^aProspective cases are defined as cases for which, at the time of initial reporting (i.e., first receipt by Novartis), the pregnancy outcome has not yet occurred or there is no report of an abnormal prenatal testing result (including cases where prenatal testing has not yet been performed, or cases where prenatal testing has been performed but results were either normal or not specified

^bRetrospective cases are defined as cases for which at the time of initial reporting (i.e., first receipt by Novartis), the pregnancy outcome has already occurred, or prenatal testing results were abnormal (regardless of whether the pregnancy outcome has occurred)
 

Prospective cases

• As of March 25, 2023, 181 prospective pregnancies with maternal exposure to ofatumumab were identified
• A total of 43 outcomes were known in 181 prospectively reported pregnancies^c

• Among prospective cases, most of the women were exposed to ofatumumab in the first trimester
• No congenital anomalies or serious infections were reported in the 23 live births

^c57 pregnancy outcomes were lost to follow-up (including outcome missing) and 83 pregnancy outcomes were pending. ^dIncludes cohort of 183 fetuses; two pregnancies involving twins; ^eone case was lost to follow-up; ^fIncluding Therapeutic abortion and Elective termination. ^gTwo cases of therapeutic abortion were performed due to ectopic pregnancy (one prospective and one retrospective case). Peri-LMP period for ofatumumab refers to 180 days prior to the LMP
LMP, last menstrual period; N, total number of pregnancies; n, number of pregnancy outcomes; NOS, not otherwise specified.

Retrospective cases

• As of March 25, 2023, 21 retrospective pregnancies were reported in women with MS who were exposed to ofatumumab; outcomes were known in all cases^h
• Cases reported retrospectively have an inherent reporting bias toward abnormal outcomes

• Among retrospective cases, most of the women were exposed to ofatumumab either in the peri-LMP period or in the first trimester
• No congenital anomalies were reported in the 7 live births

Ofatumumab may cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping ofatumumab. For more details, please refer to the Prescribing Information.

^hNo pregnancy case was lost to follow-up. ⁱIncludes cohort of 21 fetuses.
Peri-LMP period for ofatumumab refers to 180 days prior to the LMP.
LMP, last menstrual period; N, total number of pregnancies; n, number of pregnancy outcomes; NOS, not otherwise specified.
 

Ofatumumab treatment interruptions/ discontinuations