If one wants to keep the dose to a minimum - how long would one have to wait until they could eat breakfast? 1 hour? 2 hours?
I take it at night a couple hours after dinner.
drugs.com/food-interactions...
ADJUST DOSING INTERVAL: Food increases the oral bioavailability of ibrutinib. The mechanism of interaction is unknown. According to the product labeling, administration with food increases ibrutinib exposure approximately 2-fold compared to administration after overnight fasting.
So should I continue to take my Ibrutinib with my breakfast?
One can always call the manufacturer Pharmacyclics at 877-877-3535 8am-8 pm eastern. They are very helpful.
Hoffy. I have called the manufacturer at numerous times and their replies were very unsatisfactory. They just tried to collect information for their own records. I am sorry but I never got any good impression from the people that I spoke to on the phone.
Well, that is interesting. The following is written in the label if my Ibrutinib bottle..
"Take with 240ml of water at least 30 minutes before or 2 hours after food."
Supplied to me as part of the Clarity trial.
Best, Rob
I was started in hospital at 22.00 hours. I have a milky drink about 30 min later. Does that count as food. It stops me having indigestion all night.
On my container it says"take 3 tablets with water at the same time each day".
On the leaflet there is no mention about food with the 'how to take' instructions.
I do have a note about taking same time of day, in my trial notes. It also lists four foods to avoid. I think the trial could possibly be more specific than normal instructions (that's a guess) to meet their proocol.
David, your question and the variety of replies as far as instructions certainly makes me squeamish about having the administration of such a drug be my sole responsibility---Were I you, I'd be calling the hemo/onco to get some clarification.
And, thank you for the question, it will make me extra vigilant in having instructions be detailed from the one who prescribes while being alert to the possibility of needing to verify.
As another reference point, ACP-196 (Acalabrutinib) can be taken with or without meals. These directions are on the pill bottle. When I started taking the medicine, you could not eat 3 hours before and one hour after taking the medicine. I would set the alarm clock for 5 am, wake up, take the medicine and go back to bed. I was grateful when it was changed.
Hi Greenblue, just came across this post. Husband will start treatment soon and I wonder where you're receiving the acalabrutinib. How are you doing and feeling? What's been your experience with the drug and the trial site. Thanks very much.
Barb,
I got into the Acalabrutinib (ACP-196) phase 1 drug trial at MD Anderson. I started on the drug in February 2015. At the time I was very sick. I would sleep all day. My immune system was poor so I couldn't eat anything uncooked. This included salads. I would avoid crowds. The drug has been a life changer. My CBC is normal. Since Acalabrutinib is a second generation BTK, it is more targeted and doesn't have the side effects of Ibrutinib. I have had only positive side effects - my eczema is less severe so I do not have to treat it and my sinuses are clear for the first time in 30 years (I do not need any sinus medicine). My life is back to normal and the transformation was quick.
Tell your husband that there is no better time to have CLL. Five years ago there would not have been an effective treatment for me.
The ACP – 196 likely improve your IGE which causes less skin irritation issues.
I am glad you're doing well!!
Hoffy,
Thanks. After reading your message I googled IGE. Now it makes sense. I started looking at my old lab results. IGG, IGM and IGA are measured but not IGE. I will be at MD Anderson next month and will ask Dr. Wierda. The mystery is solved. My eczema was so bad I would scratch it like poison ivy. As to my sinuses, I am off all medication after 30 years of steroidal sprays.
Thanks for the quick reply. Wow! So great to hear your experience with acalabrutinib! Did you have previous treatment? Husband hasn't yet and I'm afraid he may not qualify for acalabrutinib trial unless he shows another negative marker - +12 and unmutated but this may have changed. I hear so many difficult things about ibrutinib - and a lot of good - that it's frustrating to think he may not be able to get the more targeted drug. What's next for you? Will you stay on it indefinitely even if MRD? It is wonderful that there are new successful options though it complicates decision making and a bit raises my anxiety about choosing right doctor and treatment center. We're going to Dana Farber next week for treatment opinion though we live in Chicago. Local hematologist he'd been seeing isn't tied in to new options and trials.
I had never been treated. I am unmutated so FCR was ruled out. Ibrutinib was not approved for first line treatment at the time. So my first oncologist sent me to MD Anderson. My trial is supposed to end in November. My expectation is that I will continue on Acalabrutinib. I am not MRD negative. I do not know where the drug is in the FDA approval process.
Dana Farber is a great institution. I would seriously consider OSU which is much closer and has been doing great cutting edge research trials. Dr. Byrd is one of the CLL greats. He also published the first test results on Acalabrutinib. I suggest that you google him. A lot of HealthUnlocked members are in drug trials there. I would see if your husband could get into a drug trial at OSU. At MD Anderson my cost has only been my medical deductible. If I were not at MD Anderson, I would be at OSU.
We tried first to get an appt at OSU. 6 months to see Dr Byrd and we were reluctant to rely on very junior doctor they offered who is not even listed as one of their CLL specialists. Feels tricky at this poInt since I think Mark may need treatment very soon - spleen is huge. Don't know if we'll have option to confer w/dr Byrd. Hoping dr davids at Dana Farber will connect us there if acalabrutinib is appropriate but I have the sense that DF is big into IB + venetoclax. Trying to not get ahead of things but I'm trying to be proactive.
Hey Junior Dr. Can many times be fine since they work with the main doctor anyways. I do that at UC San Diego. The junior doctor many times has more time as well and you can schedule appointment with the main doctor for later on . The I plus V trial could be very good as well that is what I am on and the hope is that you can and treatment after about a year or so
You are in the most promising drug trial.
Greenblue, is there a particular reason you say IB + V is most promising, especially since you've done so well on a acalabrutinib? Wish there were an acalabrutinib + V trial.
Venetoclax and Ibrutinib are AbbVie drugs. No way are they going to test with Acalabrutinib which is now owned by AstraZeneca.
IB + V are achieving deeper remissions. There is a greater potential to go off all medicines. Still, it is the early stages of testing. As to Acalabrutinib, I do not ever see stopping to take the drug.
Thanks ! I hope so
Thanks, Hoffy. I know we're likely to see more Junior people along the way. Just want to know that we start with someone who's seen many CLL patients, given the many individual presentations. Guess I'm trying to control whateverI can for my husbandthough I realize also how little is in my or his control.
Barb,
When I started at MD Anderson, Dr. Philip Thompson was a junior doctor assisting Dr. Wierda. Dr. Thompson is brilliant and now a senior doctor.
Hoffy, please refer to the DRUG LABEL... the website you reference often contains, old or incorrect, or misinterpreted data...
Ibrutinib is absorbed after oral administration with a median Tmax of 1 to 2 hours. Ibrutinib exposure increases with doses up to 840 mg. The steady-state AUC (mean ± standard deviation) observed in patients at 560 mg is 953 ± 705 ng∙h/mL and in patients at 420 mg is 680 ± 517 ng∙h/mL.
Absolute bioavailability in fasted condition (n = 8) was 2.9% (90% CI = 2.1 – 3.9) and doubled when combined with a meal. Administration with food increased ibrutinib Cmax and AUC by approximately 2 to 4- and 2-fold, respectively, compared with administration of ibrutinib after overnight fasting.
DailyMeds by mandate has the latest drug label information...
dailymed.nlm.nih.gov/dailym...
I refer you to the actual study that looked at this in healthy people and in a few CLL previously treated
ncbi.nlm.nih.gov/pmc/articl...
~chris
I take mine wit breakfast ti increase the levels as I have no AEs and higher levels are quite safe for most.
Sounds good !
Can someone translate in laymens terms 'oral bioavailability'...what is this?
The amount of a drug consumed by mouth, that is available at any given time to perform its function.
Many drugs are consumed, but then need to be broken down in the gut or small intestines and coverted by the liver for use, so it takes time to become available in the blood. Ibrutinib is metabolized primarily by the cytochrome P450 (CYP) family of enzymes, specifically CYP3A enzymes...
Ibrutinib oral bioavailability is 3.9% in a fasting state, 8.4% in a fed state, and 15.9% after consumption of grapefruit juice
ncbi.nlm.nih.gov/pmc/articl...
In general
bioavailability...the degree to which a drug or other substance becomes available to the target tissue after administration.
~chris
At this point I'm not sure if talking ibrutunib with food is a good thing or not. I have just started ibrutinib this week and am taking it without food with no problems so far. But if twice as much is bio-available with food, won't taking half as much with food be equivilant to taking a regular dose without food? Not suggesting anyone do this, but curious if that makes sense.
I take it each morning on an empty stomach with 16 ozs of water, at the same time each am. I wait 1 hour to eat breakfast. Has worked okay...
Best to ask your Doctor. My doctor recommended it at night before bed to avoid interaction with food. From my perspective it will be strongest at night when I am sleeping as well.
You want to take the regular dose. If possible. Depending how you take it can change your bio availability. You don't want to play with this though because it is not known what exactly gets into your system. The goal is to try to keep a constant level throughout the day. That is why they want you to take it at the same time every day.
In the beginning when I started taking Ibrutinib I found I had quite a lot of indigestion and taking the drug with meals seemed to alleviate this.
A071402 Phase 3 clinical trial - Obinituzumab+Ibrutinib+Venetoclax
Venatoclax mono therapy
Tachycardia and Ibrutinib 
140mg of Ibrutinib per day
