Givosiran Pregnancy and Breastfeeding Warnings

Brand names: Givlaari

Medically reviewed by Drugs.com. Last updated on Nov 25, 2024.

Givosiran Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
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:
-There are maternal and embryofetal risks associated with acute hepatic porphyria (AHP) during pregnancy.

Animal studies have revealed evidence of reproductive and maternal toxicity. In an embryofetal development study, adverse developmental outcomes were observed at all doses (0.5, 1.5, and 5 mg/kg/day) that caused maternal toxicity. In rabbits, increased postimplantation loss occurred at 1.5 mg/kg/day or higher doses, whereas abortions occurred at 5 mg/kg/day or following a single 20 mg/kg dose. At 20 mg/kg, an increased incidence of skeletal variations of the sternebrae was seen. There are no controlled data in human pregnancy.

Porphyria attacks are often triggered by hormonal changes during pregnancy. Porphyria attacks occur in 24% to 95% of pregnant women with AHP, with maternal mortality ranging from 2% to 42%. Pregnancy in patients with AHP is associated with higher rates of spontaneous abortion, hypertension, and low birth weight infants.

AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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

Givosiran Breastfeeding Warnings

Benefit should outweigh risk.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the child.

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. A risk to newborns or infants cannot be excluded.

See references

Further information

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