Tysabri and fertility

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Tysabri and fertility

Postby AngelaO » Wed Feb 17, 2010 3:44 pm

I am 21 and going to be starting Tysabri. Im getting married in June and weve been discussing having children in the future. Ive heard some concerns about Tysabri lowering fertility. I called both my neuro and Biogen and neither one had any information. The person I talked to at Biogen actually suggested I ask to my dr about it! Ive seen the study regarding the guinnie pigs, but have there been any studies done on humans? Does anyone here have any experience?
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Postby LR1234 » Thu Feb 18, 2010 3:41 am

I have chosen not to start any DMD because I want to have kids at some point soon and I think it is worse to start and stop then not to start at all (thats just my opinion)
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Re: Tysabri and fertility

Postby HarryZ » Thu Feb 18, 2010 7:10 am

AngelaO wrote:I am 21 and going to be starting Tysabri. Im getting married in June and weve been discussing having children in the future. Ive heard some concerns about Tysabri lowering fertility. I called both my neuro and Biogen and neither one had any information. The person I talked to at Biogen actually suggested I ask to my dr about it! Ive seen the study regarding the guinnie pigs, but have there been any studies done on humans? Does anyone here have any experience?


From all that I have read about Tysabri, Biogen/Elan have not done any studies of the drug that involved pregnant patients. So for now, there is no data to look at.

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Postby LR1234 » Thu Feb 18, 2010 7:32 am

We do know however that there is some evidence of a rebound effect with Tysabri, so if you are planning on getting pregnant within the year I would give it a miss. (Maybe go for something like LDN and/or copaxone)
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Postby HarryZ » Thu Feb 18, 2010 8:51 am

LR1234 wrote:We do know however that there is some evidence of a rebound effect with Tysabri, so if you are planning on getting pregnant within the year I would give it a miss. (Maybe go for something like LDN and/or copaxone)


The evidence that has been reported comes from actual patients who have stopped using Tysabri and end up becoming quite ill.

Supposedly, when asked, Biogen has stated that they do not plan to do any kind of studies or trials on what is being called the "rebound effect". I guess the wrong kind of results would not be good for business!!

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Postby AngelaO » Thu Feb 18, 2010 11:18 am

We dont plan on having kids for a couple years. Ive been on Rebif and im Copaxone right now. My neuro just wants me on Ty for a year (or so she says) to get my MRIs stable and then move on to something else. I did bring up LDN, but the way my MRIs are going she said it would be better to go with something thats proven to have high effacy than risking it on other meds.
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Postby HarryZ » Thu Feb 18, 2010 1:10 pm

AngelaO wrote:We dont plan on having kids for a couple years. Ive been on Rebif and im Copaxone right now. My neuro just wants me on Ty for a year (or so she says) to get my MRIs stable and then move on to something else. I did bring up LDN, but the way my MRIs are going she said it would be better to go with something thats proven to have high effacy than risking it on other meds.


Be careful when it comes to "high efficacy" claims by the drug companies who manufacture the likes of Tysabri and Rebif.

The trials they use to state their efficacy hang their hat on the reduction of MRI lesions. But there is little if any correlation between the number of lesions and MS disease progression. In many instances, lesions also come and go randomly.

If you plan to start a family in a couple of years, you are best off to talk to a doc who is familiar with pregnancy and these very powerful, immune system altering drugs. Don't take the sole advice of a specialist in one field who knows little about the other.

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Postby LR1234 » Thu Feb 18, 2010 1:14 pm

I agree with Harry. Also LDN's efficiency has not been tested in clinical trials as there is no money for the pharmas in the drug, it seems to be effective for some people so might be worth a try along with the copaxone. (they can be taken together)
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Postby dee522 » Wed May 12, 2010 5:04 am

I know this topic was being talked about a while back on this forum but it is something I have worried about ad nauseum and I really don't want to say I won't EVER have children now BECAUSE I've been on Tysabri for 4 infusions! The last MRI was in April and there was shown to be zero activity and zero lesions.

Can I not just stop already :lol:

I actually didn't 'feel' like I had MS until right after my 2nd Tysabri infusion in February 2010. I consulted with my neuropsychotherapist on this and he said to forget about having children :cry:

I tried Copaxone before the Tysabri and after the 4th shot hung it up, the side effects of itching and swelling at the injection site would NOT go down or desist, so I said I wouldn't take anymore. My neuro said I HAD to be on something to stop progression and after she saw that I wouldn't take any drugs (steroids etc.) she got mad.

SOOOOOOO I gave in and got on the Tysabri because it was one infusion every 28 days and no drugs or needles in my house.

But is my dream of children gone now :cry:
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Postby HarryZ » Wed May 12, 2010 6:23 am

I actually didn't 'feel' like I had MS until right after my 2nd Tysabri infusion in February 2010. I consulted with my neuropsychotherapist on this and he said to forget about having children :cry:


I would ask your neurophsychotherapist on what data or information he is basing his recommendation to you. To my knowledge, there has not been any kind of trial information done on Tysabri's effect on pregnancy.

On the other hand, it is known that pregnancy does tend to increase the risk of exacerbations with MS so it is a tough decision for anyone to make.

Whatever decision you make, ensure that you are well informed before making it. Best of luck.

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Postby facetspera » Wed May 12, 2010 3:46 pm

It's a tough call try to consider a drug therapy in connection with future fertility. Since Tysabri was fast tracked, and is so new, I think there just isn't a lot of informaiton. on areas like fertility.

Don't know if it is at all useful, but my neurologist said I would need an 8 month wash out from Tysabri before going on any other drug. Eight months to clear it out of your system indicates to me that it is pretty potent. But the situatioon isn't identical to going off it to become pregnant.

Regarding pregnancy and MS, I had read that often women have pregnancies with less ms activity and then after giving birth that changes. This led to some research about hormonal levels and MS.

Good luck with what you choose. I find it difficult to look at all the issues related to the various therapies, and I am not even adding the issue of fertility to the mix.
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Postby RuSmolikova » Thu May 13, 2010 7:22 am

Source: EMEA, 2007
Embryo-foetal development
The objective of the 2 studies studying embryo-foetal development was to evaluate the potential effects of natalizumab treatment on the development of foetal guinea pigs in females treated prior (2 or 28 days) to implantation through the end of organogenesis.
Natalizumab treatment had no effect on gross pathology lesions or uterine weights in the females. No effects were seen on pregnancy rate, number of corpora lutea, number of implantations, number of early or late resorption, or number of dead and live foetuses. Pregnancy rates were 73, 67, 83 and 73% in the vehicle, 3, 10, and 30 mg/kg groups, respectively. Skeletal malformations and variations were seen in pups from all groups. No histological changes in the heart, thymus, liver, spleen, and intestinal tract were seen that were considered treatment related.
Alternate day dosing at doses up to 30 mg/kg was tolerated in pregnant female guinea pigs during the approximately 2 months of dosing. No significant abortion rates, fetotoxicity, or teratogenicity were observed following treatment with natalizumab prior to and through the period of organogenesis.
The transfer of natalizumab to the guinea pig foetuses as well as the induction on anti-natalizumab antibodies was demonstrated.
A study in pregnant cynomolgus monkeys treated with natalizumab during organogenesis (GD20-GD70) demonstrated natalizumab-related changes in the foetus that included mild anaemia, reduced platelet counts, increased spleen weights and reduced liver and thymus weights. These changes were associated with increased splenic extramedullary haematopoiesis, thymic atrophy and decreased hepatic haematopoiesis. No abortifacient effects, fetotoxicity, or teratogenicity was observed in the
study following treatment with natalizumab through the period of organogenesis.
In cynomolgus monkeys treated with natalizumab until parturition, low levels of natalizumab were detected in the breast milk of some animals, indicating the possibility for transfer of natalizumab into breast milk in humans.
Prenatal and postnatal development, including maternal function
One study (309-033-11) evaluated the potential for developmental effects in infants born to females treated with natalizumab and addressed the influence of natalizumab on the immune function. The
study was designed to assess any effects in offspring following exposure during organogenesis and during full gestation in cynomolgus monkeys. Significant numbers of pregnancies were lost to abortions and stillbirths during the study.
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Postby HarryZ » Thu May 13, 2010 9:05 am

Thanks RuSmolikova for that information.

Not sure if I would be comfortable with the results from guinea pigs and monkeys. Sure makes it a difficult decision for a person who is considering becoming pregnant.

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Postby RuSmolikova » Thu May 13, 2010 12:53 pm

HarryZ wrote:...Not sure if I would be comfortable with the results from guinea pigs and monkeys....


And are you comfortable with Cristiano L.?
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Postby HarryZ » Thu May 13, 2010 5:19 pm

And are you comfortable with Cristiano L.?


You know that I am not comfortable with any comments that come from Biogen employees when it comes to information on Tysabri. We all know their track record.

I guess from the information that you have so nicely provided, there really isn't a definitive answer for anyone who wants to know if it is safe to use Tysabri and become pregnant.
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