Calquence Use In Pregnancy & Lactation

Pregnancy: CALQUENCE should not be used during pregnancy and women of childbearing potential should be advised to avoid becoming pregnant while receiving CALQUENCE. There are insufficient clinical data on CALQUENCE use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Based on findings from animal studies, there may be a risk to the foetus from exposure to acalabrutinib during pregnancy. Administration of acalabrutinib to pregnant rabbits at exposures 2.4-times the human AUC at the recommended dose was associated with reduced foetal growth (see Pharmacology: Toxicology: Preclinical safety data under Actions). Dystocia was observed in a rat study involving dosing animals from implantation throughout gestation, parturition and lactation at exposures >2.3-times the human AUC at the recommended dose (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Lactation: It is not known whether acalabrutinib is excreted in human milk. There are no data on the effect of acalabrutinib on the breast-fed infant or on milk production. Acalabrutinib and its active metabolite were present in the milk of lactating rats. A risk to the suckling child cannot be excluded. Breast-feeding mothers are advised not to breast-feed during treatment with CALQUENCE and for 2 days after receiving the last dose.
Fertility: There are no data on the effect of CALQUENCE on human fertility. In a nonclinical study of acalabrutinib in male and female rats, no adverse effects on fertility parameters were observed (see Pharmacology: Toxicology: Preclinical safety data under Actions).