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Jadenu
deferasirox
Black Box Warnings .
Renal Failure
contraindicated if eGFR <40; measure Cr x2 at baseline; monitor renal fxn at least qmo; monitor renal fxn 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 dz; incr. monitoring during tx and adjust dose if renal impairment risk, incl. concomitant nephrotoxic agent use and peds pts w/ 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 pts w/ advanced hematologic malignancies and/or low Plt; monitor pts and D/C tx if suspected GI ulcer or hemorrhage
Adult Dosing .
Dosage forms: TAB: 90 mg, 180 mg, 360 mg
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 w/ 2 measurements w/in 1wk; give on empty stomach or w/ light meal; use minimum effective dose
iron overload, chronic non-transfusion-dependent thalassemia-assoc.
- [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 w/ 2 measurements w/in 1wk; give on empty stomach or w/ 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: TAB: 90 mg, 180 mg, 360 mg
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 w/ 2 measurements w/in 1wk; hold tx for acute illness w/ volume depletion risk; give on empty stomach or w/ light meal; use minimum effective dose
iron overload, chronic non-transfusion-dependent thalassemia-assoc.
- [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 w/ 2 measurements w/in 1wk; consider holding tx for acute illness w/ volume depletion risk; give on empty stomach or w/ 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