pregnant women.

It is not known if the product is excreted in human milk. A risk to a breast-fed child cannot be excluded.

Before administering radiopharmaceuticals 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 breast-feeding 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, breast-feeding should be interrupted for three days and the expressed feeds discarded. These three days correspond to 10 half-lives of technetium (^99mTc) (60 hours). At that time the remaining activity represents about 1/1000 of the initial activity in the body.

Close contact with infants should be restricted during the first 12 hours after the injection.

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.

It has no or negligible influence on the ability to drive and use machines.

In the most recent clinical study in which 123 patients were administered besilesomab as an anti-granulocyte monoclonal antibody, the most commonly reported adverse reaction was the development of anti-mouse antibodies (HAMA) in 14% of the patients, after a single administration (16 positive over 116 assayed one and/or three months after the administration).

The table below reports adverse reactions by MedDRA system organ classes. The frequencies are based on the most recent clinical trial and non interventional safety survey.

The frequency listed below is defined using the following convention: 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).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. For diagnostic nuclear medicine investigations the frequency of these adverse reactions is not known. As the effective dose is about 6.9 mSv when the maximal recommended activity of 800 MBq is administered these adverse reactions are expected to occur with a low probability.