There are no adequate data from the use of palifermin in pregnant women. Studies in animals have shown reproductive and developmental toxicity. The potential risk to the human embryo or foetus is unknown. Palifermin should not be used during pregnancy unless clearly necessary
It is not known whether palifermin is excreted in human milk, therefore it should not be administered to women who are breast-feeding.
In studies in rats, no adverse effects on reproductivity/fertility parameters were observed at doses of up to 100 micrograms/kg/day. Systemic toxicity (clinical signs and/or changes in body weight) and adverse effects on male and female fertility parameters were seen at doses ≥300 micrograms/kg/day (5-fold higher than the recommended human dose).
Not relevant.
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