Revolade Use In Pregnancy & Lactation

Effects on fertility: Eltrombopag did not affect female or male fertility in rats at doses 2-4 or 1-2 times the human clinical exposure (based on AUC) in ITP patients at 75 mg/day and in HCV patients at 100 mg/day, respectively.
However, due to differences in TPO receptor specificity, data from nonclinical species do not fully model effects in humans.
Use in pregnancy - Pregnancy Category B3: Eltrombopag was not teratogenic in rats or rabbits at doses up to 20 mg/kg/day and 150 mg/kg/day respectively. The doses resulted in exposures 2 and 0.5 fold the expected clinical AUC in ITP patients at 75 mg/day and subclinical exposures in HCV patients at 100 mg/day. At the maternally toxic dose of 60 mg/kg/day in rats, foetal weights were significantly reduced and there was an increase in foetal variation, cervical rib, when administered during the period of organogenesis. Eltrombopag treatment during early embryogenesis was associated with an increase in pre-and post-implantation loss (or embryonic death). Due to the fact that eltrombopag is not pharmacologically active in rats or rabbits, the potential teratogenicity of eltrombopag may not have been fully revealed in the studies with these animal species.
There are no adequate and well-controlled studies of REVOLADE in pregnant woman. The effect of REVOLADE on human pregnancy is unknown. REVOLADE should not be used during pregnancy unless the expected benefit clearly out-weighs the potential risk to the foetus.
Use in lactation: It is not known whether REVOLADE is excreted in human milk. Eltrombopag was detected in the pups of lactating rats 10 days post-partum suggesting the potential for transfer during lactation. REVOLADE is not recommended for nursing mothers unless the expected benefit justifies the potential risk to the infant.