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Women of childbearing potential/Contraception: In women of childbearing potential, a negative pregnancy test should be obtained within 7 days prior to initiation of therapy. Effective contraception should be used before the first dose is administered and for at least one week after the last dose.
Pregnancy: There are no data from the use of ELZONRIS in pregnant women. Animal reproduction studies have not been conducted with tagraxofusp (see Pharmacology: Toxicology: Preclinical safety data under Actions).
ELZONRIS should not be used during pregnancy unless the clinical condition of the woman requires treatment with tagraxofusp.
Breast-feeding: It is unknown whether tagraxofusp/metabolites are excreted in human milk.
A risk to breast-feeding newborns/infants cannot be excluded.
Breast-feeding should be discontinued during treatment with ELZONRIS and for at least one week after the last dose.
Fertility: No fertility studies have been conducted with tagraxofusp (see Pharmacology: Toxicology: Preclinical safety data under Actions). There are no data on the effect of tagraxofusp on human fertility.
