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.
-According to some authorities: Use should be avoided as a precautionary measure.

AU TGA pregnancy category: B3
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 women who are (or plan to become) pregnant may be considered following an assessment of the risks and benefits of therapy.
-Some authorities recommend females of childbearing potential use effective contraception during treatment and for 3 days after the last dose.
-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, greater than the human exposure at the maximum recommended human dose (MRHD) resulted in no adverse effects on embryofetal development. Placental transfer was demonstrated in rabbits. There are no controlled data in human pregnancy.

There are risks to the mother and fetus associated with untreated PNH in pregnancy. PNH 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.

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

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; however, as this drug is more than 91% protein bound, the amount in breast milk is expected to be low.

See references

Further information

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

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