Usual Adult Dose for Multiple Myeloma

IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE:

• Cycles 1 and 2: 10 mg/kg IV once a week on Days 1, 8, 15, and 22 of a 28-day cycle
• Cycle 3 and beyond: 10 mg/kg IV once every 2 weeks on Days 1 and 15 of a 28-day cycle until disease progression or unacceptable toxicity

• Patients should be premedicated 45 to 90 minutes before administration of elotuzumab with dexamethasone 8 mg IV, an H1 blocker (e.g., diphenhydramine 25 to 50 mg IV or orally or equivalent); an H2 blocker (e.g., ranitidine 50 mg IV or equivalent), and acetaminophen 650 to 1000 mg orally.
• On days that elotuzumab is administered, give dexamethasone 28 mg orally 3 to 24 hours before elotuzumab (in addition to the dexamethasone 8 mg IV 45 to 90 minutes prior to elotuzumab).
• On days that elotuzumab is not administered but dexamethasone is scheduled (Days 8 and 22 of Cycle 3 and beyond) give dexamethasone 40 mg orally.

• Cycles 1 and 2: 10 mg/kg IV once a week on Days 1, 8, 15, and 22 of a 28-day cycle
• Cycle 3 and beyond: 20 mg/kg IV once every 4 weeks on Day 1 of a 28-day cycle until disease progression or unacceptable toxicity

• Patients should be premedicated 45 to 90 minutes before administration of elotuzumab with dexamethasone 8 mg IV, an H1 blocker (e.g., diphenhydramine 25 to 50 mg IV or orally or equivalent); an H2 blocker (e.g., ranitidine 50 mg IV or equivalent), and acetaminophen 650 to 1000 mg orally.

• On days that elotuzumab is administered, give dexamethasone 28 mg orally between 3 and 24 hours before elotuzumab (in addition to the dexamethasone 8 mg IV between 45 and 90 minutes before elotuzumab).
• On days that elotuzumab is not administered but a dose of dexamethasone is scheduled (days 8 and 22 of cycle 3 and all subsequent cycles), give 40 mg orally.

• On days that elotuzumab is administered, give dexamethasone 8 mg orally 3 to 24 hours before elotuzumab (in addition to the dexamethasone 8 mg IV 45 to 90 minutes prior to elotuzumab).
• On days that elotuzumab is not administered but dexamethasone is scheduled (Days 8 and 22 of Cycle 3 and beyond) give dexamethasone 20 mg orally.

• Time interval 0 to 30 min: Rate 0.5 mL/min
• Time interval 30 to 60 min: Rate 1 mL/min
• Time interval 60 min or more: Rate 2 mL/min

• Time interval 0 to 30 min: Rate 3 mL/min
• Time interval 30 min or more: Rate 4 mL/min

• Time interval 30 to 60 min: Rate 5 mL/min

• Time interval 0 to 30 min: Rate 3 mL/min
• Time interval 30 min or more: Rate 4 mL/min

• Time interval 30 min or more: Rate 5 mL/min

• In combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received 1 to 3 prior therapies
• In combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least 5 prior therapies including lenalidomide and a proteasome inhibitor

Usual Geriatric Dose for Multiple Myeloma

Refer to adult dosing.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Monitor liver enzymes and adjust dosing if needed.

Dose Adjustments

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 decision on whether to administer elotuzumab should be based on clinical judgment (i.e., risk of hypersensitivity).

If a Grade 2 or higher infusion reaction occurs, interrupt the infusion and institute appropriate medical measures. Upon resolution to Grade 1 or lower, restart elotuzumab at 0.5 mL per minute and gradually increase at a rate of 0.5 mL per minute every 30 minutes as tolerated to the rate at which the infusion reaction occurred. Resume the escalation regimen if there is no recurrence of the infusion reaction.

For patients who experience an infusion reaction, monitor vital signs every 30 minutes during and for 2 hours after the end of the infusion in patients who experience an infusion reaction. If the reaction recurs, stop the infusion and do not restart on that day. Severe infusion reactions may require permanent discontinuation of therapy and emergency treatment.

Dose delays and modifications for dexamethasone, pomalidomide, and lenalidomide should be performed as recommended in their Prescribing Information.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

This drug is not removed by dialysis.

Other Comments

Reconstitution/preparation advice:

• The manufacturer product information should be consulted.

• Store under refrigeration at 2C to 8C (36F to 46F).
• Protect from light by storing in the original package until time of use.
• Do not freeze or shake.

• Instruct the patient to read the approved patient labeling.

Frequently asked questions

• What is Empliciti (elotuzumab)? and how does Empliciti work?