Deferasirox (Jadenu)

Trade Name : Jadenu

Novartis Pharmaceuticals Corporation

TABLET, FILM COATED

Strength 90 mg/1

DEFERASIROX Iron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Deferasirox (Jadenu) which is also known as Jadenu and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 90 mg/1 per ml. Read more

Deferasirox (Jadenu) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Renal Failure
  • Hepatic Failure
  • Gastrointestinal Hemorrhage
  • WARNING: RENAL FAILURE, HEPATIC FAILURE, and GASTROINTESTINAL HEMORRHAGE
  • See full prescribing information for complete boxed warning.
  • JADENU may cause serious and fatal:
  • JADENU therapy requires close patient monitoring, including laboratory tests of renal and hepatic function. ()
  • acute kidney injury, including acute renal failure requiring dialysis and renal tubular toxicity including Fanconi syndrome ()
  • hepatic toxicity, including failure ()
  • gastrointestinal hemorrhage ()
  • No data
  • JADENU is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. ()
  • 1.2
  • Limitations of Use:
  • ntttttttttThe safety and efficacy of JADENU when administered with other iron chelation therapy have not been established. ()
  • No data
  • Transfusional Iron Overload: Initial dose for patients with estimated glomerular filtration rate (eGFR) greater than 60 mL/min/1.73 m is 14 mg per kg (calculated to nearest whole tablet or nearest whole sachet content for granules) once daily. ()
  • NTDT Syndromes: Initial dose for patients with eGFR greater than 60 mL/min/1.73 m is 7 mg per kg (calculated to nearest whole tablet or nearest whole sachet content for granules) once daily. ()
  • See Full Prescribing information for information regarding monitoring, administration, and dose-reductions for organ impairment. (, , , )
  • Tablets: 90 mg, 180 mg, 360 mg. ()
  • Granules: 90 mg, 180 mg, 360 mg. ()
  • JADENU is contraindicated in patients with:
  • Estimated GFR less than 40 mL/min/1.73 m. ()n
  • Patients with poor performance status. ()n
  • Patients with high-risk MDS. ()n
  • Patients with advanced malignancies. ()
  • Patients with platelet counts less than 50 x 10/L. ()
  • Known hypersensitivity to deferasirox or any component of JADENU. ()
  • No data
  • Acute Kidney Injury: Measure serum creatinine in duplicate before starting therapy. Monitor renal function during JADENU therapy and reduce dose or interrupt therapy for toxicity. (, , )
  • Hepatic Toxicity: Monitor hepatic function. Reduce dose or interrupt therapy for toxicity. ()
  • Fatal and Nonfatal Gastrointestinal Bleeding, Ulceration, and Irritation: Risk may be greater in patients who are taking JADENU in combination with drugs that have known ulcerogenic or hemorrhagic potential. ()
  • Bone Marrow Suppression: Neutropenia, agranulocytosis, worsening anemia, and thrombocytopenia, including fatal events; monitor blood counts during JADENU therapy. Interrupt therapy for toxicity. ()
  • Age-related Risk of Toxicity: Monitor elderly and pediatric patients closely for toxicity. ()
  • Hypersensitivity Reactions: Discontinue JADENU for severe reactions and institute medical intervention. ()
  • Severe Skin Reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS): Discontinue JADENU. ()
  • The following clinically significant adverse reactions are also discussed in other sections of the labeling:
  • In patients with transfusional iron overload, the most frequently occurring (greater than 5%) adverse reactions are diarrhea, vomiting, nausea, abdominal pain, skin rashes, and increases in serum creatinine. In deferasirox-treated patients with NTDT syndromes, the most frequently occurring (greater than 5%) adverse reactions are diarrhea, rash and nausea. ()
  • No data
  • Do not take JADENU with aluminum-containing antacid preparations. ()
  • Deferasirox increases the exposure of repaglinide. Consider repaglinide dose reduction and monitor blood glucose levels. ()
  • Avoid the use of JADENU with theophylline as theophylline levels could be increased. ()nttttttttt
  • Deferasirox increases exposure of busulfan. Monitor plasma concentrations of busulfan when coadministered with deferasirox to allow dose adjustment of busulfan, as needed. ()nttttttttt
  • No data
  • Lactation: Advise women not to breastfeed. ()n
  • Cases of overdose (2 to 3 times the prescribed dose for several weeks) have been reported. In one case, this resulted in hepatitis which resolved without long-term consequences after a dose interruption. In one pediatric case, a dose of 2-3 times the prescribed dose for 6 days resulted in acute renal failure requiring hemofiltration and acute liver injury/failure, which were reversible with intensive care support. Single doses of deferasirox up to 80 mg per kg per day with the tablet for oral suspension formulation in iron-overloaded beta-thalassemic patients have been tolerated with nausea and diarrhea noted. In healthy subjects, single doses of up to 40 mg per kg per day with the tablet for oral suspension formulation were tolerated. There is no specific antidote for JADENU. In case of overdose, induce vomiting and employ gastric lavage.
  • JADENU (deferasirox) is an iron-chelating agent provided as a tablet or granules for oral use. Deferasirox is designated chemically as 4-[3,5-bis(2-hydroxyphenyl)-1-1,2,4-triazol-1-yl]benzoic acid and has the following structural formula:
  • Deferasirox is a white to slightly yellow powder. It has a molecular formula CHNO and molecular weight of 373.4 g/mol. It is insoluble in water with a pH of suspension of 4.1.
  • JADENU tablets contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, poloxamer (188), and povidone (K30). The film coating contains opadry blue.
  • JADENU Sprinkle granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone (K30), poloxamer (188).
  • No data
  • A 104-week oral carcinogenicity study in Wistar rats showed no evidence of carcinogenicity from deferasirox at doses up to 60 mg/kg/day (0.7 times the MRHD on an mg/m basis). A 26-week oral carcinogenicity study in p53 (+/-) transgenic mice has shown no evidence of carcinogenicity from deferasirox at doses up to 200 mg/kg/day (1.2 times the MRHD on an mg/m basis) in males and 300 mg/kg/day (1.7 times the MRHD on an mg/m basis) in females.
  • Deferasirox was negative in the Ames test and chromosome aberration test with human peripheral blood lymphocytes. It was positive in 1u00a0ofu00a03 oral rat micronucleus tests.
  • Deferasirox at oral doses up to 75 mg/kg/day (0.9 times the MRHD on an mg/m basis) was found to have no adverse effect on fertility and reproductive performance of male and female rats.
  • JADENU was evaluated in healthy subjects. There are no clinical data in patients with JADENU. JADENU contains the same active ingredient as Exjade (deferasirox) tablets for oral suspension. The following information is based on clinical trials conducted with Exjade tablets for oral suspension.
  • Transfusional Iron Overload
  • The primary efficacy study, Study 1 (NCT00061750), was a multicenter, open-label, randomized, active-comparator control study to compare deferasirox tablets for oral suspension and deferoxamine in patients with beta-thalassemia and transfusional hemosiderosis. Patients greater than or equal to 2 years of age were randomized in a 1:1 ratio to receive either oral deferasirox tablets for oral suspension at starting doses of 5, 10, 20, or 30 mg per kg once daily or subcutaneous deferoxamine at starting doses of 20 to 60 mg per kg for at least 5 days per week based on LIC at baseline (2 to 3, greater than 3 to 7, greater than 7 to 14, and greater than 14 mg Fe/g dry weight). Patients randomized to deferoxamine who had LIC values less than 7 mg Fe/g dry weight were permitted to continue on their prior deferoxamine dose, even though the dose may have been higher than specified in the protocol.
  • Patients were to have a liver biopsy at baseline and end of study (after 12 months) for LIC. The primary efficacy endpoint was defined as a reduction in LIC of greater than or equal to 3 mg Fe/g dry weight for baseline values greater than or equal to 10 mg Fe/g dry weight, reduction of baseline values between 7 and less than 10 to less than 7 mg Fe/g dry weight, or maintenance or reduction for baseline values less than 7 mg Fe/g dry weight.
  • A total of 586 patients were randomized and treated, 296 with deferasirox tablets for oral suspension and 290 with deferoxamine. The mean age was 17.1 years (range, 2 to 53 years); 52% were females and 88% were Caucasian. The primary efficacy population consisted of 553 patients (deferasirox tablets for oral suspension n = 276; deferoxamine n = 277) who had LIC evaluated at baseline and 12 months or discontinued due to an adverse event. The percentage of patients achieving the primary endpoint was 52.9% for deferasirox tablets for oral suspension and 66.4% for deferoxamine. The relative efficacy of deferasirox to deferoxamine cannot be determined from this study.
  • In patients who had an LIC at baseline and at end of study, the mean change in LIC was -2.4 mg Fe/g dry weight in patients treated with deferasirox tablets for oral suspension and -2.9 mg Fe/g dry weight in patients treated with deferoxamine.
  • Reduction of LIC and serum ferritin was observed with deferasirox tablet for oral suspension doses of 20 to 30 mg per kg per day. Deferasirox tablets for oral suspension doses below 20 mg per kg per day failed to provide consistent lowering of LIC and serum ferritin levels (Figure 1). Therefore, a starting dose of 20 mg per kg per day is recommended .
  • Study 2 (NCT00061763) was an open-label, noncomparative trial of efficacy and safety of deferasirox tablets for oral suspension given for 1 year to patients with chronic anemias and transfusional hemosiderosis. Similar to Study 1, patients received 5, 10, 20, or 30 mg per kg per day of deferasirox tablets for oral suspension based on baseline LIC.
  • A total of 184 patients were treated in this study: 85 patients with beta-thalassemia and 99 patients with other congenital or acquired anemias (myelodysplastic syndromes, n = 47; Diamond-Blackfan syndrome, n = 30; other, n = 22). Nineteen percent (19%) of patients were less than 16 years of age and 16% were greater than or equal to 65 years of age. There was a reduction in the absolute LIC from baseline to end of study (-4.2 mg Fe/g dry weight).
  • Study 3 (NCT00067080) was a multicenter, open-label, randomized trial of the safety and efficacy of deferasirox tablets for oral suspension relative to deferoxamine given for 1 year in patients with sickle cell disease and transfusional hemosiderosis. Patients were randomized to deferasirox tablets for oral suspension at doses of 5, 10, 20, or 30 mg per kg per day or subcutaneous deferoxamine at doses of 20-60 mg per kg per day for 5 days per week according to baseline LIC.
  • A total of 195 patients were treated in this study: 132 with deferasirox tablets for oral suspension and 63 with deferoxamine. Forty-four percent (44%) of patients were less than 16 years of age and 91% were black. At end of study, the mean change in LIC (as measured by magnetic susceptometry by a superconducting quantum interference device) in the per protocol-1 (PP-1) population, which consisted of patients who had at least 1 post-baseline LIC assessment, was -1.3 mg Fe/g dry weight for patients receiving deferasirox tablets for oral suspension (n = 113) and -0.7 mg Fe/g dry weight for patients receiving deferoxamine (n = 54).
  • One-hundred five (105) patients with thalassemia major and cardiac iron overload were enrolled in a study assessing the change in cardiac MRI T2* value [(measured in milliseconds, (ms)] before and after treatment with deferasirox. Cardiac T2* values at baseline ranged from 5 to less than 20 ms. The geometric mean of cardiac T2* in the 68 patients who completed 3 years of deferasirox tablets for oral suspension therapy increased from 11.98 ms at baseline to 17.12 ms at 3 years. Cardiac T2* values improved in patients with severe cardiac iron overload (less than 10 ms) and in those with mild to moderate cardiac iron overload (greater than or equal to 10 to less than 20 ms). The clinical significance of these observations is unknown.
  • Six hundred twenty-seven (627) patients with MDS were enrolled across 5 uncontrolled trials. Two hundred thirty-nine (239) of the 627 patients were enrolled in trials that limited enrollment to patients with IPSS Low or Intermediate 1 risk MDS, and the remaining 388 patients were enrolled in trials that did not specify MDS risk stratification but required a life expectancy of greater than 1 year. Planned duration of treatment in these trials ranged from 1 year (365 patients) to 5 years (47 patients). These trials evaluated the effects of deferasirox tablets for oral suspension therapy on parameters of iron overload, including LIC (125 patients) and serum ferritin (627 patients). The percent of patients completing planned duration of treatment was 51% in the largest 1-year study, 52% in the 3-year study and 22% in the 5-year study. The major causes for treatment discontinuation were withdrawal of consent, adverse reaction, and death. Over 1 year of follow-up across these pooled studies, mean change in serum ferritin was -332.8 (u00b12615.59) mcg/L (n = 593) and mean change in LIC was -5.9 (u00b18.32) mg Fe/g dw (n = 68). Results of these pooled studies in 627 patients with MDS suggest a progressive decrease in serum ferritin and LIC beyond 1 year in those patients who are able to continue deferasirox tablets for oral suspension.
  • Study 4 (TELESTO; NCT 00940602) was a randomized, double-blind, placebo-controlled trial performed in 225 patients with MDS (Low/Int-1 risk) and transfusional iron overload of which 149 were treated with deferasirox and 76 received placebo. The observed hazard ratio of 0.64 (95% CI: 0.42, 0.96) suggests a positive impact of deferasirox on event-free survival (EFS, a composite endpoint defined as death, worsening cardiac function, hospitalization for congestive heart failure, liver function impairment, liver cirrhosis, or progression to acute myeloid leukemia; whichever occurred first).
  • Non-Transfusion-Dependent Thalassemia
  • Study 5 (NCT00873041) was a randomized, double-blind, placebo-controlled trial of treatment with deferasirox tablets for oral suspension for patients 10 years of age or older with NTDT syndromes and iron overload. Eligible patients had an LIC of at least 5 mg Fe/g dw measured by R2 MRI and a serum ferritin exceeding 300 mcg/L at screening (2 consecutive values at least 14 days apart from each other). A total of 166 patients were randomized, 55 to the deferasirox tablets for oral suspension 5 mg/kg/day dose group, 55 to the deferasirox tablets for oral suspension 10 mg/kg/day dose group, and 56 to placebo (28 to each matching placebo group). Doses could be increased after 6 months if the LIC exceeded 7 mg Fe/g dw and the LIC reduction from baseline was less than 15%. The patients enrolled included 89 males and 77 females. The underlying disease was beta-thalassemia intermedia in 95 (57%) patients, HbE beta-thalassemia in 49 (30%) patients, and alpha-thalassemia in 22 (13%) patients. There were 17 pediatric patients in the study. Caucasians comprised 57% of the study population and Asians comprised 42%. The median baseline LIC (range) for all patients was 12.1 (2.6 to 49.1) mg Fe/g dw. Follow-up was for 1 year. The primary efficacy endpoint of change in LIC from baseline to Week 52 was statistically significant in favor of both deferasirox dose groups compared with placebo (p less than or equal to 0.001) (Table 5). Furthermore, a statistically significant dose effect of deferasirox was observed in favor of the 10 mg/kg/day dose group (10 versus 5 mg/kg/day, p = 0.009). In a descriptive analysis, the target LIC (less than 5 mg Fe/g dw) was reached by 15 (27%) of 55 patients in the 10 mg/kg/day arm, 8 (15%) of 55 patients in the 5 mg/kg/day arm, and 2 (4%) of 56 patients in the combined placebo groups.
  • Study 6 (NCT00873041) was an open-label trial of deferasirox tablets for oral suspension for the treatment of patients previously enrolled on Study 5, including cross-over to active treatment for those previously treated with placebo. The starting dose of deferasirox tablets for oral suspension in Study 6 was assigned based on the patientu2019s LIC at completion of Study 5, being 20 mg/kg/day for an LIC exceeding 15 mg Fe/g dw, 10 mg/kg/day for LIC 3 to 15 mg Fe/g dw, and observation if the LIC was less than 3 mg Fe/g dw. Patients could continue on 5 mg/kg/day if they had previously exhibited at least a 30% reduction in LIC. Doses could be increased to a maximum of 20 mg/kg/day after 6 months if the LIC was more than 7 mg Fe/g dw and the LIC reduction from baseline was less than 15%. The primary efficacy endpoint in Study 6 was the proportion of patients achieving an LIC less than 5 mg Fe/g dw. A total of 133 patients were enrolled. Twenty patients began Study 6 with an LIC less than 5 mg Fe/g dw. Of the 113 patients with a baseline LIC of at least 5 mg Fe/g dw in Study 6, the target LIC (less than 5 mg Fe/g dw) was reached by 39 (35%). The responders included 4 (10%) of 39 patients treated at 20 mg/kg/day for a baseline LIC exceeding 15 mg Fe/g dw, and 31 (51%) of 61 patients treated at 10 mg/kg/day for a baseline LIC between 5 and 15 mg Fe/g dw. The absolute change in LIC at Week 52 by starting dose is shown in Table 5.
  • JADENU 90 mg tablets are light blue in color, film-coated, oval biconvex tablets with beveled edges, debossed with u2018NVRu2019 on one side and u201890u2019 on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tabletsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026(NDC 0078-0654-15)
  • JADENU 180 mg tablets are medium blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with u2018NVRu2019 on one side and u2018180u2019 on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tabletsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026(NDC 0078-0655-15)
  • JADENU 360 mg tablets are dark blue in color, film-coated, oval biconvex tablet with beveled edges, debossed with u2018NVRu2019 on one side and u2018360u2019 on a slight upward slope in between two debossed curved lines on the other side. They are available in bottles of 30 tabletsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026(NDC 0078-0656-15)
  • Store JADENU tablets at 20u00b0C-25u00b0C (68u00b0F-77u00b0F); excursions are permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature]. Protect from moisture.
  • JADENU Sprinkle 90 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachetsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026(NDC 0078-0727-15)
  • JADENU Sprinkle 180 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachetsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026(NDC 0078-0713-15)
  • JADENU Sprinkle 360 mg granules are white to almost white granules in sachet. They are available in cartons of 30 sachetsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026(NDC 0078-0720-15)
  • Store JADENU Sprinkle granules at 20u00b0C-25u00b0C (68u00b0F-77u00b0F); excursions are permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature]. Protect from moisture.
  • Dosing Instructions
  • Advise patients to take JADENU tablets with water or other liquids. Advise patients to swallow JADENU tablets once daily with water or other liquids, preferably at the same time each day. Advise patients to take JADENU tablets on an empty stomach or with a light meal (contains less than 7% fat content and approximately 250 calories). Examples of light meals include 1 whole wheat English muffin, 1 packet jelly (0.5 ounces), and skim milk (8 fluid ounces) or a turkey sandwich (2 oz. turkey on whole wheat bread w/lettuce, tomato, and 1 packet mustard). For patients who have difficulty swallowing whole tablets, JADENU tablets may be crushed and mixed with soft foods (e.g., yogurt or applesauce) immediately prior to use and administered orally. Advise against the use of commercial crushers with serrated surfaces for crushing a single 90 mg tablet. Advise patients to immediately and completely consume the dose and not store it for future use .
  • Advise patients to take JADENU Sprinkle granules by sprinkling the full dose on soft food (e.g., yogurt or applesauce) immediately prior to use and administered orally. Advise patients to take JADENU Sprinkle granules once a day, preferably at the same time each day. JADENU Sprinkle granules may be taken on an empty stomach or with a light meal.
  • Blood Testing
  • Advise patients that blood tests will be performed frequently to check for damage to kidneys, liver, or blood cells .
  • Acute Kidney Injury, Including Acute Renal Failure
  • Caution patients about the potential for kidney toxicity when taking JADENU tablets or JADENU Sprinkle granules. Inform patients of the signs and symptoms of kidney injury. Advise patients to contact their healthcare provider immediately if they experience any of these symptoms .
  • Hepatic Toxicity and Failure
  • Caution patients about the potential for hepatic toxicity when taking JADENU tablets or JADENU Sprinkle granules. Inform patients of the signs and symptoms of hepatic toxicity. Advise patients to contact their healthcare provider immediately if they experience any of these symptoms .
  • Gastrointestinal Ulceration and Hemorrhage
  • Caution patients about the potential for the development of GI ulcers or bleeding when taking JADENU in combination with drugs that have ulcerogenic or hemorrhagic potential, such as NSAIDs, corticosteroids, oral bisphosphonates, or anticoagulants. Inform patients of the signs and symptoms of GI ulcers or bleeding. Advise patients to contact their healthcare provider for symptoms of heartburn but to seek immediate medical attention for symptoms of gastrointestinal hemorrhage .
  • Allergic Reactions
  • Serious allergic reactions (which include swelling of the throat) have been reported in patients taking -JADENU, usually within the first month of treatment. If reactions are severe, advise patients to stop taking JADENU immediately and seek immediate medical attention .
  • Severe Skin Reactions
  • Severe skin reactions have been reported in patients taking JADENU tablets or JADENU Sprinkle granules. Inform patients of the signs and symptoms of severe skin reactions. If reactions are severe, advise patients to stop taking JADENU tablets or JADENU Sprinkle granules immediately and seek immediate medical attention .
  • Skin Rash
  • Skin rashes may occur during JADENU treatment. If the skin rash is severe, advise patients to stop taking JADENU and seek medical attention .
  • Pediatric Patients with Acute Illness
  • Instruct pediatric patients and their caregivers to contact their healthcare provider during episodes of acute illness, especially if the patient has not been drinking fluids or the patient has volume depletion due to fever, vomiting, or diarrhea .
  • Auditory and Ocular Testing
  • Because auditory and ocular disturbances have been reported with deferasirox, conduct auditory testing and ophthalmic testing before starting JADENU treatment and thereafter at regular intervals. Advise patients to contact their healthcare provider if they develop visual or auditory changes during treatment .
  • Drug Interactions
  • Caution patients not to take aluminum containing antacids and JADENU tablets or granules simultaneously .
  • Caution patients about potential loss of effectiveness of drugs metabolized by CYP3A4 (e.g., cyclosporine, simvastatin, hormonal contraceptive agents) when JADENU is administered with these drugs .
  • Caution patients about potential loss of effectiveness of JADENU when administered with drugs that are potent UGT inducers (e.g., rifampicin, phenytoin, phenobarbital, ritonavir). Based on serum ferritin levels and clinical response, consider increases in the dose of JADENU when concomitantly used with potent UGT inducers .
  • Caution patients about potential loss of effectiveness of JADENU when administered with drugs that are bile acid sequestrants (e.g., cholestyramine, colesevelam, colestipol). Based on serum ferritin levels and clinical response, consider increases in the dose of JADENU when concomitantly used with bile acid sequestrants .
  • Caution patients with diabetes to monitor their glucose levels more frequently when repaglinide is used concomitantly with JADENU .
  • Handling Instructions
  • Advise patients to store JADENU in a dry, room-temperature environment .
  • Driving and Using Machines
  • Caution patients experiencing dizziness to avoid driving or operating machinery .
  • Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
  • u00a9 Novartis
  • T2019-86
  • No data
  • Package Label u2013 90 mg
  • Rx Onlyntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0654-15
  • Jadenu (deferasirox)
  • Film-coated Tablets
  • 90 mg per Tablet
  • 30 Tablets
  • Package Label u2013 180 mg
  • Rx Onlyntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0655-15
  • Jadenu (deferasirox)
  • Film-coated Tablets
  • 180 mg per Tablet
  • 30 Tablets
  • Package Label u2013 360 mg
  • Rx Onlyntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0656-15
  • Jadenu (deferasirox)
  • Film-coated Tablets
  • 360 mg per Tablet
  • 30 Tablets
  • Package Label u2013 90 mg
  • Rx Onlyntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0727-15
  • Jadenu Sprinkle (deferasirox)
  • Oral Granules
  • 90 mg
  • Each sachet contains 162 mg granule equivalent to 90 mg deferasirox
  • Contains 30 sachets
  • Novartis
  • Package Label u2013 180 mg
  • Rx Onlyntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0713-15
  • Jadenu Sprinkle (deferasirox)
  • Oral Granules
  • 180 mg
  • Each sachet contains 324 mg granule equivalent to 180 mg deferasirox
  • Contains 30 sachets
  • Novartis
  • Package Label u2013 360 mg
  • Rx Onlyntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0720-15
  • Jadenu Sprinkle (deferasirox)
  • Oral Granules
  • 360 mg
  • Each sachet contains 648 mg granule equivalent to 360 mg deferasirox
  • Contains 30 sachets
  • Novartis

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General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71247 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

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