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nilotinib

Hi All

Hope your well. It has been agreed that i will be changing to Nilotinib on Monday the reason being is that I am having a slow response to imatinib, although my last pcr was better at 5% its still not good enough. I could do with a bit of advice in regards to times etc basically when do others take there nilotinib and does it fit in easy to everyday life. I keep thinking that maybe if i did 4am and 4pm that would suit me. Also is it only water that i can drink whilst fasting?

Thanks in advance

Naomii x

Hello Naomii,

I've been on tasigna (nilotinib) for ~18 months. I find 10AM/10PM works best for me; I recently was doing 4AM/4PM while on holiday and found it pretty frustrating. As a reminder, you have to wait 2 hours after eating before taking the meds and 1 hour after taking the meds before eating. With respect to the fasting, avoid anything with any significant calorific value, such as fruit juice, milk, cappucino etc. I sometimes have black tea (with the tiniest amount of sweetener to take the edge of it) as well as water.

the UK packaging is really handy for taking your tablets out and about with you; individually sealed blister packs. I take mine at work, (even in meetings) as it's really discrete.

The only time i find taking the tablets to be inconvenient is if i'm out late on a weekend evening. Just need to plan ahead and get into a routine.

Good luck!

Chris

For me, usually 6am or when I wake and 5-6pm after fasting during the afternoon.

On the pharmacists label it says I need to fast for 30 mins after taking Tasniga. I tend to have just tea or coffee (with milk) then and eat sometime later.

I dislike the over packaging personally. Every box with a booklet and 'chads' everywhere. The card back does have the benefit of being able to write the days of the week on, to assure me that I haven't missed a dose.

Jeff

Thank you Chris and Jeff, i still can't decide but i get them tomorrow so will have to be quick about the decision. Also do you have to stick to the same time every day or can it be changed for example if you go out for a meal etc x

Hi Naomi
Sorry this is just a quick reply, hope you are doing well. I take my tablets at 10am, logic is I am usually up about 7.30 with the children so if I have breakfast by 8am I take the tablet at 10am and then can eat again from 11am. Similarly in the evening I usually eat with the children early so if I have eaten by 8pm I take my tablet at 10pm then usually crash into bed! Rock and roll! It is a pain if I am out for an evening meal, my consultant says it should always be 12 hours apart but I have been a little creative and taken it at 11pm if we were eating late. (so I fasted from 9pm) I don't know if it is because I am on a trial but I have been told ONLY WATER during the fasting period of 3 hours. (2 hours before, 1hour after) they won't even let me have peppermint tea when it's cold!
It can be a pain, especially at social gathering when everyone is drinking and I am sipping water but then they are keeping me alive so I try not to get too upset. Plus it does stop me munching on the sofa in front of the telly of an evening!
Best of luck
Thinking of you
Emma x

The gap in between all comes down to how comfortable you feel changing the timings. I sincerely try to get mine close to 12 hours apart, but it's more often like 10AM and 11PM. As Em said, weekends/late evenings can mess things slightly. From another forum, the rule i use as guidance is (8/16) i.e. never closer together than 8 hours, never further apart than 16 hours. Quite frankly I seldom go outside 10/14.

Thinking about the reasons why the fast is imposed, I strongly suggest you stick to only water until you've had a couple of EKGs to confirm you have no heart issues on the meds. You can then decide if you wish to take the risk with not sticking to the water only fast.

These are merely my personal preferences and it's all about your personal choice and level of comfort deviating from the correct guidance.

Chris

Thanks everyone for the advice, i have decided that 7am and 7pm is what i am going to try. I have taken the first dose tonight so far so good. I didn't have an ECG though, i did explain that i have palpitations at night prior to going to sleep but they did not seem concerned. I got my PCR result today and its just under 5% for some reason i could not get past 5% on imatinib which is why i changed. fingers crossed i will do well on the nilotinib and i will finally get to zero without any problems.

Thanks again all much appreciated as always xx

Nigel

Hi my name is paul i was told i had cml in august last year.I started on glivec but in last two weeks i started on nilotinib ,i was told that i was not responding to treatment as fast as they would like on the glivec. I had three lots of bone marrow tested but do not understand the results .I was told my count is at 50% what dose this mean ?
This is my first time on this site and have read many things regarding cml , Ido feel that i am no responding as well as a lot of other i have read about.i have just found out that my consultant is now leaving and that i have to see atemp .I DO FEEL THAT THE LAST TEN MONTHS HAVE BEEN A WASTE OF TIME.
PAUL

Paul,

Welcome to the group. It seems like you're very frustrated and maybe a touch angry? I get the impression you're having difficulty understanding all the information being thrown at you, and there certainly is a lot. There a several excellent links on this website; however, one of my favorites for understanding the basics (which will help you put your bone marrow biopsy results in context) is here: http://www.us.tasigna.com/patient/cml-overview.jsp - now you have to lie a little and confirm you are a US resident, but it's one of the most helpful sites i've found.

One of the most important things to track with CML is your % BCR-ABL. This is what the 50% relates to. Glivec and nilotinib work to inhibit the production of BCR-ABL, so over time you should see this value go down. ask your new temporary doctor or oncology/hematology nurse to help you track the history of this so you can put dates on the values. you also probably had PCR tests done - taken from blood samples, these also look at your BCR-ABL %.

as for changing doctors, this is annoying and i went through a similar thing this year. Try not to worry about it too much though. the important thing is you take the time to read as much about the disease as possible - the better informed you are, the better discussions you will have with your doctor. I wouldn't say the last 10 months have been a waste of time. The drugs available have a high success rate and this is a serious disease. There are people on imatinib/glivec who are still alive after 13 years! It is important that you do not compare yourself with others too much as you can become fixated and think you're not making progress - I have been there (still am some days). It is important to make sure you are responding to treatment and your BCR-ABL percentage is coming down. If you are behind the progress curve, as you've inferred, then your doctor moving you onto Nilotinib is probably a very good step.

If you do have questions, then open up a thread on this forum - approx 2 people a day in the UK get diagnosed with CML; asking questions to help your understanding will likely help you and someone else.

Best wishes

Chris

Hi Paul,

I can understand your frustration and disappointment. It is hard to deal with a diagnosis of CML in the first place and made even harder when you are not responding fast enough to therapy.

To answer your question about you test result: 50% positive for PH+ cells. At diagnosis you would be deemed 100% positive for PH+ cells (the abnormal white cell that is the marker for CML). This does not mean that ALL your white cells are PH+ - although it would seem to imply that- but it does mean that a very large majority of white cells are CML cells and the disease will eventually progress.

Imatinib (Glivec) is the 1st generation of the drugs that now save over 90% of chronic phase CML patients lives, but it is not effective enough in a large minority. That is why nilotinib and dasatinib were developed, to try to overcome the lack of efficacy imatinib has for this group of people. It looks like your results show a fairly slow response as you are still 50% positive for the abnormal (PH0 + cells. At this point -10 months- your doctors would prefer to see the population of PH+cells at a much lower level than that. ... preferably on the way to molecular levels....i.e 1.5% and dropping. It might be that you are just a slow responder, but given that 2nd generation drugs do exist and have a better profile than imatinib for some people, it is best that you try to get your PH cell population down much more quickly-
Nilotinib might well put you where you should be by 12 months- i.e showing a complete cytogenetic response-(CCyR) with PH cells at 1.5% on the International Scale (IS) or even lower.

Good luck and please update here as you go along with your new therapy, we are here to help in any way we can.
I am sorry you are losing your doctor- this is hard when you have built a good relationship with a particular doctor and many people (including me) have had to cope with some wonderful doctors moving on. However, there are many expert CML doctors working in the UK, and I am sure you will feel OK about it all as soon as your response improves.

I thought you (and maybe others) might like to read an excerpt from a recent article by Dr. Raditch on CML disease management and monitoring. The following few paragraphs might help explain in some way why your doctor has decided to change your therapy at this point.
I do urge you not to think of the last 10 months from your diagnosis as a waste of time. CML is as complex a disease as any- it is serious and life threatening if not treated correctly.
It seems to me that your doctor - and the team at whichever centre you are being treated at- is being pro-active in trying to get you the most optimal response at the right time according to present guidelines. This will go a long way to ensuring you respond to therapy in the long term, and give you the very best chance of achieving the best possible response.
There is no doubt that 2nd generation TKIs like nilotinib and dasatinib are more potent than imatinib and represent a move forward.

I hope this is helpful

Sandy

'There are several key principles that guide the management of patients with CML. The first is understanding how to follow the patient and how to measure outcomes. Today, it is still necessary to obtain a bone marrow aspirate at the beginning of treatment, because this is the only way to accurately assess whether the patient has the Ph translocation—t(9;22)(q34;q11). More importantly, a bone marrow aspirate is needed to diagnose whether the patient has abnormalities that constitute the evolution to accelerated phase or blast crisis.
The first important measure of outcome, a key milestone of therapy response, is complete hematologic remission, that is, normalization of the WBC count. The second important milestone is cytogenetic response, as assessed by analyzing the chromosomes of at least 20 metaphases. Cytogenetic responses can vary from no response (> 95% Ph-positive metaphases), minor response (36% to 95% Ph-positive metaphases), partial response (1% to 35% Ph-positive metaphases), and the gold standard of complete cytogenetic response (0% Ph-positive metaphases). A complete cytogenetic response represents approximately a 1.0-2.0 log (10- to 100-fold) reduction in disease burden.
The next, more sensitive, measure beyond cytogenetic response is molecular response by peripheral blood PCR assay, where the key milestone is MMR, defined as at least a 3 log reduction in disease burden or a ratio of < 0.1% on the International Scale. Ideally, the patient will experience a 5-6 log reduction in disease burden.

Hi Sandy
just had second visit whith temp consultant.Still have trouble understanding her lingo.She sais that i am doing fine from my blood count, but i thought the only way that the can tell what is actually occuring is from my bone marrow results, which i am still waitin for after 9 weeks.
4 weeks in to nilotinib now and i have had no side efects at all ? is this a good sign or is that the medication is not working as it shud. Is there any link to CML with chest pain and a constant swishing sound in my head. If there was this now has totaly disapeared.
Please can you advise me on how i can get hold of any charity forms, sponsore ship forms or do you have a collection box with the proper charity on it as i wish to take part in a kilamanjaro climb and would like any money raised go to the CML charity.
Regards
Paul

Hi Paul,

I think your lack of side effects might be because they are generally not the same on the different TKIs. So you will see the main side effects from imatinib disappear on nilotinib. You might get different ones but hopefully not too serious.

I would say that the swishing feeling in your head might well have been due to CML- and/or low haemaglobin (hgb)- anything under 10 seems to affect most people in one way or another.

Chest pain could be due to anxiety/indigestion- or something more serious- but I am sure your doctors would be on to that if you told them that you had this.

From what you say, I think as you have only been on nilotinib for 4 weeks so it would make sense that they are only looking at the bloods rather than the marrow results? Presumably if you have been waiting 9 weeks for the results of cytogenetics this would be from a sample taken when you were still on imatinib?
If I were in your situation I would want to see results from samples after starting nilotinib, and it might be that you will have to wait a little longer for that.

Regarding looking at marrow or blood: it depends on how low your PH+ cell count is if it is above 2% then FISH test would look at 200-500 cells from you peripheral blood sample,..../or/.....cytogenetics would test a marrow sample.
Or if you are in CCyR (complete cytogenetic response) - ie less than 1.5% PH+cells, then a molecular test (PCR) taken from a blood sample would show the level of bcr/abl (the abnormal fusion protein that is the molecular marker for PH positivity -and therefore CML)-

As you go on with nilotninb therapy then your doctors will be looking for a reduction in % of bcr/abl- they will do this by using the PCR technique taken from a peripheral blood sample. I am not sure where you are being treated but most PCR testing is done at expert labs- if you are at a general hospital then they would probably send your sample to the nearest expert centre. Usually it take around 4 weeks to get the result.

You might want to ask your doctor when you can expects to see a significant test result, either from PCR or FISH, that would indicate how your are responding to nilotinib.
If she says your blood count is 'fine' then ask for a print out (most of us do this) so that you can take a look yourself- and ask her to explain it.

In summary:

If your peripheral bloods are OK - and I assume she is saying that they are within normal range- then you would need to ask her for your PH+ cell level ... or if that is below 15% the ask for the bcr/abl % by PCR test....and ask which lab is doing your test.

I am sure you are being monitored well -that is why they have acted to change you to another more effective therapy- but you sound like you need to take yourself to another level of understanding how CML behaves- and how you are responding to therapy. To do this you need to know more detail as outlined above.

Regarding fundraising. We have recently added a 'JustGiving' account that can be used to raise funds. You need to set up a page on the Just Giving site.. see links to pages that other members have set up for their personal fundraising ventures. Click on link (in red) at top of this forum.

To set up a page for yourself just click on JustGiving button on the home page and register- its pretty straight forward and I am sure others who have already done this will advise you.

Thanks for offering to raise funds for us. Our charity number is on the top right hand of the site (Registered Charity 1114037)..... you can find our details on the Charity Commission website by a search using this number.

Hope all this helps...
Sandy