Darzalex

Adult Dosing .

Dosage forms:  INJ

Special Note

[formulation clarification]

Info: not interchangeable w/ SC daratumumab/hyaluronidase-fihj

[uses, dosing may vary]

Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, postmeds, prophylactic meds, and dosing incl. toxicity-related dose adjustments

multiple myeloma, newly diagnosed

[autologous HSCT ineligible, combo w/ bortezomib, melphalan, and prednisone]

Dose: 16 mg/kg/dose IV qwk x6 doses, then starting wk 7, give 16 mg/kg/dose IV q3wk x16 doses, then starting wk 55, give 16 mg/kg/dose IV q4wk; Info: may split 1st 16 mg/kg dose into 8 mg/kg/dose IV x1 on days 1, 2 at wk 1; give VZV prophylaxis w/in 1wk of tx start and x3mo after D/C

[autologous HSCT ineligible, combo w/ lenalidomide and dexamethasone]

Dose: 16 mg/kg/dose IV qwk x8 doses, then starting wk 9, give 16 mg/kg/dose IV q2wk x8 doses, then starting wk 25, give 16 mg/kg/dose IV q4wk; Info: may split 1st 16 mg/kg dose into 8 mg/kg/dose IV x1 on days 1, 2 at wk 1; give VZV prophylaxis w/in 1wk of tx start and x3mo after D/C

[autologous HSCT eligible, combo w/ bortezomib, thalidomide, and dexamethasone]

Dose: 16 mg/kg/dose IV qwk x8 doses, then starting wk 9, give 16 mg/kg/dose IV q2wk x4 doses for total 16wk induction tx, then upon recovery from autologous HSCT, give 16 mg/kg/dose IV q2wk x4 doses for total 8wk consolidation tx; Info: may split 1st 16 mg/kg dose into 8 mg/kg/dose IV x1 on days 1, 2 at wk 1; give VZV prophylaxis w/in 1wk of tx start and x3mo after D/C

multiple myeloma, relapsed or refractory

[combo w/ bortezomib and dexamethasone]

Dose: 16 mg/kg/dose IV qwk x9 doses, then starting wk 10, give 16 mg/kg/dose IV q3wk x5 doses, then starting wk 25, give 16 mg/kg/dose IV q4wk; Info: for pts who have received at least 1 prior tx; may split 1st 16 mg/kg dose into 8 mg/kg/dose IV x1 on days 1, 2 at wk 1; give VZV prophylaxis w/in 1wk of tx start and x3mo after D/C

[combo w/ lenalidomide and dexamethasone]

Dose: 16 mg/kg/dose IV qwk x8 doses, then starting wk 9, give 16 mg/kg/dose IV q2wk x8 doses, then starting wk 25, give 16 mg/kg/dose IV q4wk; Info: for pts who have received at least 1 prior tx; may split 1st 16 mg/kg dose into 8 mg/kg/dose IV x1 on days 1, 2 at wk 1; give VZV prophylaxis w/in 1wk of tx start and x3mo after D/C

[combo w/ pomalidomide and dexamethasone]

Dose: 16 mg/kg/dose IV qwk x8 doses, then starting wk 9, give 16 mg/kg/dose IV q2wk x8 doses, then starting wk 25, give 16 mg/kg/dose IV q4wk; Info: for pts who have received at least 2 prior tx, incl. lenalidomide and a proteasome inhibitor; may split 1st 16 mg/kg dose into 8 mg/kg/dose IV x1 on days 1, 2 at wk 1; give VZV prophylaxis w/in 1wk of tx start and x3mo after D/C

[combo w/ carfilzomib and dexamethasone]

Dose: 8 mg/kg/dose IV x1 on days 1, 2 at wk 1, then starting wk 2, give 16 mg/kg/dose IV qwk x7 doses, then starting wk 9, give 16 mg/kg/dose IV q2wk x8 doses, then starting wk 25, give 16 mg/kg/dose IV q4wk; Info: for pts who have received 1-3 prior lines of tx; give VZV prophylaxis w/in 1wk of tx start and x3mo after D/C

[monotherapy]

Dose: 16 mg/kg/dose IV qwk x8 doses, then starting wk 9, give 16 mg/kg/dose IV q2wk x8 doses, then starting wk 25, give 16 mg/kg/dose IV q4wk; Info: for pts who have received at least 3 prior lines of tx, incl. a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double-refractory to a PI and an IMiD; may split 1st 16 mg/kg dose into 8 mg/kg/dose IV x1 on days 1, 2 at wk 1; give VZV prophylaxis w/in 1wk of tx start and x3mo after D/C

renal dosing

[see below]

CrCl >15: no adjustment; CrCl <15: not defined

HD/PD: not defined

hepatic dosing

[see below]

bilirubin 1-3x ULN or AST >ULN: no adjustment; bilirubin >3x ULN: not defined

Peds Dosing .

Peds dosing is currently unavailable or not applicable for this drug.