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Lumasiran Pregnancy and Breastfeeding Warnings

Lumasiran is also known as: Oxlumo

Lumasiran Pregnancy Warnings

Animal studies have failed to reveal evidence of embryofetal toxicity or teratogenicity. In pregnant rats administered subcutaneous doses up to 45 times the maximum recommended human dose (MRHD) in women based on body surface area (BSA), no effects on embryofetal survival or fetal body weights and no drug-related fetal malformations were observed; in pregnant rabbits administered subcutaneous doses up to 90 times the MRHD based on BSA, decreases in maternal food consumption and maternal body weight gains were observed but there were no drug-related fetal findings. 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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

See references

Lumasiran Breastfeeding Warnings

According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the child.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-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 side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

References for pregnancy information

  1. "Product Information. Oxlumo (lumasiran)." Alnylam Pharmaceuticals, Cambridge, MA.
  2. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."

References for breastfeeding information

  1. "Product Information. Oxlumo (lumasiran)." Alnylam Pharmaceuticals, Cambridge, MA.
  2. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."

Further information

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