Jadenu Approved for Chonic Iron Overload
March 30, 2015 – The U.S. Food and Drug Administration (FDA) approved Jaden (deferasirox) manufactured by Novartis. Jadenu is a new dosage form for Exjade, which is also made by Novartis. In a class known as chelators, deferasirox binds to oversupplies of iron in the body, making iron inactive and allowing it to be eliminated. Both Jadenu and Exjade are used once daily to treat patients at least two-years old who have chronic iron overload, a condition when the blood levels of iron are consistently too high as a result of frequent blood transfusions. Jadenu as well as Exjade are also used for patients aged 10 years old and older with chronic iron overload due to non-transfusion-dependent thalassemia syndromes, such as sickle cell disease.
Untreated chronic iron overload increases the risk of having arthritis, diabetes, heart problems, liver diseases and other conditions. However, both Jadenu and Exjade have boxed warnings that they may cause kidney, liver or stomach damage. Patients who use them should have kidney and liver function tests every month. Exjade tablets are dissolved into a drink and administered within very specific time limits, but Jadenu tablets are swallowed whole. Jadenu tablets will be available through specialty pharmacies, but a launch date is not yet available.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.