EMPLICITI + Rd demonstrated a similar rate of AR-related
discontinuations vs Rd alone (6.0% vs 6.3%)1
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.
EMPLICITI infusion reactions occurred in ~10% of patients
- 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
INFORMATION ABOUT HEPATOTOXICITY
- Elevations in liver enzymes (AST/ALT greater than 3 times the upper limit, total bilirubin greater than 2 times the upper limit, and alkaline phosphatase less than 2 times the upper limit) consistent with hepatotoxicity were 2.5% (ERd) and 0.6% (Rd). Two patients experiencing hepatotoxicity discontinued treatment; however, 6 out of 8 patients had resolution and continued treatment. Monitor liver enzymes periodically. Stop EMPLICITI upon Grade 3 or higher elevation of liver enzymes. After return to baseline values, continuation of treatment may be considered.
Please see additional Important Safety Information below.