- Drug class: Anti-CD38 monoclonal antibody (similar to daratumumab).
- Mechanism of action:
- Targets CD38 antigen highly expressed on malignant plasma cells.
- Induces antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), apoptosis, and antibody-dependent cellular phagocytosis (ADCP).
- Indications (FDA/EMA approved):
- In combination with pomalidomide + dexamethasone (Isa-Pd) for relapsed/refractory multiple myeloma (≥2 prior therapies incl. lenalidomide & proteasome inhibitor).
- In combination with carfilzomib + dexamethasone (Isa-Kd) for relapsed/refractory multiple myeloma (≥1 prior therapy).
- Administration:
- IV infusion, weight-based (10 mg/kg).
- Requires premedication with corticosteroid, antipyretic, and antihistamine to reduce infusion-related reactions.
- Infusion times: first infusion 3–4 hrs; subsequent shorter (~75 min if tolerated).
- Key adverse effects:
- Infusion-related reactions (most common with first dose).
- Neutropenia, thrombocytopenia, anemia.
- Infections (upper respiratory, pneumonia).
- Fatigue, diarrhea.
- Rare: Hepatotoxicity.
- Drug interactions / pharmacist notes:
- Interference with serum protein electrophoresis (SPEP) and immunofixation assays (may complicate monitoring of M-protein).
- Can cause false positive indirect Coombs test (important for transfusion compatibility).
- Monitor CBC, liver function, infection risk.
- Monitoring:
- CBC before each cycle.
- Infusion reactions during and after infusion.
- M-protein levels to assess disease response (while being aware of assay interference).
