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Olanzapine / samidorphan Pregnancy and Breastfeeding Warnings

Brand names: Lybalvi

Medically reviewed by Last updated on Nov 6, 2023.

Olanzapine / samidorphan Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk.

US FDA pregnancy category: Not assigned.

Risk summary: There are insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

-A pregnancy exposure registry is available.
-Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk of experiencing extrapyramidal neurological disturbances and/or withdrawal symptoms following delivery.
-There are risks associated with untreated schizophrenia or bipolar disorder.
-Patients should be advised to notify their physician if they are pregnant or plan to become pregnant during treatment.

There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in neonates exposed to antipsychotic drugs during the third trimester of pregnancy. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Increased adverse perinatal outcomes (e.g., preterm birth) were associated with untreated schizophrenia or bipolar disorder, though it is unknown whether it is a direct result of the illness other comorbid factors. There are no controlled data using any of the drugs, alone or in combination, in human pregnancy.

To monitor the outcomes of pregnant women exposed to atypical antipsychotics, a National Pregnancy Registry for Atypical Antipsychotics has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves. For additional information:

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Olanzapine / samidorphan Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes (olanzapine); Unknown (olanzapine-samidorphan; samidorphan)
Excreted into animal milk: Yes (samidorphan); Data not available (olanzapine-samidorphan)

-The American Academy of Pediatrics classifies antipsychotics (e.g., clozapine) as drugs whose effect on the nursing infant is unknown but may be of concern.
-Exposed infants should be monitored for drowsiness, extrapyramidal side effects, and developmental milestones.
-The effects on lactation and in the nursing infant are unknown.

See references

References for pregnancy information

  1. Product Information. Lybalvi (olanzapine-samidorphan). Alkermes, Inc. 2021.

References for breastfeeding information

  1. Product Information. Lybalvi (olanzapine-samidorphan). Alkermes, Inc. 2021.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.