Ibrutinib (Imbruvica) Side Effects and Patient Stories

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Ibrutinib General Information

Background

Ibrutinib is a type of targeted therapy drug known as a kinase inhibitor. Patients who are prescribed take ibrutinib orally, usually daily, in capsule or pill form.

Dr. David Miklos of Stanford Medical Center describes the role of ibrutinib as a small molecule inhibitor that interrupts the signal from the b-cell receptor to the division inside the nucleus.

Tony Donk describes how often and how many ibrutinib pills he had to take as part of his chronic lymphocytic leukemia (CLL) treatment.

The second option, which I elected, was to begin taking a medication called Imbruvica, or ibrutinib. I take three capsules per night and will continue to take this until it no longer works. In both cases, the remission period is indefinite, so I decided to start with the less potentially debilitating medication route.

Tony Donk

Other patients have shared their experiences with ibrutinib as part of a clinical trial, like Sean Roberts, who took it for his chronic lymphocytic leukemia (CLL) diagnosis.

It’s venetoclax and ibrutinib. Ibrutinib came first, and then we did venetoclax. That started in April of 2018. I took the ibrutinib every morning for three months.

Sean Roberts

ibrutinib and venetoclax

Dr. Kerry Rogers, a CLL and hematology specialist at Ohio State University’s The James Cancer Center, says targeted agents, like ibrutinib and venetoclax-based treatments, had been compared to chemotherapies and showed longer progression-free survival.

This is a measure of how long people are alive without their leukemia returning.We have found that these targeted agents were actually better than these chemotherapies.

That means people lived longer without their CLL coming back after they took the non-chemotherapy targeted agents. Also, they have a different group of side effects that are generally better than chemotherapy.

Dr. Rogers

Cancers Treated

Ibrutinib is commonly used to treat patients with:

• Mantle cell lymphoma (MCL)
• Chronic lymphocytic leukemia (CLL)
• Waldenstrom’s macroglobulinemia (WM)
• Marginal zone lymphoma (MZL)
• Chronic graft versus host disease (cGVHD)

Mantle Cell Lymphoma

According to Dr. Miklos, ibrutinib was the first and most widely-used drug in mantle cell lymphoma treatment.

A pill you take once a day that covalently links and binds and inhibits the Bruton’s tyrosine kinase (BTK) molecule. That cell was done. The importance of that therapy where everybody responds, and yet, there are patients with about a 20 to 25-percent risk per year of progression.

Once we lose that very special target, we can go onto some other medicines like venetoclax, which has also shown benefit in the mantle cells.

Dr. David Miklos

»MORE: Read in-depth patient stories and background on mantle cell lymphoma

Chronic Lymphocytic Leukemia (CLL)

Ibrutinib is also used in the treatment of CLL, replacing chemotherapy. Dr. Tim Fenske of University of Wisconsin says before ibrutinib came on the scene, “we really only had chemotherapy and Rituxan, which is more of an immunotherapy drug.”

We’re in this new era where we have these novel or targeted agents. That really started about 10 years ago with Ibrutinib and more recently we’ve had Venetoclax.

You don’t get all the same chemotherapy side effects. It’s a highly effective way of treated CLL. It does still have possible side effects, but it does a good job.

Dr. Tim Fenske

»MORE: Learn more about what CLL is

Dr. Jacqueline Barrientos points specifically to how ibrutinib has benefited CLL patients with the 17p deletion marker.

We just published some data comparing that drug against the best chemo regimen. The big winner was Ibrutinib. Even in younger people, the best therapy is a targeted agent. Not only in patients with 17p, but with other markers as well. 

Ibrutinib Side Effects

Dr. Fenske says with targeted therapy like ibrutinib, patients don’t lose hair, typically you don’t have as big of a drop in blood counts, and in general you don’t see nausea and vomiting, but he adds they can still have side effects.

Ibrutinib can cause rashes, diarrhea, heart rhythm disruptions, muscle and joint aches, and things like that. About 20% of people wind up having to come off of these drugs because of some side effects. It really depends on the person.

Dr. Tim Fenske

People may experience some side effects with ibrutinib. Some of the more commonly reported side effects include¹:

• diarrhea
• nausea
• constipation
• vomiting
• stomach pain
• heartburn or indigestion
• decreased appetite
• excessive tiredness or weakness
• muscle, bone, and joint pain
• muscle spasms
• swelling of the hands, feet, ankles, or lower legs
• rash
• itching
• sores in the mouth and throat
• anxiety
• difficulty falling asleep or staying asleep
• cough, runny or stuffed nose
• blurred vision
• dry or watery eyes
• pink eye

Some cancer patients don’t feel any side effects, at all, like Bobby Jones, who took ibrutinib for stage 4 mantle cell lymphoma.

I did not have any side effects from anything. It was strange that I did continue to run all summer and I ran my fastest 10k, 5k times I’ve ever run before!  All the time I was taking the pills and going through treatments, so basically, they did not affect me at all.

Bobby Jones

»MORE:  Read Bobby’s mantle cell lymphoma story

New Treatments After Ibrutinib

Medical research is happening to figure out new treatments for cancer patients who stop responding to ibrutinib. Dr. Miklos says this is where patient engagement is critical in making treatment decisions, for instance for mantle cell lymphoma (MCL) patients.

“Now, physicians will have to decide who should receive BTK inhibitors and who should go right on to CAR T-cells, and that’s discussion with the patients and the families. That really is still being worked out,” says Dr. Miklos.

We’re going to be doing a new trial, where we’ll be looking at patients who’ve had ibrutinib upfront or who have not had ibrutinib yet, and using the same therapy to see what the true incidents of benefit is in that second line.

»MORE: Read more on relapsed/refractory MCL treatment options

Clinical Trials

Dr. Fenske encourages patients to consider participating in clinical trials for the next wave of cancer treatments.

There are all different kinds of trials. There are phase 1 trials which means you could be getting a really new drug. Ibrutinib, Venetoclax, and all our new drugs were a phase 1 trial at some point.

If patients hadn’t signed up for those trials, those drugs wouldn’t have made it to market. Those patients’ willingness has helped a lot of people.

Dr. Tim Fenske

»MORE: Learn more about the process of clinical trials from one program director

Medical Experts

Read more from our full interviews with medical experts.

Dr. Kerry Rogers, CLL/SLL Specialist

Dr. David Miklos, CAR T Therapy & Transplant Specialist

Dr. Jacqueline Barrientos, CLL/SLL Specialist

Dr. Tim Fenske, CLL/SLL Specialist

Ibrutinib Patient Stories

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References

1. Ibrutinib. Medline Plus, U.S. National Library of Medicine, 15 May 2010, https://medlineplus.gov/druginfo/meds/a682125.html.