PDF(Pubmed)
Abstract：
UNASSIGNED: Peripartum cardiomyopathy (PPCM) is a common cause of heart failure (HF) in the peripartum. Some medications are considered safe while breastfeeding. However, sacubitril/valsartan (Entresto), while efficacious, is not recommended in breastfeeding women due to concerns about adverse infant development, and no published data suggest otherwise.
UNASSIGNED: This study aimed to assess the transfer of sacubitril/valsartan into human milk and evaluate the infant\'s risk of drug exposure.
UNASSIGNED: The InfantRisk Human Milk Biorepository released samples and corresponding health information from five breastfeeding maternal-infant dyads exposed to sacubitril/valsartan. Sacubitril, valsartan, and LBQ657 (sacubitril active metabolite) concentrations were determined using liquid chromatography-mass spectrometry (LC/MS/MS) from timed samples 0, 1, 2, 4, 6, 8, 10, and 12 h following medication administration at steady state conditions.
UNASSIGNED: Valsartan levels were below the detection limit of 0.19 ng/mL in all milk samples. Sacubitril was measurable in all milk samples of the five participants, peaking 1 h after drug administration at a mean concentration of 1.52 ng/mL for a total infant dose of 0.00049 mg/kg/12 h and a relative infant dose (RID) calculated at 0.01%. The maximum concentration of its active metabolite LBQ657 in the milk samples was observed 4 h after medication administration and declined over the remaining 12-h dosing interval, for an average concentration of 9.5 ng/mL. The total infant dose was 0.00071 mg/kg/12 h, and the RID was 0.22%. Two mothers reported continuing to breastfeed while taking sacubitril/valsartan; both mothers stated observing no negative effects in their breastfed infants.
UNASSIGNED: The transfer of sacubitril/valsartan into human milk is minimal. These concentrations are unlikely to pose a significant risk to breastfeeding infants, with a combined calculated RID of <0.25%, which is far lower than the industry safety standards (RID <10%).
UNASSIGNED: This study aimed to assess the transfer of sacubitril/valsartan into human milk and evaluate the infant\'s risk of drug exposure.
UNASSIGNED: The InfantRisk Human Milk Biorepository released samples and corresponding health information from five breastfeeding maternal-infant dyads exposed to sacubitril/valsartan. Sacubitril, valsartan, and LBQ657 (sacubitril active metabolite) concentrations were determined using liquid chromatography-mass spectrometry (LC/MS/MS) from timed samples 0, 1, 2, 4, 6, 8, 10, and 12 h following medication administration at steady state conditions.
UNASSIGNED: Valsartan levels were below the detection limit of 0.19 ng/mL in all milk samples. Sacubitril was measurable in all milk samples of the five participants, peaking 1 h after drug administration at a mean concentration of 1.52 ng/mL for a total infant dose of 0.00049 mg/kg/12 h and a relative infant dose (RID) calculated at 0.01%. The maximum concentration of its active metabolite LBQ657 in the milk samples was observed 4 h after medication administration and declined over the remaining 12-h dosing interval, for an average concentration of 9.5 ng/mL. The total infant dose was 0.00071 mg/kg/12 h, and the RID was 0.22%. Two mothers reported continuing to breastfeed while taking sacubitril/valsartan; both mothers stated observing no negative effects in their breastfed infants.
UNASSIGNED: The transfer of sacubitril/valsartan into human milk is minimal. These concentrations are unlikely to pose a significant risk to breastfeeding infants, with a combined calculated RID of <0.25%, which is far lower than the industry safety standards (RID <10%).
摘要：
■围产期心肌病（PPCM）是围产期心力衰竭（HF）的常见原因。有些药物在母乳喂养时被认为是安全的。然而,沙库巴曲/缬沙坦（恩特雷斯托），虽然有效，由于担心婴儿发育不良，不建议母乳喂养的妇女，没有公布的数据表明情况并非如此。
■本研究旨在评估沙库必曲/缬沙坦向人乳中的转移，并评估婴儿的药物暴露风险。
■婴儿风险人乳生物栓剂发布了来自五个母乳喂养的母婴二联体的样本和相应的健康信息，这些样本和健康信息暴露于沙库必曲/缬沙坦。Sacubitril,缬沙坦,和LBQ657(sacubitril活性代谢物)浓度使用液相色谱-质谱(LC/MS/MS)从在稳态条件下给药后0、1、2、4、6、8、10和12小时的定时样品中测定。
■缬沙坦水平在所有牛奶样品中均低于0.19ng/mL的检测限。在五名参与者的所有牛奶样本中都可以测量sacubitril，给药后1小时，平均浓度为1.52ng/mL，婴儿总剂量为0.00049mg/kg/12h，相对婴儿剂量（RID）为0.01％。在药物给药后4小时观察到牛奶样品中活性代谢物LBQ657的最大浓度，并在剩余的12小时给药间隔内下降。平均浓度为9.5ng/mL。婴儿总剂量为0.00071mg/kg/12h，RID为0.22%。两名母亲报告在服用沙库巴曲/缬沙坦的同时继续母乳喂养；两位母亲都表示对母乳喂养的婴儿没有负面影响。
■沙库必曲/缬沙坦向人乳中的转移很少。这些浓度不太可能对母乳喂养的婴儿构成重大风险，合并计算的RID<0.25%，远低于行业安全标准(RID<10%)。
■本研究旨在评估沙库必曲/缬沙坦向人乳中的转移，并评估婴儿的药物暴露风险。
■婴儿风险人乳生物栓剂发布了来自五个母乳喂养的母婴二联体的样本和相应的健康信息，这些样本和健康信息暴露于沙库必曲/缬沙坦。Sacubitril,缬沙坦,和LBQ657(sacubitril活性代谢物)浓度使用液相色谱-质谱(LC/MS/MS)从在稳态条件下给药后0、1、2、4、6、8、10和12小时的定时样品中测定。
■缬沙坦水平在所有牛奶样品中均低于0.19ng/mL的检测限。在五名参与者的所有牛奶样本中都可以测量sacubitril，给药后1小时，平均浓度为1.52ng/mL，婴儿总剂量为0.00049mg/kg/12h，相对婴儿剂量（RID）为0.01％。在药物给药后4小时观察到牛奶样品中活性代谢物LBQ657的最大浓度，并在剩余的12小时给药间隔内下降。平均浓度为9.5ng/mL。婴儿总剂量为0.00071mg/kg/12h，RID为0.22%。两名母亲报告在服用沙库巴曲/缬沙坦的同时继续母乳喂养；两位母亲都表示对母乳喂养的婴儿没有负面影响。
■沙库必曲/缬沙坦向人乳中的转移很少。这些浓度不太可能对母乳喂养的婴儿构成重大风险，合并计算的RID<0.25%，远低于行业安全标准(RID<10%)。
