Darzalex

Daratumumab

In combination w/ lenalidomide & dexamethasone for patients w/ newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT) & in 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 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/ 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 proteasome inhibitor (PI) & immunomodulatory agent or who are double-refractory to PI & immunomodulatory agent.

Adult ≥18 yr Relapsed/refractory multiple myeloma Monotherapy & in combination w/ lenalidomide & low-dose dexamethasone 16 mg/kg IV infusion 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 until disease progression: Every 4 wk, 1st dose to be given at wk 25. In combination w/ bortezomib, melphalan & prednisone 16 mg/kg IV infusion 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 until disease progression: Every 4 wk, 1st dose to be given at wk 55. In combination w/ carfilzomib & dexamethasone 16 mg/kg IV infusion as 4-wk cycle regimen. Wk 1: 8 mg/kg on days 1 & 2 (total: 2 doses). Wk 2-8: Wkly (total: 7 doses). Wk 9-24: Every 2 wk, 1st dose to be given at wk 9 (total: 8 doses). Wk 25 until disease progression: Every 4 wk, 1st dose to be given at wk 25. In combination w/ bortezomib & dexamethasone 16 mg/kg IV infusion 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 until disease progression: Every 4 wk, 1st dose to be given at wk 25. In combination w/ bortezomib, thalidomide & dexamethasone 16 mg/kg IV infusion 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.

History of severe hypersensitivity.

Permanently discontinue if anaphylactic or life-threatening (Grade 4) infusion-related reactions (IRR) occurs. Premedicate w/ antihistamines, antipyretics & corticosteroids; monitor patients during & post-infusion period; administer oral corticosteroids to all patients following infusions. Patients w/ COPD may require additional post-infusion medications. Perform HBV screening in all patients before initiation. Periodically monitor CBC during treatment; patients w/ neutropenia for signs of infection. Monitor for clinical & lab signs of HBV reactivation during & for at least 6 mth of treatment. Interference w/ indirect antiglobulin test (+ve indirect Coombs test); false +ve for serum protein electrophoresis & immunofixation assays. 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, nasopharyngitis, pneumonia; anemia, neutropenia, thrombocytopenia; decreased appetite; cough; nausea, diarrhea, constipation; back & musculoskeletal chest pain, arthralgia, pain in extremity; fatigue, pyrexia; IRR.

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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