Darzalex Faspro

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

SC Adult ≥18 yr Monotherapy & in combination w/ lenalidomide or pomalidomide or carfilzomib & low-dose dexamethasone, in combination w/ bortezomib, cyclophosphamide & dexamethasone for AL amyloidosis 1,800 mg as 4-wk cycle regimen. Wk 1-8: Wkly (total: 8 doses). Wk 9-24: Every 2 wk, 1st dose to be given at wk 9 (total: 8 doses). Wk 25 onwards until disease progression: Every 4 wk, 1st dose to be given at wk 25. In combination w/ bortezomib, melphalan & prednisone 1,800 mg as 6-wk cycle regimen. Wk 1-6: Wkly (total: 6 doses). Wk 7-54: Every 3 wk, 1st dose to be given at wk 7 (total: 16 doses). Wk 55 onwards until disease progression: Every 4 wk, 1st dose to be given at wk 55. Bortezomib is given twice wkly at Wk 1, 2, 4 & 5 for 1st 6-wk cycle, followed by once wkly at Wk 1, 2, 4 & 5 for 8 more 6-wk cycles. In combination w/ bortezomib, thalidomide & dexamethasone 1,800 mg as 4-wk cycle regimen. Induction phase: Wk 1-8: Wkly (total: 8 doses). Wk 9-16: Every 2 wk, 1st dose to be given at wk 9 (total: 4 doses). Stop for high-dose chemotherapy & ASCT. Consolidation phase: Wk 1-8: Every 2 wk, 1st dose to be given at wk 1 upon re-initiation of treatment following ASCT (total: 4 doses). In combination w/ bortezomib & dexamethasone 1,800 mg as 3-wk cycle regimen. Wk 1-9: Wkly (total: 9 doses). Wk 10-24: Every 3 wk, 1st dose to be given at wk 10 (total: 5 doses). Wk 25 onwards until disease progression: Every 4 wk, 1st dose to be given at wk 25.

History of severe hypersensitivity.

Permanently discontinue if anaphylactic or life-threatening (grade 4) reactions occur. Interrupt infusion & seek immediate ophth evaluation prior to restarting if ocular symptoms occur. Not to be given IV; inj into red, bruised, tender, hard or scarred skin. History of COPD; AL amyloidosis patients w/ advanced cardiac disease (Mayo stage IIIb or NYHA class IIIb or IV). Infusion-related reactions; neutropenia/thrombocytopenia; HBV reactivation. Interference w/ indirect antiglobulin test (indirect Coombs' test), type & screen prior to starting; determination of complete response & disease progression in some patients w/ IgG kappa myeloma protein. Periodically monitor CBC during treatment & in patients w/ neutropenia for signs of infection. Perform HBV screening in all patients before initiation. Monitor for clinical & lab signs of HBV reactivation during & for at least 6 mth after treatment. Patients >120 kg. Not to be given in patients w/ hereditary fructose intolerance. May affect ability to drive & use machines. Women of reproductive potential should use effective contraception during & for 3 mth after treatment. Not to be used during pregnancy. Lactation. Ped patients ≤17 yr.

URTI, constipation, diarrhea, nausea, vomiting, pyrexia, fatigue, asthenia, pneumonia, back pain, muscle spasms, peripheral sensory neuropathy, insomnia, cough, HTN, headache, peripheral edema, dyspnea.

Interference w/ compatibility testing eg, Ab screening & cross-matching. False +ve serum protein electrophoresis & immunofixation assay results for patients w/ IgG kappa myeloma protein.

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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