Mipomersen

The Basics

What is Mipomersen?

Used to treat homozygous familial hypercholesterolemia.

Brand names for Mipomersen

Kynamro

How Mipomersen is classified

Anticholesteremic Agents, Antilipemic Agents

Mipomersen During Pregnancy

Mipomersen pregnancy category

Category BNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Mipomersen while pregnant

There are no adequate and well-controlled studies in pregnant women. Reproduction and embryofetal development studies performed in mice at doses up to 87.5 mg/kg/wk given by subcutaneous administration from mating through organogenesis and in pregnant rabbits given 52.5 mg/kg/wk, show no evidence of impaired fertility or harm to the fetus at 2 (mice) to 5 (rabbits) times clinical exposure at a 200 mg/wk therapeutic dose. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed. Pregnant rats given subcutaneous doses of 7, 35, 70 mg/kg/wk mipomersen sodium from gestation day 6 through weaning on lactation day 20, resulted in decreased rat pup survival at 70 mg/kg/wk, 3-times clinical exposure at a 200 mg/wk therapeutic dose based on body surface area comparisons across species. Dose related decreases in pup body weights, impaired reflexes and grip strength were observed at 35 mg/kg/wk (2times the anticipated human dose. Levels of mipomersen in rat milk were very low (≤0.92 μg/mL at subcutaneous doses up to 70 mg/kg/wk). Due to the poor oral bioavailability of mipomersen sodium, it was considered unlikely that these low milk exposure levels adversely affected the pups during lactation.

Taking Mipomersen While Breastfeeding

What are recommendations for lactation if you're taking Mipomersen?

No relevant published information exists with the use of mipomersen during breastfeeding. Because of a concern with disruption of infant lipid metabolism, mipomersen should not be used during breastfeeding.

Maternal / infant drug levels

No relevant published information exists with the use of mipomersen during breastfeeding. Because of a concern with disruption of infant lipid metabolism, mipomersen should not be used during breastfeeding.

Possible effects of Mipomersen on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Mipomersen

Cholestyramine, Colesevelam, Colestipol.