Contributions
Abstract: P892
Type: Poster
Abstract Category: Clinical aspects of MS - 6 MS and gender
Background: Women with multiple sclerosis (MS) experience an increased risk of relapse at postpartum period. High-dose IV methylprednisolone is the first-line treatment for acute relapses. Methylprednisolone is administered to lactating women, though there is little data as to the levels of concentration in breast milk and blood, and calculated steroid exposure to infants.
Objectives: The study aimed to determine the transfer of methylprednisolone into human milk and serum in breastfeeding MS patients.
Methods: IV methylprednisolone pulse therapy was given to 21 lactating MS patients. Breast milk samples were obtained before infusion and 1, 2, 4, 8 and 12 hours after completion from 21 patients. From 5 patients, additional blood and breast milk samples were obtained 30 minutes into infusion, straight after infusion and 1, 2, 4, 8 and 12 hours after.
Methylprednisolone concentrations were quantified by liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS).
Results: The demographics of 21 patients were as follows; aged (28.62 ± 5.1), weight in kg (70.16 ± 6.9), duration of MS in years (3.54 ± 2.2), and an EDSS (1.5 ± 0.7). Infant demographics; aged (months) (7.96 ± 5.0) and weighed (kg) (7.74 ± 2.8).
Blood and milk concentration levels peaked at 1 hour after infusion and dropped overtime at 4, 8 and 12 hours. The milk methylprednisolone concentrations were below detection limits just before infusion. Maximum levels measured at 1, 2, 4, 8 and 12 hours after infusion were 2.1 µg/ml, 1.7 µg/ml, 0.69 µg/ml, 0.17 µg/ml and 0.10 µg/ml, consecutively. The absolute infant dose was 99 µg/kg/day and the relative infant dose (RID) was 0.71% of the weight-adjusted maternal dose.
The maximum AUC0-13 h was 8,57 µg h/L, giving the milk a Cav of 0.66 µg/mL across the dose interval. The absolute infant dose was 98,98 µg/kg/day and the RID was 0.71% of the weight-adjusted maternal dose.
Conclusion: Small methylprednisolone concentration levels were transferred into breast milk. The RID for methylprednisolone was lower than the accepted RID. IV methylprednisolone therapy is typically for 3 or 5 days. Infant exposure would be very low for a breastfeeding mother an hour after infusion. Although, concentration levels may not pose a threat to the infant, mothers can choose to wait 2 to 4 hours to limit exposure further. However, results demonstrate that there is no need to wait for more than 4 hours to breastfeed.
Disclosure:
Cavit Boz: nothing to disclose
Murat Terzi: nothing to disclose
Serap Zengin Karahan: nothing to disclose
Bilge Ozbudun: nothing to disclose
Sedat Sen: nothing to disclose
Yasemin Sarac: nothing to disclose
Murat Mavis: nothing to disclose
Abstract: P892
Type: Poster
Abstract Category: Clinical aspects of MS - 6 MS and gender
Background: Women with multiple sclerosis (MS) experience an increased risk of relapse at postpartum period. High-dose IV methylprednisolone is the first-line treatment for acute relapses. Methylprednisolone is administered to lactating women, though there is little data as to the levels of concentration in breast milk and blood, and calculated steroid exposure to infants.
Objectives: The study aimed to determine the transfer of methylprednisolone into human milk and serum in breastfeeding MS patients.
Methods: IV methylprednisolone pulse therapy was given to 21 lactating MS patients. Breast milk samples were obtained before infusion and 1, 2, 4, 8 and 12 hours after completion from 21 patients. From 5 patients, additional blood and breast milk samples were obtained 30 minutes into infusion, straight after infusion and 1, 2, 4, 8 and 12 hours after.
Methylprednisolone concentrations were quantified by liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS).
Results: The demographics of 21 patients were as follows; aged (28.62 ± 5.1), weight in kg (70.16 ± 6.9), duration of MS in years (3.54 ± 2.2), and an EDSS (1.5 ± 0.7). Infant demographics; aged (months) (7.96 ± 5.0) and weighed (kg) (7.74 ± 2.8).
Blood and milk concentration levels peaked at 1 hour after infusion and dropped overtime at 4, 8 and 12 hours. The milk methylprednisolone concentrations were below detection limits just before infusion. Maximum levels measured at 1, 2, 4, 8 and 12 hours after infusion were 2.1 µg/ml, 1.7 µg/ml, 0.69 µg/ml, 0.17 µg/ml and 0.10 µg/ml, consecutively. The absolute infant dose was 99 µg/kg/day and the relative infant dose (RID) was 0.71% of the weight-adjusted maternal dose.
The maximum AUC0-13 h was 8,57 µg h/L, giving the milk a Cav of 0.66 µg/mL across the dose interval. The absolute infant dose was 98,98 µg/kg/day and the RID was 0.71% of the weight-adjusted maternal dose.
Conclusion: Small methylprednisolone concentration levels were transferred into breast milk. The RID for methylprednisolone was lower than the accepted RID. IV methylprednisolone therapy is typically for 3 or 5 days. Infant exposure would be very low for a breastfeeding mother an hour after infusion. Although, concentration levels may not pose a threat to the infant, mothers can choose to wait 2 to 4 hours to limit exposure further. However, results demonstrate that there is no need to wait for more than 4 hours to breastfeed.
Disclosure:
Cavit Boz: nothing to disclose
Murat Terzi: nothing to disclose
Serap Zengin Karahan: nothing to disclose
Bilge Ozbudun: nothing to disclose
Sedat Sen: nothing to disclose
Yasemin Sarac: nothing to disclose
Murat Mavis: nothing to disclose