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Half dose of Tasigna
Hi Karinne,
There was an article posted here a few weeks ago which links to a study about taking nilotinib (on a reduced dose) just once a day. From memory, the general recommendation is to continue to take it twice a day (and fast twice) but this study assessed how effective once a day might be. That, of course, required only one fast.
https://www.cmlsupport.org.uk/article/once-day-nilotinib-real-life-obser...
Their conclusions were:
Switching to a nilotinib QD (once daily) regimen at reduced doses as maintenance therapy after achievement of a MMR on standard-dose nilotinib BID schedule is feasible and safe in chronic phase CML pts regardless of prior treatment history and does not compromise the anti-leukemic efficacy of nilotinib. Our results may pave the way for clinical trials aiming at systematic avoidance of overtreatment and improvement of pts convenience in treatment with nilotinib.
David.
Hi,
I'm on half dose (1×150mg twice a day). This is through agreement with my haematologist consultant, rather than a formal trial. We initially went to 6-weekly testing and after 9 months went back to PCR tests every 4 months. I had stable MMR for 3+ years prior to dose reduction. Results so far have remained very stable in the 0.01% to 0.05% range.
I've definitely noticed benefits through improved skin and hair condition and my eyes are less bloodshot. I feel much clearer in my head too.
The added positive is I must be saving the NHS ~£12k per year.
Fasting is not an issue 10am and 10pm works just fine for me.
Good luck
Chris
Hi Karinne:
I started on full dose (600 mg/day) Tasigna at Dx in Oct 2016. Due to multiple side effects and good response, I have reduced my dose 3 times - first to 450 mg/day in March 2017, then to 300 mg/day in June 2017 and finally to 150 mg/day in Sep 2017. Since then, I have been bouncing between undetected and <0.003% on my PCR. Most bad side effects are either gone or much less severe.
When I was on 300 mg, my oncologist told me to take it 12 hours apart, which I did, Now I take my only pill around 8:00 AM. The fasting requirements are still relevant - do not eat for 2 hours before or 1 hour after taking.
Perhaps fasting isn't necessary on reduced dose?
Conclusion
Using nilotinib at a reduced dose of 200 mg BID under fed conditions in patients with chronic phase CML seems feasible and safe. Bioequivalence, however, was not completely conclusive. In spite of somewhat decreased PK parameters (10-12%), bioequivalence was established in terms of AUC0–12 h, Cmin and Cmax following morning intake. Following evening intake, bioequivalence was established in terms of Cmin, but not of AUC0–12 h and Cmax. In addition to monitoring high intra-patient variability, it is advisable to use therapeutic drug monitoring when implementing the intake of a reduced dose of nilotinib with food in clinical practice.
Perhaps not, but I don't eat in the morning anyway, so I still abide by the fasting rules by default. Also, I don't want anything in my stomach messing with uptake or in any way neutralizing the TKI when I'm already on a very low dose (150 mg once a day). And finally, if it ain't broke,... LOL
It's my understanding that food (especially fatty food) increases uptake of TKIs. If I remember correctly, taking Sprycel with a meal increases uptake an average of 14%. I'm pretty sure that's why Tasigna has the fasting regimen, it can cause too much uptake of the suggested dose if taken with a high fat meal.
I agree, if it's been working for you, there's no need to change.