Landiolol Pregnancy and Breastfeeding Warnings

Brand names: Rapiblyk

Landiolol Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

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

Comments:
-Neonates born to mothers receiving this drug during pregnancy may be at risk for hypotension, hypoglycemia, bradycardia, and respiratory depression.
-Neonates exposed to this drug during pregnancy and labor should be monitored for hypotension, hypoglycemia, bradycardia, and respiratory depression and should be managed accordingly.

Animal studies have failed to reveal evidence of embryofetal toxicity. After IV dosing in pregnant rats and rabbits during organogenesis, no adverse embryofetal effects were observed in rats at systemic exposures (AUC) about 2.7-times the exposure at the maximum recommended human dose or in rabbits at 100 mg/kg/day (resulting systemic exposure not determined). In pregnant rats, distribution of this drug to the placenta and fetus was observed. There are no controlled data in human pregnancy; drug exposure was limited to a single injection at time of cesarean delivery in a small trial.

Bradycardia, hypoglycemia, and respiratory depression have been observed in neonates with maternal use of beta-blockers in pregnancy near time of delivery.

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.

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Landiolol Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-The breastfed infant should be monitored for bradycardia and other symptoms of beta blockade (e.g., lethargy [hypoglycemia]).

See references

Further information

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

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