ASH Clinical News Hematology Pipeline Update: Drug Updates from the | Page 11
NOW APPROVED
in combination with Rd
I UNOSTIMULATORY
THE FIRST AND ONLY
ANTIBODY INDICATED FOR THE TREATMENT OF ULTIPLE YELOMA
in patients who had received 1 to 3 prior therapies
INDICATION
EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple
myeloma who have received one to three prior therapies.
SELECTED IMPORTANT SAFETY INFORMATION
Infusion Reactions
• EMPLICITI can cause infusion reactions. Common symptoms include fever, chills, and hypertension. Bradycardia and
hypotension also developed during infusions. In the trial, 5% of patients required interruption of the administration of
EMPLICITI for a median of 25 minutes due to infusion reactions, and 1% of patients discontinued due to infusion reactions. Of
the patients who experienced an infusion reaction, 70% (23/33) had them during the first dose. If a Grade 2 or higher infusion
reaction occurs, interrupt the EMPLICITI infusion and institute appropriate medical and supportive measures. If the infusion
reaction recurs, stop the EMPLICITI infusion and do not restart it on that day. Severe infusion reactions may require permanent
discontinuation of EMPLICITI therapy and emergency treatment.
• Premedicate with dexamethasone, H1 Blocker, H2 Blocker, and acetaminophen prior to infusing with EMPLICITI.
Rd=lenalidomide + dexamethasone.
Please see additional Important Safety Information and Brief Summary of Prescribing Information for EMPLICITI on the following pages.