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Tasigna and the fasting the period

Does any one know the actual reason for the fasting of 1hr before and 2hrs after food?
Has anyone not strictly followed it and has progress been good to remission or made it slower.
Has anyone been told that non compliance for example fasting,smoking and or alcohol affected progression, slowed up the process to 2nd stage remission?

Hi - it's exceptionally important to fast appropriately when taking Tasigna / nilotinib.

The reason is that if you eat with Tasigna it's bioavailability is increased. That means your body is exposed to more of it than it should be. It can increase existing side effects, or bring on new ones. Given Tasigna has side effects which include cardiac issues this is really not something to be taken lightly.

If you find that the schedule for Tasigna is not compatible with your life, speak to your doctor. No other TKI has this particular restriction. 

I have not heard that smoking is an issue, other than the fact that there may be a co-morbidity with smoking and Tasigna (since it can cause or increase heart problems). From my understanding it's primarily food, perhaps with more limited studying of alcohol. The recommendation is that water is the only thing you take on the fasting schedule with Tasigna is water and I would really stick to that. As I said, if that is a problem for you you really must speak to your doctor with consideration to switching to a TKI which you can adhere to.

David.

Regarding nilotinib and fasting: as David has already advised, it is very important and necessary to follow the instructions for the correct times when you should fast when taking this drug (other TKIs do not have such food/drink fasting requirements). The issue is that food and drinks, other than water, must not be mixed with the active componant of nilotinib for the reasons that David has already outlined.

If you cannot adhere to the correct administration then you really are risking an increase in serious side effects and possibly more importantly a lack of control of your BCR-ABL levels. This could mean that over time your disease could become more difficult to treat. It is really not worth the risk. As there are other equally effective TKIs that may suit your lifestyle a little better - although they also require strict daily adherence if they are to be effective in the longer term- it may be best to discuss the possibility of changing therapy with your doctor.

For CML, adherence to TKI therapy is the single most important issue surrounding sub-optimal responses over the long term.

Sandy 

During the fasting periods, the official guidance on the Tasigna leaflet is: 

"Tasigna should be taken twice daily at approximately 12-hour intervals and must be taken on an empty stomach. No food should be consumed for at least 2 hours before the dose is taken and for at least 1 hour after the dose is taken."

You'll notice that just says food, and does not make any mention of drinks. However, the guidance usually given is still water only.

However, the leaflet also goes on to say:

"Overdose with nilotinib has been reported, where an unspecified number of Tasigna capsules were ingested in combination with alcohol and other drugs. Events included neutropenia, vomiting, and drowsiness. In the event of overdose, the patient should be observed and appropriate supportive treatment given."

I don't think there's an issue with drinking alcohol in moderation whilst on nilotinib treatment, but the guidance would seem to be fairly strict with water-only during the fasting periods. 

David.

I was diagnosed in March 2016 and have had a great response to Nilotinib.  My BCR-ABL is "virtually undetectible" and my molecular response is 4.5.  Honestly, I think I have ignored my second fast period (4-7pm) about 12 times since then.  Maily because of holidays, weddings and afternoon type celebrations that I wanted to join in with.  I know I shouldn't and I am normally extremely regimented - but I sometimes think "I want to join in!".  If I saw any ill effects from it - then I would stop - but while I am healthy, I don't feel the odd slip hurts.  I have confessed to my consultant.  He gave me a *look*. 

Take your tablets correctly and follow the regime strictly as much as you possibly can.  But if you slip once in a while, don't beat yourself up - you have to live too!

 

Good luck.

The NIFO Study:  Paper 118149 abstract 235915 0

At this year’s ASH 2018 congress, a poster on the “NIFO Study” (NIlotinib with FOod), conducted by the academic Amsterdam Medical Center, was published.  https://www.cmladvocates.net/3-news/newsflash/871-ashfoodeffects

 

I was wondering if any of you taking nilotinib at low dose had considered taking it with food (not grapefruit crying) after reading this study. enlightened

I have been on Tasigna 150 mg/1x/day (25% of starting dose) for 18 months now and I have never once considered violating the fast period.  I must admit that 1 fast period per day is easier than 2, but Tasigna beat me up so badly at higher doses, I don't want to take the chance despite what this study says.  In addition, I have been >MR4.5 for nearly 2 years now, so if it ain't broke don't fix it.