Pregnancy: PAXOLL can cause harm to foetus when administered to a pregnant woman. Teratogenic potential could not be assessed at higher doses due to extensive fetal mortality. Woman of childbearing potential should be advised to avoid becoming pregnant during therapy with PAXOLL.
Lactation: It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, it is recommended that nursing be discontinued when receiving PAXOLL therapy.