FDA pregnancy category: B

Mipomersen should be used in pregnancy only if clearly needed.

Females of reproductive potential should be encouraged to use effective contraception during mipomersen therapy.

There are no controlled data in pregnant women. Reproduction and embryofetal development studies performed in mice at doses up to 87.5 mg/kg/week given by subcutaneous administration from mating through organogenesis and in pregnant rabbits given 52.5 mg/kg/week, show no evidence of impaired fertility or harm to the fetus at 2 (mice) to 5 (rabbits) times clinical exposure at a 200 mg/week therapeutic dose.

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A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

The effects in the nursing infant are unknown.

Lactating rats administered mipomersen at doses up to 70 mg/kg/week (3 times the anticipated systemic exposure from a 200 mg/week dose consumed less food while nursing. This correlated with reduced weight gain in the rat pups, and decreased pup survival.

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