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Home > Other safety-related topics > Pregnancy

Pregnancy Outcomes

 

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  • Ofatumumab treatment was discontinued in all women following confirmation of the pregnancy 
Pregnancy outcomes

As of the cut-off date, outcomes were known in 30 pregnancies:

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Infant outcomes
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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.

aanomalies corresponds to both during pregnancy or post-partum.

 

Additional information

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References

1. Data on File. PSUR (Cut-off date: 25 Mar 2022); Novartis Pharma AG.
2. Hellwig K, et al. Poster presented at CMSC 2022.