Danicopan Pregnancy and Breastfeeding Warnings

Brand names: Voydeya

Medically reviewed by Drugs.com. Last updated on Apr 19, 2024.

Danicopan Pregnancy Warnings

Benefit should outweigh risk.

US FDA pregnancy category: Not assigned

Risk summary: There are no data available on use of this drug in pregnant individuals to inform a drug-related risk.

Comments:
-The use of this drug in pregnant women (or women planning to become pregnant) may be considered following an assessment of the risks and benefits.
-There are risks to the mother and fetus associated with untreated paroxysmal nocturnal hemoglobinuria (PNH) in pregnancy.

Animal studies have failed to reveal evidence of adverse developmental effects. Administration of this drug to pregnant rats and rabbits during the period of organogenesis at exposures 25 and 18-times, respectively, above the human exposure at the maximum recommended human dose (MRHD) based on AUC resulted in no adverse effects on embryo-fetal development. Reductions in male and female fertility and copulation/conception indices were observed in rabbits at mean exposures 13 times the MRHD based on AUC. There are no controlled data in human pregnancy.

PNH in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombotic events, infections, bleeding, miscarriages, and increased maternal mortality, and adverse fetal outcomes, including fetal death and premature 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.

See references

Danicopan Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 3 days after the last dose.

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

Comments:
-There is a potential for adverse reactions in the breastfed child, including serious infections with encapsulated bacteria and increased liver enzymes.
-No data are available on the presence of this drug in human milk or the effects on milk production.
-When a drug is present in animal milk, it is likely to be present in human milk.

See references

Further information

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