Chemical formula: C₁₈H₂₃FINO₂ Molecular mass: 427.291 g/mol PubChem compound: 3086674
Animal reproductive toxicity studies have not been performed with this product. Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus. Administration of 185 MBq of ioflupane (123I) results in an absorbed dose to the uterus of 2.6 mGy. Ioflupane (123I) is contraindicated in pregnancy.
It is not known whether ioflupane (123I) is excreted in 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 breastfeeding, 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 3 days and substituted by formula feeding. During this time, breast milk should be expressed at regular intervals and the expressed feeds should be discarded.
No fertility studies have been performed. No data are available.
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.
The following undesirable effects are recognised for ioflupane (123I).
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).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
| MedDRA Body system SOCs | Adverse reaction Preferred term | Frequency |
|---|---|---|
| Immune system disorders | Hypersensitivity | Not known |
| Metabolism and nutrition disorders | Appetite increased | Uncommon |
| Nervous system disorders | Headache | Common |
| Dizziness, formication (paraesthesia), dysgeusia | Uncommon | |
| Ear and labyrinth disorders | Vertigo | Uncommon |
| Vascular disorders | Blood pressure decreased | Not known |
| Respiratory, thoracic and mediastinal disorders | Dyspnea | Not known |
| Gastrointestinal disorders | Nausea, dry mouth | Uncommon |
| Vomiting | Not known | |
| Skin and subcutaneous tissue disorders | Erythema, pruritus, rash, urticaria, hyperhidrosis | Not known |
| General disorders and administration site conditions | Injection site pain (intense pain or burning sensation following administration into small veins) | Uncommon |
| Feeling hot | Not known |
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 4.6 mSv when the maximal recommended activity of 185 MBq is administered these adverse events are expected to occur with a low probability.
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