Deferasirox (Page 2 of 11)

2.3 Administration


Swallow deferasirox tablets once daily with water or other liquids, preferably at the same time each day. 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). Do not take deferasirox tablets with aluminum-containing antacid products [see Drug Interactions ( 7.1)] .

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. Commercial crushers with serrated surfaces should be avoided for crushing a single 90 mg tablet. The dose should be immediately and completely consumed and not stored for future use.
For patients who are currently on chelation therapy with deferasirox tablets for oral suspension and converting to deferasirox tablets, the dose should be about 30% lower, rounded to the nearest whole tablet. The table below provides additional information on dosing conversion to deferasirox tablets.

Deferasirox Tablets for oral suspension Deferasirox Tablets
Transfusion-Dependent Iron Overload
Starting Dose 20 mg/kg/day 14 mg/kg/day
Titration Increments 5-10 mg/kg 3.5-7 mg/kg
Maximum Dose 40 mg/kg/day 28 mg/kg/day
Non-Transfusion-Dependent Thalassemia Syndromes
Starting Dose 10 mg/kg/day 7 mg/kg/day
Titration Increments 5-10 mg/kg 3.5-7 mg/kg
Maximum Dose 20 mg/kg/day 14 mg/kg/day

2.4 Use in Patients With Baseline Hepatic or Renal Impairment


Patients with Baseline Hepatic Impairment
Mild (Child-Pugh A) Hepatic Impairment: No dose adjustment is necessary.
Moderate (Child-Pugh B) Hepatic Impairment: Reduce the starting dose by 50%.
Severe (Child-Pugh C) Hepatic Impairment: Avoid deferasirox tablets [see Warnings and Precautions ( 5.2), Use in Specific Populations ( 8.7)] .
Patients with Baseline Renal Impairment
Do not use deferasirox in adult or pediatric patients with eGFR less than 40 mL/min/1.73 m 2 [ see Dosage and Administration ( 2.5), Contraindications ( 4)].
For patients with renal impairment (eGFR 40 to 60 mL/min/1.73 m 2), reduce the starting dose by 50% [see Use in Specific Populations ( 8.6)] .

Exercise caution in pediatric patients with eGFR between 40 and 60 mL/minute/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)] .

2.5 Dose Modifications for Decreases in Renal Function While on Deferasirox Tablets


Deferasirox tablets are contraindicated in patients with eGFR less than 40 mL/min/1.73 m 2 [see Contraindications ( 4)] .
For decreases in renal function while receiving deferasirox tablets [see Warnings and Precautions (5.1)] , modify the dose as follows:
Transfusional Iron Overload
Adults:
• If the serum creatinine increases by 33% or more above the average baseline measurement, repeat the serum creatinine within 1 week, and if still elevated by 33% or more, reduce the dose by 7 mg per kg.
Pediatric Patients (ages 2 years to 17 years):
• Reduce the dose by 7 mg per kg if eGFR decreases by greater than 33% below the average baseline measurement and repeat eGFR within 1 week.
• Interrupt deferasirox tablets 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. Avoid use of other nephrotoxic drugs [see Warnings and Precautions ( 5.1)] .

• In the setting of decreased renal function, evaluate the risk benefit profile of continued deferasirox tablets use. Use the minimum effective deferasirox tablets dose and monitor renal function more frequently, by evaluating tubular and glomerular function. Titrate dosing based on renal injury. Consider dose reduction or interruption and less nephrotoxic-therapies until improvement of renal function. If signs of renal tubular or glomerular injury occur in the presence of other risk factors such as volume depletion, reduce or interrupt deferasirox tablets to prevent severe and irreversible renal injury [see Warnings and Precautions ( 5.1)] .
All Patients (regardless of age):
• Discontinue therapy for eGFR less than 40 mL/min/1.73 m 2 [see Contraindications ( 4)] .
Non-Transfusion-Dependent Thalassemia Syndromes
Adults:
• If the serum creatinine increases by 33% or more above the average baseline measurement, repeat the serum creatinine within 1 week, and if still elevated by 33% or more, interrupt therapy if the dose is 3.5 mg per kg, or reduce by 50% if the dose is 7 or 14 mg per kg.
Pediatric Patients (ages 10 years to 17 years):
• Reduce the dose by 3.5 mg per kg if eGFR decreases by greater than 33% below the average baseline measurement and repeat the eGFR within 1 week.
• Increase monitoring frequency for pediatric patients who have acute illnesses, which can cause volume depletion, such as vomiting, diarrhea, or prolonged decreased oral intake. Consider dose interruption until oral intake and volume status are normal. Avoid use of other nephrotoxic drugs [see Warnings and Precautions ( 5.1)] .
• In the setting of decreased renal function, evaluate the risk benefit profile of continued deferasirox tablets use. Use the minimum effective deferasirox tablets dose and monitor renal function more frequently, by evaluating tubular and glomerular function. Titrate dosing based on renal injury. Consider dose reduction or interruption and less nephrotoxic therapies until improvement of renal function. If signs of renal tubular or glomerular injury occur in the presence of other risk factors such as volume depletion, reduce or interrupt deferasirox tablets to prevent severe and irreversible renal injury [see Warnings and Precautions ( 5.1)].
All Patients (regardless of age): • Discontinue therapy for eGFR less than 40 mL/min/1.73 m 2 [see Contraindications ( 4)].

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