Dejex Dosage/Direction for Use

Recommended Dose: Do not chew or swallow tablets whole.
Completely disperse tablets in water, orange juice, or apple juice (use 100 mL for total doses < 1 g; 200 mL for doses ≥ 1 g); stir to form a fine suspension and drink entire contents. Rinse remaining residue with more fluid and drink.
Avoid dispersion of tablets in milk due to slowed dissolution or carbonated drinks due to foaming.
Administer at same time each day on an empty stomach, at least 30 minutes before food.
Transfusional iron overload: Treatment should be initiated after the transfusion of approximately 20 units (about 100 mL/kg) of packed red blood cells or when there is evidence of clinical monitoring that chronic iron overload is present (e.g., serum ferritin consistently > 1,000 mcg/L). Dose (in mg/kg) must be calculated and rounded to the nearest whole tablet size.
Initial dose: 20 mg/kg once daily.
An initial daily dose of 30 mg/kg may be considered for patients receiving more than 14 mL/kg/month of packed red blood cells, and for whom the objective is the reduction of iron overload.
An initial daily dose of 10 mg/kg may be considered for patients receiving less than 7 mL/kg/month of packed red blood cells, and for whom the objective is the maintenance of the body iron level.
For patients already well-managed on treatment with deferoxamine, a starting dose of deferasirox that is numerically half that of the deferoxamine dose could be considered (e.g., a patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 20 mg/kg/day of deferasirox).
Dose adjustment: It is recommended that serum ferritin be monitored every month and that the dose of Dejex is adjusted, if necessary, every 3 to 6 months based on the trends in serum ferritin. Dose adjustments may be made in step of 5 to 10 mg/kg; and are to be tailored to the individual patient's response and therapeutic goals.
In patients not adequately controlled with 30 mg/kg/day, doses up to 40 mg/kg/day may be considered for serum ferritin levels persistently > 2,500 mcg/L and not decreasing over time (doses above 40 mg/kg/day are not recommended).
In patients whose serum ferritin level has reached the target (usually between 500 and 1,000 microgram/L), dose reductions in steps of 5 to 10 mg/kg should be considered to maintain serum ferritin levels within the target range. If serum ferritin falls consistently below 500 microgram/L, an interruption of treatment should be considered.
Non-transfusion-dependent thalassemia syndromes: Treatment should only be initiated with evidence of chronic iron overload (liver iron concentration (LIC) ≥ 5 mg Fe/g dry weight or serum ferritin >800 mcg/L.
In patients with no LIC assessment, caution should be taken during chelation therapy to minimize the risk of over-chelation.
Initial dose: 10 mg/kg once daily.
Dose adjustment: It is recommended that serum ferritin be monitored every month. Every 3 to 6 months of treatment, consider a dose increase in increments of 5 to 10 mg/kg if the patient's LIC is ≥ 7 mg Fe/g dry weight, or serum ferritin is consistently >2,000 microgram/L and not showing a downward trend, and the patient is tolerating the drug well. Doses above 20 mg/kg are not recommended because there is no experience with doses above this level in patients with non-transfusion-dependent thalassemia syndromes.
Consider dose adjustment to not exceed 10 mg/kg, if the patient's LIC is < 7 mg Fe/g dry weight, or serum ferritin is < 2,000 microgram/L.
In patients in whom LIC was not assessed and serum ferritin is ≤ 2,000 microgram/L, dosing should not exceed 10 mg/kg.
Once a satisfactory body iron level has been achieved (LIC < 3 mg Fe/g dry weight or serum ferritin < 300 mcg/L), treatment should be interrupted. Treatment should be re-initiated when there is evidence from clinical monitoring that chronic iron overload is present.
Special population: Pediatric patients: The dosing recommendations for pediatric patients are the same as for adult patients. Changes in weight of pediatric patients over time must be taken into account when calculating the dose.
Elderly patients: The dosing recommendations for elderly patients are the same as for adult patients. Elderly patients experienced a higher frequency of adverse reactions than younger patients and should be monitored closely for adverse reactions that may require a dose adjustment.
Renal impairment: Deferasirox must be used with caution in patients with serum creatinine levels above the age-appropriate upper limit of the normal range (ULN). Caution should especially be used in patients with creatinine clearance between 40 and less than 60 mL/min, particularly in case where there are additional risk factors that may impair renal function such as concomitant medications, dehydration, or severe infections. The initial dosing recommendations for patients with renal impairment are the same as described previously.
Serum creatinine should be monitored monthly in all patients and if necessary daily doses can be reduced by 10 mg/kg (see Precautions).
In patients in whom creatinine clearance < 40 mL/min or serum creatinine > 2 times the age-appropriate upper limit of the normal range (ULN), the use is contraindicated.
Hepatic impairment: Hepatic function in all patients should be monitored before the initiation of treatment, every 2 weeks during the first month and monthly thereafter (see Precautions).
Moderate impairment ( Child - Pugh class B): Initial: Reduce dose by 50%;
Severe impairment (Child - Pugh class C): Avoid use.