Tecfidera and Fertility

[premington]

Hi!

My wife and I have been talking about having another child. I'm on Tecfidera and we were concerned about fertility issues and possible birth defects while I'm on the medication. I'm a male... She would NOT be on Tecfidera. She doesn't have MS; only I have MS.

I've looked online and don't see anything related to males on MS. Only that it's unknown how it might affect females.

Does anyone know anything about male issues related to being on this medication that could cause problems for the baby after conception?

Thanks!

-Paul

[Marco]

Paul,
I haven't seen any information to directly answer your question about Tecfidera. I have posted what pregnancy information is widely available below. I would contact MS ActiveSource directly at 1-800-456-2255 and ask them your question.


Tecfidera is FDA pregnancy category C.

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

From the prescribing information:
8.1 Pregnancy
Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. In animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (DMF) was administered during pregnancy and lactation at clinically relevant doses. TECFIDERA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In rats administered DMF orally (25, 100, 250 mg/kg/day) throughout organogenesis, embryofetal toxicity (reduced fetal body weight and delayed ossification) were observed at the highest dose tested. This dose also produced evidence of maternal toxicity (reduced body weight). Plasma exposure (AUC) for monomethyl fumarate (MMF), the major circulating metabolite, at the no-effect dose is approximately three times that in humans at the recommended human dose (RHD) of 480 mg/day. In rabbits administered DMF orally (25, 75, and 150 mg/kg/day) throughout organogenesis, embryolethality and decreased maternal body weight were observed at the highest dose tested. The plasma AUC for MMF at the no-effect dose is approximately 5 times that in humans at the RHD.

Oral administration of DMF (25, 100, and 250 mg/kg/day) to rats throughout organogenesis and lactation resulted in increased lethality, persistent reductions in body weight, delayed sexual maturation (male and female pups) and reduced testicular weight at the highest dose tested. Neurobehavioral impairment was observed at all doses. A no-effect dose for developmental toxicity was not identified. The lowest dose tested was associated with plasma AUC for MMF lower than that in humans at the RHD.

Pregnancy Registry
There is a pregnancy registry that monitors pregnancy outcomes in women exposed to TECFIDERA during pregnancy. Encourage patients to enroll by calling 1-800-456-2255.



Compare that to Aubagio
FDA Pregnancy Category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

From aubagio.com
AUBAGIO may harm your unborn baby. Do not take AUBAGIO if you are pregnant or are of childbearing age and not using effective birth control. You should have a pregnancy test before you start taking AUBAGIO. After stopping AUBAGIO, continue using effective birth control until you have tests to make sure your blood levels of AUBAGIO are low enough. If you become pregnant while taking AUBAGIO or within 2 years after you stop taking it, tell your doctor right away and enroll in the AUBAGIO Pregnancy Registry at 1-800-745-4447, option 2, which collects health information about you and your baby.

If you are a man taking AUBAGIO whose partner plans to become pregnant, you should stop taking AUBAGIO and talk with your doctor about reducing the levels of AUBAGIO in your blood quickly. If your partner does not plan to become pregnant, use effective birth control while taking AUBAGIO.

[premington]

Thank you for the informative reply, Marco. The last sentence in the post is most disconcerting, although this relates to Aubagio, not Tecfidera.

I think your recommendation to contact MS ActiveSource is a good one. I'll give them a call. I might call my neuro also, although he probably won't know. I'm only the second patient he has who is on Tecfidera. Couldn't hurt to inform him though. He might have some advice as well.

Will report back any important information I find.

Thanks again!

-Paul

[Marco]

There's a tremendous difference between Category C (Tecfidera) and Category X (Aubagio). I wanted you to see the FDA does look at pregnancy implications included for men. There's just so little available data for men that I would be on the phone just like you. It also doesn't mean Aubagio is a bad drug -- it just means for people trying to get pregnant it isn't the right one.

I hope things work out for you ...

[Mariag]

Tecfidera and fertility, any new info?

Hi Paul, it has been a while since you posted this. I wanted to know if you ended up finding information about potential issues regarding male fertility or baby issues if conceived whilst the father is taking tecfidera?
Me and my husband are pretty much in the same situation at the moment, we have been offered either tecfidera or cladribine for him and not sure which to go for. One factor is that we plan to try for a baby in a year or so and so my husband will be already in his treatment.

Any information will be very much appreciated.

thanks

Maria

Hi!

My wife and I have been talking about having another child. I'm on Tecfidera and we were concerned about fertility issues and possible birth defects while I'm on the medication. I'm a male... She would NOT be on Tecfidera. She doesn't have MS; only I have MS.

I've looked online and don't see anything related to males on MS. Only that it's unknown how it might affect females.

Does anyone know anything about male issues related to being on this medication that could cause problems for the baby after conception?

Thanks!

-Paul

[Selsia]

I recently had my eggs frozen (same but different) and after speaking with my neuro and my fertility doctor they were only concerned about the medication during pregnancy and when nursing. Incidentally I got a normal number of high quality frozen eggs out of the process. I hope that helps.

[kpsanelo]

I recently had my eggs frozen (same but different) and after speaking with my neuro and my fertility doctor they were only concerned about the medication during pregnancy and when nursing. Incidentally I got a normal number of high quality frozen eggs out of the process. I hope that helps.

In my opinion no one should take any kind of drug unless it is that necessary.. First talk to you doctor about the medicine and possibly be it with you.