The primary objective of the lactation study is to characterize the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who receive BRIUMVI™ therapeutically for the treatment of relapsing forms of multiple sclerosis (RMS).
Participant has independently decided to be treated with BRIUMVI™ prior to providing consent to participate in the study
Diagnosis of RMS, to include clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS)
Willing to breastfeed or pump regularly during the study period to maintain milk supply and exclusively pump breast milk for the 24-hour period of breast milk collection Day 1 post IV dose
Plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning
Any active infection or other condition that would prevent the individual from breastfeeding
History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts
History of mastectomy
Evidence of mastitis or any other significant active infection at Day 1 (pre-dose) that would prevent collection of milk from one or both breasts
The study population will include breastfeeding individuals with RMS who are exposed to BRIUMVI™.
Cohort
Prospective
No intervention
Other interventionNo intervention
Area Under the Milk Concentration-time Curve from Time 0 to Infinity (AUC0-inf) of BRIUMVI™
Area Under the Milk Concentration-time Curve from Time 0 to the Last Measurable Observed Concentration (AUC0-last) of BRIUMVI™
Area Under the Milk Concentration-Time Curve from Time 0 to 24 Hours Post-Dose (AUC0-24) of BRIUMVI™
Maximum Observed Milk Concentration of BRIUMVI™ (Cmax)
Amount Excreted (Ae) of BRIUMVI™ in Milk
Total amount of drug excreted in milk (mg) as: Σ(total drug concentration in each milk collection x milk volume in each milk collection)
Fraction of Dose Excreted (Fe) in Milk of BRIUMVI™
Fraction of dose excreted in milk calculated as Ae/Administered dose
Infant Dose (ID) of BRIUMVI™
Infant dose = Ʃ drug concentration in each milk collection multiplied by the expressed milk volume in each milk collection.
Relative Infant Dose (RID) of BRIUMVI™
Relative infant dose = infant dose milligrams/kilograms (mg/kg)/ \[Maternal Dose (mg)/Maternal Bodyweight (kg)\] multiplied by 100
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