Olandus/Olandus ODT Use In Pregnancy & Lactation

Olandus 5/Olandus 10: There are no adequate and well-controlled trials with Olanzapine in pregnant females. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Olanzapine is excreted in human milk. It is recommended that women receiving Olanzapine tablets should not breast feed. Safety and effectiveness of the drug in pediatric patients have not been established.
Olandus ODT 5/Olandus ODT 10: Use in Pregnancy: Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with olanzapine.
Use in Lactation: Patients should be advised not to breast-feed an infant if they are taking olanzapine.
Olandus ODT 15: Use in Pregnancy: Category C. There are no adequate and well-controlled studies in pregnant women. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with Olanzapine. Neonates exposed to antipsychotic drugs (including Olanzapine) during the third trimester of pregnancy are at risk of experiencing extrapyramidal neurological disturbances and/or withdrawal symptoms following delivery. There have been post-market reports of agitation, hypertonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required additional medical treatment or monitoring. Olanzapine ODT should be used during pregnancy only if the anticipated benefit outweighs the risk, and the administered dose and duration of treatment should be as low and as short as possible.
Use in Lactation: In a study in lactating, healthy women Olanzapine was excreted in breast milk. Mean infant exposure (mg/kg) at steady state was estimated to be 1.8% of the maternal Olanzapine dose (mg/kg). Patients should be advised not to breast feed if they are taking Olanzapine.