Answer
Fabhalta (iptacopan) has no or limited pregnancy data in humans; animal studies showed no reproductive harm at 2–8 times maximum recommended human-dose exposure, and use during pregnancy or when planning pregnancy may only be considered if necessary following careful assessment of risks and benefits.
Sources for this answer
- FABHALTA 200 mg hard capsulesNovartis Pharmaceuticals UK Ltd · emc · SmPC §4.6 Fertility, pregnancy and lactation · Version 4Document updated
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