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#1 Badger

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Posted 25 April 2012 - 11:27 AM

I've been on Sprycel for about nine miserable months.  After feeling like total crap for a long time (mostly due to fluid on my lungs and stomach issues), my onc is having me stop the Sprycel for a couple weeks to see if the way I feel improves.  I've been off for two days and feel a thousand times better.  Anyway, I'm guessing that a switch to Tasigna will be upcoming.  So, how the heck do you take this stuff?  I see people talking about fasting, and I know you're not supposed to take it with food.  I don't eat breakfast, but have a full glass of cranberry juice in the morning.  Does this qualify as "food" or could I take Tasigna with this?  Also, what do you suggest as a starting dose?



#2 triciad

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Posted 25 April 2012 - 12:24 PM

Hi Badger-

I started Tasigna 3 1/2 years ago after experiencing the same issues you had on Sprycel. I drink whatever I want during my "fasting" times...to include wine and I've experienced no issues.  I am taking two 200mg in the morning and two at night (800mg total).  I take two when I wake up (6:30) and then wait an hour before I eat.  The evenings are a little bit more of a challenge but I now have a routine.  I usually eat dinner around 5:30 or 6 and then take my dose at 7:30 or 8.  I can snack an hour later.  Traveling or evenings out sometimes changes my evening dose time.  It is important to fast because I've had times where I ate too close to taking my dose and experienced a racing heart and was jittery for a while. In my case, Tasigna has been the best as far as side effects (Gleevec 1 year and Sprycel 2 1/2) and the fasting has not been an inconvenience like I thought it would before starting. Good luck to you!

Tricia



#3 Trey

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Posted 25 April 2012 - 05:15 PM

Standard Tasigna dosage is 300mg twice per day.

The issue with eating and Tasigna is not about direct food/drug interactions as such.  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 does.  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 mainly relates to those who had an elongated 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



#4 acb

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Posted 25 April 2012 - 08:35 PM

Just wondering ... Sprycel also has the warning/issue about QT prolongation. Why does it not require fasting? Are the lawyers at BMS just not as smart as those at Novartis ?  Also, what is the reasoning behind a split dose for Tasignia and a single dose for Sprycel? (I am sure this has been explained before, I just can't remember.)

Thanks!



#5 Trey

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Posted 26 April 2012 - 09:15 AM

Sprycel has the same QT issue, but Tasigna had what looks like some bad luck during its clinical trials, so they were required by the FDA to post the warning.  But a couple years of experience has not shown any significant QT issues for either drug.  The fasting seems to me to be an attempt to look like something is being done to limit the chances that a patient will eat some food that will keep Tasigna in the body longer, which effectively increases the dosage.  But normal dosage used to be 400mg twice per day, and now is 300mg twice per day, so the fasting does not make sense to me at the lower dosage.  But drinking a soda or eating crackers certainly do not affect Tasigna clearance from the body.  As I said, if it were me and with no history of QT issues, I would likely ignore the fasting issue entirely, or at a minimum eat some crackers or other light snack with the Tasigna.

The split dosage is another attempt to limit a spike in body drug dosage and therefore exert some control over the QT issue.  Although this makes more sense than the fasting, Tasigna has a half life in the body of about 17 hours.  The approximate half-life of Sprycel is 5 hours, and Gleevec is 18 hours.  So the dosage is somewhat evened out by splitting.  Sprycel starting dosage used to be 70mg twice per day, but then went to 100mg once per day.  That reduced dosage eliminated the split dosage issue for QT reasons, if that was ever the rationale for BMS recommending it in the first place.  Anyway, split dosage is a good idea to reduce side effects.  I did it with Gleevec almost from the beginning.



#6 triciad

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Posted 26 April 2012 - 12:37 PM

Quote from Trey: "I would likely ignore the fasting issue entirely, or at a minimum eat some crackers or other light snack with the Tasigna."

Trey,

It has been established in many posts that you are obviously the expert in all things CML and I'm typically a lurker on these blogs offering minimal feedback, however; I respectfully disagree with your recommendation of ignoring the fasting issue entirely.  I have taken Tasigna faithfully for 3 1/2 years and have definitely experienced a racing heart and jitters when I have taken my dose too close to the time I have eaten.  I realize it doesn't mean I'm having a heart attack or will experience the QT issue but it is something Tasigna users should at least be cautious about and test the waters.  You did recommend a light snack or crackers and that may be the way to go but I wouldn't recommend ignoring their recommendation altogether.  Just my two cents.

Tricia






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