Iptacopan Pregnancy and Breastfeeding Warnings

Brand names: Fabhalta

Iptacopan Pregnancy Warnings

Benefit should outweigh risk.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Risk summary: Insufficient data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-After assessing the risks and benefits, use of this drug in pregnant patients or those planning to become pregnant may be considered.
-There are risks to the mother and fetus associated with untreated paroxysmal nocturnal hemoglobinuria and immunoglobulin A nephropathy in pregnancy.

Animal studies have failed to reveal evidence of embryofetal toxicity. After oral administration to rats and rabbits during organogenesis, no embryofetal toxicity occurred at doses corresponding to 4- and 6-times, respectively, the maximum recommended human dose based on AUC. There are no controlled data in human pregnancy.

Paroxysmal nocturnal hemoglobinuria in pregnancy is associated with adverse maternal outcomes (including worsening cytopenias, thrombosis, infections, bleeding, miscarriages, and increased maternal mortality) and adverse fetal outcomes (including fetal death and premature delivery). Immunoglobulin A nephropathy in pregnancy is associated with adverse maternal outcomes (including increased rates of cesarean section, pregnancy-induced hypertension, preeclampsia, and preterm delivery) and adverse fetal/neonatal outcomes (including stillbirth and low birth weight).

AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.

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

Iptacopan Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 5 days after the last dose.
-According to some authorities: Benefit should outweigh risk.

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

Comments:
-No information is available on the use of this drug during breastfeeding.
-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 (e.g., serious infections from encapsulated bacteria) in the breastfed child due to this drug or the mother's underlying condition should be considered.

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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