Transfer of rosuvastatin into breast milk: liquid chromatography&amp;ndash;mass spectrometry methodology and clinical recommendations

Lwin, Ei Mon Phyo; Leggett, Catherine; Ritchie, Usha; Gerber, Jacobus P.; Song, Yunmei; Hague, William; Turner, Sean; Upton, Richard N.; Garg, Sanjay

doi:10.2147/dddt.s184053

Cited by 12 publications

(7 citation statements)

References 15 publications

(25 reference statements)

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“…There are few studies on breastfeeding and statins in humans. Two studies showed that rosuvastatin is transferred into breast milk, but that statin exposure for the infant seems to be low [27,28]. Others have suggested that the health benefits of breastfeeding while using rosuvastatin may outweigh the low risk of statin exposure for the child [29].…”

Section: Statin Use During Breastfeeding Is Understudiedmentioning

confidence: 99%

Loss of statin treatment years during pregnancy and breastfeeding periods in women with familial hypercholesterolemia

et al. 2021

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Background and aims: Women with heterozygous familial hypercholesterolemia (FH) are recommended to initiate statin treatment at the same age as men (from 8 to 10 years of age). However, statins are contraindicated when pregnancy is planned, during pregnancy and breastfeeding. The aim of the study was to determine the duration of pregnancy-related off-statin periods and breastfeeding in FH women. Methods: A cross-sectional study using an anonymous online self-administered questionnaire was conducted. Women with FH were recruited through Lipid Clinics in Norway and Netherlands and national FH patient organizations. Results: 102 women with FH (n = 70 Norwegian and n = 32 Dutch) were included in the analysis. Total length of pregnancy-related off-statin periods was estimated for 80 women where data were available, and was median (min-max) 2.3 (0-14.2) years. Lost statin treatment time was estimated for 67 women where data were available, and was median (min-max) 18 (0-100)% at mean (SD) age of 31 (4.3) years at last pregnancy. More women breastfed in Norway (83%) and for longer time [8.5 [1-42] months] compared to the Netherlands [63%, p = 0.03; 3.6 (0-14) months, p < 0.001]. Eighty-six percent of the women reported need for more information on pregnancy and breastfeeding in relation to FH. Conclusions: Young FH women lose years of treatment when discontinuing statins in relation to pregnancy and breastfeeding periods and should be closely followed up to minimize the duration of these off-statin periods. Whether these periods of interrupted treatment increase the cardiovascular risk in FH women needs to be further elucidated.

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Section: Statin Use During Breastfeeding Is Understudiedmentioning

confidence: 99%

Loss of statin treatment years during pregnancy and breastfeeding periods in women with familial hypercholesterolemia

et al. 2021

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“…The effects of scutellarin on the rosuvastatin uptake in OATP1B1 transfected HEK293T cells were assayed by LC-MS/MS. The method was validated by examining the selectivity, sensitivity, accuracy, precision, recovery, matrix effect and stability profiles of rosuvastatin 16 .…”

Section: Determination Of Rosuvastatin Uptake In Oatp1b1-hek293t Cellmentioning

confidence: 99%

Scutellarin inhibition of the rosuvastatin uptake in rat hepatocytes and the competition for organic anion transporting polypeptide 1B1 in HEK293T cells

Liu

Guo²,

Liu³

et al. 2020

Sci Rep

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www.nature.com/scientificreports www.nature.com/scientificreports/ by hepatocytes 13 . However, the mechanism of OATP1B1 involvement remains unclear, or whether scutellarin and rosuvastatin compete for OATP1B1. Therefore, in this study, we treated rats with rosuvastatin alone, or with a combination of rosuvastatin and a series concentration of scutellarin, to examine the plasma and hepatic levels of rosuvastatin in rats, as well as in OATP1B1 transfected HEK293T cells. Materials and MethodsAnimals. A total of 48 healthy male Sprague-Dawley rats weighing 230-270 g were obtained by the Experimental Animal Center of Nanchang University Medical College. Animals were housed in individual cages in an air-conditioned room at room temperature of 25 ± 1 °C with a 12 h light: 12 h dark period. The study was approved by the Ethical Committee of JiangXi Medical College, and all experiments were carried out with humane care according the Animal Care and Use Committee (ACUC) of Nanchang University Medical College. Rats were given free access to drinking water, after experiments, rats were euthanized by intraperitoneal injection of sodium pentobarbital with a dose of 200 mg/kg. Treatment and sampling. The rats were randomly divided into two groups with 24 rats in each group: the rosuvastatin group (rosuvastatin 10 mg/kg) and the combination treatment group (rosuvastatin 10 mg/kg + scutellarin 50 mg/kg), the concentrations used in the animal were transformed from clinical dose. The treatment was administered by gavage in the morning before feeding, and scutellarin was administered immediately following the rosuvastatin administration for the combination treatment group. In each group, 6 rats were maintained throughout the study and used for orbital vein blood sampling (0.15 ml) at 0 (before), 0.5, 1.0, 1.5, 2.0, 3.0, 5.0, 8.0, 12.0, 18.0, 24.0 h post treatment, to obtain the concentration-time profile data. Six of the remaining rats in each group were sacrificed at 1 h, 2 h, and 6 h post treatment (each time point) to sample the 0.5 ml of eyeball blood and the liver tissues. Blood was stored in heparinized tubes and the plasma was separated by centrifugation, then stored at −80 °C for further analysis. Scientific RepoRtS |(2020) 10:1308 | https://doi.

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“…The methods for the collection and analysis of human milk and plasma samples were consistent with those described in our previous research (Leggett et al, 2020; Lwin, Gerber, et al, 2018; Lwin, Leggett, et al, 2018). During the study period, the participant took modafinil 300 mg at 9 a.m. and 100 mg at 12:30 p.m. on Day 1, and 300 mg at 9:30 a.m. and 100 mg at 1 p.m. on Day 2.…”

Section: Managementmentioning

confidence: 82%

Infant Exposure to Armodafinil Through Human Milk Following Maternal Use of Modafinil

et al. 2022

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Introduction Narcolepsy, a condition adversely affecting psychological, social, and cognitive function, is more prevalent in females of childbearing age than the general population. Modafinil and armodafinil are central nervous system stimulants approved for treatment of narcolepsy. Infant exposure to these agents through human milk has not been investigated. Poor quality medication safety information during lactation is associated with early cessation of breastfeeding and suboptimal healthcare for the breastfeeding family. Main Issue In this case study, we measured the concentration of armodafinil (the most active form of modafinil) in human milk and infant plasma to quantify infant exposure. Management The participant was a 30-year-old primipara with narcolepsy, taking modafinil (300 mg morning, 100 mg noon) while breastfeeding her 6-week-old infant despite the paucity of safety information. Armodafinil concentrations were measured in eight serial human milk samples collected over a 26-hr period and in single maternal and infant plasma samples using ultra performance liquid chromatography - tandem mass spectrometry. The average concentration of armodafinil in human milk was 1.96 mg/L; the relative infant dose was 4.85%; the theoretical infant dose was 0.294 mg/kg/day. Maternal and infant plasma concentrations of armodafinil were 12.02 mg/L and 0.19 mg/L, respectively. The participant continued to exclusively breastfeed the infant, who had normal growth and development. Conclusion Based on these findings, relatively small amounts of armodafinil pass into human milk, with consequent limited infant exposure. Consideration can be given to the use of modafinil or armodafinil during breastfeeding, provided the infant is monitored. Further studies are needed to confirm these findings.

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Transfer of rosuvastatin into breast milk: liquid chromatography–mass spectrometry methodology and clinical recommendations

Cited by 12 publications

References 15 publications

Loss of statin treatment years during pregnancy and breastfeeding periods in women with familial hypercholesterolemia

Loss of statin treatment years during pregnancy and breastfeeding periods in women with familial hypercholesterolemia

Scutellarin inhibition of the rosuvastatin uptake in rat hepatocytes and the competition for organic anion transporting polypeptide 1B1 in HEK293T cells

Infant Exposure to Armodafinil Through Human Milk Following Maternal Use of Modafinil

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