LYMPHOSEEK Kit for radiopharmaceutical preparation Ref.[10981] Active ingredients: Technetium ⁹⁹ᵐTc tilmanocept

Potential for hypersensitivity or anaphylactic reactions

The possibility of hypersensitivity including severe life-threatening fatal anaphylactic/anaphylactoid reactions must always be considered.

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 be immediately available.

Individual benefit/risk justification

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.

Renal and hepatic impairment

Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible. The estimated radiation dose to the patient would not exceed 2.28 mSv even if none of a 74 MBq dose were eliminated (see section 4.2).

Patient preparation

The patient should be well hydrated before the start of the examination and frequent voiding of urine during the initial hours after examination would reduce radiation exposure to the patient.

Specific warnings

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

For precautions with respect to environmental hazard, see section 6.6.

Adding very large volumes of tracing agents or other injectants temporally or anatomically proximal to Lymphoseek could affect the in vivo disposition of Lymphoseek. Additional tracing agents should not be injected within 30 minutes of Lymphoseek administration.

No interaction studies have been performed.

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.

Pregnancy

There are no data from the use of Lymphoseek in pregnant women. No reproductive toxicity studies in animals were performed, and it is not known if Lymphoseek 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.

Breast-feeding

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.

Fertility

Animal fertility studies have not been conducted with Lymphoseek.

Lymphoseek 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 Lymphoseek. These reactions were temporally related to Lymphoseek 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.

Reporting of suspected adverse reactions

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.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6 and 12.