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Tasigna rules


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#1 djm

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Posted 08 August 2012 - 07:06 AM

I have been switched to Tasigna from Gleevec.  And I have a question regarding the whole 'no eating 2 hours before and 1 hour after' rule.

Does that also include drinks as well?  Can I have coffee with cream and sugar?  What about a Propel Zero Water?

Thanks.

DJ



#2 Trey

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Posted 08 August 2012 - 09:32 AM

Water is not an issue, although grapefruit juice would be on the list of drinks to avoid.  The issue with eating and Tasigna is not so much about direct food/drug interactions.  It is a response from Novartis (lawyers?) to the heart QT elongation issue since there is a possibility that some foods can cause the drug to stay in the bloodstream longer, as grapefruit apparently can.  So theoretically, a 300mg dose could act more like roughly 350mg (just guessing on the increase -- no one knows for sure) when consumed with some foods.  But in a study of 846 patients taking Tasigna the QT interval issue was monitored.  The study concludes that:

"No  patients in the study had prolongation of QT interval  >500  milliseconds.  No sudden deaths occurred in any of the  treatment arms"

http://multivu.prnew...novartis/44499/

Novartis says:  "You may lower your chances for having QT prolongation with TASIGNA if you take TASIGNA on an empty stomach."

The heart QT cycle issue most directly relates to those who had an elongated heart QT cycle before starting Tasigna.  If a person has a normal QT cycle while taking Tasigna, one could ask whether the 2 hour eating restriction was really necessary.  I am no one to question the Novartis statement, but if it were me, and my QT was normal while taking Tasigna, I doubt I personally would be so worried about the 2 hour warning.  But get permission from your doc if you want to ignore the eating restriction.  Note that this Novartis statement is fairly wimpy and does not sound like a dire warning, just an "oh by the way" kind of statement.  But they put it in their dosing instructions for everyone to account for a 2% issue.  Not trying to tell people what to do, just trying to put the 2 hour eating restriction issue into perspective.

Here is the complete Novartis info sheet for Tasigna:

http://www.us.tasign...376875332121825



#3 Lori's okay

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Posted 08 August 2012 - 10:42 AM

DJ

Though I would never, ever, under any circumstances argue with Trey....

Several places on the internet I have read that the increase of the bio-availability of Tasigna if taken with food is 82%....this refers to AUC meaning area under curve.  That refers to a graph of blood level of the medicine versus time, so as the blood level gradually falls after taking the meds one sees a gradually decreasing curve, the area under the curve is what is available.  These articles also mention that taking with fatty foods had a greater impact.  If you want to search for these references use nilotinib rather than Tasigna as your search term.

For me, I'm quite careful with the eating schedule, especially any foods with fat.  Early on I seemed to have worse side effects if I took it too close to the time I ate.

http://www.us.tasign...376911797215187

Here is the link to an abstract (I'm not willing to pay for access to the full article) that reports on a study testing for a way for folks who cannot swallow the capsules to take the meds by mixing it in food.  (I take mine in 1 teaspoon of applesauce as I have difficulty swallowing the capsules.)  The thing about this that is interesting is that even with one teaspoon of yogurt there was a small increase in the bio-availability.  Link to abstract here:

http://jcp.sagepub.c...1/1580.abstract

Very best of luck to you!

Lori

(PS on a lighter note:  I just clicked on the word nilotinib to see if it was in spell check.....the only suggested spelling was guillotine.....so much for the gallows humor on this forum!!)


DX 09-2011 PCR 8.08 not IS WBC 17 , Began Tasigna 600mg  

in 2012 Tasigna 450mg/day ,in 2013-2017 Tasigna 300mg/day

DATE/PCR

09-11/ 8.08 not IS

03-12/ 0.054 not IS

06-12/ 0.035 not IS

09-12/ PCRU, 01-13/ PCRU

4-13/ 0.042 IS

7-13/ 0.014 IS

11-13/ PCRU, 04-14/ PCRU

8-14/ 0.006 IS

PCRU: 12-14/ 05-15/ 10-15/ 02-16/ 

09-16/ 02-17/ 09-17/ 

10-17 tapered off 

11-3-17 Stopped Tasigna

1-15-18 still PCRU

 


#4 djm

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Posted 08 August 2012 - 10:58 AM

Thanks Trey and Lori for your response.  I don't have a problem not eating food according to the guidelines that Novartis has set out.  And for the most part, I understand why.

I was mainly asking about being able to have a cup of coffee or two with cream and sugar (I haven't been able to go black, at least not yet ) during that time frame where I can't eat. Does the whole no eating notion, apply to having coffee, or propel zero grape flavored water, or a coca-cola?

I mean the guidelines say no eating...it doesn't say no eating or drinking.  Maybe I'm just being paranoid...



#5 triciad

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Posted 08 August 2012 - 12:27 PM

Hi DJ -

I have been taking 800mg Tasigna for almost 4 years and I drink wine, coffee (with lots of cream), orange juice, tea, etc in the 3 hour window with absolutely no reaction or interaction. I've actually used all of those drinks to take my dose (even wine ). However, I've had a few issues with eating too close to my dosing schedule in the past so I'm faithful about waiting. I'm sure certain foods can have more of an affect as Lori indicates and I've also tested cutting the time a little especially on the hour wait.  I have eaten within 1/2 hour or 45 mins and experienced no issues.  Everyone is different and it may take some time to test the waters.

Best wishes to you on switching to Tasigna.  I took Gleevec and Sprycel previously and Tasigna has been the best by far (side effects) although I am only at .04% PCR.  After 7 years, it frustrates me that I cannot get to the lowest levels like I see many others but I am at least steady right now.

Take care,

Tricia



#6 Trey

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Posted 08 August 2012 - 03:14 PM

True enough that if someone eats a McMega Cheeseburger with supersized fries, that would have more impact than eating a couple crackers or something so the stomach is not entirely empty.  So your point is valid that eating a full, high fat meal with Tasigna is not a good idea.  The main issue on DJ's mind as I see it is that most people, including me, just don't want to take any pill of any type on an empty stomach. 

Novartis says that Tasigna bioavailability is roughly 30%.  Taken with food they say: "Administration of Tasigna 30 minutes or 2 hours after food increased bioavailability of nilotinib by 29% or 15%."  So the 82% you cited is not bioavailability, but rather a total Area Under the Curve number which is not representative of  bioavailability.

https://docs.google....m1ydxp5ww&pli=1

Anyway, most patients are not taking max dosage, and also do not have a QT prolongation issue, so the eating restriction issue must be put into the context of the individual patient.  But the FDA warning for the 1% - 2% people to which it applies was placed on all who take Tasigna.  Just to follow this point, I find it ironic that we are told to avoid grapefruit juice but not McMega Burgers with fries.  Also, for some reason the CML patients in that one study cited did not react to the high fat meal as much as those without CML who took it for the study.  Certainly the conservative approach is to follow the eating restrictions, but in my own case I would modify them to eat something (crackers, etc) with the Tasigna if not on max dose and since I do not have a heart QT prolongation issue. 



#7 soundoff

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Posted 08 August 2012 - 04:29 PM

Hi djm,

I have been on Tasigna for 2 years and I will only take Tasigna
with water. I have heard of people taking it with apple sauce. When I eat or
drink other things in the 3 hour window I can feel the effects. My suggestion
is to only take water in the 3 hour window. You can experiment if you like but
just don't get too close to the actual time that you take the Tasigna. Best of
luck...

Soundoff



#8 WoofWoof

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Posted 08 August 2012 - 05:57 PM

Hi Soundoff- I'm also on Tasigna but cheat all the time on the food thingy. What effects are you feeling when eating during the 3 hour interval?


I have cancer but it doesn't have me


#9 hannibellemo

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Posted 08 August 2012 - 07:46 PM

Yeah, I'm with Woof, inquiring minds want to know. A couple of you have mentioned feeling effects - what are they, please?

Pat


Pat

 

"You can't change the direction of the wind but you can adjust your sails."

DX 12/08; Gleevec 400mg; liver toxicity; Sprycel 100mg.; CCyR 4/10; MMR 8/10; Pleural Effusion 2/12; Sprycel 50mg. Maintaining MMR; 2/15 PCRU; 8/16 drifting in and out of undetected like a wave meeting the shore. Retired 12/23/2016! 18 months of PCRU, most recent at Mayo on 7/25/17 was negative at their new sensitivity reporting of 0.003.<p>


#10 Ray99

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Posted 08 August 2012 - 08:50 PM

I am on Tasigna 300mg 2x a day.  I have been following the food restriction religiously, except I did drink coffee sometime with the pills.  My onc said that food will reduce the effectiveness of the drug (poor absorption presumably), otherwise no harm.



#11 Lori's okay

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Posted 13 August 2012 - 08:25 AM

HI Pat and Woof,

You asked about effects if eating in the no-food window, not sure if you were asking a specific person, but here's my two cents.

Especially early on, if I took the Tasigna too soon after eating,  I had all the side effects just magnified.  The one that scared me was a pounding pulse that continued for a couple of hours.  Also had bone aches magnified, flushed red skin,  and just felt bad all over.  I'm really careful now, so don't have this unless I've had to be off the meds a while and am coming back to it.

Doing generally well now.  Just hope it is still working, am on 450mg a day.

Lori


DX 09-2011 PCR 8.08 not IS WBC 17 , Began Tasigna 600mg  

in 2012 Tasigna 450mg/day ,in 2013-2017 Tasigna 300mg/day

DATE/PCR

09-11/ 8.08 not IS

03-12/ 0.054 not IS

06-12/ 0.035 not IS

09-12/ PCRU, 01-13/ PCRU

4-13/ 0.042 IS

7-13/ 0.014 IS

11-13/ PCRU, 04-14/ PCRU

8-14/ 0.006 IS

PCRU: 12-14/ 05-15/ 10-15/ 02-16/ 

09-16/ 02-17/ 09-17/ 

10-17 tapered off 

11-3-17 Stopped Tasigna

1-15-18 still PCRU

 


#12 chriskuo

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Posted 13 August 2012 - 05:07 PM

I've found that following the Tasigna guidelines really helps with losing and keeping weight off.






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