JADENUTM, a new formulation of PrEXJADE® (deferasirox) is a once-daily oral tablet that removes excess iron from the body1
Dorval, Quebec, May 6, 2016 – Canadians requiring treatment for chronic iron overload have a new treatment option with the availability of JADENU™ (deferasirox) following its recent approval by Health Canada. JADENU™ contains the same active ingredient (deferasirox) as EXJADE®. However, JADENU™ film-coated tablet is a new oral formulation of deferasirox. JADENU™ is a tablet that should be swallowed whole and that requires a different dosing regimen and method of administration compared to EXJADE®, which must be dissolved in liquid.
JADENUTM should be swallowed whole with water or other liquids, preferably at the same time each day and should be taken on an empty stomach or with a light meal. For patients unable to swallow whole tablets, it can also be crushed and administered by sprinkling the full dose on a soft food such as yogurt or applesauce.1
“Iron overload is a major concern in the follow up of patients for whom life is dependent on regular transfusions, partly because iron overload is not easily assessed. Inability to diagnose and address this transfusion side effect can lead to damage to multiple organs and death. JADENU™, the new formulation of deferasirox, may provide a more manageable way for patients to adhere to therapy and hopefully better results at reducing iron overload and maintaining an adequate level afterwards for patients who remain chronically transfused,” said Dr. Denis Soulières, MD, hematologist and medical oncologist, Centre hospitalier de l'Université de Montréal (CHUM).
The Health Canada approval of JADENU™ includes a Notice of Compliance with conditions (NOC/c) for the management of chronic iron overload in patients with transfusion-dependent anemias aged six years or older and the management of chronic iron overload in patients with transfusion-dependent anemias aged two to five who cannot be adequately treated with deferoxamine. The NOC/c was granted to reflect the need for further follow-up to verify the clinical benefit. The Health Canada approval of JADENU™ also includes a Notice of Compliance for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes (NTDT) aged 10 years and older.1
About chronic iron overload
Chronic iron overload is a life-threatening cumulative toxicity that results from blood transfusions required to treat thalassemia, myelodysplastic syndromes, sickle cell disease, and other conditions. Chronic iron overload also can occur in patients with NTDT due to increased iron absorption in the stomach and intestines.2,3 If left untreated, chronic iron overload can damage the liver and heart as the body has no mechanism to remove excess iron.4,5,6 Receiving as few as 20 units of blood (10 in children) over time can lead to chronic iron overload.7 Iron overload and consequent serious organ damage are managed with chelation therapy, which removes certain metals, such as iron, from the body. These agents bind to the iron and remove it through the urine or stool.6
Blood transfusions are also crucial in treating children born with the genetic disorder thalassemia, and iron overload is a constant concern.8 “Iron chelators have significantly changed the prognosis of people born with thalassemia allowing these patients to be treated with regular blood transfusions.” said Helen Ziavras, President, Thalassemia Foundation of Canada. “When you are dealing with a child who needs to take treatment on a daily basis, you need it to be tolerable and to go down as smoothly and as fast as possible! Having the option of being able to crush JADENU™ into soft foods such as yogurt or applesauce, is particularly useful for parents caring for children with thalassemia. This is a welcome new alternative for younger patients.”
For Cindy Anthony, Executive Director, Aplastic Anemia and Myelodysplasia Association of Canada, the new treatment is important: “Patients with blood disorders and their families have so many things to deal with. They are living with a very serious condition, which means treatment is an important part of their day-to-day life. The approval of JADENU™ is an important step forward because a simplified mode of administration gives these patients one less thing to worry about and is an immense help.”
Sickle cell disease is one of the conditions normally treated with blood transfusions. “The approximately 5,000 Canadians with sickle cell disease9 understand the importance and need to control the buildup of iron in their blood. Being able to control iron overload with a simplified daily tablet that can be taken at a time that is convenient to the patients represents a great improvement,” said Lanre Tunji-Ajayi, President & Executive Director, Sickle Cell Disease Association of Canada. “This treatment is a welcomed option and we hope that patients in Canada will soon have access to it.”
JADENU™ (deferasirox) is an iron chelator indicated for the management of chronic iron overload in patients with transfusion-dependent anemias aged six years or older and the management of chronic iron overload in patients with transfusion-dependent anemias aged two to five who cannot be adequately treated with deferoxamine. JADENU™ is also indicated for the treatment of chronic iron overload in patients with NTDT syndromes aged 10 years and older.
JADENU™ is available by prescription in three strengths: 90 mg, 180 mg and 360 mg. JADENUTM is a strength-adjusted formulation of deferasirox with higher bioavailability compared to EXJADE® dispersible tablets. JADENUTM requires a different dosing regimen and method of administration compared to EXJADE®. To avoid dosing errors, it is important that prescriptions of deferasirox specify both the type of formulation (dispersible tablet or film-coated tablet) and the prescribed dose in mg/kg/day. The dosage of JADENU™ is adjusted by weight, individual patient tolerability and level of iron in the body.
Important Safety Information
JADENU™ contains deferasirox, its active ingredient. Deferasirox is contraindicated in patients with moderate and severe renal impairment and has not been studied in patients with severe hepatic impairment. Deferasirox can cause the following clinically significant adverse events: acute renal failure, hepatic failure and gastrointestinal haemorrhage and perforations. The most frequently occurring adverse events in the therapeutic trials of deferasirox were diarrhea, vomiting, nausea, headache, constipation, dyspepsia, abdominal pain, pyrexia, cough, proteinuria, increases in serum creatinine and transaminases, pruritis and skin rash. Gastrointestinal disorders, increases in serum creatinine and skin rash were dose related.
JADENU™ is contraindicated in patients with estimated creatinine clearance (ClCr) <60 mL/min or serum creatinine >2 times the age-appropriate upper limit of normal (ULN); in high risk myelodysplastic syndrome (MDS) patients, any other MDS patient with a life expectancy < 1 year and patients with other hematological and non-hematological malignancies who are not expected to benefit from chelation therapy due to the rapid progression of their disease; in patients with platelet counts < 50 x 109/L; in patient with hypersensitivity to JADENU™ or to any of the excipients.
JADENU™ should not be combined with other iron chelator therapies as the safety and efficacy of such combinations has not been established.
For additional information, please refer to the JADENU™ Product Monograph.
The foregoing release contains forward-looking statements that can be identified by words such as "hope," "will," "as soon as possible," "expected," or similar terms, or by express or implied discussions regarding potential additional marketing approvals or new indications or labeling for JADENU™, or regarding potential future revenues from JADENU™. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that JADENU™ will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that JADENU™ will be submitted or approved for sale in any additional markets or at any particular time. Nor can there be any guarantee that JADENU™ will be commercially successful in the future, or will achieve any particular level of revenue. In particular, management's expectations regarding JADENU™ could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures and reimbursement issues; unexpected safety issues; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis Pharmaceuticals Canada Inc.
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1. Novartis Pharmaceuticals Canada, Product Monograph for JADENU™ (deferasirox tablets), February 19, 2016, pp. 4-5; 25. 2. Andrews NC. Disorder of iron metabolism. N Engl J Med. 1999; 341:1986-1995. Pp. 1993-94. 3. Taher A, Vichinsky E, Musallam K, Cappellini MD, Viprakasit V. Guidelines for the Management on Non Transfusion Dependent Thalassaemia (NTDT). Nicosia, Cyprus: Thalassaemia International Federation; 2013, pp 35 & 37. 4. Kohgo Y, Ikuta K, Ohtake T, Torimoto Y, Kato J. Body iron metabolism and pathophysiology of iron overload. Int J Hematol. 2008 Jul; 88(1):7-15.p. 7. 5. Musallam et al. Elevated liver iron concentration is a marker of increased morbidity in patients with beta thalassemia intermedia. Haematologica. 2011, 96(11): 1605–1612. p. 1605. 6. Centers for Disease Control and Prevention (CDC), Diamond Blackfan Anemia, Chelation Therapy, accessed Feb. 15, 2016 at: http://www.cdc.gov/ncbddd/dba/chelation.html 7. Porter JB. Practical management of iron overload. Br J Haematol. 2001:115:239- 252. p. 241. 8. Thalassemia Foundation of Canada, Frequently Asked Questions, How can thalassemia be treated? Accessed Feb. 15, 2016 at: http://www.thalassemia.ca/resources/faq-2/ 9. Sickle Cell Disease Association of Canada, homepage slide #5, accessed Feb. 15, 2016, at: http://www.sicklecelldisease.ca/