Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis

Exclusion Criteria14

• Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
• Participant taking medications prohibited by the study protocol at screening.
• Pregnant woman, confirmed by positive serum pregnancy test during screening.
• Female of childbearing potential should use effective contraception as per local label.
• Participant has history of chronic alcohol abuse or drug abuse in the last year.
• Participant has any medical, obstetrical, psychiatric or other medical condition that, in the opinion of the Investigator, can jeopardize or would compromise the subject's ability to participate in this study or confound the study assessment.
• Participant has history of breast implants, breast augmentation, or breast reduction surgery.
• Participant has received anti-CD20 agents during the second and third trimesters of pregnancy.
• Active infections, including mastitis (participant may be included once the infection is resolved).
• Prior or current history of primary or secondary immunodeficiency, or participant in an otherwise severely immunocompromised state.
• Participant with active hepatitis B disease prior to the initiation or re-initiation of ofatumumab. (Participant with positive hepatitis B serology should consult a liver disease medical standards to prevent hepatitis B reactivation.)
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• Any contraindication as per local label.
• Participant who has an infant with any abnormality that may interfere with breastfeeding or confound the study assessment in the opinion of the Investigator.