ELOQUENT-2 SELECTED SAFETY PROFILE
EMPLICITI + Rd demonstrated a similar rate of AR-related discontinuations vs Rd alone (6.0% vs 6.3%)1
ADVERSE REACTIONS ≥10% WITH ERd AND 5% OR HIGHER THAN Rd1,8
Based on a median of 19 cycles in the ERd arm (n=318) and 14 cycles in the Rd arm (n=317)1
The term “fatigue” is a grouping of the following terms: fatigue and asthenia.
The term “cough” is a grouping of the following terms: cough, productive cough, and upper airway cough.
The term “peripheral neuropathy” is a grouping of the following terms: peripheral neuropathy, axonal neuropathy, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy.
The term “pneumonia” is a grouping of the following terms: pneumonia, atypical pneumonia, bronchopneumonia, lobar pneumonia, bacterial pneumonia, fungal pneumonia, pneumonia influenza, and pneumococcal pneumonia.
AR, adverse reactions; ERd, EMPLICITI + lenalidomide + dexamethasone; Rd, lenalidomide + dexamethasone.
LABORATORY ABNORMALITIES WORSENING FROM BASELINE WITH ≥10% ERd AND >5% THAN Rd1
EMPLICITI INFUSION REACTIONS OCCURRED IN ~10% OF PATIENTS (all grades)1
- Premedication consisting of dexamethasone, H1 blocker, H2 blocker, and acetaminophen must be administered prior to EMPLICITI infusion1
- 70% of infusion reactions occurred during the first dose, based on a median of 19 cycles in the ERd arm1
- The most common symptoms of an infusion reaction included fever, chills and hypertension. Bradycardia and hypotension also developed during infusions1
- 5% of patients required interruption of the administration of EMPLICITI for a median of 25 minutes due to infusion reaction1
- 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 management1
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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