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Ocrelizumab Pregnancy and Breastfeeding Warnings

Ocrelizumab is also known as: Ocrevus

Ocrelizumab Pregnancy Warnings

In animal studies, this drug caused depletion of B-lymphocytes in lymphoid tissue (spleen and lymph nodes) and perinatal deaths (some associated with bacterial infections), renal toxicity (glomerulopathy and inflammation), lymphoid follicle formation in the bone marrow, and severe decreases in circulating B-lymphocytes in neonates. 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.

This drug should be used during pregnancy only if the benefit outweighs the risk. US FDA pregnancy category: Not assigned. Risk Summary: There are no adequate data on the developmental risk associated with use of this drug in pregnant women. There are no data on B-cell levels in human neonates following maternal exposure; however, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. This drug is a humanized monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier. In animal studies at doses similar to or greater than equivalent human doses, increased perinatal mortality, depletion of B-cell populations, renal, bone marrow, and testicular toxicity were observed in the offspring in the absence of maternal toxicity. Comments: -Women of childbearing potential should use adequate contraception while receiving this drug and for 6 months after the last dose.

See references

Ocrelizumab Breastfeeding Warnings

Safety has not been established. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: -Human IgG is excreted in human milk and the potential for absorption of this drug to lead to B-cell depletion in the infant is unknown.

See references

References for pregnancy information

  1. "Product Information. Ocrevus (ocrelizumab)." Genentech, South San Francisco, CA.

References for breastfeeding information

  1. "Product Information. Ocrevus (ocrelizumab)." Genentech, South San Francisco, CA.

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