Technetium ⁹⁹ᵐTc tilmanocept

There are no data from the use of technetium Tc 99m tilmanocept in pregnant women. No reproductive toxicity studies in animals were performed, and it is not known if technetium Tc 99m tilmanocept can cause foetal harm when administered to a pregnant woman.

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.

It is not known whether technetium Tc 99m tilmanocept is excreted into human milk.

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 administration is considered necessary, breast-feeding should be interrupted for 24 hours post injection and the expressed feeds discarded.

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.

Fertility

Animal fertility studies have not been conducted with Lymphoseek.

Technetium Tc 99m tilmanocept has no or negligible influence on the ability to drive and use machines.

Summary of safety profile

In clinical trials with 553 patients, the most common adverse reactions were:

• Injection site irritation (0.7%; 4 of 553 patients)
• Injection site pain (0.2%; 1 of 553 patients)

Other adverse reactions were uncommon, and of mild severity and short duration.

Tabulated list of adverse reactions

Clinical studies have evaluated the incidence of adverse reactions listed below in 553 subjects 18 years and above who received technetium Tc 99m tilmanocept. These reactions were temporally related to technetium Tc 99m tilmanocept administration and could be due to other medicinal products administered to patients or surgical procedures.

Adverse reactions observed during clinical studies are listed below by frequency category. Frequency categories are defined as follows: 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) and not known (frequency cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Exposure to ionizing radiation is linked with cancer induction and a potential for the development of hereditary defects. As the effective dose to an adult (70 kg) is 1.32 mSv when the maximal recommended activity of 74 MBq is administered adverse reactions are expected to occur with a low probability.