(deferasirox) Learn about a once-daily prescription tablet for chronic iron overload (IO).

Transcription

1 NO MORE MIXING. NO MORE MEASURING. NO MORE MEALTIME WORRIES. (deferasirox) Learn about a once-daily prescription tablet for chronic iron overload (IO). If a patient experiences dizziness while taking JADENU, they should avoid driving or operating machinery. INDICATIONS IMPORTANT SAFETY INFORMATION for JADENU (deferasirox) Tablets Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) JADENU is indicated for the treatment of chronically elevated levels of iron in the blood caused by repeated blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. In these patients, deferasirox lowered the levels of iron in the blood (measured by serum ferritin levels) and liver (measured by liver iron concentration) There are ongoing studies to find out how JADENU works over a longer period of time Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes JADENU is 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. JADENU should be used when these patients have elevated levels of iron in the liver (measured by liver iron concentrations of at least 5 milligrams of iron per gram of liver dry tissue weight) and in the blood (measured by serum ferritin levels greater than 300 mcg/l) There are ongoing studies to find out how JADENU works over a longer period of time Limitations on the Use of JADENU It is not known if JADENU is safe or effective when taken with another therapy that lowers iron levels in the blood There are patients with a serious blood disorder known as myelodysplastic syndromes (MDS) that may take JADENU to treat chronically elevated levels of iron in the blood caused by repeated blood transfusions. The iron-lowering effects and safety of JADENU have not been studied in clinical trials specifically designed for just these patients with MDS Please see additional Important Safety Information throughout, and full Prescribing Information, including Boxed WARNING, available at What is the most important safety information to know about JADENU? JADENU contains deferasirox, the same active ingredient in EXJADE 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. Your doctor should check your kidneys with a blood test called serum creatinine and/or creatinine clearance: Before taking JADENU Monthly during treatment If you already have a history of kidney problems or are at risk for kidney problems, your doctor should check your kidneys: Every week for the first month Monthly during treatment Your doctor should check your liver with blood tests called serum transaminases and bilirubin: Before taking JADENU Every other week for the first month after starting JADENU Monthly during treatment

2 What is chronic iron overload? What is chronic iron overload (IO)? Iron overload is the buildup of excess iron in the body. The extra iron can get stored in the heart and liver, harming these important organs. What causes chronic iron overload? Chronic iron overload can result from genetic defects or from frequent blood transfusions required to treat certain types of anemia. Three conditions in particular (thalassemia, sickle cell disease, and myelodysplastic syndromes) are characterized by a defect in the production of blood and may require frequent or repeated transfusions. Because the body cannot eliminate the extra iron received through these transfusions, an excess amount of iron builds up in the body. What are the signs and symptoms of chronic iron overload? There are no obvious symptoms of chronic iron overload. Since the disease often goes unnoticed, it is key that the patient s doctor checks for iron overload with blood work and other tests. What is serum ferritin? Serum ferritin is a measurement of iron stored in the body. What happens if chronic iron overload is not treated? Excess iron from multiple blood transfusions overwhelms the body s natural ability to store iron. Over time, iron overload, left undiagnosed and untreated, can lead to the buildup of iron in the heart and the liver. Transfused patients are often treated for chronic iron overload with a type of drug therapy called iron chelation, which removes excess iron from the body. What is liver iron concentration (LIC)? LIC is a measure of iron accumulation in the liver. INDICATIONS Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) JADENU is indicated for the treatment of chronically elevated levels of iron in the blood caused by repeated blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. In these patients, deferasirox lowered the levels of iron in the blood (measured by serum ferritin levels) and liver (measured by liver iron concentration) There are ongoing studies to find out how JADENU works over a longer period of time Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes JADENU is 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. JADENU should be used when these patients have elevated levels of iron in the liver (measured by liver iron concentrations of at least 5 milligrams of iron per gram of liver dry tissue weight) and in the blood (measured by serum ferritin levels greater than 300 mcg/l) There are ongoing studies to find out how JADENU works over a longer period of time

3 What is JADENU? What is JADENU? JADENU is an iron chelation medication in a tablet form that can help rid the body of excess iron due to blood transfusions in patients aged 2 years and older and non-transfusiondependent thalassemia (NTDT) in patients aged 10 years and older. JADENU was approved by the US Food and Drug Administration (FDA) on March 30, It is made from the same active ingredient as EXJADE for oral suspension. How does JADENU differ from current iron removal therapy? JADENU is a once-daily tablet that can be swallowed whole with water or other liquids, preferably at the same time each day, offering a single-step treatment option that doesn t require dispersion in liquid like EXJADE. This means it can be taken anywhere, without time-consuming preparation. JADENU can also be taken with or without a light meal, while EXJADE must be taken on an empty stomach. Light meals are meals that contain less than 7% fat and ~250 calories. Examples of a light meal include a whole wheat English muffin, a packet of jelly, and skim milk or a turkey sandwich with 2 oz. of turkey on whole wheat bread with lettuce, tomato, and one packet of mustard. How is JADENU dosed? JADENU dosing is based on weight. If a patient is currently taking EXJADE, he or she should be aware that JADENU tablet strengths are less than EXJADE tablet strengths. The patient s doctor will determine how much JADENU a patient will need to adequately control his or her iron. Available JADENU strengths are 90 mg, 180 mg, and 360 mg. However, dosing is weight based so a patient may take multiple pills a day. Patients should keep their doctor informed of any weight changes, as the dose may need to be adjusted if a patient gains or loses weight. If a patient is currently on treatment and his or her doctor wants to switch to JADENU, does it mean the old medicine isn t working? No. If a patient switches to JADENU, that does not mean that his or her old treatment isn t working. If patients have questions or concerns about why they are being switched or about their new regimen, they should talk openly with their doctor and ask as many questions as they feel are necessary. How should JADENU be stored? JADENU should be stored at room temperature at 25 C (77 F); excursions are permitted between 15 and 30 C (59 86 F). Do not store medicine in hot, damp, or humid places. Keep all medications out of the reach of children. INDICATIONS Limitations on the Use of JADENU It is not known if JADENU is safe or effective when taken with another therapy that lowers iron levels in the blood There are patients with a serious blood disorder known as myelodysplastic syndromes (MDS) that may take JADENU to treat chronically elevated levels of iron in the blood caused by repeated blood transfusions. The iron lowering effects and safety of JADENU have not been studied in clinical trials specifically designed for just these patients with MDS IMPORTANT SAFETY INFORMATION You should not take JADENU if you have: Certain kinds of kidney problems Preexisting severe liver problems High-risk MDS Advanced cancer Low blood counts (low platelets) An allergy to JADENU or any ingredient of JADENU

4 Who can take JADENU? Is JADENU safe for use in children? JADENU has been approved by the FDA for use in children as young as 2 years of age with chronic iron overload due to blood transfusions. JADENU has been approved by the FDA for use in treating patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called NTDT and who have a liver iron concentration, or LIC, of at least 5 milligrams of iron per gram of liver dry weight and a serum ferritin level greater than 300 mcg/l. Can a patient take JADENU while pregnant or breastfeeding? Those patients taking JADENU should talk to their doctor if they think they are pregnant or plan to become pregnant. There are no adequate and well-controlled clinical studies of JADENU in pregnant women. JADENU should be used during pregnancy only if the benefit to the patient clearly exceeds the potential risk to the fetus. Patients who are breastfeeding should discuss discontinuing the drug or discontinuing nursing, taking into consideration the importance of the drug to the mother. Who should not take JADENU? Patients should not take JADENU if they have: Certain kinds of kidney problems Preexisting severe liver problems High-risk myelodysplastic syndromes Advanced cancer Low blood counts (low platelets) An allergy to JADENU or any ingredient of JADENU IMPORTANT SAFETY INFORMATION (cont) Kidneys If you have a pre-existing kidney condition, are elderly, have multiple medical conditions, or are taking medicine that affects your kidneys, you are at increased risk of complications. Your doctor will give you a blood test (called serum creatinine and/or creatinine clearance) every week for the first month you are taking JADENU or if your dose has changed, and then every month after that. Your doctor may adjust your dose based on the results of these tests Your doctor may also collect urine samples monthly Some patients developed severe kidney problems while taking deferasirox, in some cases fatal, and in some cases requiring dialysis. Most of the fatalities occurred in patients who were very ill because of their disease Liver If you have a preexisting severe liver problem, you should not use JADENU If you have mild or moderate liver problems, your doctor will give you blood tests called serum transaminases and bilirubin before starting treatment, every 2 weeks during the first month of treatment, and then monthly. Your doctor may adjust your dose based on the results of these tests Some patients developed severe liver problems, in some cases fatal, while taking deferasirox. Many of these patients were older than 55 years of age and/or had multiple medical conditions already affecting their liver

5 What can a patient expect from JADENU? How can patients tell if JADENU is working? Patients will be able to tell if JADENU is working by having their serum ferritin levels tested. They should make sure they stay on top of treatment and get their iron levels tested once a month or as directed by their physician. Why would a doctor adjust a patient s dose? Dose adjustments can occur for a number of reasons. The patient s doctor will monitor his or her serum ferritin level monthly and adjust the dose if necessary. If the patient has gained or lost weight, the dose may need to be adjusted. Also, if the patient experiences side effects, the dose may be adjusted. Patients should ask their doctor or nurse if they are concerned about a dose adjustment of any kind. In patients not adequately controlled with doses of 21 mg per kg (eg, serum ferritin levels persistently above 2500 mcg/l and not showing a decreasing trend over time), doses of up to 28 mg per kg may be considered. Doses above 28 mg/kg are not recommended. How long does it take for JADENU to start working? Each patient s response varies. The prescribing doctor will determine at what serum ferritin level to stop or interrupt treatment. Are there any available clinical trials for JADENU? Please visit for information about Novartis clinical trials. How long will a patient be on JADENU? Only the prescribing doctor can tell a patient when to discontinue use of JADENU. It is important that patients continue to take treatment exactly as prescribed unless they are directed by the prescribing doctor to stop. Does JADENU work as well as EXJADE? JADENU is made from deferasirox, the same active ingredient as EXJADE for oral suspension. Studies show that deferasirox can help remove excess iron in patients with chronic iron overload. JADENU is a tablet form of deferasirox that can be swallowed whole. The FDA approval of JADENU is based on studies showing that it works the same as EXJADE, while delivering the same levels of the drug in the body. Bleeding in the Stomach or Intestines Some patients developed stomach irritation or bleeds while taking deferasirox. In some cases, stomach bleeds were fatal, usually in patients who were elderly and had preexisting blood cancers and/or low blood counts (low platelets) Talk to your doctor if you are taking other drugs that can also irritate your stomach or cause a stomach bleed (eg, pain relievers/ anti-inflammatory drugs, corticosteroids, oral bisphosphonates, blood thinners) Blood Disorders Some patients developed severe blood disorders, in some cases fatal, while on deferasirox therapy. Having a preexisting blood disorder may increase the risk Your doctor will give you a blood test to check your blood counts

6 What can a patient expect from JADENU? What are the side effects of JADENU? Studies evaluating the safety of JADENU are ongoing. However, there are side effects associated with deferasirox, the active ingredient in JADENU. Common side effects include: Nausea Vomiting Diarrhea Stomach pain Changes in kidney function Skin rash Mild to moderate rashes often resolve spontaneously. Interrupt treatment with JADENU in severe cases. Starting at low doses while taking an oral steroid for a short time may be considered Increased Risks When Used in Elderly Patients Since deferasirox has been on the market, there have been reports of serious reactions, sometimes leading to death. These serious reactions and deaths have happened most often when deferasirox was taken by elderly patients Allergic Reactions Serious allergic reactions (which include swelling of the throat) have been reported in patients taking deferasirox, usually within the first month of treatment If you develop swelling of the throat, a severe rash, hearing problems, or vision disturbances, stop taking JADENU and contact your doctor immediately

7 How do patients take JADENU? How do patients take JADENU? JADENU should be taken exactly as prescribed. JADENU should be swallowed once daily with water or other liquids, preferably at the same time each day. JADENU can be taken with a light meal or on an empty stomach with water or other liquids. JADENU IS A SIMPLE-TO-TAKE TABLET. Once daily Anytime, anywhere With or without a light meal JADENU tablets should be swallowed once daily with water or other liquids, preferably at the same time each day For patients who have difficulty swallowing whole tablets, JADENU tablets may be crushed and mixed with soft foods (eg, yogurt or applesauce) 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 Light meals are meals that contain less than 7% fat and ~250 calories. Examples of a light meal include a whole wheat English muffin, a packet of jelly, and skim milk or a turkey sandwich with 2 oz. of turkey on whole wheat bread with lettuce, tomato, and one packet of mustard JADENU offers convenient administration for chronic iron overload treatment that fits into a patient s daily routine The prescribing doctor will calculate the dose and tell the patient how many tablets to take each day After starting therapy, the doctor will monitor the patient s serum ferritin level monthly and adjust the dose if necessary Doses are based on weight. Patients should keep their doctor informed of any weight changes, as their dose may need to be adjusted if they gain or lose weight Aluminum-containing antacids should not be taken at the same time Serious Skin Reactions Severe skin disorders that result in a very serious rash, called Stevens-Johnson syndrome and erythema multiforme, have been reported during treatment with deferasirox. If you develop a severe rash, stop taking JADENU and contact your doctor immediately Mild to moderate skin rashes may occur during treatment with deferasirox. Let your doctor know if the rash doesn t go away on its own or gets worse. Your doctor may need to change your dose of JADENU Hearing and Vision Changes Changes to hearing and vision have been reported in patients taking deferasirox. If you notice changes in your hearing or eyesight, contact your doctor immediately You may also receive a hearing or vision test prior to receiving JADENU and yearly thereafter. Your doctor may change your dose based on the results of these tests

8 Will JADENU affect other medications a patient is taking? Can patients take JADENU with other medications, both prescription and over-the-counter? JADENU should not be combined with other iron chelation therapies as safety of such combinations has not been established. Patients should be cautioned not to take aluminum-containing antacids and JADENU simultaneously. Patients should tell their doctor about all medications they are taking or intend to take. The prescribing doctor should decide whether JADENU can be taken with other medications. Is there any drug-to-drug interaction? Yes, there are possible interactions with other drugs. Patients should read the full Prescribing Information, including Boxed WARNING, and Medication Guide for more information. Patients should be encouraged to speak with their doctor or a pharmacist who is familiar with their medications before taking JADENU. Does JADENU contain latex? No. JADENU does not contain latex. Does JADENU contain gelatin? No. JADENU does not contain gelatin. Does JADENU contain gluten? No. JADENU does not contain gluten. Does JADENU contain lactose? No. JADENU does not contain lactose. Common Side Effects The most commonly reported side effects related to deferasirox in clinical trials were mainly nausea, vomiting, diarrhea, stomach pain, increases in kidney laboratory values, and skin rash Let your doctor know if you are experiencing any side effects. Your doctor may need to change your dose If you experience diarrhea or vomiting, you must continue to drink fluids You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA-1088 Taking Other Medicines with JADENU If you are taking other medicines, such as birth control pills, diabetes drugs, seizure drugs, cholesterol-lowering drugs, or medicine for serious illnesses, talk to your doctor. JADENU may affect how these drugs work Talk to your doctor to determine if prescription JADENU therapy is right for you.

9 What resources are available for JADENU? Can patients get help paying for JADENU? Yes. Novartis is committed to helping patients access the medications they need. For more information, patients can visit the additional resources section of the JADENU website. Also, patients can call to speak to a Novartis representative to see if there are programs that can help. Where can patients get more information about JADENU? Encourage patients to talk to their doctor to learn more about JADENU and to find out if it s right for them. For additional information on resources, support programs, and more, patients can visit How is JADENU distributed? JADENU is available at specialty pharmacies nationwide and select in-office and hospital pharmacies. INDICATIONS Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) JADENU is indicated for the treatment of chronically elevated levels of iron in the blood caused by repeated blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. In these patients, deferasirox lowered the levels of iron in the blood (measured by serum ferritin levels) and liver (measured by liver iron concentration) There are ongoing studies to find out how JADENU works over a longer period of time Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes JADENU is 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. JADENU should be used when these patients have elevated levels of iron in the liver (measured by liver iron concentrations of at least 5 milligrams of iron per gram of liver dry tissue weight) and in the blood (measured by serum ferritin levels greater than 300 mcg/l) There are ongoing studies to find out how JADENU works over a longer period of time Please see Important Safety Information throughout, including Boxed WARNING on page 1, and full Prescribing Information, available at Novartis Pharmaceuticals Corporation East Hanover, New Jersey Novartis 11/15 JAD