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Jadenu Sprinkle
deferasirox
Black Box Warnings .
Renal Failure
contraindicated if eGFR <40; measure Cr x2 at baseline; monitor renal function at least qmo; monitor renal function qwk x4 at tx start, then at least qmo if baseline renal impairment or acute renal failure risk; decr. start dose if pre-existing renal disease; incr. monitoring during tx and adjust dose if renal impairment risk, including concomitant nephrotoxic agent use and peds patients with volume depletion or overchelation
Hepatic Failure
monitor ALT, AST, bilirubin at baseline, then q2wk x2, then at least qmo; decr. dose if Child-Pugh Class B impairment and avoid use if Child-Pugh Class C impairment
Gastrointestinal Hemorrhage
incr. risk in elderly patients with advanced hematologic malignancies and/or low Plt; monitor patients and D/C tx if suspected GI ulcer or hemorrhage
Adult Dosing .
Dosage forms: GRANULE: 90 mg per packet, 180 mg per packet, 360 mg per packet
iron overload, chronic transfusional
- [14-21 mg/kg/dose PO qd]
- Start: 14 mg/kg/dose PO qd; Max: 28 mg/kg/day; Info: adjust dose by 3.5-7 mg/kg/day q3-6mo based on serum ferritin trends (see pkg insert); hold tx if serum ferritin levels <500 mcg/L; decr. dose by 7 mg/kg/day if Cr >33% above baseline confirmed with 2 measurements within 1wk; give on empty stomach or with light meal; use minimum effective dose
iron overload, chronic non-transfusion-dependent thalassemia-associated
- [7-14 mg/kg/dose PO qd]
- Start: 7 mg/kg/dose PO qd; Max: 14 mg/kg/day; Info: adjust dose based on serum ferritin trends and liver iron concentration (see pkg insert); hold tx if serum ferritin levels <300 mcg/L and/or liver iron concentration <3 mg Fe/g dw; decr. dose 50% or hold tx if already on 3.5 mg/kg/day if Cr >33% above baseline confirmed with 2 measurements within 1wk; give on empty stomach or with light meal; use minimum effective dose
renal dosing
- [see below]
- eGFR 40-60: decr. usual start dose by 50%; eGFR <40: contraindicated
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class B: decr. usual start dose by 50%; Child-Pugh Class C: avoid use
Peds Dosing .
- Dosage forms: GRANULE: 90 mg per packet, 180 mg per packet, 360 mg per packet
iron overload, chronic transfusional
- [2 yo and older]
- Dose: 14-21 mg/kg/dose PO qd; Start: 14 mg/kg/dose PO qd; Max: 28 mg/kg/day; Info: adjust dose by 3.5-7 mg/kg/day q3-6mo based on serum ferritin trends (see pkg insert); hold tx if serum ferritin levels <500 mcg/L; decr. dose by 7 mg/kg/day if eGFR decr. >33% below baseline confirmed with 2 measurements within 1wk; hold tx for acute illness with volume depletion risk; give on empty stomach or with light meal; use minimum effective dose
iron overload, chronic non-transfusion-dependent thalassemia-associated
- [10 yo and older]
- Dose: 7-14 mg/kg/dose PO qd; Start: 7 mg/kg/dose PO qd; Max: 14 mg/kg/day; Info: adjust dose based on serum ferritin trends and liver iron concentration (see pkg insert); hold tx if serum ferritin levels <300 mcg/L and/or liver iron concentration <3 mg Fe/g dw; decr. dose by 3.5 mg/kg/day if eGFR decr. >33% below baseline confirmed with 2 measurements within 1wk; consider holding tx for acute illness with volume depletion risk; give on empty stomach or with light meal; use minimum effective dose
renal dosing
- [see below]
- eGFR 40-60: decr. usual start dose by 50%; eGFR <40: contraindicated
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class B: decr. usual start dose by 50%; Child-Pugh Class C: avoid use