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deferasirox
generic
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: DISPERSE TAB: 125 mg, 250 mg, 500 mg; TAB: 90 mg, 180 mg, 360 mg; GRANULE: 90 mg per pkt, 180 mg per pkt, 360 mg per pkt
iron overload, chronic transfusional
- [disperse tab form]
- Dose: 20-30 mg/kg/dose PO qd; Start: 20 mg/kg/dose PO qd; Max: 40 mg/kg/day; Info: adjust dose by 5-10 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 10 mg/kg/day if Cr >33% above baseline confirmed w/ 2 measurements w/in 1wk; give 30min before meals; use minimum effective dose
- [tab or granule form]
- 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 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.
- [disperse tab form]
- Dose: 10-20 mg/kg/dose PO qd; Start: 10 mg/kg/dose PO qd; Max: 20 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 5 mg/kg/day if Cr >33% above baseline confirmed w/ 2 measurements w/in 1wk; give 30min before meals; use minimum effective dose
- [tab or granule form]
- 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 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: DISPERSE TAB: 125 mg, 250 mg, 500 mg; TAB: 90 mg, 180 mg, 360 mg; GRANULE: 90 mg per pkt, 180 mg per pkt, 360 mg per pkt
iron overload, chronic transfusional
- [disperse tab form, 2 yo and older]
- Dose: 20-30 mg/kg/dose PO qd; Start: 20 mg/kg/dose PO qd; Max: 40 mg/kg/day; Info: adjust dose by 5-10 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 10 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 30min before meals; use minimum effective dose
- [tab or granule form, 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.
- [disperse tab form, 10 yo and older]
- Dose: 10-20 mg/kg/dose PO qd; Start: 10 mg/kg/dose PO qd; Max: 20 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 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 30min before meals; use minimum effective dose
- [tab or granule form, 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