Daratumumab

SAME 1,800 mg DOSE, DIFFERENT SCHEDULES BY REGIMEN. With bortezomib, melphalan and prednisone (VMP; 6-week cycles): weekly weeks 1-6 (6 doses), then every 3 weeks weeks 7-54 (16 doses, first every-3-week dose at week 7), then every 4 weeks from week 55 until progression. With bortezomib, thalidomide and dexamethasone (VTd; 4-week cycles, newly diagnosed patients eligible for autologous stem cell transplant): induction weekly weeks 1-8 then every 2 weeks weeks 9-16 (4 doses); stop for high-dose chemotherapy and ASCT; consolidation every 2 weeks weeks 1-8 (4 doses) on re-initiation after ASCT. With bortezomib, lenalidomide and dexamethasone (VRd; 4-week cycles, ASCT-eligible): induction weekly weeks 1-8, then every 2 weeks weeks 9-16 (4 doses); stop for high-dose chemotherapy and ASCT; consolidation every 2 weeks weeks 17-24 (4 doses); maintenance every 4 weeks from week 25 until progression — DARZALEX can be discontinued in patients who have achieved MRD negativity sustained for 12 months and have had at least 24 months of maintenance. A VRd 3-week-cycle regimen for newly diagnosed patients ineligible for ASCT is also listed at 1,800 mg but its schedule table was truncated out of the fetched extract — verify against the full SPC. COMPANION DEXAMETHASONE DOSES AS STATED: with Rd/Pd, 40 mg/week (reduced to 20 mg/week for patients over 75 years); with VTd, 40 mg on days 1, 2, 8, 9, 15, 16, 22 and 23 of cycles 1-2, 40 mg on days 1-2 and 20 mg on days 8, 9, 15, 16 of cycles 3-4, and 20 mg on days 1, 2, 8, 9, 15, 16 in cycles 5-6; with VRd, 40 mg on days 1-4 and days 9-12 of each 28-day cycle during induction and consolidation (cycles 1-6). PRE- AND POST-MEDICATION: pre- and post-injection medicinal products must be given to reduce the risk of infusion-related reactions — pre-medicate with antihistamines, antipyretics and corticosteroids, and give oral corticosteroids to all patients after injection to reduce delayed IRRs; consider leukotriene inhibitors on cycle 1 day 1 in smouldering multiple myeloma; patients with COPD may need additional post-injection medicines (short- and long-acting bronchodilators, inhaled corticosteroids). SWITCHING: for patients already on intravenous daratumumab, the subcutaneous solution may be substituted starting at the next scheduled dose. INTERRUPTION: discontinue immediately and permanently for anaphylactic or life-threatening (grade 4) reactions; interrupt and obtain immediate ophthalmologic evaluation if ocular symptoms occur; delay may be required to allow blood count recovery. PAEDIATRIC: no paediatric posology appears in the fetched extract. NOTE: this draft is from the DARZALEX 1800 mg subcutaneous SPC — the intravenous daratumumab formulation has different (body-weight-based) dosing that is NOT in this source; do not transpose.