Acalabrutinib: tablets vs capsules

[MikeOr]

We were notified today that our Acalabrutinib capsules have been discontinued, and we will be getting tablets (pills) instead. Have any of you had experience with Acalabrutinib tablets before ?

[AussieNeil Administrator]

Those of us on Proton Pump Inhibitor (PPI) medications, such as opeprazole or pantoprazole for Gastro-Esophageal Reflux Disease {GERD or GORD, depending on how you spell oesphagus), were required to switch to the less effective Histamine H2 Antagonist treatments, such as famotidine, in order to be able to take acalabrutinib capsules. The H2 antagonist needs to taken 2 hours after acalabrutinib The switch to tablets lifts that restriction.

Up to a third of the population have GERD, so this is an important improvement in the acalabrutinib formulation that should result in more people staying on their treatment. (Poorly controlled GERD can result in people feeling rather miserable, particularly if they are also struggling with nause or other gastrointestinal side effects from taking acalabrutinib.) See for example Long-term management of gastroesophageal reflux disease with pantoprazole

ncbi.nlm.nih.gov/pmc/articl...

Neil

[lindalou5 in reply to AussieNeil]

I just jotted a message off to my CLL doc to see what he can offer for advice on this subject. I am diagnosed with GERD and refused to take omeprazole (I did not want to take something like that if I could control the 'issues' without it.) I wonder at times if the use of other antacids and antigas meds interfered with Calquence as it has been so slow in reduction of my WBC..still at 130,000, but going down about 30,000 every three months. I would really appreciate your input if you would care to give it. thanks

[AussieNeil Administrator in reply to lindalou5]

Per the current calquence.com website, the capsule formulation of acalabrutinib/Calquence will soon no longer be available.

"CALQUENCE IS NOW TRANSITIONING TO TABLETS

Ask your doctor about CALQUENCE tablets today."

This is following the FDA approval of the tablet formulation across all current indications for treatment. astrazeneca.com/media-centr...

Because the capsule formulation required a strong acid environment for absorption, it was important to take your acalabrutinib tablets 2 hours before your antacid medications. This ensured time for a strong acid environment to develop and time for the capsule content absorption into the blood stream. If the sequencing of your acalabrutinib and antacid meds deviated sufficiently from this, you risked poor acalabrutinib absorption and hence poor control of your CLL.

Neil

[uide3095 in reply to AussieNeil]

Hi Neil, luckily for me I don’t have the gastrointestinal condition you guys have, so my question is, does the capsule take longer to absorb into the bloodstream because it needs higher acid and your other meds reduce it, therefore the tablet form would absorb into the bloodstream quicker and hence starts to work more quickly. Sorry if I’ve not put my question across well. I guess my question is what could be the effects of it for us who don’t need the slower absorption. Or shouldn’t it make any difference ?

[AussieNeil Administrator in reply to uide3095]

Uide, per this link which I also provided above astrazeneca-us.com/media/pr...

"The approval by the US Food and Drug Administration (FDA) was based on results from the ELEVATE-PLUS trials presented during the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition in December 2021.1

In the trials, results showed the CALQUENCE capsule and tablet formulations are bioequivalent, indicating the same efficacy and safety profile can be expected with the same dosing strength and schedule.1 The tablet can be taken with gastric acid-reducing agents, including proton pump inhibitors (PPIs), antacids and H2-receptor antagonists (H2RAs).1,2 The majority of observed adverse events (AEs) in these studies were mild with no new safety concerns identified.1"

(my emphasis)

Neil

[MikeOr in reply to AussieNeil]

Thanks AussieNeil !

[Sushibruno in reply to AussieNeil]

Good to know Neil👍.

[Shepherd777 in reply to AussieNeil]

Does the tablet mean we won't have to take an anti-acid pill anymore?

[AussieNeil Administrator in reply to Shepherd777]

It means that those of us who need to take the more effective PPI drugs to keep our GERD under control and who were previously unable to take acalabrutinib can now do so.

[DoriZett in reply to AussieNeil]

I got 2 bleeding ulcers for taking the "lesser" acid reducers and had to stop treatment. Back on Prilosec now and W&W....

[lindalou5]

Thank you Neil.

I just found out from my specialty clinic that my next script will be the tablets.. So excited to see if things get easier! Without you guys, I would eventually have gotten them because as you said- they are done with the capsules. But nice to look forward to the change in a few weeks.

[Sushibruno in reply to lindalou5]

👍👍👍

[Podgeof5]

Mike, I have been taking the pill form for several weeks now. I haven't noticed any change and don't expect any change when my blood is next tested in about 2 weeks. It has permitted me to return to my preferred antacid, for which I am grateful.

[Kingfish6]

Well, they (tried) to do this with Imbruvica in 2018, then I & others had side effects from the tablets. Possibly some additive. Luckily the capsules were reinstated.

[Leo71 in reply to Kingfish6]

This is a bit of a concern as my husband often notices a difference with different brands of the same medication such as aciclovir and has to ask pharmacy to supply a particular brand. They can only think it is certain additives, such as colouring.

[Kingfish6 in reply to Leo71]

Enough people complained so mfr'r ended up keeping the capsules. Yes, something besides the active ingredient caused a reaction.

[Luv2Craft in reply to Kingfish6]

Kingfish6 In your post you state that the manufacturer is going to continue making Calquence capsules. What pharmacy are you buying them from. I thought Biologics specialty pharmacy was the only one who sold them. They notified me 2 weeks ago that they ran out.

[MikeOr in reply to Luv2Craft]

I think Kingfish actually did not mean Acalabrutinib. Capsules of Acalabrutinib have been, indeed, discontinued.

[Luv2Craft in reply to MikeOr]

Thanks Mike.

[Kingfish6 in reply to Leo71]

Not only the tablet problem, but Pharma cut the dose from 30 days to 28 days. Of course this was not little $ in their pocket for 2 days -- big $. Interesting, after older game changing drugs like Imbruvica & Acal, disturbing that cost hasn't come down with more competition.

[JLJC]

the only thing I know that is important is that when transitioning from capsules to tablets there is an advisory to not mix the two. Use your capsules up then start tablets. In other words, don’t take a capsule for your am dose and start the tablets for your pm dose. Or vice versa.

[HailMary-USA in reply to JLJC]

Hi JLJC.

Have you been advised to take a drug break when transitioning from capsules to tablets?

Asking because all doses are to be 12 hours apart, so we would indeed be taking a pm capsule followed by a morning tablet.

Thanks and best wishes.

Mary

[JLJC in reply to HailMary-USA]

i read the insert when my tablets came and I also asked the pharmacist at my specialty pharmacy that dispenses the calquence and that is all he told me about not taking in the same day but I get your point with the 12 hour period in between so not sure why it matters?

Also maybe they just don’t want people mixing capsules and tablets going forward because of the people that need to benefit from the tablets only and so across the board disclaimer saying use all your capsules before starting tablets.

[HailMary-USA in reply to JLJC]

Thanks!

[Kingfish6]

Hi, I believe I commented that I'm referring to Imbruvica, NOT Calquence, when in 2018, the Imbruvica mgr'r wanted to discontinue capsules in favor of tablets. The negative was side effects. when I(& other's) took the tablets, PLUS the supply went from 30 days to 28 days, PLUS tablet size/content limited. You can guess why Pharma is doing this ...... $. I get my Imbruvica from Biologics, though Costco pharmacy called me once that they can also supply. It just could be that the Acal tablets will present no problems. With Imbruvica tablets , enough people. complained to their docs that the mfr'f changed their mind.

[morepork in reply to Kingfish6]

Alas, despite protests here in NZ about Ibrutinib capsules changing to table form - and to full dose tablets only, nothing changed ! So we are still wrestling with hard to access 'pop out' tablet packaging, with each card having only 10 tablets rather than a fortnight's worth - I don't understand why that number. 😒

[AussieNeil Administrator in reply to morepork]

See healthunlocked.com/cllsuppo...

Sadly, I can't see manufacturers making a special production run for small populations of those that can't take the tablets, such as the Australian and New Zealand markets, for example.

Neil

[AussieNeil Administrator in reply to morepork]

Standard packaging for zanubrutinib is 30, I think I was supplied with bottles of 60 acalabrutinib capsules on my trial, so perhaps standard packaging for BTKi drugs is for 30 days supply.

[morepork in reply to AussieNeil]

Thanks ! Ahah - the 30 tablets per month make sense of the cards of 10 at a time.

😊

[Nucleusman]

in tablet form now allows you to use PPIs again