37 replies to this topic

[Trey]

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 400mg dose could act more like roughly 450mg (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

[reedgirl]

Trey,

  One of the questions Greg's dr asked when his liver counts were high was if he had been taking his med's on an empty stomach.  They also asked about it for his side effects too.  Kind of made it sound like if he weren't taking it on an empty stomach that would contribute to the high liver counts and the more severe side effects.  Although, considering he has only taken it on an empty stomach and still has those issues, guess it doesn't really matter

Thanks for the insight, makes a person wonder if it is necessary to be so time conscious!

Audrey

[AliceJane]

Thanks Trey, from reading your reply I know this is not a stomach issue.  And I know I will show my ignorance by next questions;

What is a QT cycle and what is QT elongation?

I know this has to do with the heart.

And speaking of hearts, one thing I have learned from reading here is you are heart of this board.  So thank you for all you do.

alice

[Marnie]

HI, AliceJane. . .

If you just google "QT Elongation" you can get pretty good descriptions and a picture of the portion of the heart beat cycle that is the QT interval.  When you get your EKG, the numbers are all listed on the page.  Be sure that you look at the corrected QT interval (QTc).  My QT interval was WAY higher than the high risk number, which freaked me out at first.  Then I did a little research online and got a better feel for what everything means, and realized that my QTc was within normal range.

Marnie

[cometbro]

I've been taking Tasigna on a 16/8 hour interval (7 a.m., 11 p.m.) since i've started 2 months ago and i'm doing fine so far.  This was because I told my doctor

that I will probably have trouble taking it at 7 a.m., then 7 p.m. (because i'll probably be having dinner or doing something else at this time).  I asked him if I can take it when I normally wake up (7 a.m.) and when I normally am preparing to sleep (11 p.m.).  He said it is fine.

I've noticed that a lot of people seem to want to take this strictly on the 12 hour interval, and since I was concerned for long term use of my current interval, I decided to get a second opinion and email Dr. Druker about this.  I actually had 2 questions for him.

His reponse on my 16/8 hour interval question was this:

"The half-life of Tasigna is long enough that 16/8 hour interval should be fine."

My second question to him was about the use of alcohol and Tasigna.  My concern was that alcohol consumption would be worse for people on Tasigna, as opposed to Gleevec and Sprycel because of the way the liver breaks down Tasigna.  His response was:

"An occasional drink is fine as long as your liver enzymes are normal."

So there you have it...what ever "half-life" means, it is what allows of a not-too-strict time interval.  I understand about playing it safe, since that is what Novartis put on their labeling, and it is always in the back of my mind, but so far, week by week, i've been progressing as I should.

[WoofWoof]

I have been on Tasigna for 15 months. Take the morning dosage when I first wake up 0600 or so, but will also take it earlier if a nature call (dog or cat pestering me). Evening is about 4:00PMish. Yes I have eaten food within the 3 hour blackout. But blood counts are doing well & EKGs are terrific.

[cometbro]

Hey Woof, so it seems you are on a 10/14 hr interval for the most part.  Not as extreme as my 8/16 interval but it's good to see that you've been doing it for 15 months and you are doing well.  Just curious about the side effects in that time span, have you had any or I should say, anything out of the ordinary (itchyness, dryness)?

[jwbwater]

@mike43147:

Happy to see that you had such a good response to tasigna.  I just switched from gleevec three weeks ago after a BMB showed progression to AP.  I saw from your previous posts that you have the F317L mutation, my mutation test detected no mutations which sounded good at the time, but maybe a mutation that has resistance to gleevec,  but not tasigna would have been a better result.   I have some additional chromosomal mutations that I should probably read about, but I'm trying to strike that balance between being informed and staying positive.  Well here's hoping for a response like yours anyway  

I'm in that limbo period right now after starting a new drug, but not knowing if it's working.  Exciting times!

Anyway, glad to hear you are doing so well on tasigna.

Happy New Year.

[WoofWoof]

Cometbro- As I have posted before, I have plagued with rashes. Mostly under control with lotions & Prednisose but still bothersome. Some shortness of breath but can walk 18 holes of golf (about 6 miles).

Best of luck to you.

[cometbro]

Woof, good to hear its under control for the most part.  I hope that soon they develop something more targeted so we don't have to deal with any side effects, or at least very minor, were it's unnoticeable.  I would be afraid of switching medicines though..you never feel comfortable changing something that is working.  I guess that is why so many people are still on Gleevec, even though it is supposedly "less targeted".

[jlcoombes72]

Hi all,

I've just been switched from sprycel to Tasigna and am very confused re the doseage - 300 vs 400 mg. twice a day. My oncologist isn't familiar with this drug so it's up to me and the latest literature to get the information. any help out there?

Thanks.

Judy

[reedgirl]

Judy,

  Why were you switched from Sprycel to Tasigna?  My husband started with 300mg once a day then bumped up to 300mg twice a day.

Good luck to you on the new med's

Audrey

[cpsn0000]

Audrey,

How is your husband doing with blood counts, especially for his liver, wbc, iron, and platlett counts? I am going for my visit on Friday where I am scheduled to go to my regular dose of 300mg 2x a day from the 300mg per day to get my body used to the drug. So far, had no side effects and hope this continues with the increased dose.

Thanks,

G-Men

[CallMeLucky]

Hi Judy - your statement about your Dr. not knowing about the drug and it  being "up to you" to figure out the right treatment/dosage is very  concerning.  From what I know of your history, you were dx about 6 mo ago, took Gleevec but had to stop due to side effects, then switched to Sprycel and again stopped due to side effects.  It would be good to know where you are with testing.  I am assuming you are in chronic phase.  Did you acheive any response form the drugs you were on?  Have your blood counts returned to normal?  Do you know what your FISH and PCR results are?

Latest NCCN guidlines appear to show 300 mg Tasigna twice a day for newly diagnosed, first line treatment.  If you are switching to Tasigna from another drug due to poor response, then it looks like they call for 400 mg twice a day.  I'm not sure what that means for you.  If you were responding well but couldn't handle side effects then a CML specialist might put you at 300 mg twice a day, or they might even ease you into it and start at once a day and then bump up soon after.  On other hand if you have not had good response, they might want to get you with 400 mg to get things under control.

My suggestion is to get a consultation with an hematologist/oncologist who specializes in CML.  Your sensistivity to the drugs seems to show you are not a typical case, not to say that you won't do well, but you are having trouble finding a drug/dosage that works for you and doesn't cause bad side effects.  You need a doctor who is well versed in this area and can guide you appropriately.  It should not be left to you to figure this out on your own.

If you cannot get a consultation with a specialist then you may want to at least email someone like Dr Druker to get his input.  At the very least you should download a copy of the latest NCCN guidelines (you have to sign up but it is free) read them, and bring them with you to your doctor to discuss.

http://www.nccn.org/index.asp

Best of luck, I hope you find the right treatment that allows you to start feeling better soon.

[Trey]

Show your Onc this:

Recent data about Tasigna dosages shows that 300mg twice per day is  just as effective as 400mg twice per day:

http://www.caring4ca...ewsItemId=45184

Here is more info:

http://community.lls...age/34465#34465

[missymel]

Hi everyone,

Glad to see some familar names on here.

I have been on Tasigna since Feb 2008. I was dx in June 2006. Been thru both Gleevac and Sprycel

Did AMN107 trail in 2007. So glad that people are continuing to respond well to Tasigna. Yeah!!

I also am doing well on it and have had no side effects to date. I am also on 400mg bid. Interesting article

with the 300mg choice. I will have to talk to Onc about it. My pack comes in bubble pkg of 2(200mg capsules).

Trey so happy to see you are still helping so many people, hope you are well. Love to all.

Mel Clarke

missymel218@gmail.com or on facebook Melissa Woodall-Clarke

[reedgirl]

G-Men,

  His WBC, RBC, Platelets, etc have all been good, just slightly under normal, but good.  His bilibrubin elevated within four days after starting at half dosage.  His alt, ast has also been elevated since he started taking the pill.  He is now in the midst of a two week break to give them a chance to come down.  His bilirubin came down within the first week, but the other two went up so he's off for another week.  Hopefully Monday he'll go back on.

  I wish you luck on your increased dosage.  My husband seemed to have the same side effects when they increased his dosage as what he had on 300mg.  After about 2 months they subsided a bit.  When they increased him to 600mg the side effects were back only worse.  He was only on the 600mg for 3 1/2 weeks when they took him off.  By the end of the first week the rash was gone and the yellow in his eyes was gone. I do hope you stay the same with the increase as you were with the half dose, seems like you should tolerate the increase well since you didn't suffer too much at 300.

Let us know how you make out with your increase.

Audrey

[cpsn0000]

Reedgirl,

Thank you so much for responding. It seems like some people have no problems with side effects on Tasigna, or have some side effects like your husband and I, or have some serious side effects which doesn't seem to be a regular occurence. I will get my blood work on Friday which will be 1 week as designated by Tasigna to check my EKG and make sure blood counts are ok, if not, like you mentioned, take a drug break. I was on Gleevec before and had no problems with side effects except for 2 weeks of muscle cramps and thats all.

Did the benadryl help ease the rash for your husband before it went away entirely? I am the same exact chicken red bumps as you described. When I called hospital tonight, they said its rare to have rash get bad enough where it goes onto your hands or in your mouth, but if so, even though this is very, very rare, seek medical attention ASAP.

So much fun having CML and getting over the inital side effects......