Noxafil Use In Pregnancy & Lactation

Use in Pregnancy: Pregnancy Category B3 - There are no adequate studies in pregnant women. A total of three pregnancies have been reported in female subjects treated with posaconazole. Two pregnancies were electively terminated; no examination was reported on the foetuses. Another pregnancy was diagnosed at a follow-up visit approximately 1 month after the completion of a full 16-week prophylactic treatment with POS oral 200 mg TID in a patient who had received an allogeneic haematopoietic stem cell transplant. The subject delivered a healthy full-term male infant via caesarean section.
Studies in rats have shown reproductive toxicity including post implantation loss, increased skeletal variations, teratogenicity (craniofacial malformations), increased gestation length, dystocia, and reduced postnatal viability at exposure levels lower than those expected at the recommended doses in humans. An increase in post implantation loss and increased skeletal variations were seen in rabbits at plasma exposure levels greater than those of humans receiving therapeutic doses of posaconazole.
NOXAFIL must not be used during pregnancy unless the benefit to the mother clearly outweighs the risk to the foetus. Women of childbearing potential must be advised to always use effective contraceptive measure during treatment and for at least 2 weeks after completing therapy.
Use in Lactation: Posaconazole is excreted in milk of lactating rats. The excretion of posaconazole in human breast milk has not been investigated. Women taking posaconazole should not breastfeed.