Gazyva Use In Pregnancy & Lactation

Pregnancy: GAZYVA should be avoided during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. Women of child-bearing potential should use effective contraception while receiving GAZYVA and for 18 months following treatment with GAZYVA (see Pharmacology: Pharmacokinetics: Elimination under Actions). Postponing vaccination with live vaccines should be considered for infants born to mothers who have been exposed to GAZYVA during pregnancy until the infants' B cell levels are within normal ranges.
No studies in pregnant women have been performed. A reproduction study in cynomolgus monkeys showed no evidence of embryo-foetal toxicity or teratogenic effects but resulted in a complete depletion of B-lymphocytes in offspring. B-cell counts returned to normal levels in the offspring, and immunologic function was restored within 6 months of birth (See Pharmacology: Toxicology: Nonclinical Safety: Reproductive Toxicity under Actions). Furthermore, the serum concentrations of GAZYVA in offspring were similar to those in the mothers on day 28 post-partum, whereas concentrations in milk on the same day were very low, suggesting that GAZYVA crosses the placenta.
Labor and Delivery: No data to report.
Lactation: Since human IgG is secreted in human milk and the potential for absorption and harm to the infant is unknown, women should be advised to discontinue nursing during GAZYVA therapy and for 18 months after the last dose of GAZYVA (see Pharmacology: Pharmacokinetics: Elimination under Actions). Animal studies have shown excretion of GAZYVA in breast milk (See Pharmacology: Toxicology: Nonclinical Safety: Reproductive Toxicity under Actions).