Matching articles for "Exjade"
In Brief: Jadenu - A New Formulation of Deferasirox for Iron Overload (online only)
The Medical Letter on Drugs and Therapeutics • April 25, 2016; (Issue 1493)
The FDA has approved an oral tablet formulation of deferasirox (Jadenu [ jade' new] – Novartis) for once-daily treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in...
The FDA has approved an oral tablet formulation of deferasirox (Jadenu [ jade' new] – Novartis) for once-daily treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients ≥2 years old or chronic iron overload in patients ≥10 years old with non-transfusion-dependent thalassemia syndromes. A once-daily, oral tablet for suspension formulation of deferasirox (Exjade) was approved in 2005 for the same indications.1 Jadenu and Exjade are the only once-daily oral formulations for iron chelation available in the US.
No new clinical trials were required for approval of Jadenu, which was based on earlier clinical trials with Exjade. The most common adverse effects reported with use of deferasirox in clinical trials were diarrhea, vomiting, nausea, abdominal pain, rash, neutropenia, and increases in serum creatinine. Severe skin reactions, including Stevens-Johnson syndrome and erythema multiforme, have been reported rarely. Hearing loss and ocular disturbances, including cataracts, have been reported with deferasirox; patients taking the drug should have annual auditory and ophthalmic exams. Gastrointestinal ulceration and hemorrhage and renal and hepatic toxicity have also occurred.
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No new clinical trials were required for approval of Jadenu, which was based on earlier clinical trials with Exjade. The most common adverse effects reported with use of deferasirox in clinical trials were diarrhea, vomiting, nausea, abdominal pain, rash, neutropenia, and increases in serum creatinine. Severe skin reactions, including Stevens-Johnson syndrome and erythema multiforme, have been reported rarely. Hearing loss and ocular disturbances, including cataracts, have been reported with deferasirox; patients taking the drug should have annual auditory and ophthalmic exams. Gastrointestinal ulceration and hemorrhage and renal and hepatic toxicity have also occurred.
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Deferiprone (Ferriprox) for Iron Overload
The Medical Letter on Drugs and Therapeutics • February 20, 2012; (Issue 1384)
The FDA has approved deferiprone (de fer’ i prone;
Ferriprox – ApoPharma), an oral chelating agent
available in Europe since 1999, for use as a second-line
treatment of iron overload due to blood...
The FDA has approved deferiprone (de fer’ i prone;
Ferriprox – ApoPharma), an oral chelating agent
available in Europe since 1999, for use as a second-line
treatment of iron overload due to blood transfusions
(transfusional hemosiderosis) in patients with
thalassemia. Two other iron chelating agents, deferoxamine
(Desferal, and others), which is usually
administered subcutaneously, and oral deferasirox
(Exjade), are available for use as first-line therapy in
the US.
Deferasirox (Exjade): A New Iron Chelator
The Medical Letter on Drugs and Therapeutics • April 24, 2006; (Issue 1233)
Deferasirox (Exjade - Novartis), an oral chelating agent, recently received accelerated approval from the FDA as an orphan drug for oral treatment of chronic iron overload due to blood transfusions...
Deferasirox (Exjade - Novartis), an oral chelating agent, recently received accelerated approval from the FDA as an orphan drug for oral treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients >2 years old. Deferasirox is a tridentate (2 molecules of deferasirox bind to one atom of iron) chelating agent with high affinity for iron. It has much lower affinity for zinc and copper.