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Managing Side Effects in Iron Chelation Therapy

Insights From:Thomas Prebet, MD, PhD, Yale Cancer Center; Heather Leitch, MD, PhD, St. Paul’s Hospital;Vinod Pullarkat, MD, City of Hope Medical Center
Published: Friday, Nov 11, 2016


Transcript:

Heather Leitch, MD, PhD:
The new formulation of deferasirox, which is the film-coated tablet, Jadenu, became approved by Health Canada just a couple of months ago, and we don’t yet have reimbursement in place. So, the experience with this agent in Canada is limited. It was approved about a year ago in the United States, and so our United States colleagues do have some experience with this agent.

Based on the experience of our United States colleagues, GI side effects with Jadenu, the film-coated tablet, are less than with Exjade. This is because of the lack of lactose in the new formulation and also the lack of some of the other GI irritants. So, that is less of an issue.

We do need to be wary of creatinine increases, as we did with the old, 10-year-old formulation: the dispersible tablet, Exjade. And so, that requires to be closely monitored. We also need to do the rest of the monitoring as per guidelines, such as monitoring liver tests, because these can be increased early during iron chelation therapy. We should really do the rest of the monitoring as recommended, not only for iron overload, but also for side effects of iron chelation therapy, as discussed previously.

Vinod Pullarkat, MD: The active ingredient of Jadenu is the same as for Exjade. They both contain deferasirox. So, the side effects, like renal toxicity or skin rash, I don’t expect them to be different with Jadenu, as compared to Exjade, when they are dosed at an equivalent dose. Since the bioavailability of Jadenu is more, if you give a higher dose, then you will see more toxicity. But we don’t have data that the other toxicities are any different. For a gastrointestinal toxicity, one would expect a better toxicity profile because Jadenu does not have the other substances that are found in Exjade to make it more soluble.

Heather Leitch, MD, PhD: Because it does not have lactose in the formulation and because of some of the other components, it has less in the way of GI intolerance. And so, it is better tolerated by patients. The adherence at 3 months is improved by 10% over the classical formulation of deferasirox. So, I think that in the future, most of our patients—not only because of GI intolerance, but also because of convenience—will be appropriate for switching over to the new formulation. But, we’re not there yet because of the reimbursement issue.

Vinod Pullarkat, MD: If a patient is tolerating Exjade well and has been on it for a long time, I don’t switch that patient. For new patients, I’m starting off with Jadenu because it’s likely that they will tolerate the drug better. Patients I switch are patients who experience side effects that are gastrointestinal in nature. Those are the patients where I think it is reasonable to switch them to Jadenu, hoping that the side effect profile will be improved.

Transcript Edited for Clarity
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Transcript:

Heather Leitch, MD, PhD:
The new formulation of deferasirox, which is the film-coated tablet, Jadenu, became approved by Health Canada just a couple of months ago, and we don’t yet have reimbursement in place. So, the experience with this agent in Canada is limited. It was approved about a year ago in the United States, and so our United States colleagues do have some experience with this agent.

Based on the experience of our United States colleagues, GI side effects with Jadenu, the film-coated tablet, are less than with Exjade. This is because of the lack of lactose in the new formulation and also the lack of some of the other GI irritants. So, that is less of an issue.

We do need to be wary of creatinine increases, as we did with the old, 10-year-old formulation: the dispersible tablet, Exjade. And so, that requires to be closely monitored. We also need to do the rest of the monitoring as per guidelines, such as monitoring liver tests, because these can be increased early during iron chelation therapy. We should really do the rest of the monitoring as recommended, not only for iron overload, but also for side effects of iron chelation therapy, as discussed previously.

Vinod Pullarkat, MD: The active ingredient of Jadenu is the same as for Exjade. They both contain deferasirox. So, the side effects, like renal toxicity or skin rash, I don’t expect them to be different with Jadenu, as compared to Exjade, when they are dosed at an equivalent dose. Since the bioavailability of Jadenu is more, if you give a higher dose, then you will see more toxicity. But we don’t have data that the other toxicities are any different. For a gastrointestinal toxicity, one would expect a better toxicity profile because Jadenu does not have the other substances that are found in Exjade to make it more soluble.

Heather Leitch, MD, PhD: Because it does not have lactose in the formulation and because of some of the other components, it has less in the way of GI intolerance. And so, it is better tolerated by patients. The adherence at 3 months is improved by 10% over the classical formulation of deferasirox. So, I think that in the future, most of our patients—not only because of GI intolerance, but also because of convenience—will be appropriate for switching over to the new formulation. But, we’re not there yet because of the reimbursement issue.

Vinod Pullarkat, MD: If a patient is tolerating Exjade well and has been on it for a long time, I don’t switch that patient. For new patients, I’m starting off with Jadenu because it’s likely that they will tolerate the drug better. Patients I switch are patients who experience side effects that are gastrointestinal in nature. Those are the patients where I think it is reasonable to switch them to Jadenu, hoping that the side effect profile will be improved.

Transcript Edited for Clarity
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