Kesimpta Use In Pregnancy & Lactation

Women of childbearing potential: Women of childbearing potential should use effective contraception (methods that result in less than 1% pregnancy rates) while receiving Kesimpta and for 6 months after the last administration of Kesimpta.
Pregnancy: There is a limited amount of data from the use of ofatumumab in pregnant women. Ofatumumab may cross the placenta and cause foetal B-cell depletion based on findings from animal studies (see Pharmacology: Toxicology: Preclinical safety data under Actions). No teratogenicity was observed after intravenous administration of ofatumumab to pregnant monkeys during organogenesis.
Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. The potential duration of B-cell depletion in infants exposed to ofatumumab in utero, and the impact of B-cell depletion on the safety and effectiveness of vaccines, are unknown (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Treatment with ofatumumab should be avoided during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.
To help determine the effects of ofatumumab in pregnant women, healthcare professionals are encouraged to report all pregnancy cases and complications that happen during treatment or within 6 months after the last dose of ofatumumab to the local representative of the marketing authorisation holder by sending email to safety.hk@novartis.com in order to allow monitoring of these patients through the PRegnancy outcomes Intensive Monitoring programme (PRIM). In addition, all adverse pregnancy events should be reported.
Lactation: The use of ofatumumab in women during lactation has not been studied. It is unknown whether ofatumumab is excreted in human milk. In humans, excretion of IgG antibodies in milk occurs during the first few days after birth, which is decreasing to low concentrations soon afterwards. Consequently, a risk to the breast-fed child cannot be excluded during this short period. Afterwards, ofatumumab could be used during breast-feeding if clinically needed. However, if the patient was treated with ofatumumab up to the last few months of pregnancy, breast-feeding can be started immediately after birth.
Fertility: There are no data on the effect of ofatumumab on human fertility.
Non-clinical data did not indicate potential hazards for humans based on male and female fertility parameters assessed in monkeys.