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Cizzyoc wrote:Hi, I'm hoping to get some information from people who may know information or be in a similar position. My husband has been diagnosed with MS and is due to start Tecfidera soon. We want to try for another baby but we are worried as we don't know if the drug can cause infertility or birth defects. We have asked the MS nurse assigned to him but she can't give us a real answer on it. Obviously his Health is the most important thing so we need to get him started on medication very soon.

Really interested to know your thought or if you are using
Tecfidera And in the same position?

Thanks

C

Impairment of Fertility

In male rats, oral administration of DMF (75, 250, and 375 mg/kg/day) prior to and throughout
the mating period had no effect on fertility; however, increases in non-motile sperm were
observed at the mid and high doses. The no-effect dose for adverse effects on sperm is similar to
the recommended human dose (RHD) of 480 mg/day on a body surface area (mg/m2
) basis.

In female rats, oral administration of DMF (20, 100, and 250 mg/kg/day) prior to and during
mating and continuing to gestation day 7 caused disruption of the estrous cycle and increases in
embryolethality at the highest dose tested. The highest dose not associated with adverse effects
(100 mg/kg/day) is twice the RHD on a mg/m2
basis.

Testicular toxicity (germinal epithelial degeneration, atrophy, hypospermia, and/or hyperplasia)
was observed at clinically relevant doses in mice, rats, and dogs in subchronic and chronic oral
toxicity studies of DMF, and in a chronic oral toxicity study evaluating a combination of four
fumaric acid esters (including DMF) in rats.