Darzalex Dosage

Generic name: daratumumab
Drug class: CD38 monoclonal antibodies

Medically reviewed by  A Ras MD.

Recommended Adult Dosing

Dosage forms:  INJ

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 until dz progression; Info: may split 1st 16 mg/kg dose into 8 mg/kg/dose IV x1 on days 1, 2 at wk 1; give HSV prophylaxis during tx 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 until dz progression; Info: may split 1st 16 mg/kg dose into 8 mg/kg/dose IV x1 on days 1, 2 at wk 1; give HSV prophylaxis during tx 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 starting wk 1 after autologous HSCT, give 16 mg/kg/dose IV q2wk x4 doses as 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 HSV prophylaxis during tx 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 until dz progression; Info: may split 1st 16 mg/kg dose into 8 mg/kg/dose IV x1 on days 1, 2 at wk 1; give HSV prophylaxis during tx 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 until dz progression; give HSV prophylaxis during tx 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 until dz progression; Info: may split 1st 16 mg/kg dose into 8 mg/kg/dose IV x1 on days 1, 2 at wk 1; give HSV prophylaxis during tx 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 until dz progression; Info: for pts refractory to 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 HSV prophylaxis during tx 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 until dz progression; Info: for pts refractory to at least 3 lines of tx, incl. proteasome inhibitors and immunomodulatory agents; may split 1st 16 mg/kg dose into 8 mg/kg/dose IV x1 on days 1, 2 at wk 1; give HSV prophylaxis during tx and x3mo after D/C

Renal dosing

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

HD/PD: not defined

Hepatic dosing

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

SRC: NLM .