Darzalex Faspro (daratumumab/ hyaluronidase-fihj)

Adult Dosing .

Dosage forms:  INJ: 120 mg/2000 units per mL

Special Note

[drug name clarification]

Info: nonproprietary name = daratumumab/hyaluronidase-fihj

[equivalency or interchangeability info]

Info: not interchangeable with IV daratumumab; do not substitute on a mg to mg basis

[uses, dosing may vary]

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

multiple myeloma, newly diagnosed

[autologous HSCT ineligible, combo with bortezomib, melphalan, and prednisone]

Dose: 1800 mg/30,000 units SC qwk x6 doses, then starting wk 7, give 1800 mg/30,000 units SC q3wk x16 doses, then starting wk 55, give 1800 mg/30,000 units SC q4wk; Info: give VZV prophylaxis within 1wk of tx start and x3mo after D/C

[autologous HSCT ineligible, combo with bortezomib, lenalidomide, and dexamethasone]

Dose: 1800 mg/30,000 units SC qwk x6 doses, then starting wk 7, give 1800 mg/30,000 units SC q3wk x6 doses, then starting wk 25, give 1800 mg/30,000 units SC q4wk; Info: give VZV prophylaxis within 1wk of tx start and x3mo after D/C

[autologous HSCT ineligible, combo with lenalidomide and dexamethasone]

Dose: 1800 mg/30,000 units SC qwk x8 doses, then starting wk 9, give 1800 mg/30,000 units SC q2wk x8 doses, then starting wk 25, give 1800 mg/30,000 units SC q4wk; Info: give VZV prophylaxis within 1wk of tx start and x3mo after D/C

[autologous HSCT eligible, combo with bortezomib, thalidomide, and dexamethasone]

Dose: 1800 mg/30,000 units SC qwk x8 doses, then starting wk 9, give 1800 mg/30,000 units SC q2wk x4 doses for total 16wk induction tx, then upon recovery from autologous HSCT, give 1800 mg/30,000 units SC q2wk x4 doses for total 8wk consolidation tx; Info: give VZV prophylaxis within 1wk of tx start and x3mo after D/C

[autologous HSCT eligible, combo with bortezomib, lenalidomide, and dexamethasone]

Dose: 1800 mg/30,000 units SC qwk x8 doses, then starting wk 9, give 1800 mg/30,000 units SC q2wk x4 doses for total 16wk induction tx, then upon recovery from autologous HSCT, give 1800 mg/30,000 units SC q2wk x4 doses for total 8wk consolidation tx; Info: give VZV prophylaxis within 1wk of tx start and x3mo after D/C

multiple myeloma, relapsed or refractory

[combo with bortezomib and dexamethasone]

Dose: 1800 mg/30,000 units SC qwk x9 doses, then starting wk 10, give 1800 mg/30,000 units SC q3wk x5 doses, then starting wk 25, give 1800 mg/30,000 units SC q4wk; Info: for patients who have received at least 1 prior tx; give VZV prophylaxis within 1wk of tx start and x3mo after D/C

[combo with lenalidomide and dexamethasone]

Dose: 1800 mg/30,000 units SC qwk x8 doses, then starting wk 9, give 1800 mg/30,000 units SC q2wk x8 doses, then starting wk 25, give 1800 mg/30,000 units SC q4wk; Info: for patients who have received at least 1 prior tx; give VZV prophylaxis within 1wk of tx start and x3mo after D/C

[combo with pomalidomide and dexamethasone]

Dose: 1800 mg/30,000 units SC qwk x8 doses, then starting wk 9, give 1800 mg/30,000 units SC q2wk x8 doses, then starting wk 25, give 1800 mg/30,000 units SC q4wk; Info: for patients who have received at least 1 prior line of tx, including lenalidomide and a proteasome inhibitor; give VZV prophylaxis within 1wk of tx start and x3mo after D/C

[combo with carfilzomib and dexamethasone]

Dose: 1800 mg/30,000 units SC qwk x8 doses, then starting wk 9, give 1800 mg/30,000 units SC q2wk x8 doses, then starting wk 25, give 1800 mg/30,000 units SC q4wk; Info: for patients who have received 1-3 prior lines of tx; give VZV prophylaxis within 1wk of tx start and x3mo after D/C

[monotherapy]

Dose: 1800 mg/30,000 units SC qwk x8 doses, then starting wk 9, give 1800 mg/30,000 units SC q2wk x8 doses, then starting wk 25, give 1800 mg/30,000 units SC q4wk; Info: for patients who have received at least 3 prior lines of tx, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double-refractory to a PI and an IMiD; give VZV prophylaxis within 1wk of tx start and x3mo after D/C

smoldering multiple myeloma, high-risk

[monotherapy]

Dose: 1800 mg/30,000 units SC qwk x8 doses, then starting wk 9, give 1800 mg/30,000 units SC q2wk x8 doses, then starting wk 25, give 1800 mg/30,000 units SC q4wk for up to 3y; Max: 3y; Info: give VZV prophylaxis within 1wk of tx start and x3mo after D/C

light chain amyloidosis, newly diagnosed

[combo with bortezomib, cyclophosphamide, and dexamethasone]

Dose: 1800 mg/30,000 units SC qwk x8 doses, then starting wk 9, give 1800 mg/30,000 units SC q2wk x8 doses, then starting wk 25, give 1800 mg/30,000 units SC q4wk for up to 2y; Max: 2y; Info: give VZV prophylaxis within 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]

mild impairment: no adjustment; moderate-severe impairment: not defined

Peds Dosing .

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