Infusion rate for EMPLICITI1
EMPLICITI should be initiated at 0.5 mL/min. If no infusion reactions develop, the infusion rate may be increased in a stepwise fashion as shown below.
Rate of infusion
|Cycle 1, Dose 1|
|0–30 min||0.5 mL/min
|30–60 min||1 mL/min
|≥60 min||2 mL/min*
|Cycle 1, Dose 2|
|0–30 min||3 mL/min
|≥30 min||4 mL/min*
|Cycle 1, Dose 3 and Beyond|
*Continue this rate until infusion is complete.
Presence and severity of infusion reactions may lengthen the infusion time for EMPLICITI.
Administer the entire EMPLICITI infusion with an infusion set and a sterile, nonpyrogenic, low-protein-binding filter (with a pore size of 0.2–1.2 micrometer) using an automated infusion pump. Do not mix EMPLICITI with, or administer as an infusion with, other medicinal products. No physical or biochemical compatibility studies have been conducted to evaluate the coadministration of EMPLICITI with other agents. See Dose modifications below for infusion rate following a Grade 2 or higher infusion reaction.
Dose modifications: dose delay, interruption, or discontinuation1
If a Grade 2 or higher infusion reaction occurs during EMPLICITI administration:
- Interrupt the infusion and institute appropriate medical and supportive measures
- Upon resolution to Grade 1 or lower, restart EMPLICITI at 0.5 mL/min
- Gradually increase infusion at a rate of 0.5 mL/min every
30 minutes as tolerated to the rate at which the infusion reaction occurred
- Resume escalation regimen if there is no recurrence of the infusion reaction
- In patients who experience an infusion reaction, monitor vital signs every 30 minutes for 2 hours after the end of the EMPLICITI infusion. If the infusion reaction recurs, stop the EMPLICITI infusion and do not restart on that day. Severe infusion reactions may require permanent discontinuation of EMPLICITI therapy and emergency treatment1
- If the dose of one drug in the regimen is delayed, interrupted, or discontinued, the treatment with the other drugs may continue as scheduled. However, if dexamethasone is delayed or discontinued, the administration of EMPLICITI should be based on clinical judgment (ie, risk of hypersensitivity)1
- Dose delay and modification for dexamethasone and lenalidomide should be performed as recommended in their prescribing information1
IMPORTANT SAFETY INFORMATION ABOUT ADVERSE REACTIONS
- Infusion reactions were reported in approximately 10% of patients treated with EMPLICITI with lenalidomide and dexamethasone. All reports of infusion reaction were Grade 3 or lower. Grade 3 infusion reactions occurred in 1% of patients.
- Serious adverse reactions were 65% (ERd) and 57% (Rd). The most frequent serious adverse reactions in the ERd arm compared to the Rd arm were: pneumonia (15%, 11%), pyrexia (7%, 5%), respiratory tract infection (3.1%, 1.3%), anemia (2.8%, 1.9%), pulmonary embolism (3.1%, 2.5%), and acute renal failure (2.5%, 1.9%).
- The most common adverse reactions in ERd and Rd, respectively (≥20%) were fatigue (62%, 52%), diarrhea (47%, 36%), pyrexia (37%, 25%), constipation (36%, 27%), cough (34%, 19%), peripheral neuropathy (27%, 21%), nasopharyngitis (25%, 19%), upper respiratory tract infection (23%, 17%), decreased appetite (21%, 13%), and pneumonia (20%, 14%).
Please see additional Important Safety Information below.