Iptacopan Pregnancy and Breastfeeding Warnings

Brand names: Fabhalta

Iptacopan Pregnancy Warnings

Benefit should outweigh risk.

US FDA pregnancy category: Not assigned

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Comments:
-Considering the risks and benefits, the administration of this drug may be considered in pregnant women or those intending to conceive.
-Pregnancy-related paroxysmal nocturnal hemoglobinuria is linked to unfavorable maternal effects such as exacerbated cytopenias, thrombosis, infections, bleeding, miscarriages, increased maternal mortality, and adverse fetal consequences, including fetal demise and premature delivery.

Animal studies have failed to reveal evidence of embryotoxicity. 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.

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 final dose.

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

Comments:
-The effects in the nursing infant are unknown.

See references

Further information

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

Medical Disclaimer