Ibrance Use In Pregnancy & Lactation



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Full Prescribing Info
Use In Pregnancy & Lactation
Fertility: There were no effects on estrous cycle (female rats) or mating and fertility in rats in nonclinical studies. However, no clinical data have been obtained on fertility in human females. Based on male reproductive organ findings (seminiferous tubule degeneration in testis, epididymal hypospermia, lower sperm motility and density, and decreased prostate secretion) in nonclinical safety studies, male fertility may be compromised by treatment with palbociclib (see Pharmacology: Toxicology: Preclinical safety data under Actions). Men should consider sperm preservation prior to beginning therapy with IBRANCE.
Women of childbearing potential/pregnancy: There are no adequate and well-controlled studies using IBRANCE in pregnant women. Based on findings in animals and mechanism of action, palbociclib can cause fetal harm when administered to a pregnant woman. In animal studies, palbociclib was fetotoxic at maternally-toxic doses. IBRANCE is not recommended during pregnancy and in women of childbearing potential not using contraception.
Females of childbearing potential who are receiving this medicinal product, or their male partners should use adequate contraceptive methods during therapy and for at least 21 days or 97 days after completing therapy for females and males, respectively.
Lactation: No studies have been conducted in humans to assess the effect of IBRANCE on milk production, its presence in breast milk, or its effects on the breastfed child. It is unknown whether palbociclib is excreted in human milk. Patients receiving palbociclib should not breastfeed.
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