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The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for BREXAFEMME and any potential adverse effects on the breastfed child from BREXAFEMME or from the underlying maternal condition.","Pregnancy":"BREXAFEMME use is contraindicated in pregnancy because it may cause fetal harm. In pregnant rabbits, oral ibrexafungerp administered during organogenesis was associated with rare malformations including absent forelimb(s), absent hindpaw, absent ear pinna, and thoracogastroschisis at dose exposures greater or equal to approximately times the human exposure at the RHD.","Geriatric use":"Clinical studies with ibrexafungerp did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. No clinically meaningful differences in the pharmacokinetics of ibrexafungerp were observed in geriatric patients compared to younger adults.","Paediatric use":"The safety and effectiveness of BREXAFEMME for treatment of VVC have been established in post-menarchal pediatric females. Use of BREXAFEMME in post-menarchal pediatric patients is supported by evidence from adequate and well-controlled studies of BREXAFEMME in adult non-pregnant women with additional safety data from post-menarchal pediatric females."}},"trials":[],"aliases":[],"company":"GSK","patents":[{"applNo":"N214900","source":"FDA Orange Book","status":"Active","expires":"Jun 10, 2039","useCode":"U-3159","territory":"US","drugProduct":false,"patentNumber":"11534433","drugSubstance":false},{"applNo":"N214900","source":"FDA Orange Book","status":"Active","expires":"Aug 28, 2030","useCode":"U-3159","territory":"US","drugProduct":true,"patentNumber":"8188085","drugSubstance":true},{"applNo":"N214900","source":"FDA Orange Book","status":"Active","expires":"Jan 19, 2035","useCode":"U-3159","territory":"US","drugProduct":false,"patentNumber":"10370406","drugSubstance":false},{"applNo":"N214900","source":"FDA Orange Book","status":"Active","expires":"Jan 19, 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