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In the reproductive toxicity studies in rat and rabbit, the No Observed Adverse Effect Level (NOAEL) of albuvirtide intravenously injected were 4 folds and 2 folds of human equivalent dose, respectively, and no toxicity to parental fertility and embryonic development was observed. Since no clinical data are available in pregnant women, it could only be used when there is a clear clinical need and the expected benefit is greater than the risk to the pregnant women.
It is unknown whether albuvirtide is excreted in human breast milk. HIV-infected women should not breastfeed infants so as to avoid HIV transmission. Lactating women should not breastfeed infants if they are receiving AIKENING.
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