(BPT) - Pharmaceutical companies have sought to address the problem some patients have with swallowing pills by developing tablets that can also be crushed prior to administration. Such options have been helpful with very old and young patients who tend to have the most difficulty swallowing pills.
Jadenu™ (deferasirox), an iron chelation therapy in tablet form that treats patients who suffer from a condition known as chronic iron overload, has been approved by the U.S. Food and Drug Administration (FDA) to now also be taken in a crushed form. Chronic iron overload is a serious condition that can affect people with sickle cell disease, thalassemia and myelodysplastic syndromes, which can require multiple blood transfusions, and with anemias like non-transfusion-dependent thalassemia.
For patients who have difficulty swallowing whole tablets, Jadenu tablets may be crushed and mixed with soft foods (e.g., yogurt or apple sauce) immediately prior to use and administered orally. Commercial crushers with serrated surfaces should be avoided for crushing a single 90 mg tablet. The dose should be immediately and completely consumed and not stored for future use.
“Children and elderly patients are more likely to have difficulty swallowing their medication as tablets. It is crucial to have additional administration options, like crushing, available,” says Dr. Elliott Vichinsky, Director of Hematology and Oncology at UCSF Benioff Children's Hospital Oakland.
A different formulation of Exjade® (deferasirox), Jadenu was developed by Novartis Pharmaceuticals Corporation to help simplify treatment administration for patients with chronic iron overload. While Exjade has to be mixed in liquid before administration, Jadenu is swallowed whole, which may be a problem for certain patients. The FDA’s approval for Jadenu to be crushed is an important option for young children who may have difficulty swallowing tablets.
For more information, visit Jadenu.com.
About JADENU (deferasirox) Tablets
Jadenu is an iron chelator indicated for the treatment of chronically elevated levels of iron in the blood caused by repeated blood transfusions (transfusional hemosiderosis) in patients ages 2 years and older. Jadenu is also indicated to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT). These indications are approved under accelerated approval based on a reduction of iron levels in the liver (measured by liver iron concentration) and blood (measured by serum ferritin levels). Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. There are ongoing studies to find out how Jadenu works over a longer period of time.
It is not known if Jadenu is safe or effective when taken with other iron chelation therapy. Controlled clinical trials of deferasirox in patients with myelodysplastic syndromes (a serious blood disorder) and chronic iron overload due to blood transfusions have not been performed.
In the United States, Jadenu is available by prescription only.
Important Safety Information about JADENU (deferasirox) Tablets
Jadenu contains deferasirox, the same active ingredient in Exjade (deferasirox) tablets for oral suspension. Deferasirox may cause serious kidney problems, liver problems, and bleeding in the stomach or intestines. In some cases, these problems were fatal. Kidney problems occurred particularly in patients with multiple medical conditions and those who were very ill because of their disease. Bleeding in the stomach or intestines occurred more often in elderly patients. Liver problems were more likely to happen in patients older than 55 years.
Jadenu should not be taken by patients with pre-existing severe kidney and liver problems; high-risk myelodysplastic syndromes; advanced cancer; low platelet counts; or an allergy to Jadenu.
Since deferasirox has been on the market, there have been reports of serious reactions, sometimes leading to death. Severe blood disorders (including neutropenia, agranulocytosis, worsening anemia and thrombocytopenia), serious allergic reactions (including swelling of the throat), severe skin reactions (including Stevens Johnson syndrome and erythema multiforme), decreased hearing and vision changes have been reported. These serious reactions and deaths have happened most often when deferasirox was taken by elderly patients. The most commonly reported side effects related to deferasirox in clinical trials were nausea, vomiting, diarrhea, stomach pain, increases in kidney laboratory values, and skin rash.
Please see full Prescribing Information including Boxed WARNING available at www.jadenu.com.
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