Tecfidera Fertility for Men

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Cizzyoc
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Joined: Wed Sep 20, 2017 2:33 pm

Tecfidera Fertility for Men

Post by Cizzyoc »

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
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euphoniaa
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Re: Tecfidera Fertility for Men

Post by euphoniaa »

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
Hi Cizzyoc and welcome!

It looks like Tecfidera is too new to have much scientific study yet on either male fertility or female pregnancy. According to the official Full Prescribing Information, "There are no adequate and well-controlled studies in pregnant women." Therefore, they have started a Pregnancy Registry to record patients' experiences.

And this is about all it says in the Full Prescribing Information on the subject of male fertility:
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.


Here's a link to Tecfidera's Full Prescribing Information. There are some pretty serious and/or annoying potential side effects:
https://www.tecfidera.com/content/dam/c ... g-info.pdf

I would also suggest that you check out the posts in the Tecfidera subforum here at TiMS to read other patients' experiences and some very helpful suggestions to alleviate side effects: http://www.thisisms.com/forum/tecfidera ... arate-f52/ There are individual forums for every approved MS med here.

Best of luck to you both!
Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)
Cizzyoc
Newbie
Posts: 3
Joined: Wed Sep 20, 2017 2:33 pm

Re: Tecfidera Fertility for Men

Post by Cizzyoc »

Thanks for the reply , I will look into the links and see if I find more details/information.

C
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