Complete SPL Sections
WARNING: RENAL FAILURE, HEPATIC FAILURE, and GASTROINTESTINAL HEMORRHAGE
BOXED WARNING SECTION
Renal Failure Deferasirox can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders. Evaluate baseline renal function prior to starting or increasing deferasirox dosing in all patients. Deferasirox is contraindicated in adult and pediatric patients with eGFR less than 40 mL/min/1.73 m 2 . Measure serum creatinine in duplicate prior to initiation of therapy. Monitor renal function at least monthly. For patients with baseline renal impairment or increased risk of acute renal failure, monitor renal function weekly for the first month, then at least monthly. Reduce the starting dose in patients with preexisting renal disease. During therapy, increase the frequency of monitoring and modify the dose for patients with an increased risk of renal impairment, including use of concomitant nephrotoxic drugs, and pediatric patients with volume depletion or overchelation [see Dosage and Administration (2.1, 2.4, 2.5), Warnings and Precautions (5.1), Adverse Reactions (6.1, 6.2)]. Hepatic Failure Deferasirox can cause hepatic injury including hepatic failure and death. Measure serum transaminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter. Avoid use of deferasirox in patients with severe (Child-Pugh C) hepatic impairment and reduce the dose in patients with moderate (Child-Pugh B) hepatic impairment [see Dosage and Administration (2.4), Warnings and Precautions (5.2)] . Gastrointestinal Hemorrhage Deferasirox can cause gastrointestinal (GI) hemorrhages, which may be fatal, especially in elderly patients who have advanced hematologic malignancies and/or low platelet counts. Monitor patients and discontinue deferasirox for suspected GI ulceration or hemorrhage [see Warnings and Precautions (5.3)] .
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
125 mg tablets Off-white, round uncoated tablets, flat with beveled edge, debossed with “568” on one side and plain on other side. 250 mg tablets Off-white, round uncoated tablets, flat with beveled edge, debossed with “569” on one side and plain on other side. 500 mg tablets Off-white, round uncoated tablets, flat with beveled edge, debossed with “570” on one side and plain on other side.
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
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)].
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
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)]
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
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 to 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 up to 80 mg per kg per day in iron overloaded beta-thalassemic patients have been tolerated with nausea and diarrhea noted. In healthy volunteers, single doses of up to 40 mg per kg per day 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.
11 DESCRIPTION
DESCRIPTION SECTION
Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis(2-hydroxyphenyl)-1 H -1,2,4-triazol-1-yl]-benzoic acid and its structural formula is: Deferasirox is a white to slightly yellow powder. Its molecular formula is C 21 H 15 N 3 O 4 and its molecular weight is 373.4 g/mol. Inactive Ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
Transfusional Iron Overload The primary efficacy study, Study 1 (NCT00061750), was a multicenter, open-label, randomized, active-comparator control study to compare deferasirox 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 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 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 n=276; deferoxamine n=277) who had LIC evaluated at baseline and 12 months or discontinued due to an adverse reaction. The percentage of patients achieving the primary endpoint was 52.9% for deferasirox 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 and -2.9 mg Fe/g dry weight in patients treated with deferoxamine. Reduction of LIC and serum ferritin was observed with deferasirox doses of 20 to 30 mg per kg per day. Deferasirox 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 [see Dosage and Administration (2.1)] . Figure 1. Changes in Liver Iron Concentration and Serum Ferritin Following Deferasirox Tablets (5 to 30 mg per kg per day) in Study 1 Study 2 (NCT00061763) was an open-label, noncomparative trial of efficacy and safety of deferasirox 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 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 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 relative to deferoxamine given for 1 year in patients with sickle cell disease and transfusional hemosiderosis. Patients were randomized to deferasirox at doses of 5, 10, 20, or 30 mg per kg per day or subcutaneous deferoxamine at doses of 20 to 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 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 (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 magnetic resonance imaging (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 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 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 (±2615.59) mcg/L (n=593) and mean change in LIC was -5.9 (±8.32) 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. Study 4 (TELESTO; NCT00940602) 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 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 5 mg/kg/day dose group, 55 to the deferasirox 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 compri...
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
Deferasirox tablets are provided as 125 mg, 250 mg, and 500 mg tablets for oral suspension. 125 mg Off-white, round uncoated tablets, flat with beveled edge, debossed with “568” on one side and plain on other side. Bottles of 30 with Child-resistant cap.....................................................................NDC 62756-568-83 Bottles of 60 with Child-resistant cap.....................................................................NDC 62756-568-86 250 mg Off-white, round uncoated tablets, flat with beveled edge, debossed with “569” on one side and plain on other side. Bottles of 30 with Child-resistant cap.....................................................................NDC 62756-569-83 Bottles of 60 with Child-resistant cap.....................................................................NDC 62756-569-86 500 mg Off-white, round uncoated tablets, flat with beveled edge, debossed with “570” on one side and plain on other side. Bottles of 30 with Child-resistant cap.....................................................................NDC 62756-570-83 Bottles of 60 with Child-resistant cap.....................................................................NDC 62756-570-86 Store deferasirox tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Dosing Instructions Advise patients to take deferasirox tablets once daily on an empty stomach at least 30 minutes prior to food, preferably at the same time every day. Instruct patients to completely disperse the tablets in water, orange juice, or apple juice, and drink the resulting suspension immediately. After the suspension has been swallowed, resuspend any residue in a small volume of the liquid and swallow [see Dosage and Administration (2.3)] . Advise patients not to chew tablets or swallow them whole [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 tablets 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 health care 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 tablets, usually within the first month of treatment. If reactions are severe, advise patients to stop taking deferasirox tablets 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 tablets treatment. If the skin rash is severe, advise patients to stop taking deferasirox tablets 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 tablets, conduct auditory testing and ophthalmic testing before starting deferasirox tablets 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 tablets are administered with these drugs [see Drug Interactions (7.2)] . Caution patients about potential loss of effectiveness of deferasirox tablets 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 tablets when concomitantly used with potent UGT inducers [see Drug Interactions (7.5)] . Caution patients about potential loss of effectiveness of deferasirox tablets 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 tablets 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 tablets [see Drug Interactions (7.3)] . Driving and Using Machines Caution patients experiencing dizziness to avoid driving or operating machinery [see Adverse Reactions (6.1)] .
MEDICATION GUIDE
SPL MEDGUIDE SECTION
Dispense with Medication Guide available at: https://www.sunpharma.com/usa/products MEDICATION GUIDE Deferasirox (dee fer' a sir ox) tablets for oral suspension What is the most important information I should know about deferasirox tablets? Deferasirox can cause serious side effects, including: Kidney problems . Deferasirox can cause sudden (acute) kidney problems, including kidney failure that may require treatment with dialysis, and may cause death. Deaths have happened mostly in people who also have other health problems and had a blood disorder that was in an advanced stage. Adults and children who already have kidney problems and are taking certain medicines with deferasirox may also have an increased risk of sudden kidney problems. Be sure to tell your healthcare provider about all the medicines you take during treatment with deferasirox. Your healthcare provider should do blood and urine tests to check your or your child’s kidney function before and during treatment with deferasirox. Call your or your child’s healthcare provider right away if: your child becomes sick with fever, vomiting, or diarrhea and cannot drink fluids normally during treatment with deferasirox. Your child may be dehydrated. Your child’s healthcare provider may need to temporarily stop treatment with deferasirox and treat your child for dehydration to help prevent kidney problems. Your child’s healthcare provider may monitor your child’s kidney function more closely. you notice that you or your child are passing less urine than usual during treatment with deferasirox. Liver problems. Deferasirox can cause liver problems, including liver failure that can sometimes cause death. Liver problems with deferasirox may be more common in people who are over 55 years of age but can also happen in children. Liver failure has happened more often in people with cirrhosis of the liver and failure of other organs. Liver failure has also happened along with kidney problems in certain children who become dehydrated. See “Kidney problems” above. Your healthcare provider should do blood tests to check your liver function before you start and regularly during treatment with deferasirox. Call your healthcare provider right away, if you develop any of the following signs and symptoms: drowsiness upper right stomach-area (abdomen) pain yellowing or increased yellowing of your skin or eyes, dark urine Bleeding, ulcers, and tears of the stomach or intestine. Severe stomach and intestine bleeding (hemorrhage) that have caused death have happened in some people treated with deferasirox, especially in elderly people who have advanced blood cancers or low platelet counts. Some people have also had ulcers of the stomach or intestine, sometimes with tears (perforation) that have caused death. In some people who have taken deferasirox, including children and adolescents, irritation of the upper gastrointestinal tract, ulcers, and bleeding have happened, but did not cause death. Your risk of severe bleeding (hemorrhage) may be increased if you take deferasirox along with other medicines that can cause ulcers or bleeding, such as: nonsteroidal anti-inflammatory drugs (NSAIDs) corticosteroids certain osteoporosis medicines called oral bisphosphonates blood thinner medicines Before you start taking deferasirox, tell your healthcare provider if you are taking one of these medicines. Ask your healthcare provider if you are not sure. If you develop an ulcer of the stomach or intestine, or severe bleeding, your healthcare provider may stop deferasirox tablets. Elderly people may be at a higher risk of developing serious side effects and death due to serious side effects with deferasirox. Your healthcare provider may need to monitor you more closely during treatment with deferasirox. Tell your healthcare provider if you get heartburn during treatment with deferasirox tablets. Get emergency medical help right away if you vomit blood or pass black or bloody stools, or if you have severe stomach-area (abdomen) pain during treatment with deferasirox tablets. See "What are the possible side effects of deferasirox tablets?" for more information about side effects. What is deferasirox? Deferasirox is a prescription medicine that is used to treat: people 2 years of age and older who have an increased amount of iron in their blood for a long period of time (chronic), caused by repeated blood transfusions certain people 10 years of age or older with thalassemia who have an increased amount of iron in their blood but who are not receiving regular blood transfusions It is not known if deferasirox is safe and effective when used with other medicines to treat an increased amount of iron in the blood. It is not known if deferasirox is safe and effective for treating children under 2 years of age who have an increased amount of iron in their blood for a long period of time (chronic) caused by repeated blood transfusions. It is not known if deferasirox is safe and effective for treating children under 10 years of age with thalassemia who have an increased amount of iron in their blood, but who are not receiving regular blood transfusions. Do not take deferasirox tablets if you: have certain kidney problems have high-risk myelodysplastic syndrome (MDS) have advanced cancer have a low platelet count are allergic to deferasirox or any of the ingredients in deferasirox tablets. See the end of this Medication Guide for a list of the ingredients in deferasirox tablets. Ask your healthcare provider if you are not sure if you have any of the medical conditions listed above. Before taking deferasirox tablets, tell your healthcare provider about all of your medical conditions, including if you: have kidney problems have liver problems have advanced cancer. See “Do not take deferasirox tablets if you” have a blood disorder that may increase your risk for bleeding are pregnant or plan to become pregnant. It is not known if deferasirox can harm your unborn baby. Hormonal forms of birth control may not be as effective if used during treatment with deferasirox. You could become pregnant. Talk to your healthcare provider about other birth control options that you can use during this time. Tell your healthcare provider right away if you become pregnant during treatment with deferasirox. are breastfeeding or plan to breastfeed. It is not known if deferasirox passes into your breast milk and can harm your baby. You and your healthcare provider should decide if you will take deferasirox or breastfeed. You should not do both. Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how deferasirox works, and deferasirox may affect how other medicines work. Also, your risk of sudden kidney problems or severe bleeding may be increased if you take deferasirox with certain medicines. See "What is the most important information I should know about deferasirox tablets?” Avoid taking the following medicines during treatment with deferasirox: antacid products (medicines used to treat heartburn) that contain aluminum theophylline certain medicines to lower your cholesterol, called bile acid sequestrants. Ask your healthcare provider if you are not sure if you take one of these medicines. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. How should I take deferasirox tablets? Take deferasirox tablets exactly as your healthcare provider tells you to. Do not change your dose of deferasirox tablets or stop taking it unless your healthcare provider tells you to. Take deferasirox tablets 1 time every day, preferably at the same time every day. Take deferasirox tablets on an empty stomach at least 30 minutes before eating food. Do not chew deferasirox tablets or swallow them whole. Place the prescribed number of deferasirox tablets in a cup with water, orange ...
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 125 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 62756-568-83 Deferasirox Tablets for oral suspension* 125 mg DO NOT CHEW OR SWALLOW WHOLE. * Tablets MUST be dispersed in water, orange or apple juice prior to ingestion . PHARMACIST: Dispense with Medication Guide to each patient. Rx only 30 Tablets SUN PHARMA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 250 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 62756-569-83 Deferasirox Tablets for oral suspension* 250 mg DO NOT CHEW OR SWALLOW WHOLE. * Tablets MUST be dispersed in water, orange or apple juice prior to ingestion . PHARMACIST: Dispense with Medication Guide to each patient. Rx only 30 Tablets SUN PHARMA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 500 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 62756-570-83 Deferasirox Tablets for oral suspension* 500 mg DO NOT CHEW OR SWALLOW WHOLE. * Tablets MUST be dispersed in water, orange or apple juice prior to ingestion . PHARMACIST: Dispense with Medication Guide to each patient. Rx only 30 Tablets SUN PHARMA