Darzalex

Daratumumab

Multiple myeloma.

Pre-infusion medication: Administer 1-3 hr prior to every infusion: Monotherapy: Methylprednisolone 100 mg (or equiv). May be reduced to 60 mg following 2nd infusion. Combination therapy: Dexamethasone 20 mg (or equiv), paracetamol/acetaminophen 650-1,000 mg, diphenhydramine 25-50 mg (or equiv). Post-infusion medication: Monotherapy: Methylprednisolone 20 mg (or equiv) on each of the 2 days following all infusions (beginning the day after infusion). Combination therapy: Methylprednisolone ≤20 mg (or equiv) the day after infusion. Adult ≥18 yr 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 given at wk 9 (total: 8 doses). Wk 25 onwards until disease progression: Every 4 wk, 1st dose 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 given at wk 7 (total: 16 doses). Wk 55 onwards until disease progression: Every 4 wk, 1st dose given at wk 55. Bortezomib is given twice wkly at wk 1, 2, 4 & 5 for the 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 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 given at wk 9 (total: 4 doses). Stop for high-dose chemotherapy & ASCT. Consolidation phase: Wk 1-8: Every 2 wk, 1st dose given at wk 1 upon re-initiation of treatment following ASCT (total: 4 doses). In combination w/ bortezomib 16 mg/kg IV infusion as 3-wk cycle regimen. Wk 1-9: Wkly (total: 9 doses). Wk 10-24: Every 2 wk, 1st dose given at wk 10 (total: 5 doses). Wk 25 onwards until disease progression: Every 4 wk, 1st dose given at wk 25.

Hypersensitivity.

Infusion-related reactions (IRRs). Permanently discontinue use if anaphylactic reaction or life-threatening (grade 4) IRR occurs. Interrupt infusion if ocular symptoms occur & seek immediate ophth evaluation prior to restarting. Consider use of post-infusion medications including short & long-acting bronchodilators & inhaled corticosteroids in patients w/ history of COPD. Monitor patients throughout infusion & post-infusion period; CBC periodically during treatment; signs of infection in patients w/ neutropenia. Perform HBV screening in all patients prior to initiation & monitor for clinical & lab signs of HBV reactivation during & for at least 6 mth following end of treatment. May result in +ve indirect Coombs test. Report of fatigue which should be taken into account when driving or using 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.

Interferes w/ compatibility testing, including Ab screening & cross matching. May lead to false +ve results in serum protein electrophoresis & immunofixation assays.

Targeted Cancer Therapy

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

Rx