Oleptiss 360 mg Film-coated Tablet

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. …

• 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
• 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
• See full prescribing information for information regarding monitoring, administration, and dose-reductions for organ impairment. 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
• Pediatric patients (e.g., Schwartz equations)
• Obtain urinalyses and serum electrolytes to evaluate renal tubular function [ see Dosage and Administration , Warnings and Precautions ]. …

90 mg deferasirox tablets Yellow colored, film coated oval, biconvex tablets with beveled edges debossed with 'D' on one side and '90' on another side. 180 mg deferasirox tablets Yellow colored, film coated oval, biconvex tablets with beveled edges debossed with 'D' on one side and '180' on another side. …

• Transfusional Iron Overload The safety and effectiveness of deferasirox have been established
• Pediatric patients 2 years of age and older
• For the treatment of transfusional iron overload [see Dosage and Administration ]
• Safety and effectiveness have not been established
• 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. …

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). …

• 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). …

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 Precautio …

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. …

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. …

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 …

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. …

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. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.