Givlaari Pregnancy Warnings
In rabbits receiving subcutaneous doses of this drug during the period of organogenesis, adverse developmental outcomes were observed at doses that produced maternal toxicity. All tested doses (0.5, 1.5, and 5 mg/kg/day) were maternally toxic based on decreased body weight gain. At 1.5 mg/kg/day or greater (about 5 times the maximum recommended human dose), an increase in post implantation loss was observed. In women with AHP, porphyria attacks are often triggered by hormonal changes of pregnancy. There are no controlled data in human pregnancy
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.
Benefit should outweigh risk
US FDA pregnancy category: Not assigned
Risk Summary: There are no available data in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; administration to pregnant rabbits has shown adverse developmental outcomes at doses that have produced maternal toxicity.
Comments:
-There are maternal and embryo-fetal risks associated with acute hepatic porphyria (AHP) during pregnancy; porphyria attacks occur in 24% to 95% of women with AHP with maternal mortality ranging from 2% to 42%; pregnancy in AHP patients is associated with higher rates of spontaneous abortion, hypertension, and low birth weight infants.
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Givlaari Breastfeeding Warnings
Benefit should outweigh risk
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.
See references
