Imbruvica Use In Pregnancy & Lactation

Pregnancy: There are no adequate and well-controlled studies of Ibrutinib (Imbruvica) in pregnant women. Based on findings in animals, Ibrutinib (Imbruvica) may cause fetal harm when administered to pregnant women.
Ibrutinib (Imbruvica) should not be used during pregnancy. Women of child-bearing potential must use highly effective contraceptive measures while taking Ibrutinib (Imbruvica). Women should avoid becoming pregnant while taking Ibrutinib (Imbruvica) and for up to 1 month after ending treatment. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. The time period following treatment with Ibrutinib (Imbruvica) where it is safe to become pregnant is unknown.
Men should be advised not to father a child or donate sperm while receiving Ibrutinib (Imbruvica), and for 3 months following completion of treatment (see Pharmacology: Toxicology: Non-Clinical Information: Fertility under Actions).
Ibrutinib was studied for effects on embryo-fetal development in pregnant rats given oral doses of 10, 40, and 80 mg/kg/day. Ibrutinib at a dose of 80 mg/kg/day (approximately 14 times the AUC of ibrutinib and 9.5 times the AUC of the dihydrodiol metabolite compared to patients at the dose of 560 mg daily) was associated with increased post-implantation loss and increased visceral malformations (heart and major vessels). Ibrutinib at a dose of ≥40 mg/kg/day (≥ approximately 5.6 times the AUC of ibrutinib and 4.0 times the AUC of the dihydrodiol metabolite compared to patients at a dose of 560 mg daily) was associated with decreased fetal weights.
Ibrutinib was also administered orally to pregnant rabbits during the period of organogenesis at oral doses of 5, 15, and 45 mg/kg/day. Ibrutinib at a dose of 15 mg/kg/day or greater was associated with skeletal malformations (fused sternebrae) and ibrutinib at a dose of 45 mg/kg/day was associated with increased post-implantation loss. Ibrutinib caused malformations in rabbits at a dose of 15 mg/kg/day (approximately 2.0 times the exposure (AUC) in patients with MCL or MZL administered ibrutinib 560 mg daily and 2.8 times the exposure in patients with CLL or WM receiving ibrutinib dose 420 mg per day).
Breast-feeding: It is not known whether ibrutinib or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Ibrutinib (Imbruvica), breast-feeding should be discontinued during Ibrutinib (Imbruvica) treatment.