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Women of childbearing potential/Contraception in males and females: 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 (see Interactions).
Pregnancy: There are no or limited amount of data from the use of palbociclib in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). IBRANCE 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 breast-fed child. It is unknown whether palbociclib is excreted in human milk. Patients receiving palbociclib should not breast-feed.
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 (see Pharmacology: Toxicology: Preclinical safety data under Actions). Thus, men may consider sperm preservation prior to beginning therapy with IBRANCE.
