Ibrelyn Use In Pregnancy & Lactation

Women of Childbearing Potential/Contraception: Females of childbearing potential who are receiving this medicinal product, or their male partners should use adequate contraceptive methods (e.g., double-barrier contraception) during therapy and for at least 3 weeks or 14 weeks after completing therapy for females and males, respectively.
Pregnancy: There are no or limited amount of data from the use of palbociclib in pregnant women. Studies in animals have shown reproductive toxicity. Palbociclib is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: No studies have been conducted in humans or animals to assess the effect of palbociclib 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.
Fertility: There were no effects on oestrous cycle (female rats) or mating and fertility in rats (male or female) in nonclinical reproductive studies. However, no clinical data have been obtained on fertility in humans. 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. Thus, men may consider sperm preservation prior to beginning therapy with Palbociclib.