Hyaluronidase / ocrelizumab Pregnancy and Breastfeeding Warnings

Brand names: Ocrevus Zunovo

Medically reviewed by Drugs.com. Last updated on Nov 5, 2024.

Hyaluronidase / ocrelizumab Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: There are no adequate data on the developmental risk associated with the use of this drug in pregnant women to inform a drug related risk.

Comments:
-This drug is a humanized monoclonal antibody of an immunoglobulin G1 subtype. Immunoglobulins are known to cross the placenta.
-Although maternal exposure to this drug has not been studied in clinical trials, transient peripheral B-depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy.
-Women of childbearing potential should use effective contraception while receiving this drug and for 6 months after the last dose.

Animal studies in pregnant monkeys, reported depletion of B-lymphocytes in lymphoid tissue in fetuses following intravenous administration of ocrelizumab (loading doses of 15 or 75 mg/kg on gestation days 20, 21, and 22 followed by weekly doses of 20 or 100 mg/kg) during organogenesis. Additionally, IV administration of ocrelizumab at similar dosages during organogenesis and continuing through the neonatal period, resulted in perinatal deaths, renal toxicity, lymphoid follicle formation in bone marrow, and severe decreases in circulating B-lymphocytes in neonates. Animal studies with hyaluronidase dosed daily by subcutaneous injection to pregnant mice during the period of organogenesis at dose levels up to 2,200,000 U/kg (greater than 5700 times the recommended human dose), found no evidence of teratogenicity. However, reduced fetal weight and increased numbers of fetal resorptions were observed. 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.

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Hyaluronidase / ocrelizumab Breastfeeding Warnings

Safety has not been established; the benefit should outweigh the risk.

Excreted into human milk: Unknown
Excreted into animal milk: Ocrelizumab: Yes; Hyaluronidase: Unknown

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Human IgG is excreted in human milk, but the potential for absorption of ocrelizumab to lead to B-cell depletion in the breastfeeding infant is unknown. The amounts of ocrelizumab in milk are low and it is likely to be partially destroyed in the infant's gastrointestinal tract. Infants exposed to ocrelizumab alone during breastfeeding have shown no evidence of harm.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

Further information

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