ELOQUENT-3 SELECTED SAFETY PROFILE
Low discontinuation rates due to adverse reactions were observed in both EPd (5%) and Pd alone (1.8%)1
ADVERSE REACTIONS ≥10% WITH EPd AND ≥5% vs Pd (all Grades)1
Based on a median of 9 cycles in the EPd arm and 5 cycles in the Pd arm.
The term “pneumonia” is a grouping of the following terms: pneumonia, atypical pneumonia, lower respiratory tract infection, pneumococcal sepsis, pneumonia bacterial, and pneumonia influenza.
LABORATORY ABNORMALITIES WORSENING FROM BASELINE AND ≥10% WITH EPd AND >5% vs Pd1
- Premedication consisting of dexamethasone, H1 blocker, H2 blocker, and acetaminophen must be administered prior to EMPLICITI infusion
- All infusion reactions occurred during the first treatment cycle, based on a median of 9 cycles in the EPd arm
- The only infusion reaction symptom was chest discomfort (2%), which was Grade 1
- Severe infusion reactions may require permanent discontinuation of EMPLICITI therapy and emergency treatment. Interrupt EMPLICITI infusion for Grade 2 or higher infusion reactions and institute appropriate medical management
SELECTED IMPORTANT SAFETY INFORMATION
Interference with Determination of Complete Response
- EMPLICITI is a humanized IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein.
Please see additional Important Safety Information below.
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