Exjade Not Recommended For High-Risk Myelodysplastic Syndromes Patients
The U.S. Food and Drug Administration’s (FDA) evaluation of Exjade (deferasirox) has concluded that the drug should not be prescribed to myelodysplastic syndromes (MDS) patients with poor prognoses or high-risk disease due to the possibility of liver or kidney impairment and gastrointestinal bleeding. It now requires Novartis, which markets Exjade, to include a highlighted “black box warning” in the prescribing information cautioning physicians and patients about its potentially serious or fatal side effects.
Exjade is an iron chelating agent that works to remove excess iron, which may have built up in the heart, liver, and endocrine cells due to repeated blood transfusions. The drug binds free iron in the blood and prevents the metal from forming toxic deposits.
Novartis released the revised prescribing information for Exjade on February 17, stating that the kidney and liver damage or gastrointestinal bleeding could be fatal, especially for elderly patients or those with high-risk MDS. Patients with underlying liver or kidney conditions or platelet counts less than 50×109/L were also cautioned about the side effects. The black box warning is the strictest type of warning required by the FDA.
The FDA first began investigating the safety of Exjade in September 2009 (see related Beacon article), due to previous analyses that showed MDS patients taking Exjade had a greater risk of serious side effects than patients without MDS.
Although doctors are still free to prescribe the iron chelating agent, the new black box warning will, according to Novartis, “enhance the ability of physicians to appropriately treat patients who are prescribed or taking Exjade to manage transfusional iron overload.”
An alternative iron chelating agent available to MDS patients in the U.S. is deferoxamine (Desferal). The FDA also is reviewing Ferriprox (deferiprone) for approval in the U.S. It is currently available in a number of countries outside of the U. S. In addition, there is evidence that wheat grass juice may be a natural option for reducing excess iron.
For more information about the FDA’s announcement about Exjade’s safety, please see the FDA Web site. For more information about excess iron and chelation therapy in MDS patients, please see the related MDS Beacon resource article.
Related Articles:
- FDA Analyzing Safety Of Exjade In MDS Patients
- Exjade May Be More Effective Than Ferriprox In Certain Lower-Risk MDS Patients (EHA 2011)
- FDA Approves Ferriprox … But Not For Myelodysplastic Syndromes Patients
- Beacon BreakingNews – FDA Examining Exjade Safety In MDS Patients
- Treatment For Excess Iron May Improve Blood Cell Counts In Some Transfusion-Dependent MDS Patients
What constitutes “high risk” MDS patients? My 86 year old mother has been prescribed Exjade because she has iron overload from transfusions. She seems to be in good health regardless of her MDS without kidney or liver problems but some stomach upsets due to food. Her doctor has presribed 500mg daily and she has not yet started the drug. What kind of monitoring do you suggest? I understand the creatinine level is a must. Should we plan on other routine tests during her taking the drug to ward off any dangerous side effects? I am very worried about renal and/or liver failure. Do the risks outweigh the benefits of this drug? Are there alternatives to chelation which are less lethal?
Please advise.
Thank you.
Hello Donna.
MDS patients are classified into different categories of MDS such as low risk, intermediate risk-1, intermediate risk-2, or high risk.
Many different factors go into calculating a number score for an MDS patient including how many immature bone marrow cells the patient has, any chromosomal/genetic abnormalities, and what the patient’s blood counts are.
Each number score means a certain category of MDS. In the International Prognostic Scoring System (IPSS), high risk MDS patients have a score of 2.5 or higher.
According to the MDS Foundation, chelation is the only treatment for transfusion-dependent iron overload.
However, there are certain diet changes that can be made to help lower the amount of excess iron. Dairy, foods high in fiber, and tea can interfere with how the body absorbs iron. Raw shellfish, alcohol, and tobacco smoke should be avoided.
As for your remaining questions, we have forwarded them along to an MDS specialist and will keep you updated.
Thank you very much Linda. We are on the way to the oncologist and this information assists in our discussions with him.
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