Jadenu Generics Available

December 9, 2019 – The U.S. FDA has approved generics from multiple manufacturers, including Alembic Pharmaceuticals and Dr. Reddy’s, for Novartis’s Jadenu® (deferasirox) film-coated tablets. Deferasirox is indicated to treat chronic iron overload due to blood transfusions in patients who are at least two years of age, as well as chronic iron overload in certain patients who are at least 10 years of age and have non-transfusion-dependent thalassemia (NTDT).

Chronic iron overload occurs when the amount of iron in the body exceeds the body’s ability to store it. The excess iron finds its way to the body’s organs, including the liver, pancreas, thyroid, and heart. Complications and symptoms of iron overload are varied, and can include but aren’t limited to fatigue, joint pain, irregular heartbeat, organ damage, and an increased risk of arthritis, heart disease, and other chronic and serious health conditions.

Recommended dosing with deferasirox is based on individual patient factors that include eGFR test results (a measure of kidney function) and whether the patient has NTDT or is experiencing chronic iron overload due to blood transfusions. A black box warning cautions that deferasirox is associated with a risk of renal failure, hepatic (liver) failure, and gastrointestinal hemorrhage.

First FDA approved in 2005, deferasirox is also available as an oral suspension both as a generic and under the brand name Exjade® (Novartis). In addition, a granule form, Jadenu Sprinkle (Novartis), is available exclusively as a brand name product. Generic deferasirox film-coated tablets have launched at wholesale acquisition costs (WACs) that range from $760.08 to $4560.48 per 30-count of the 360mg strength, compared to $5,067.20 for the brand.