Inclisiran Pregnancy and Breastfeeding Warnings

Brand names: Leqvio

Inclisiran Pregnancy Warnings

Use should be avoided.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.

Risk summary: Based on mechanism of action, this drug may cause fetal harm; no data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-As a precaution, it is preferable to avoid the use of this drug during pregnancy.
-According to some authorities: This drug should be discontinued when pregnancy is recognized; alternatively, the ongoing therapeutic needs of the individual patient should be considered.
---Treatment of hyperlipidemia is not generally needed during pregnancy; atherosclerosis is a chronic process and stopping lipid-lower agents during pregnancy should have little effect on the outcome of long-term primary hyperlipidemia therapy for most patients.

Animal studies have failed to reveal evidence of embryofetal toxicity or teratogenicity. After subcutaneous dosing in rats and rabbits, no adverse developmental effects were observed at doses up to 5 and 10 times, respectively, the maximum recommended human dose (MRHD) based on body surface area (BSA) comparison/dose; after subcutaneous dosing in rats, no evidence of maternal toxicity, no effects on maternal performance, and no adverse developmental effects in offspring (including survival, growth, physical and reflexological development, behavior, reproductive performance) were observed at doses up to 5 times the MRHD (based on BSA comparison/dose). This drug crosses the placenta and was detected in rat fetal plasma at levels that were 65 to 154 times lower than maternal levels. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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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Inclisiran 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: 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, but a risk to nursing neonates/infants cannot be excluded; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-Oligonucleotide-based products generally have poor oral bioavailability; therefore, low levels of this drug in milk is considered unlikely to adversely affect an infant's development during lactation.

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Further information

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

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