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Fertility on Dasatinib

Dear all CML Supporters,

Since diagnosis last September at the age of 32, my wife and I have found our plans for starting a family somewhat hampered.

Long story short- my fertility has imrpoved dramatically and our fertility specialist says that we have a good chance of conceiving naturally.

Great news, except for the fact that I'm on Dasatinib and there is little evidence out there about the effect that this might have on a child.

3% of people who conceive naturally have the chance that there child will have some kind of physical abnormality- heart, lungs, brain etc- and if I was a woman on the same drugs it would be a different matter, as 9 months pregnancy would obviously increase the foetus' contact with the Chemotherapy.

I'm posting in the hope that somone has experience of a similar dilemma. We want a baby so much, and we need to make a decision and live with it.

The way I feel is that sometimes humans get sick- my parents certainly never thought that when they had me 32 years later I'd get CML. My motto at the moment is very much "S*** happens", and with that in mind there is very little reason why we shouldn't have a healthy baby that grows and lives a healthy and long life.

I would really appreciate anyone's thoughts on this. I know it's a personal decision, but it would help us to feel as informed as possible.

And once more just to say what a constant source of inspiration and support this website is to me- long may it continue its important work.

Best wishes-

Adam

Any new information?

My husband started dasatinib a few months ago. I got pregnant when he just started the treatment, but ended up miscarrying. Of course we will never know whether or not the miscarriage is due to dasatinib or not. We are unsure whether or not to try for another child. I have been trying to get information from the drug company, but it seems so limited. Does anyone know if there is more information on the safety of pregnancy with the male using dasatinib? The drug company shared the study they did of following 9 pregnancies from male dasatinib users, and 7 of the babies were healthy (the other two not reported). However, they did not follow these babies. Even if the babies were healthy at birth, I wonder if there was health issues later on? I wonder if there has been reports of babies born from male dasatinib users with lung or bone issues, ect.? It is so hard to make a decision with such little information. I don't want to base a decision on fear, but at the same time I want to be responsible.

recently pregnant

I know that this was posted several years ago, and I am really hoping that someone reads this, as I am in hopes to get good news about the pregnancy's I have read about in this forum. I was wondering if you could enlighten me on any information and Dasatinib 100mg a day and pregnancy outcomes.

My husband was diagnosed almost a year ago and we just found out that I am pregnant. He was on tasigna before and had a small break and in the last 10 weeks started on Sprycal. As this is our third child, and very unexpected we are trying to gather as much info as possible about this pregnancy.

any thoughts or info is welcome.

Sasha

Dasatinib and pregnancy

Hi Sasha,

My husband was diagnosed in 2005 age 34,he had two years on imatinib then put on to dasatinib 140mg in 2007, as we already had one child and therefore not eligible for fertility treatment, the hospital sent us to a local fertility clinic for some tests on his sperm, of which they said there did not appear to be any problems so we were advised to go for it.

I conceived naturally at age 41 a few months later, and at 20 weeks the hospital did a thorough scan of the baby and there were no apparent problems, in fact they seemed more concerned with my age than the dasatinib effect on the baby.

We had a healthy girl in Dec 2010,who is now 3 1/2, and has brought us much joy,and is still healthy , i think you will no doubt worry through the whole of the pregnancy as we did, especially as my husband had been on the medication in total for 5 years at the time and no one new the impact on the foetus.

When you do go for your scans just mention his medication and make sure that they scan you thoroughly, and good luck, I hope our experience will help you.

Louise

Hi Adam,  I was wondering if

Hi Adam, 

I was wondering if I would be able to email you?? My email address is ajblackshaw@gmail.com

I was hoping to talk to you about the progress of your wifes pregnancy, as I have just fallen pregnant and my husband is taking dasatinib. We cant find much information about it online, and I was just hoping to talk to someone in a similiar situation. 

Kind Regards

Amanda

Fertility

Hi there, just wondered how u was doing with the pregnancy? My partner is on dastinib and we would like to try for a baby but worry about the side effects of this drug. He has been on it 18 months now.

Any help would be greatful.

Thanks,

Anne

Perfectly healthy baby born whilst hubbie taking sprycel!

Hi Anne,
Im sorry about my delayed response... I dont always log on and check this website. 
I am happy to say that my husband and I gave birth to a PERFECTLY healthy baby girl 8 weeks ago on the 20th August. The dasatanib has not affected her at all!
Ill give you some background information about where we were at. My husband was 32 when diagnosed 4.5 years ago. He spent 2.5 years on Glivec, and then switched to dasatanib due to a P-Loop mutation. He had been taking dasatanib for 2 years. I was 28 when I fell pregnant, and gave birth 3 days after my 29th  birthday! 
I spent alot of time researching dasatanib and pregnancy, and every case that I found where the male was taking the dasatanib, the baby was perfectly healthy. 
My husbands haematologist contacted the drug supplier of sprycel in Australia, and we received information on other pregnancies that they have tracked.

I'll type it in below for you...and for others... as it was quite reassuring to us. 

From Bristol-Myers Squib... 

"The potential effects of dasatinib on sperm have not been studied. Sexually active male patients taking dasatinib should use adequate contraception. No specific studies have been conducted in animals to evaluate the effects of dasatinib on fertility. Dasatinib caused atrophy/degeneration of the testis in rats and monkeys and an increase in the number of copora lutea in the ovaries in rates at doses producing plasma exposure levels below or close to that anticipated in patients receiving dasatinib therapy. 

Case Studies

A poster presentation at the American Society of Hematology, 2008 assessed the effects of dasatinib in 13 female patients who became pregnant, and 9 male patients who conceived children while receiving therapy with dasatinib. The assessment was presented as patient case studies from dasatinib trials and postmarketing reports. 

Data was obtained via clinical study reports for 16 patients in phase I-III dasatinib trials and post-marketing surveillance compiled from 6 voluntarily submitted reports from community physicians. Due to the limited data, and the absence of any robust data, the outcomes of this analysis should be interpreted with caution. 

The baseline characteristics of the 9 male patients are described in the table below. 
(I cant insert the table, so will just put it in as best I can.)

Table. Baseline characteristics of male patients who conceived children whilst on dasatinib therapy. 

Patient A - Age (not reported), Disease (not reported), months on dasatinib (not reported), risk factors (not reported)

Patient B - Age (38), Disease (Chronic Phase - Chronic Myeloid Leukaemia), Months on Dasatinib (12), Risk factors (previous cytarabine therapy; partner on oral contraceptive ethinylestradiol)

Patient C - Age (34), Disease (Chronic Phase - Chronic Myeloid leukaemia), Months on Dasatinib (6), Risk factors (previous therapy with hydroxyurea, anagrelide; multiple concomitant medications including influenza vaccine)

Patient D - Age (43), Disease (Blast crisis - chronic myeloid leukaemia), Months on dasatinib (10), Risk factors - (Anemia; bleeding tendency; prior hydroxyurea therapy; concomitant antibiotics)

Patient E - Age (32), Disease - (chronic myeloid leukaemia), Months on dasatinib (not reported), risk factors - (history of GVHD; ex-tabacco use; prior hydroxyurea, interferon and cytarabine therapy)

Patient F - Age (41), Disease - (chronic myeloid leukaemia), months on dasatinib (7), risk factors (psoriasis; sleep apnea; prior interferon therapy; multiple concomitant medications)

Patient G - Age (49), Disease - (Chronic Phase - chronic myeloid leukaemia), Months on dasatinib (8), risk factors (age; alcohol and tabacco use; concomitant furosemide and lorazepam)

Patient H - Age (not reported), disease (not reported) months on dasatinib (1) risk factors (not reported)

Patient I - Age (24), disease (chronic myeloid leukaemia), months on dasatinib (1), risk factors (not reported)

The outcomes of infants born are available for seven of the nine patients. In all cases, normal, healthy infants were born to partners. 

Please note that Bristol-Myers Squibb does not recommend the use of Sprycel in any manner that is inconsistent with that described in the full prescribing information. For a complete discussion of Sprycel please refer to the full prescribing information. " 

I hope this information is of some help to you. I am hoping that our pregnancy can help others who are wanting to conceive... 

Take care

Amanda

Hopeful news from USA for you!

The American site - CML Talk has a lot about convceiving with CML.

Here is a link from Dean http://www.newcmldrug.com/Discuss/reply.asp?ID=34404&Reply=34404

that will make you feel very hopeful.

CML2 site is also full of such stories .... also States based.

Good luck

Beth

Thank You

All info is greatly appreciated..

Thanks Beth

In the same boat!!

Hi Adam,

First time of actually using this site but I have been reading it regularly!

My partner, Tom (age 25) was diagnosed March this year with CML Chronic phase. He was on hydroxyurea for 2weeks and then opted for the Spirit 2 Trial and has been on (100mg)Dasatinib since. Side effects have been minimal and already having cytogenetic response!

Just before starting treatment he stored sperm and just recently we have been discussing our options. His consultant referred us to the fertility dept at Coventry University Hospital, he also advised us that once Tom is in full remission (or to allow treatment for at least 2yrs) we can consider coming off the Dasatinib and going onto Interferon which will allow us to try naturally!

Coventry Hospital Fertility dept was not as we expected, firstly as his consultant has indicated we have a future possibility of conceiving natuarly and secondly I already have a 9yr old from previous relationship...this therefore means we do not fit the criteria for NHS IVF!

So without the means of paying for IVF ourselves we have been researching all our options!

We have been told by his consultant to take precautions and not to conceive whilst Tom is on Dasatinib! However, now doing some homework it looks like there is little evidence to suggest a man on treatment would have an unhealthy child!

Please can you let us know what you have found out or your thoughts and feelings.... or any suggestions of who to speak to!!

 

Thank You

All the Best

same boat...

Hi Kerry,

Nice to hear from you, and great news that Tom is responding so well- I have a moment everyday when I can't quite believe that I'm fortunate enough to still be here!

The fertility side of things is really untested water as it sounds like you're finding out, with Dasatanib being such a new drug.

I have a huge amount of faith and respect for my consultant in Bristol, Dr. Roger Evely, and his guidance continues to be invaluable. All his reading and research indicated that Dasatanib should have little or no effect on sperm at a molecular level and therefore should not effect pregnancy, although there is some evidence that TKI's such as Das can effect fertility levels, making conception more difficult.

Our fertility specialist researched this too, and as I say in my initial posting he concluded that the risk would be no more than a micro fraction higner than with a regular conception, if at all. We were in fact pushing ahead with trying naturally and waiting for the start of IVF procedures when Bec got pregnant. She's now 5 months in and the baby seems to be fit and healthy.

Last time I had a check up with Dr. Evely he asked why we had made the decision to keep trying naturally. I told him our reasons based on the research and the risks for us vs. the risks for anyone, and it meant a huge amount to me that Dr. Evely admitted that he would made exactly the same decision had he been in our shoes.

I am sad to hear that you have been told you are not eligible for IVF on the NHS. I would be surprised if this was national policy and not just that of your local PCT, and you may benefit from talking to a charity like Macmillan to find out more about fertility in CML and the relevent treatment for couples in your position.

At the end of the day it really is a heart issue- it means the world to us to be having this baby, especially given what the last year has taught us about the fragility of life.

My advice, based on our experience so far, would be the same as Sandy Craine the founder of this site- to go for it and don't look back. Maybe give yourself a period of time- a year, 18 months- and see what happens. If it doesn't work for you then you can start looking for other options. Tom and you are still young- keep your fitness levels up and stay positive. Don't let the baby blues in too much as this becomes a vicous cycle when it comes to fertility...

All the best, and don't hesitate to post further. This is a great community and a fine sounding board for both celebration and frustration.

 

Best wishes-

Adam

Thank You...

Hi Adam,

Thank you so much for your response!

We are so pleased for the both of you and a huge congratulations! This is our first step of even researching into this option and its an absolute delight to read your happy news.

We do have a couple of questions and hope you dont mind sharing...

Are you on the Spirit 2 Trial? ... Just a concern that if we make this decision will it have any repercussions?

Have you had or been entiled to extra tests and check ups on the baby's progress and health?

It's amazing how this didn't even seem like an option a few days ago and frustrating at the same time as the only option we have been left with was for Tom to change his drugs once at a safe point in the future. For me this doesn't even seem like a viable option...I couldn't live with myself if anything was to happen!

The national policy for IVF on the NHS has a standard criteria of that of no previous children even from previous relationships. We have looked into appealing etc and do have a follow-up appointment in January, this is what has brought us to this point.

Thank you for the suggestion of contacting Macmillan, a starting point that we completely overlooked. :) We have also started researching specialists worldwide for further opinions aswell. I hope you don't mind me asking but what helped make your decision? It's just I can see this as a never-ending debate that ultimately is going to be down to what we believe and feel is right..I just wondered what helped you?

The journey so far has been overwhelming and you are so right about the fragility of life, with so much more  appreciation for the possibilities. 

Your advice and kind words have been a great help and we can't thank you enough.

All the best

Kerry

 

 

You're on the right track...

Hi Kerry,

Thanks for the supportive words. In response to your questions:

Are you on the Spirit 2 Trial? ... Just a concern that if we make this decision will it have any repercussions?

- I am on Spirit 2 trial, and it was kind of an issue but not really. My specialist was concerned that the legislation from the trial guys was pretty full on and draconian- basically they are covering their backs- so he approached them and they said that because it's such a new drug, they have to have a bottom line, and that is that people should not try to concieve. However, at the end of the day, accidents do happen and so I presume that this is how my consultant has pitched it to the trials folk. I'm pretty sure that their advice is just a recommendation, so I don't think there can be any repercussions if you get pregnant. Again, check with your specialist

Have you had or been entiled to extra tests and check ups on the baby's progress and health?

- not sure what we're entitled to... our fertility consultant did push for us to have an early scan- we had our 12 week scan and then they did one at around 18 weeks but they couldn't get all the info they needed, so we had another at 20 weeks. All was fine but the specialist wants to see us at 32 weeks to make sure. The midwife care we've had at our local health centre has been great, and they've taken my treatment into account and taken really good care of us.

I am with you on the uncertainty of switching medication if it is working with Tom- it's not worth the risk if he's healthy.

More and more research is being revealed that for a man on Dasatinib conceiving isn't a problem. If it is a woman with CML and on a TKI it's obviously different, as the embryo is inside her for 9 months and has a prolonged exposure to the drug.

I am again saddened by the national policy on IVF. Are you able to get some kind of testimony from your GP or Specialist, perhaps? We had to be very clear that we had been trying for over two years before I was diagnosed, and we were married, although I don't think that has any bearing. We had to wait as usual for our appointments- there was no fast tracking involved.

Concerning our decision, I don't know... it wasn't just that we wanted it- there were a lot of discussion that I guess everyone has- the nature of raising a child in the world at the moment, the selfish aspect of having children- we really believe that we're going to be great parents, that we're meant to be parents and that especially with me being ill it was important that we carry on as normal with starting our family. Anyone who takes the decision to 'pull the goalie' and go for babies is taking a risk, and there are no guarantees for anyone, and we live in an amazing country with an incredible health service, so I don't see that there is anything wrong with being educated about the risks and calculating what the chances are for you.

Like I said, the fact that my consultant said that he would of done the same thing meant the world to us, and I think ultimately it's a brave decision to take, not a foolhardy one.

I hope that you are getting the kind of support you deserve with these decisions. Have you been offered councilling by the NHS? I cannot recommend this enough- time out to sit down and talk things through with someone objective in the room.

If you need anything else please feel free to write. You're not alone, and the chances of a successful pregnancy are on your side- this site has many entries where CML families are producing healthy and happy offspring.

Wishing you three all the luck in the world-

 

Bec & Adam xx

.

.

Ask your doctor about the

Ask your doctor about the possibilities of conceiving a baby. I guess there is more hope that yuo would have a healthy child as it's not your wife who is on medicine. Have some dose of optimism.

- Miriam (<a href="hospitals123.com">hospitals</a>)"

I wish you the best

Hi Adam,

My son - only age 12 - was diagnosed at 10 and I did have concern about future fertility.  I think I may have posted the topic here, but I also asked the same question on some other blogs.

The response I received - as to Gleevec - is that it does not impact sperm.  As you probably already know, it's not inherited and the BCR/ABL gene should not pass in sperm. 

While there's not as much info on Dasatinib, there is quite a bit available.  Through my research on various issues that have come up, I've found that the lead researchers/scientists on the respective TKIs are very receptive and have responded - via email - to several of my inquiries.  You may want to locate a lead researcher on Dasatininb trials/studies.  They're usually continuing their work at a major university or hospital.

And as another person mentioned here, CML hematologic conferences are great to attend.  You can usually run your stats by the best of the best CML scientists - and get an honest assessment.

You may also want to contact the pharmaceutical company, Squibb, which manufactures Dasatinib.  I've found that Novartis has been very helpful in providing information on Gleevec.

Best wishes to you and your wife.  I had all my kids in my 30's - and I think my kids are better for it.

Take care.

Tracey  

Imatinib experiences

I've only got my experience on Imatinib, but they are similar to your situation...

Have read this forum since diagnosis (Nov 2007). Fertility issues were one of the things that were important to me and my wife at that time too.

I'm being treated at Hammersmith and consultants there indicated they were happy for us to try for children - I was on Imatinib 400mg. From my own reading, it implied that the exposure to the hydroxyurea which I took in the first few weeks had more potential to cause problems than the Imatinib. My consultant arranged for me to have an apppointment with the fertility doc at Hammersmith who indicated he knew of no problems with Imatinib where the father was taking it. He did say there was a risk fathering a child on any medication, and that as there was little/no data specifically on Imatinib, in his opinion this was unquantifiably small.

I understand there is little data on Dasatinib too, so you perhaps the same argument would be applied? Obviously if there was a recognised medical risk, then we wouldn't have taken the "chance" as it were and had to deal with it. We also didn't want to look back in years to come and wonder "what if". People are taking all sorts of medication and the interactions are not that well understood so doctors cannot say 100% it doesn't affect. I'm certainly not saying be all "gun-ho" about it, but you have to weigh-up all the (little) data and make your own choices.

What does your consultant say? Perhaps they could arrange you to chat with the fertility dept. at your hospital (or even at Hammersmith?) so you can gather more opinion/data?

We were lucky enough to have a healthy baby boy who is now 8 months old!

Am happy to chat more on our experiences if you want to drop you email address out. Best Wishes.

TKI's and sperm

Dear Adam.... go ahead:o))) 

ALL the CML expert clinicians that I have listened to over the years- and 3 high level ones at a conference just this last week stressed once again that they are very sure that imatinib (or any other TKI) has NO detrimental effect on sperm.

There are many younger CML men who have had children. If you would like to talk to one of them then let me know and I will put you in touch with him, I know he will be glad to advise by email. 

You are right, for women on TKI therapy it is a different proposition because the drugs can have an effect on the foetus in the first trimester. However there are also quite a few women who have managed their pregnancies with either Interferon or Leukopheresis- this is of course if their doctor feels the risk of progression is low.

Thanks for the words of encouragement regarding this Website. It certainly helps to know that people benefit from it.

In the same boat!

Hi Sandy,

I've posted a comment to Adam earlier today and from reading your comments wondered if you could also put us intouch with any men with CML who have had children (especially if they are on Dasatinib)?

You seem very positive about this possibility and it's encouraged us to look into this further!....

If you have any other thoughts or suggestions we are open to anything!

Massive Thanks

Kerry

Nilotinib

Hi Adam,

My husband is on nilotinib being treated at Hammersmith.  While he was on imatinib the advice was, "no baby issues, if you want one go for it" (OK, I admit I paraphrased that slightly!)

Now that he is on nilotinib the advice has changed.  We have been advised against natural conception, and rather to go the assisted fertility route, which includes a number of different options from basic IUI through to the more invasive IVF.

Sandy - it sounds like you've heard differently, and that natural conception while the bloke is taking nilotinib/dastinib is ok.  If so could you perhaps elaborate on where you got this information, as perhaps it's worth us getting a second opinion, or at least having another discussion with our consultant, and the opinion of other specialists would help facilitate this discussion.

Good luck to you and your parnter Adam, I hope you find an option that you are happy with.

Bhiru

Bhiru- male fertility and nilotinib

 

Dear Bhiru... as promised I asked for advice from one of the CML clinicians in EU and the reply is that the advice you have been given regarding nilotinib and its effect on sperm is a conservative (safe) one because of the lack of data regarding nilotinib... but when considering it all nilotinib should not be any different in effect from imatinib (which has no such warning for males) - as both have the same mechanism of action and neither drug is teratogenic -see link to wikipaedia

http://en.wikipedia.org/wiki/Teratology

  My understanding from this is as it was before.... these drugs are thought to be safe regarding sperm although with regard to nilotinib that is still unofficial for now. But as always you should discuss this with Jed's doctor before making any decision on likely risks etc.

Sandy ;o)

 

 

Bhiru

Hi Bhiru, yes I did hear differently but I will check that out as soon as I can and get back to you. I think it might be the fact that nilotinib does not have as much data supporting it as imatinib does so it is a cautionary thing. 

I will let you know as soon as I can.

Best.... Sandy