Deferasirox
Tablet, For Suspension · Oral
Uses
Deferasirox tablets are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. ( 1.1 ) Deferasirox tablets are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L.( 1.2 ) Limitations of Use The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. ( 1.3 ) 1.1 Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) Deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. 1.2 Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes Deferasirox tablets are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L. 1.3 Limitations of Use The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established.
Dosage and administration
Transfusional Iron Overload: Initial dose for patients with estimated glomerular filtration rate (eGFR) greater than 60 mL/min/1.73 m 2 is 14 mg per kg (calculated to nearest whole tablet ) once daily. ( 2.1 ) NTDT Syndromes: Initial dose for patients with eGFR greater than 60 mL/min/1.73 m 2 is 7 mg per kg (calculated to nearest whole tablet) once daily. ( 2.2 ) See full prescribing information for information regarding monitoring, administration, and dose-reductions for organ impairment. ( 2.1 , 2,2 , 2.3 , 2.4 ) 2.1Transfusional Iron Overload Deferasirox tablets therapy should only be considered when a patient has evidence of chronic transfusional iron overload. The evidence should include the transfusion of at least 100 mL/kg of packed red blood cells (e.g., at least 20 units of packed red blood cells for a 40 kg person or more in individuals weighing more than 40 kg), and a serum ferritin consistently greater than 1,000 mcg/L. Prior to starting therapy, or increasing dose, evaluate: Serum ferritin level Obtain renal function Obtain serum creatinine in duplicate (due to variations in measurements). Calculate the estimated glomerular filtration rate (eGFR). Use a prediction equation appropriate for adult patients (e.g., CKD-EPI, MDRD method) and in pediatric patients (e.g., Schwartz equations). Obtain urinalyses and serum electrolytes to evaluate renal tubular function [ see Dosage and Administration (2.4) , Warnings and Precautions (5.1)]. Serum transaminases and bilirubin [ see Dosage and Administration (2.4), Warnings and Precautions (5.2)] Baseline auditory and ophthalmic examinations [see Warnings and Precautions (5.10)] Initiating Therapy: The recommended initial dose of deferasirox tablets for patients 2 years of age and older with eGFR greater than 60 mL/min/1.73 m 2 is 14 mg per kg body weight orally, once daily. Calculate doses (mg per kg per day) to the nearest whole tablet. Changes in weight of pediatric patients over time must be taken into account when calculating the dose. During Therapy: Monitor serum ferritin monthly and adjust the dose of deferasirox tablets, if necessary, every 3 to 6 months based on serum ferritin trends. Use the minimum effective dose to achieve a trend of decreasing ferritin Make dose adjustments in steps of 3.5 or 7 mg per kg and tailor adjustments to the individual patient’s response and therapeutic goals. In patients not adequately controlled with doses of 21 mg per kg (e.g., serum ferritin levels persistently above 2,500 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 per kg are not recommended [ see Warnings and Precautions (5.6)]. Adjust dose based on serum ferritin levels If the serum ferritin falls below 1,000 mcg/L at 2 consecutive visits, consider dose reduction especially if the deferasirox tablets dose is greater than 17.5 mg/kg/day [see Adverse Reactions (6.1)]. If the serum ferritin falls below 500 mcg/L, interrupt deferasirox tablets therapy to minimize the risk of overchelation, and continue monthly monitoring [ see Warnings and Precautions (5.6)] . Evaluate the need for ongoing chelation therapy for patients whose conditions no longer require regular blood transfusions. Use the minimum effective dose to maintain iron burden in the target range [see Warnings and Precautions (5.6)]. Monitor blood counts, liver function, renal function and ferritin monthly [see Warnings and Precautions (5.1 , 5.2 , 5.4 )]. Interrupt deferasirox tablets for pediatric patients who have acute illnesses, which can cause volume depletion, such as vomiting, diarrhea, or prolonged decreased oral intake, and monitor more frequently. Resume therapy as appropriate, based on assessments of renal function, when oral intake and volume status are normal [see Dosage and Administration ( 2.4 , 2.5 ), Warnings and Precautions ( 5.1) , Use in Specific Populations ( 8.4), Clinical Pharmacology ( 12.3)]. 2.2 Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes Deferasirox tablets therapy should only be considered when a patient with NTDT syndrome has an LIC of at least 5 mg Fe/g dw and a serum ferritin greater than 300 mcg/L. Prior to starting therapy, obtain: LIC by liver biopsy or by an FDA-cleared or approved method for identifying patients for treatment with deferasirox therapy Serum ferritin level on at least 2 measurements 1-month apart [ see Clinical Studies (14)] Baseline renal function: Obtain serum creatinine in duplicate (due to variations in measurements). Calculate the estimated glomerular filtration rate (eGFR). Use a prediction equation appropriate for adult patients (e.g., CKD-EPI, MDRD method) and in pediatric patients (e.g., Schwartz equations). Obtain urinalyses and serum electrolytes to evaluate renal tubular function [ see Dosage and Administration (2.4), Warnings and Precautions (5.1)]. Serum transaminases and bilirubin [ see Dosage and Administration (2.4), Warnings and Precautions (5.2)] Baseline auditory and ophthalmic examinations [ see Warnings and Precautions (5.10)] Initiating Therapy: The recommended initial dose of deferasirox tablets for patients with eGFR greater than 60 mL/min/1.73 m 2 is 7 mg per kg body weight orally once daily. Calculate doses (mg per kg per day) to the nearest whole tablet. If the baseline LIC is greater than 15 mg Fe/g dw, consider increasing the dose to 14 mg/kg/day after 4 weeks. During Therapy: Monitor serum ferritin monthly to assess the patient’s response to therapy and to minimize the risk of overchelation [ see Warnings and Precautions (5.6)]. Interrupt treatment when serum ferritin is less than 300 mcg/L and obtain an LIC to determine whether the LIC has fallen to less than 3 mg Fe/g dw. Use the minimum effective dose to achieve a trend of decreasing ferritin. Monitor LIC every 6 months. After 6 months of therapy, if the LIC remains greater than 7 mg Fe/g dw, increase the dose of deferasirox to a maximum of 14 mg/kg/day.
Dosage forms and strengths
360 mg deferasirox tablets Yellow colored, film coated oval, biconvex tablets with beveled edges debossed with 'D' on one side and '360' on another side. Tablets: 360 mg.( 3 )
Contraindications
Deferasirox is contraindicated in patients with: Estimated GFR less than 40 mL/min/1.73 m 2 [see Dosage and Administration (2.5) , Warnings and Precautions (5.1) ]; Poor performance status [see Warnings and Precautions ( 5.1, 5.3 )]; High-risk myelodysplastic syndromes (this patient population was not studied and is not expected to benefit from chelation therapy); Advanced malignancies [see Warnings and Precautions ( 5.1, 5.3 )]; Platelet counts less than 50 x 10 9 /L [see Warnings and Precautions ( 5.3 , 5.4 )]; Known hypersensitivity to deferasirox or any component of deferasirox [see Warnings and Precautions ( 5.7 ), Adverse Reactions (6.2)]. Estimated GFR less than 40 mL/min/1.73 m 2 . ( 4 ) Patients with poor performance status. ( 4 ) Patients with high-risk myelodysplastic syndrome (MDS). ( 4 ) Patients with advanced malignancies. ( 4 ) Patients with platelet counts less than 50 x 10 9 /L. ( 4 ) Known hypersensitivity to deferasirox or any component of deferasirox. ( 4 )
Warnings and precautions
Acute Kidney Injury: Measure serum creatinine in duplicate before starting therapy. Monitor renal function during deferasirox therapy and reduce dose or interrupt therapy for toxicity. ( 2.1 , 2.4 , 5.1 ) Hepatic Toxicity: Monitor hepatic function. Reduce dose or interrupt therapy for toxicity. ( 5.2 ) Fatal and Nonfatal Gastrointestinal (GI) Bleeding, Ulceration, and Irritation: Risk may be greater in patients who are taking deferasirox in combination with drugs that have known ulcerogenic or hemorrhagic potential. ( 5.3 ) Bone Marrow Suppression: Neutropenia, agranulocytosis, worsening anemia, and thrombocytopenia, including fatal events; monitor blood counts during deferasirox therapy. Interrupt therapy for toxicity. ( 5.4 ) Age-related Risk of Toxicity: Monitor elderly and pediatric patients closely for toxicity. ( 5.5 ) Hypersensitivity Reactions: Discontinue deferasirox for severe reactions and institute medical intervention. ( 5.7 ) Severe Skin Reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS): Discontinue deferasirox. ( 5.8 ) 5.1 Acute Kidney Injury, Including Acute Renal Failure Requiring Dialysis and Renal Tubular Toxicity Including Fanconi Syndrome Deferasirox is contraindicated in patients with eGFR less than 40 mL/min/1.73 m 2 . Exercise caution in pediatric patients with eGFR between 40 and 60 mL/min/1.73 m 2 . If treatment is needed, use the minimum effective dose and monitor renal function frequently. Individualize dose titration based on improvement in renal injury [see Use in Specific Populations (8.6)] . For patients with renal impairment (eGFR 40 to 60 mL/min/1.73 m 2 ) reduce the starting dose by 50% [see Dosage and Administration (2.4 , 2.5 ), Use in Specific Populations (8.6)] . Deferasirox can cause acute kidney injury including renal failure requiring dialysis that has resulted in fatal outcomes. Based on postmarketing experience, most fatalities have occurred in patients with multiple comorbidities and who were in advanced stages of their hematological disorders. In the clinical trials, adults and pediatric deferasirox-treated patients with no preexisting renal disease experienced dose-dependent mild, non-progressive increases in serum creatinine and proteinuria. Preexisting renal disease and concomitant use of other nephrotoxic drugs may increase the risk of acute kidney injury in adult and pediatric patients. Acute illnesses associated with volume depletion and overchelation may increase the risk of acute kidney injury in pediatric patients. In pediatric patients, small decreases in eGFR can result in increases in deferasirox exposure, particularly in younger patients with body surface area typical of patients less than age 7 years. This can lead to a cycle of worsening renal function and further increases in deferasirox tablets for oral suspension exposure, unless the dose is reduced or interrupted. Renal tubular toxicity, including acquired Fanconi syndrome, has been reported in patients treated with deferasirox, most commonly in pediatric patients with beta-thalassemia and serum ferritin levels less than 1,500 mcg/L [see Warnings and Precautions (5.6) , Adverse Reactions (6.1 , 6.2 ), Use in Specific Populations (8.4), Clinical Pharmacology (12.3) ] . Evaluate renal glomerular and tubular function before initiating therapy or increasing the dose. Use prediction equations validated for use in adult and pediatric patients to estimate GFR. Obtain serum electrolytes and urinalysis in all patients to evaluate renal tubular function [ s ee Dosage and Administration (2.1,2.2)]. Monitor all patients for changes in eGFR and for renal tubular toxicity weekly during the first month after initiation or modification of therapy and at least monthly thereafter.Dose reduction or interruption may be considered if abnormalities occur in levels of markers of renal tubular function and/or as clinically indicated. Monitor serum ferritin monthly to evaluate for overchelation. Use the minimum dose to establish and maintain a low iron burden. Monitor renal function more frequently in patients with preexisting renal disease or decreased renal function. In pediatric patients, interrupt deferasirox during acute illnesses, which can cause volume depletion such as vomiting, diarrhea, or prolonged decreased oral intake, and monitor renal function more frequently. Promptly correct fluid deficits to prevent renal injury. Resume therapy as appropriate, based on assessments of renal function, when oral intake and volume status are normal [see Dosage and Administration (2.5) , Warnings and Precautions (5.6) , Adverse Reactions (6.1 , 6.2) , Use in Specific Populations (8.4) ] . 5.2Hepatic Toxicity and Failure Deferasirox can cause hepatic injury, fatal in some patients. In Study 1, 4 patients (1.3%) discontinued deferasirox because of hepatic toxicity (drug-induced hepatitis in 2 patients and increased serum transaminases in 2 additional patients). Hepatic toxicity appears to be more common in patients greater than 55 years of age. Hepatic failure was more common in patients with significant comorbidities, including liver cirrhosis and multiorgan failure [ see Adverse Reactions (6.1)]. Acute liver injury and failure, including fatal outcomes, have occurred in pediatric deferasirox-treated patients. Liver failure occurred in association with acute kidney injury in pediatric patients at risk for overchelation during a volume-depleting event. Interrupt deferasirox therapy when acute liver injury or acute kidney injury is suspected and during volume depletion. Monitor liver and renal function more frequently in pediatric patients who are receiving deferasirox in the 14 to 28 mg/kg/day range and when iron burden is approaching normal.
Side effects
The following clinically significant adverse reactions are also discussed in other sections of the labeling: Acute Kidney Injury, Including Acute Renal Failure Requiring Dialysis, and Renal Tubular Toxicity Including Fanconi Syndrome [ see Warnings and Precautions (5.1,5.6)] Hepatic Toxicity and Failure [ see Warnings and Precautions (5.2,5.6)] GI Hemorrhage [ see Warnings and Precautions (5.3 )] Bone Marrow Suppression [ see Warnings and Precautions (5.4)] Hypersensitivity [see Warnings and Precautions (5.7) ] Severe Skin Reactions [see Warnings and Precautions (5.8) ] Skin Rash [see Warnings and Precautions (5.9)] Auditory and Ocular Abnormalities [see Warnings and Precautions (5.10) ] 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Deferasirox was evaluated in healthy volunteer trials. Currently, there are no clinical data in patients with deferasirox tablets. Deferasirox contains the same active ingredient as deferasirox tablets for oral suspension. The following adverse reactions have been reported with deferasirox tablets for oral suspension. Transfusional Iron Overload A total of 700 adult and pediatric patients were treated with deferasirox for 48 weeks in premarketing studies. These included 469 patients with beta-thalassemia, 99 with rare anemias, and 132 with sickle cell disease. Of these patients, 45% were male, 70% were Caucasian, and 292 patients were less than 16 years of age. In the sickle cell disease population, 89% of patients were black. Median treatment duration among the sickle cell patients was 51 weeks. Of the 700 patients treated, 469 (403 beta-thalassemia and 66 rare anemias) were entered into extensions of the original clinical protocols. In ongoing extension studies, median durations of treatment were 88 to 205 weeks. Six hundred twenty-seven (627) patients with myelodysplastic syndrome (MDS) were enrolled across 5 uncontrolled trials. These studies varied in duration from 1 to 5 years. The discontinuation rate across studies in the first year was 46% (Adverse Events (AEs) 20%, withdrawal of consent 10%, death 8%, other 4%, lab abnormalities 3%, and lack of efficacy 1%). Among 47 patients enrolled in the study of 5-year duration, 10 remained on deferasirox at the completion of the study. Table 1 displays adverse reactions occurring in greater than 5% of deferasirox-treated beta-thalassemia patients (Study 1), sickle cell disease patients (Study 3), and patients with MDS (MDS pool). Abdominal pain, nausea, vomiting, diarrhea, skin rashes, and increases in serum creatinine were the most frequent adverse reactions reported with a suspected relationship to deferasirox. Gastrointestinal symptoms, increases in serum creatinine, and skin rash were dose related. Table 1. Adverse Reactions a Occurring in >5% of Deferasirox-treated Patients in Study 1, Study 3, and MDS Pool Study 1 (Beta-thalassemia) Study 3 (Sickle Cell Disease) MDS Pool Adverse Reactions Deferasirox N=296 n(%) Deferoxamine N=290 n(%) Deferasirox N=132 n(%) Deferoxamine N=63 n(%) Deferasirox N=627 n(%) Abdominal Pain b 63 (21) 41 (14) 37 (28) 9 (14) 145 (23) Diarrhea 35 (12) 21 (7) 26 (20) 3 (5) 297 (47) Creatinine Increased c 33 (11) 0 (0) 9 (7) 0 89 (14) Nausea 31 (11) 14 (5) 30 (23) 7 (11) 161 (26) Vomiting 30 (10) 28 (10) 28 (21) 10 (16) 83 (13) Rash 25 (8) 9 (3) 14 (11) 3 (5) 83 (13) Abbreviation: MDS, myelodysplastic syndrome. a Adverse reaction frequencies are based on AEs reported regardless of relationship to study drug. b Includes ‘abdominal pain’, ‘abdominal pain lower’, and ‘abdominal pain upper.’ C Includes ‘blood creatinine increased’ and ‘blood creatinine abnormal’. See also Table 2. In Study 1, a total of 113 (38%) patients treated with deferasirox had increases in serum creatinine greater than 33% above baseline on 2 separate occasions (Table 2) and 25 (8%) patients required dose reductions. Increases in serum creatinine appeared to be dose related [see Warnings and Precautions (5.1)] . In this study, 17 (6%) patients treated with deferasirox developed elevations in serum glutamic-pyruvic transaminase (SGPT)/ALT levels greater than 5 times the upper limit of normal (ULN) at 2 consecutive visits. Of these, 2 patients had liver biopsy proven drug-induced hepatitis and both discontinued deferasirox therapy [see Warnings and Precautions (5.2)] . An additional 2 patients, who did not have elevations in SGPT/ALT greater than 5 times the ULN, discontinued deferasirox because of increased SGPT/ALT. Increases in transaminases did not appear to be dose related. Adverse reactions that led to discontinuations included abnormal liver function tests (2 patients) and drug-induced hepatitis (2 patients), skin rash, glycosuria/proteinuria, Henoch Schönlein purpura, hyperactivity/insomnia, drug fever, and cataract (1 patient each). In Study 3, a total of 48 (36%) patients treated with deferasirox had increases in serum creatinine greater than 33% above baseline on 2 separate occasions (Table 2) [see Warnings and Precautions (5.1)] . Of the patients who experienced creatinine increases in Study 3, 8 deferasirox-treated patients required dose reductions.
Drug interactions
Do not take deferasirox with aluminum-containing antacid preparations.( 7.1 ) Deferasirox increases the exposure of the repaglinide. Consider repaglinide dose reduction and monitor blood glucose levels. ( 7.3 ) Avoid the use of deferasirox with theophylline as theophylline levels could be increased. ( 7.4 ) Deferasirox increases exposure of busulfan. Monitor plasma concentrations of busulfan when coadministered with deferasirox to allow dose adjustment of busulfan, as needed. ( 7.7 ) 7.1Aluminum-Containing Antacid Preparations The concomitant administration of deferasirox and aluminum-containing antacid preparations has not been formally studied. Although deferasirox has a lower affinity for aluminum than for iron, do not take deferasirox with aluminum-containing antacid preparations. 7.2Agents Metabolized by CYP3A4 Deferasirox may induce CYP3A4 resulting in a decrease in CYP3A4 substrate concentration when these drugs are coadministered. Closely monitor patients for signs of reduced effectiveness when deferasirox is administered with drugs metabolized by CYP3A4 (e.g., alfentanil, aprepitant, budesonide, buspirone, conivaptan, cyclosporine, darifenacin, darunavir, dasatinib, dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine, everolimus, felodipine, fentanyl, hormonal contraceptive agents, indinavir, fluticasone, lopinavir, lovastatin, lurasidone, maraviroc, midazolam, nisoldipine, pimozide, quetiapine, quinidine, saquinavir, sildenafil, simvastatin, sirolimus, tacrolimus, tolvaptan, tipranavir, triazolam, ticagrelor, and vardenafil) [ see Clinical Pharmacology (12.3)]. 7.3Agents Metabolized by CYP2C8 Deferasirox inhibits CYP2C8 resulting in an increase in CYP2C8 substrate (e.g., repaglinide and paclitaxel) concentration when these drugs are coadministered. If deferasirox and repaglinide are used concomitantly, consider decreasing the dose of repaglinide and perform careful monitoring of blood glucose levels. Closely monitor patients for signs of exposure related toxicity when deferasirox is coadministered with other CYP2C8 substrates [ see Clinical Pharmacology (12.3)]. 7.4Agents Metabolized by CYP1A2 Deferasirox inhibits CYP1A2 resulting in an increase in CYP1A2 substrate (e.g., alosetron, caffeine, duloxetine, melatonin, ramelteon, tacrine, theophylline, tizanidine) concentration when these drugs are coadministered. An increase in theophylline plasma concentrations could lead to clinically significant theophylline induced CNS or other adverse reactions. Avoid the concomitant use of theophylline or other CYP1A2 substrates with a narrow therapeutic index (e.g., tizanidine) with deferasirox. Monitor theophylline concentrations and consider theophylline dose modification if you must coadminister theophylline with deferasirox. Closely monitor patients for signs of exposure related toxicity when Deferasirox is coadministered with other drugs metabolized by CYP1A2 [ see Clinical Pharmacology (12.3)]. 7.5Agents Inducing UDP-glucuronosyltransferase (UGT) Metabolism Deferasirox is a substrate of UGT1A1 and to a lesser extent UGT1A3. The concomitant use of deferasirox with strong UGT inducers (e.g., rifampicin, phenytoin, phenobarbital, ritonavir) may result in a decrease in deferasirox efficacy due to a possible decrease in deferasirox concentration. Avoid the concomitant use of strong UGT inducers with deferasirox. Consider increasing the initial dose of deferasirox if you must coadminister these agents together [ see Dosage and Administration ( 2.5 ), Clinical Pharmacology (12.3)]. 7.6Bile Acid Sequestrants Avoid the concomitant use of bile acid sequestrants (e.g., cholestyramine, colesevelam, colestipol) with deferasirox due to a possible decrease in deferasirox concentration. If you must coadminister these agents together, consider increasing the initial dose of deferasirox [ see Dosage and Administration ( 2.5 ), Clinical Pharmacology (12.3)]. 7.7 Busulfan Increased exposure of busulfan was observed with concomitant use with deferasirox. Monitor plasma concentrations of busulfan when coadministered with deferasirox to allow dose adjustment of busulfan as needed [ see Clinical Pharmacology (12.3)].
Use in specific populations
Lactation: Advise women not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary There are no studies with the use of deferasirox in pregnant women to inform drug-associated risks. Administration of deferasirox to rats during pregnancy resulted in decreased offspring viability and an increase in renal anomalies in male offspring at doses that were about or less than the recommended human dose on a mg/m 2 basis. No fetal effects were noted in pregnant rabbits at doses equivalent to the human recommended dose on an mg/m 2 basis. Deferasirox should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown.All pregnancies had a background risk of birth defect, loss, or other adverse outcomes. However, the background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data In embryo-fetal developmental studies, pregnant rats and rabbits received oral deferasirox during the period of organogenesis at doses up to 100 mg/kg/day in rats and 50 mg/kg/day in rabbits (1.2 times the maximum recommended human dose (MRHD) on an mg/m 2 basis). These doses resulted in maternal toxicity but no fetal harm was observed. In a prenatal and postnatal developmental study, pregnant rats received oral deferasirox daily from organogenesis through lactation day 20 at doses of 10, 30, and 90 mg/kg/day (0.1, 0.3, and 1.0 times the MRHD on a mg/m 2 basis). Maternal toxicity, loss of litters, and decreased offspring viability occurred at 90 mg/kg/day (1.0 times the MRHD on a mg/m 2 basis), and increases in renal anomalies in male offspring occurred at 30 mg/kg/day (0.3 times the MRHD on a mg/m 2 basis). 8.2 Lactation Risk Summary No data are available regarding the presence of deferasirox or its metabolites in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. Deferasirox and its metabolites were excreted in rat milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in a breastfeeding child from deferasirox and its metabolites, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother. 8.3 Females and Males of Reproductive Potential Contraception Counsel patients to use non-hormonal method(s) of contraception since deferasirox can render hormonal contraceptives ineffective [see Drug Interactions (7.2) ]. 8.4 Pediatric Use Transfusional Iron Overload The safety and effectiveness of deferasirox have been established in pediatric patients 2 years of age and older for the treatment of transfusional iron overload [see Dosage and Administration (2.1) ]. Safety and effectiveness have not been established in pediatric patients less than 2 years of age for the treatment of transfusional iron overload. Pediatric approval for treatment of transfusional iron overload was based on clinical studies of 292 pediatric patients 2 years to less than 16 years of age with various congenital and acquired anemias. Seventy percent of these patients had beta-thalassemia [see Indications and Usage (1) , Dosage and Administration (2.1), Clinical Studies (14)] . In those clinical studies, 173 children (ages 2 to < 12 years) and 119 adolescents (ages 12 to < 17 years) were exposed to deferasirox. Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes The safety and effectiveness of Deferasirox have been established in patients 10 years of age and older for the treatment of chronic iron overload with non-transfusion-dependent thalassemia (NTDT) syndromes [ see Dosage and Administration (2.2)]. Safety and effectiveness have not been established in patients less than 10 years of age with chronic iron overload in NTDT syndromes. Pediatric approval for treatment of NTDT syndromes with liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L was based on 16 pediatric patients treated with deferasirox therapy (10 years to less than 16 years of age) with chronic iron overload and NTDT. Use of deferasirox in these age groups is supported by evidence from adequate and well-controlled studies of deferasirox in adult and pediatric patients [ see Indications and Usage (1.2), Dosage and Administration (2.2), Clinical Studies (14)]. In general, risk factors for deferasirox-associated kidney injury include preexisting renal disease, volume depletion, overchelation, and concomitant use of other nephrotoxic drugs. Acute kidney injury, and acute liver injury and failure has occurred in pediatric patients. In a pooled safety analysis, pediatric patients with higher deferasirox exposures had a greater probability of renal toxicity and decreased renal function, resulting in increased deferasirox exposure and progressive renal toxicity/kidney injury. Higher rates of renal AEs have been identified among pediatric patients receiving deferasirox tablets for oral suspension doses greater than 25 mg/kg/day equivalent to 17.5 mg/kg/day deferasirox when their serum ferritin values were less than 1,000 mcg/L [ see Dosage and Administration (2.5) , Warnings and Precautions (5.1 , 5.6 ), Adverse Reactions (6.1 , 6.2 )] . Monitoring recommendations for all pediatric patients with Transfusional Iron Overload and NTDT It is recommended that serum ferritin be monitored every month to assess the patient’s response to therapy and to minimize the risk of overchelation [ see Warnings and Precautions (5.6)]. Monitor renal function by estimating GFR using an eGFR prediction equation appropriate for pediatric patients and evaluate renal tubular function.
Pregnancy
8.1 Pregnancy Risk Summary There are no studies with the use of deferasirox in pregnant women to inform drug-associated risks. Administration of deferasirox to rats during pregnancy resulted in decreased offspring viability and an increase in renal anomalies in male offspring at doses that were about or less than the recommended human dose on a mg/m 2 basis. No fetal effects were noted in pregnant rabbits at doses equivalent to the human recommended dose on an mg/m 2 basis. Deferasirox should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown.All pregnancies had a background risk of birth defect, loss, or other adverse outcomes. However, the background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data In embryo-fetal developmental studies, pregnant rats and rabbits received oral deferasirox during the period of organogenesis at doses up to 100 mg/kg/day in rats and 50 mg/kg/day in rabbits (1.2 times the maximum recommended human dose (MRHD) on an mg/m 2 basis). These doses resulted in maternal toxicity but no fetal harm was observed. In a prenatal and postnatal developmental study, pregnant rats received oral deferasirox daily from organogenesis through lactation day 20 at doses of 10, 30, and 90 mg/kg/day (0.1, 0.3, and 1.0 times the MRHD on a mg/m 2 basis). Maternal toxicity, loss of litters, and decreased offspring viability occurred at 90 mg/kg/day (1.0 times the MRHD on a mg/m 2 basis), and increases in renal anomalies in male offspring occurred at 30 mg/kg/day (0.3 times the MRHD on a mg/m 2 basis).
Pediatric use
8.4 Pediatric Use Transfusional Iron Overload The safety and effectiveness of deferasirox have been established in pediatric patients 2 years of age and older for the treatment of transfusional iron overload [see Dosage and Administration (2.1) ]. Safety and effectiveness have not been established in pediatric patients less than 2 years of age for the treatment of transfusional iron overload. Pediatric approval for treatment of transfusional iron overload was based on clinical studies of 292 pediatric patients 2 years to less than 16 years of age with various congenital and acquired anemias. Seventy percent of these patients had beta-thalassemia [see Indications and Usage (1) , Dosage and Administration (2.1), Clinical Studies (14)] . In those clinical studies, 173 children (ages 2 to < 12 years) and 119 adolescents (ages 12 to < 17 years) were exposed to deferasirox. Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes The safety and effectiveness of Deferasirox have been established in patients 10 years of age and older for the treatment of chronic iron overload with non-transfusion-dependent thalassemia (NTDT) syndromes [ see Dosage and Administration (2.2)]. Safety and effectiveness have not been established in patients less than 10 years of age with chronic iron overload in NTDT syndromes. Pediatric approval for treatment of NTDT syndromes with liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L was based on 16 pediatric patients treated with deferasirox therapy (10 years to less than 16 years of age) with chronic iron overload and NTDT. Use of deferasirox in these age groups is supported by evidence from adequate and well-controlled studies of deferasirox in adult and pediatric patients [ see Indications and Usage (1.2), Dosage and Administration (2.2), Clinical Studies (14)]. In general, risk factors for deferasirox-associated kidney injury include preexisting renal disease, volume depletion, overchelation, and concomitant use of other nephrotoxic drugs. Acute kidney injury, and acute liver injury and failure has occurred in pediatric patients. In a pooled safety analysis, pediatric patients with higher deferasirox exposures had a greater probability of renal toxicity and decreased renal function, resulting in increased deferasirox exposure and progressive renal toxicity/kidney injury. Higher rates of renal AEs have been identified among pediatric patients receiving deferasirox tablets for oral suspension doses greater than 25 mg/kg/day equivalent to 17.5 mg/kg/day deferasirox when their serum ferritin values were less than 1,000 mcg/L [ see Dosage and Administration (2.5) , Warnings and Precautions (5.1 , 5.6 ), Adverse Reactions (6.1 , 6.2 )] . Monitoring recommendations for all pediatric patients with Transfusional Iron Overload and NTDT It is recommended that serum ferritin be monitored every month to assess the patient’s response to therapy and to minimize the risk of overchelation [ see Warnings and Precautions (5.6)]. Monitor renal function by estimating GFR using an eGFR prediction equation appropriate for pediatric patients and evaluate renal tubular function. Monitor renal function more frequently in pediatric patients in the presence of renal toxicity risk factors, including episodes of dehydration, fever and acute illness that may result in volume depletion or decreased renal perfusion. Use the minimum effective dose [ see Warnings and Precautions (5.1)]. Interrupt deferasirox in pediatric patients with transfusional iron overload, and consider dose interruption in pediatric patients with non-transfusion-dependent iron overload, for acute illnesses, which can cause volume depletion, such as vomiting, diarrhea, or prolonged decreased oral intake, and monitor more frequently. Resume therapy as appropriate, based on assessments of renal function, when oral intake and volume status are normal. Evaluate the risk benefit profile of continued deferasirox use in the setting of decreased renal function. Avoid use of other nephrotoxic drugs [see Dosage and Administration (2.5), Warnings and Precautions (5.1)] . Juvenile Animal Toxicity Data Renal toxicity was observed in adult mice, rats, and marmoset monkeys administered deferasirox at therapeutic doses. In a neonatal and juvenile toxicity study in rats, deferasirox was administered orally from postpartum Day 7 through 70, which equates to a human age range of term neonate through adolescence. Increased renal toxicity was identified in juvenile rats compared to adult rats at a dose based on mg/m 2 approximately 0.4 times the recommended dose of 20 mg/kg/day. A higher frequency of renal abnormalities was noted when deferasirox was administered to non-iron overloaded animals compared to iron overloaded animals. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s JADENU ® (deferasirox) tablets. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Geriatric use
8.5 Geriatric Use Four hundred thirty-one (431) patients greater than or equal to 65 years of age were studied in clinical trials of deferasirox in the transfusional iron overload setting. Two hundred twenty-five (225) of these patients were between 65 and 75 years of age while 206 were greater than or equal to 75 years of age. The majority of these patients had myelodysplastic syndrome (MDS) (n=393). In these trials, elderly patients experienced a higher frequency of adverse reactions than younger patients. Monitor elderly patients for early signs or symptoms of adverse reactions that may require a dose adjustment. Elderly patients are at increased risk for toxicity due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range. In elderly patients, including those with MDS, individualize the decision to remove accumulated iron based on clinical circumstances and the anticipated clinical benefit and risks of deferasirox tablets for oral suspension therapy.
Overdosage
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. Early signs of acute overdose are digestive effects such as abdominal pain, diarrhea, nausea, and vomiting. Hepatic and renal disorders have been reported, including cases of liver enzyme and creatinine increased with recovery after treatment discontinuation. An erroneously administered single dose of 90 mg/kg led to Fanconi syndrome which resolved after treatment. There is no specific antidote for deferasirox. In case of overdose, it may be treated with induction of vomiting or gastric lavage, and by symptomatic treatment.
Description
Deferasirox is an iron-chelating agent provided as a tablet for oral use. Deferasirox is designated chemically as 4-[3,5-bis(2-hydroxy-phenyl)-1 H -1,2,4-triazol-1-yl] benzoic acid and has the following structural formula: Deferasirox is a white to slightly yellow colour powder. It has a molecular formula C 21 H 15 N 3 O 4 and molecular weight of 373.36. Deferasirox tablets contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, lactose monohydrate, low substituted hydroxy propyl cellulose, microcrystalline cellulose, poloxamer (188), povidone (K30) and sodium stearyl fumarate. The film coating contains .hypromellose, titanium dioxide, propylene glycol, talc and iron oxide yellow. structure
Mechanism of action
12.1 Mechanism of Action Deferasirox is an orally active chelator that is selective for iron (as Fe 3+ ). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio. Although deferasirox has very low affinity for zinc and copper, there are variable decreases in the serum concentration of these trace metals after the administration of deferasirox. The clinical significance of these decreases is uncertain.
How supplied
Deferasirox 360 mg tablets are yellow colored, film coated oval, biconvex tablets with beveled edges debossed with 'D' on one side and '360' on another side. They are available in bottles of 30 tablets (NDC 73190-052-30).). Store deferasirox tablets at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
Patient information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Dosing Instructions Advise patients to take deferasirox tablets with water or other liquids. Advise patients to swallow deferasirox tablets once daily with water or other liquids, preferably at the same time each day. Advise patients to take deferasirox 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, deferasirox 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 [ see Dosage and Administration (2.3)] . Blood Testing Advise patients that blood tests will be performed frequently to check for damage to kidneys, liver, or blood cells [see Warnings and Precautions (5.1 , 5.2 , 5.3 , 5.4 , 5.5)] . Acute Kidney Injury, Including Acute Renal Failure Caution patients about the potential for kidney toxicity when taking deferasirox tablets. 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 [see Warnings and Precautions (5.1) ]. Hepatic Toxicity and Failure Caution patients about the potential for hepatic toxicity when taking deferasirox tablets. 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 [see Warnings and Precautions (5.2) ]. GI Ulceration and Hemorrhage Caution patients about the potential for the development of GI ulcers or bleeding when taking deferasirox 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 GI hemorrhage [ see Warnings and Precautions (5.3)]. 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 reactions are severe, advise patients to stop taking deferasirox immediately and seek immediate medical attention [see Warnings and Precautions (5.7 )] . Severe Skin Reactions Severe skin reactions have been reported in patients taking deferasirox tablets. Inform patients of the signs and symptoms of severe skin reactions. If reactions are severe, advise patients to stop taking deferasirox tablets immediately and seek immediate medical attention [see Warnings and Precautions (5.8) ]. Skin Rash Skin rashes may occur during deferasirox treatment. If the skin rash is severe, advise patients to stop taking deferasirox and seek medical attention [ see Warnings and Precautions (5.9)]. 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 [see Warnings and Precautions (5.1)] . Auditory and Ocular Testing Because auditory and ocular disturbances have been reported with deferasirox, conduct auditory testing and ophthalmic testing before starting deferasirox treatment and thereafter at regular intervals. Advise patients to contact their healthcare provider if they develop visual or auditory changes during treatment [see Warnings and Precautions (5.10)] . Drug Interactions Caution patients not to take aluminum containing antacids and deferasirox tablets simultaneously [see Drug Interactions (7.1)] . Caution patients about potential loss of effectiveness of drugs metabolized by CYP3A4 (e.g., cyclosporine, simvastatin, hormonal contraceptive agents) when deferasirox is administered with these drugs [see Drug Interactions (7.2)] . Caution patients about potential loss of effectiveness of deferasirox 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 deferasirox when concomitantly used with potent UGT inducers [see Drug Interactions (7.5)] . Caution patients about potential loss of effectiveness of deferasirox 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 deferasirox when concomitantly used with bile acid sequestrants [see Drug Interactions (7.6)] . Caution patients with diabetes to monitor their glucose levels more frequently when repaglinide is used concomitantly with deferasirox [see Drug Interactions (7.3)] . Handling Instructions Advise patients to store deferasirox in a dry, room-temperature environment [see How Supplied/Storage and Handling (16)] . Driving and Using Machines Caution patients experiencing dizziness to avoid driving or operating machinery [see Adverse Reactions (6.1)] . Manufactured by: MSN Pharmaceuticals Inc. Piscataway, NJ 08854-3714 Manufactured for: AvKARE Pulaski, TN 38478 Issued: 10/2025
Label text from the FDA structured product label by AvKARE (revised Jan 14, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Deferasirox in 78 products
Deferasirox NDC products (78)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 45963-456 | Deferasirox 500 mg/1 Tablet, For Suspension | Actavis Pharma, Inc. | ANDA |
| 45963-455 | Deferasirox 250 mg/1 Tablet, For Suspension | Actavis Pharma, Inc. | ANDA |
| 62332-324 | Deferasirox 125 mg/1 Tablet, For Suspension | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-325 | Deferasirox 250 mg/1 Tablet, For Suspension | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-326 | Deferasirox 500 mg/1 Tablet, For Suspension | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-410 | Deferasirox 90 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-411 | Deferasirox 180 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-412 | Deferasirox 360 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 46708-412 | Deferasirox 360 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Limited | ANDA |
| 46708-411 | Deferasirox 180 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Limited | ANDA |
| 46708-410 | Deferasirox 90 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Limited | ANDA |
| 46708-326 | Deferasirox 500 mg/1 Tablet, For Suspension | Alembic Pharmaceuticals Limited | ANDA |
| 46708-325 | Deferasirox 250 mg/1 Tablet, For Suspension | Alembic Pharmaceuticals Limited | ANDA |
| 46708-324 | Deferasirox 125 mg/1 Tablet, For Suspension | Alembic Pharmaceuticals Limited | ANDA |
| 69238-1486 | Deferasirox 90 mg/1 Tablet, Film Coated | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-1487 | Deferasirox 180 mg/1 Tablet, Film Coated | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-1488 | Deferasirox 360 mg/1 Tablet, Film Coated | Amneal Pharmaceuticals NY LLC | ANDA |
| 67877-549 | Deferasirox 125 mg/1 Tablet, For Suspension | Ascend Laboratories, LLC | ANDA |
| 67877-554 | Deferasirox 360 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-553 | Deferasirox 180 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-552 | Deferasirox 90 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 67877-551 | Deferasirox 500 mg/1 Tablet, For Suspension | Ascend Laboratories, LLC | ANDA |
| 67877-550 | Deferasirox 250 mg/1 Tablet, For Suspension | Ascend Laboratories, LLC | ANDA |
| 59651-410 | Deferasirox 90 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-411 | Deferasirox 180 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-412 | Deferasirox 360 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-447 | Deferasirox 90 mg/1 Granule | Aurobindo Pharma Limited | ANDA |
| 59651-448 | Deferasirox 180 mg/1 Granule | Aurobindo Pharma Limited | ANDA |
| 59651-449 | Deferasirox 360 mg/1 Granule | Aurobindo Pharma Limited | ANDA |
| 73190-052 | Deferasirox 360 mg/1 Tablet | AvKARE | ANDA |
| 69452-161 | Deferasirox 500 mg/1 Tablet, For Suspension | Bionpharma Inc. | ANDA |
| 69452-160 | Deferasirox 250 mg/1 Tablet, For Suspension | Bionpharma Inc. | ANDA |
| 69452-159 | Deferasirox 125 mg/1 Tablet, For Suspension | Bionpharma Inc. | ANDA |
| 31722-011 | Deferasirox 90 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-012 | Deferasirox 180 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-031 | Deferasirox 360 mg/1 Granule | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-030 | Deferasirox 180 mg/1 Granule | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-029 | Deferasirox 90 mg/1 Granule | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-013 | Deferasirox 360 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 69097-570 | Deferasirox 360 mg/1 Granule | Cipla USA Inc. | ANDA |
| 69097-560 | Deferasirox 180 mg/1 Granule | Cipla USA Inc. | ANDA |
| 69097-550 | Deferasirox 90 mg/1 Granule | Cipla USA Inc. | ANDA |
| 43598-855 | Deferasirox 125 mg/1 Tablet, For Suspension | Dr. Reddy's Laboratories Inc | ANDA |
| 43598-851 | Deferasirox 360 mg/1 Tablet | Dr. Reddy's Laboratories Inc | ANDA |
| 43598-852 | Deferasirox 180 mg/1 Tablet | Dr. Reddy's Laboratories Inc | ANDA |
| 43598-853 | Deferasirox 90 mg/1 Tablet | Dr. Reddy's Laboratories Inc | ANDA |
| 43598-854 | Deferasirox 500 mg/1 Tablet, For Suspension | Dr. Reddy's Laboratories Inc | ANDA |
| 43598-856 | Deferasirox 250 mg/1 Tablet, For Suspension | Dr. Reddy's Laboratories Inc | ANDA |
| 68462-494 | Deferasirox 125 mg/1 Tablet, For Suspension | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-495 | Deferasirox 250 mg/1 Tablet, For Suspension | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-496 | Deferasirox 500 mg/1 Tablet, For Suspension | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 69539-074 | Deferasirox 180 mg/1 Tablet | MSN LABORATORIES PRIVATE LIMITED | ANDA |
| 69539-075 | Deferasirox 360 mg/1 Tablet | MSN LABORATORIES PRIVATE LIMITED | ANDA |
| 69539-073 | Deferasirox 90 mg/1 Tablet | MSN LABORATORIES PRIVATE LIMITED | ANDA |
| 69539-023 | Deferasirox 500 mg/1 Tablet, For Suspension | MSN LABORATORIES PRIVATE LIMITED | ANDA |
| 69539-022 | Deferasirox 250 mg/1 Tablet, For Suspension | MSN LABORATORIES PRIVATE LIMITED | ANDA |
| 69539-021 | Deferasirox 125 mg/1 Tablet, For Suspension | MSN LABORATORIES PRIVATE LIMITED | ANDA |
| 72603-233 | Deferasirox 360 mg/1 Tablet, Film Coated | NorthStar Rx LLC | ANDA |
| 72603-232 | Deferasirox 180 mg/1 Tablet, Film Coated | NorthStar Rx LLC | ANDA |
| 72603-231 | Deferasirox 90 mg/1 Tablet, Film Coated | NorthStar Rx LLC | ANDA |
| 72205-391 | Deferasirox 500 mg/1 Tablet, For Suspension | Novadoz Pharmaceuticals LLC | ANDA |
| 72205-390 | Deferasirox 250 mg/1 Tablet, For Suspension | Novadoz Pharmaceuticals LLC | ANDA |
| 72205-389 | Deferasirox 125 mg/1 Tablet, For Suspension | Novadoz Pharmaceuticals LLC | ANDA |
| 62756-568 | Deferasirox 125 mg/1 Tablet, For Suspension | Sun Pharmaceutical Industries, Inc. | ANDA |
| 62756-569 | Deferasirox 250 mg/1 Tablet, For Suspension | Sun Pharmaceutical Industries, Inc. | ANDA |
| 62756-570 | Deferasirox 500 mg/1 Tablet, For Suspension | Sun Pharmaceutical Industries, Inc. | ANDA |
| 0480-7012 | Deferasirox 250 mg/1 Tablet, For Suspension | Teva Pharmaceuticals, Inc. | ANDA |
| 0480-7011 | Deferasirox 125 mg/1 Tablet, For Suspension | Teva Pharmaceuticals, Inc. | ANDA |
| 0480-7013 | Deferasirox 500 mg/1 Tablet, For Suspension | Teva Pharmaceuticals, Inc. | ANDA |
| 70700-271 | Deferasirox 360 mg/1 Tablet | Xiromed, LLC | ANDA |
| 70700-270 | Deferasirox 180 mg/1 Tablet | Xiromed, LLC | ANDA |
| 70700-269 | Deferasirox 90 mg/1 Tablet | Xiromed, LLC | ANDA |
| 70771-1471 | Deferasirox 90 mg/1 Tablet, Film Coated | Zydus Lifesciences Limited | ANDA |
| 70771-1472 | Deferasirox 180 mg/1 Tablet, Film Coated | Zydus Lifesciences Limited | ANDA |
| 70771-1473 | Deferasirox 360 mg/1 Tablet, Film Coated | Zydus Lifesciences Limited | ANDA |
| 70710-1277 | Deferasirox 360 mg/1 Tablet, Film Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1276 | Deferasirox 180 mg/1 Tablet, Film Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1275 | Deferasirox 90 mg/1 Tablet, Film Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
Deferasirox recalls
- D-0095-2024 Nov 15, 2023 · Class II · Ongoing
Failed Dissolution Specifications
Frequently asked questions
What is Deferasirox used for?
Deferasirox tablets are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. ( 1.1 ) Deferasirox tablets are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at…
What are the side effects of Deferasirox?
The following clinically significant adverse reactions are also discussed in other sections of the labeling: Acute Kidney Injury, Including Acute Renal Failure Requiring Dialysis, and Renal Tubular Toxicity Including Fanconi Syndrome [ see Warnings and Precautions (5.1,5.6)] Hepatic Toxicity and Failure [ see Warnings and Precautions (5.2,5.6)] GI Hemorrhage [ see Warnings and Precautions (5.3 )]… See the full label for the complete list.
Who makes Deferasirox?
Deferasirox is listed by 20 labelers in the FDA NDC directory, including Actavis Pharma, Inc., Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited, Amneal Pharmaceuticals NY LLC.
Has Deferasirox been recalled?
The FDA enforcement database lists 1 recall for Deferasirox, most recently D-0095-2024 (class ii): Failed Dissolution Specifications