Darzalex

Multiple myeloma. In combination w/ bortezomib, melphalan & prednisone or in combination w/ lenalidomide & dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant. In combination w/ bortezomib, thalidomide & dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant. In combination w/ lenalidomide & dexamethasone or bortezomib & dexamethasone for patients who have received at least 1 prior therapy. In combination w/ carfilzomib & dexamethasone in patients w/ relapsed or refractory multiple myeloma who have received 1-3 prior lines of therapy. Monotherapy for patients who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) & an immunomodulatory agent (IMiD) or who are double-refractory to PI & IMiD. Soln for inj: In combination w/ pomalidomide & dexamethasone in patients who have received 1 prior therapy including lenalidomide & a PI & were lenalidomide-refractory, or who have received at least 2 prior therapies that included lenalidomide & a PI & have demonstrated disease progression on or after last therapy. In combination w/ bortezomib, cyclophosphamide & dexamethasone for newly diagnosed patients w/ light chain (AL) amyloidosis.

Conc for soln for infusion Adult ≥18 yr Monotherapy & combination therapy w/ 4-wk cycle regimens (eg, lenalidomide) 16 mg/kg IV infusion. Wk 1-8: Wkly (total of 8 doses). Wk 9-24: Every 2 wk, 1st dose to be given at wk 9 (total of 8 doses). Wk 25 onwards until disease progression: Every 4 wk, 1st dose to be given at wk 25. Combination therapy w/ bortezomib, melphalan & prednisone (6-wk cycle regimen) for newly diagnosed multiple myeloma ineligible for ASCT 16 mg/kg IV infusion. Wk 1-6: Wkly (total of 6 doses). Wk 7-54: Every 3 wk, 1st dose to be given at wk 7 (total of 16 doses). Wk 55 onwards until disease progression: Every 4 wk, 1st dose to be given at wk 55. Combination therapy w/ bortezomib, thalidomide & dexamethasone (4-wk cycle regimen) for newly diagnosed multiple myeloma eligible for ASCT 16 mg/kg IV infusion. Induction: Wk 1-8: Wkly (total of 8 doses). Wk 9-16: Every 2 wk, 1st dose to be given at wk 9 (total of 4 doses). Stop for high-dose chemotherapy & ASCT. Consolidation: Wk 1-8: Every 2 wk, 1st dose to be given at wk 1 upon re-initiation of treatment following ASCT (total of 4 doses). Combination therapy w/ 3-wk cycle regimen (eg, bortezomib) for relapsed/refractory multiple myeloma 16 mg/kg IV infusion. Wk 1-9: Wkly (total of 9 doses). Wk 10-24: Every 3 wk, 1st dose to be given at wk 10 (total of 5 doses). Wk 25 onwards until disease progression: Every 4 wk, 1st dose to be given at wk 25. Soln for inj Adult ≥18 yr Monotherapy & combination therapy w/ 4-wk cycle regimens (eg, lenalidomide, pomalidomide, carfilzomib) 1,800 mg SC over 3-5 min. Wk 1-8: Wkly (total of 8 doses). Wk 9-24: Every 2 wk, 1st dose to be given at wk 9 (total of 8 doses). Wk 25 onwards until disease progression: Every 4 wk, 1st dose to be given at wk 25. Combination therapy w/ bortezomib, melphalan & prednisone (6-wk cycle regimen) for newly diagnosed multiple myeloma ineligible for ASCT 1,800 mg SC over 3-5 min. Wk 1-6: Wkly (total of 6 doses). Wk 7-54: Every 3 wk, 1st dose to be given at wk 7 (total of 16 doses). Wk 55 onwards until disease progression: Every 4 wk, 1st dose to be given at wk 55. Combination therapy w/ bortezomib, thalidomide & dexamethasone (4-wk cycle regimen) for newly diagnosed multiple myeloma eligible for ASCT 1,800 mg SC over 3-5 min. Induction: Wk 1-8: Wkly (total of 8 doses). Wk 9-16: Every 2 wk, 1st dose to be given at wk 9 (total of 4 doses). Stop for high-dose chemotherapy & ASCT. Consolidation: Wk 1-8: Every 2 wk, 1st dose to be given at wk 1 upon re-initiation of treatment following ASCT (total of 4 doses). Combination therapy w/ 3-wk cycle regimen (eg, bortezomib) for relapsed/refractory multiple myeloma 1,800 mg SC over 3-5 min. Wk 1-9: Wkly (total of 9 doses). Wk 10-24: Every 3 wk, 1st dose to be given at wk 10 (total of 5 doses). Wk 25 onwards until disease progression: Every 4 wk, 1st dose to be given at wk 25. Combination therapy w/ bortezomib, cyclophosphamide & dexamethasone (4-wk cycle regimen) for AL amyloidosis 1,800 mg SC over 3-5 min. Wk 1-8: Wkly (total of 8 doses). Wk 9-24: Every 2 wk, 1st dose to be given at wk 9 (total of 8 doses). Wk 25 onwards until disease progression: Every 4 wk, 1st dose to be given at wk 25.

Hypersensitivity.

Targeted Cancer Therapy

L01FC01 - daratumumab ; Belongs to the class of CD38 (Clusters of Differentiation 38) inhibitors. Used in the treatment of cancer.

POM