Darzalex

Daratumumab

In combination w/ lenalidomide & dexamethasone or w/ bortezomib, melphalan & prednisone for the treatment of adults w/ newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). In combination w/ bortezomib, thalidomide & dexamethasone for the treatment of adults w/ newly diagnosed multiple myeloma who are eligible for ASCT. In combination w/ lenalidomide & dexamethasone, or bortezomib & dexamethasone, for the treatment of adults w/ multiple myeloma who have received at least 1 prior therapy. Monotherapy for the treatment of adults w/ relapsed & refractory multiple myeloma, whose prior therapy included a proteasome inhibitor & an immunomodulatory agent & who have demonstrated disease progression on the last therapy. SC: In combination w/ pomalidomide & dexamethasone for the treatment of adults w/ multiple myeloma who have received 1 prior therapy containing a proteasome inhibitor & lenalidomide & were lenalidomide-refractory, or who have received at least 2 prior therapies that included lenalidomide & a proteasome inhibitor & have demonstrated disease progression on or after the last therapy. In combination w/ cyclophosphamide, bortezomib & dexamethasone for the treatment of adults w/ newly diagnosed systemic light chain (AL) amyloidosis.

IV In combination w/ lenalidomide & dexamethasone (4-wk cycle dosing regimen) & monotherapy for multiple myeloma 16 mg/kg infused wkly on wk 1-8, every 2 wk on wk 9-24, every 4 wk on wk 25 onwards until disease progression. In combination w/ bortezomib, melphalan & prednisone ([VMP]; 6-wk cycle dosing regimen) for multiple myeloma 16 mg/kg infused wkly on wk 1-6, every 3 wk on wk 7-54, every 4 wk on wk 55 onwards until disease progression. In combination w/ bortezomib, thalidomide & dexamethasone ([VTd]; 4-wk cycle dosing regimen) for multiple myeloma Induction phase: 16 mg/kg infused wkly on wk 1-8, every 2 wk on wk 9-16. Stop for high-dose chemotherapy & ASCT. Consolidation phase: 16 mg/kg infused every 2 wk on wk 1-8. In combination w/ bortezomib & dexamethasone (3-wk cycle dosing regimen) for multiple myeloma 16 mg/kg infused wkly on wk 1-9, every 3 wk on wk 10-24, every 4 wk on wk 25 onwards until disease progression. SC Inj into the SC tissue of the abdomen approx 7.5 cm to the right or left of the navel over approx 3-5 min. In combination w/ lenalidomide & dexamethasone or pomalidomide & dexamethasone (4-wk cycle dosing regimen) & monotherapy for multiple myeloma 1,800 mg wkly on wk 1-8, every 2 wk on wk 9-24, every 4 wk on wk 25 onwards until disease progression. In combination w/ bortezomib, melphalan & prednisone ([VMP]; 6-wk cycle dosing regimen) for multiple myeloma 1,800 mg wkly on wk 1-6, every 3 wk on wk 7-54, every 4 wk on wk 55 onwards until disease progression. In combination w/ bortezomib, thalidomide & dexamethasone ([VTd]; 4-wk cycle dosing regimen) for multiple myeloma Induction phase: 1,800 mg wkly on wk 1-8, every 2 wk on wk 9-16. Stop for high-dose chemotherapy & ASCT. Consolidation phase: 1,800 mg every 2 wk on wk 1-8. In combination w/ bortezomib & dexamethasone ([Vd]; 3-wk cycle dosing regimen) for multiple myeloma 1,800 mg wkly on wk 1-9, every 3 wk on wk 10-24, every 4 wk on wk 25 onwards until disease progression. In combination w/ bortezomib, cyclophosphamide & dexamethasone ([VCd]; 4-wk cycle dosing regimen) for AL amyloidosis 1,800 mg wkly on wk 1-8, every 2 wk on wk 9-24, every 4 wk on wk 25 onwards until disease progression.

Hypersensitivity.

Pre-medicate w/ antihistamines, antipyretics, & corticosteroids as well as monitor for infusion‑related reactions (IRR). Immediately & permanently discontinue if an anaphylactic reaction or life-threatening IRR occurs. May increase neutropenia & thrombocytopenia induced by background therapy. Monitor CBC periodically during treatment. Monitor patients w/ neutropenia for signs of infection. Interference w/ indirect antiglobulin test (indirect Coombs test). Patients should be typed & screened prior to starting treatment. Phenotyping may be considered prior to starting treatment. Interference w/ serum protein electrophoresis (SPE) & immunofixation (IFE) assays can impact the determination of complete response & of disease progression in some patients w/ IgGκ myeloma protein. Reports of HBV reactivation. Perform HBV screening before treatment initiation. Monitor patients w/ evidence of +ve HBV serology for clinical & lab signs of HBV reactivation during, & for at least 6 mth following end of treatment. Women of child‑bearing potential should use effective contraception during, & for 3 mth after cessation of treatment. Not recommended during pregnancy & in women of childbearing potential not using contraception. Discontinue breast-feeding or discontinue/abstain from Darzalex therapy. Safety & efficacy in childn <18 yr have not been established. IV: Patients on a controlled Na diet. SC: Potential for reduced efficacy in patients w/ body wt >120 kg. Patients w/ hereditary fructose intolerance should not be given this medicinal product.

IRRs, fatigue, nausea, diarrhoea, constipation, pyrexia, cough, neutropenia, thrombocytopenia, anaemia, peripheral oedema, peripheral sensory neuropathy, URTI. IV: Dyspnoea, asthenia.

Binds to CD38 on RBCs & interferes w/ compatibility testing, including Ab screening & cross-matching. False +ve SPE & IFE assay results.

Targeted Cancer Therapy

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

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