Technetium ⁹⁹ᵐTc sestamibi

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. Close contact with infants should be restricted during the initial 24 hours following injection.

Fertility

No studies on fertility 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.

Technetium (^99mTc) sestamibi has no or negligible influence on the ability to drive and use machines.

The following table presents how the frequencies are reflected in this section: 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 from the available data).

Immune system disorders

Rare: Severe hypersensitivity reactions such as dyspnoea, hypotension, bradycardia, asthenia and vomiting (usually within two hours of administration), angioedema. Other hypersensitivity reactions (allergic skin and mucosa reactions with exanthema (pruritus, urticaria, oedema), vasodilatation).

Very rare: Other hypersensitivity reactions have been described in predisposed patients.

Nervous system disorders

Uncommon: Headache.

Rare: Seizures (shortly after administration), syncope.

Cardiac disorders

Uncommon: Chest pain/angina pectoris, abnormal ECG.

Rare: Arrhythmia.

Gastrointestinal disorders

Uncommon: Nausea.

Rare: Abdominal pain.

Skin and subcutaneous tissue disorders

Rare: local reactions at the injection site, hypoaesthesia and paraesthesia, flushing.

Not known: Erythema multiforme.

General disorders and administration site conditions

Common: Immediately after injection, a metallic or bitter taste, partly in combination with dry mouth and an alteration in the sense of smell may be observed.

Rare: Fever, fatigue, dizziness, transient arthritic-like pain.

Other disorders

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 16.4 mSv when the maximal recommended activity of 2000 MBq (500 at rest and 1500 MBq at stress) for a 1-day-protocol is administered these adverse reactions are expected to occur with a low probability.