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Ravulizumab Pregnancy and Breastfeeding Warnings

Ravulizumab is also known as: Ultomiris

Medically reviewed by Drugs.com. Last updated on Feb 1, 2019.

Ravulizumab Pregnancy Warnings

Animal studies using a mouse analog of this drug molecule (murine anti-C5 antibody) showed increased rates of developmental abnormalities and an increased rate of dead and moribund offspring at doses 0.8 to 2.2 times the human dose. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity 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.

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned.

Risk Summary: There are no available data on the use of this drug in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with untreated paroxysmal nocturnal hemoglobinuria (PNH) in pregnancy.

Comments:
-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.
-Human IgG is known to cross the human placental barrier, so this drug may potentially cause terminal complement inhibition in the fetal circulation.

See references

Ravulizumab Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-The effects in the nursing infant are unknown.
-Since many medicinal products and immunoglobulins are secreted into human milk, and because of the potential for serious adverse reactions in a nursing child, breastfeeding should be discontinued during therapy and for 8 months after.

See references

References for pregnancy information

  1. "Product Information. Ultomiris (ravulizumab)." Alexion Pharmaceuticals Inc, Cheshire, CT.

References for breastfeeding information

  1. "Product Information. Ultomiris (ravulizumab)." Alexion Pharmaceuticals Inc, Cheshire, CT.

Further information

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

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