Olezarsen Pregnancy and Breastfeeding Warnings

Brand names: Tryngolza

Medically reviewed by Drugs.com. Last updated on Feb 3, 2025.

Olezarsen Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Patients with familial chylomicronemia syndrome (FCS) are at risk for pancreatitis during pregnancy due to defects in lipid metabolism and increased triglyceride levels.

Animal studies have not been reported with this drug. However, the unconjugated antisense oligonucleotide (ASO), which shares the same nucleotide sequence but lacks N-acetyl galactosamine, has been evaluated; animal studies with the unconjugated ASO showed no adverse developmental outcomes at doses about 21 times the maximum recommended clinical dose. There are no controlled data in human pregnancy.

Triglyceride levels rise in the third trimester of pregnancy. In patients with lipid metabolism disorders like FCS, severe gestational hypertriglyceridemia can occur, increasing the risk of acute pancreatitis.

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

Olezarsen Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-There are no data on the effects of this drug on milk production.
-Developmental and health benefits of breastfeeding should be considered along with 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 unconjugated antisense oligonucleotide, which shares the same nucleotide sequence but lacks N-acetyl galactosamine, was found in low levels in the milk of lactating mice. Oligonucleotide-based products usually have low oral bioavailability, so it's unlikely that the small amounts found in breast milk would reach clinically significant levels in breastfed infants.

See references

Further information

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