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Empliciti Dosage

Generic name: ELOTUZUMAB 300mg
Dosage form: injection, powder, lyophilized, for solution

Medically reviewed by Drugs.com. Last updated on Oct 28, 2019.

Recommended Dosing when EMPLICITI Is Used in Combination with Lenalidomide and Dexamethasone

The recommended dosage of EMPLICITI is 10 mg/kg administered intravenously every week for the first two cycles (28-day cycle) and every 2 weeks thereafter in conjunction with the recommended dosing of lenalidomide and low-dose dexamethasone as described below. Continue treatment until disease progression or unacceptable toxicity.

Refer to the dexamethasone and lenalidomide prescribing information for additional information.

Administer premedications before each dose of EMPLICITI [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)].

Administer dexamethasone as follows:

On days that EMPLICITI is administered, give dexamethasone 28 mg orally between 3 and 24 hours before EMPLICITI plus 8 mg intravenously between 45 and 90 minutes before EMPLICITI.
On days that EMPLICITI 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.

The recommended dosing is presented in Table 1.

Table 1: Recommended Dosing Schedule of EMPLICITI in Combination with Lenalidomide and Dexamethasone
Cycle 28-Day Cycles 1 and 2 28-Day Cycles 3+
* Premedicate with the following 45 to 90 minutes prior to EMPLICITI infusion: 8 mg intravenous dexamethasone, H1 blocker: diphenhydramine (25 to 50 mg orally or intravenously) or equivalent; H2 blocker: ranitidine (50 mg intravenously) or equivalent; acetaminophen (650 to 1000 mg orally).
Oral dexamethasone (28 mg) taken between 3 and 24 hours before EMPLICITI infusion.
** Intravenous dexamethasone 45-90 minutes before EMPLICITI infusion.

Day of Cycle

1

8

15

22

1

8

15

22

Premedication*

EMPLICITI (mg/kg) intravenously

10

10

10

10

10

10

Lenalidomide (25 mg) orally

Days 1-21

Days 1-21

Dexamethasone (mg) orally

28

28

28

28

28

40

28

40

Dexamethasone** (mg) intravenously

8

8

8

8

8

8

Day of Cycle

1

8

15

22

1

8

15

22

Recommended Dosing when EMPLICITI Is Used in Combination with Pomalidomide and Dexamethasone

The recommended dosage of EMPLICITI is 10 mg/kg administered intravenously every week for the first two cycles (28-day cycle). Starting at cycle 3 (28-day cycle), administer EMPLICITI 20 mg/kg intravenously every 4 weeks. Administer EMPLICITI in conjunction with pomalidomide and low-dose dexamethasone as described below (Table 2). Continue treatment until disease progression or unacceptable toxicity.

Refer to the dexamethasone and pomalidomide prescribing information for additional information.

Administer premedications before each dose of EMPLICITI [seeDosage and Administration (2.3)andWarnings and Precautions (5.1)].

Administer dexamethasone as follows:

On days that EMPLICITI is administered, for patients 75 years or younger give dexamethasone 28 mg orally between 3 and 24 hours before EMPLICITI plus 8 mg intravenously between 45 and 90 minutes before EMPLICITI and for patients older than 75 years give dexamethasone 8 mg orally between 3 and 24 hours before EMPLICITI plus 8 mg intravenously between 45 and 90 minutes before EMPLICITI.
On days that EMPLICITI is not administered but a dose of dexamethasone is scheduled (Days 8, 15 and 22 of cycle 3 and all subsequent cycles), give 40 mg orally to patients 75 years or younger and 20 mg orally to patients older than 75 years.

The recommended dosing is presented in Table 2.

Table 2: Recommended Dosing Schedule of EMPLICITI in Combination with Pomalidomide and Dexamethasone
Cycle 28-Day Cycles 1 and 2 28-Day Cycles 3+
* Premedicate with the following 45 to 90 minutes prior to EMPLICITI infusion: 8 mg intravenous dexamethasone, H1 blocker: diphenhydramine (25 to 50 mg orally or intravenously) or equivalent; H2 blocker: ranitidine (50 mg intravenously) or equivalent; acetaminophen (650 to 1000 mg orally).
† Oral dexamethasone taken between 3 and 24 hours before EMPLICITI infusion.
** Intravenous dexamethasone 45-90 minutes before EMPLICITI infusion.

Day of Cycle

1

8

15

22

1

8

15

22

Premedication*

EMPLICITI (mg/kg) intravenously

10

10

10

10

20

Pomalidomide (4 mg) orally

Days 1-21

Days 1-21

Dexamethasone† (mg) orally ≤75 years old

28

28

28

28

28

40

40

40

Dexamethasone† (mg) orally >75 years old

8

8

8

8

8

20

20

20

Dexamethasone** (mg) intravenously

8

8

8

8

8

Premedication

Dexamethasone

When EMPLICITI is used in combination with lenalidomide or pomalidomide and dexamethasone, divide dexamethasone into an oral and intravenous dose and administer as shown in Table 1 and Table 2 [see Dosage and Administration (2.1, 2.2)].

Other Medications

In addition to dexamethasone, complete administration of the following medications 45 to 90 minutes prior to EMPLICITI infusion:

H1 blocker: diphenhydramine (25 to 50 mg orally or intravenously) or equivalent H1 blocker.
H2 blocker: ranitidine (50 mg intravenously or 150 mg orally) or equivalent H2 blocker.
Acetaminophen (650 to 1000 mg orally).

Dose Modifications

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, base the decision whether to administer EMPLICITI on clinical judgment (i.e., risk of hypersensitivity).

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 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 (see Table 3 and Table 4).

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 [see Warnings and Precautions (5.1)]. Severe infusion reactions may require permanent discontinuation of EMPLICITI therapy and emergency treatment.

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

Administration

Administer the entire EMPLICITI infusion with an infusion set and a sterile, nonpyrogenic, low-protein-binding filter (with a pore size of 0.2 to 1.2 micrometer) using an automated infusion pump.

Initiate EMPLICITI infusion at a rate of 0.5 mL per minute for 10 mg/kg dose. The infusion rate may be increased in a stepwise fashion as described in Table 3 if no infusion reactions develop. The maximum infusion rate should not exceed 5 mL per minute.

Table 3: Infusion Rate for EMPLICITI 10 mg/kg
Cycle 1, Dose 1 Cycle 1, Dose 2 Cycle 1, Dose 3 and 4
and All Subsequent Cycles

Time Interval

Rate

Time Interval

Rate

Rate

0-30 min

0.5 mL/min

0-30 min

3 mL/min

30-60 min

1 mL/min

30 min or more

4 mL/min

5 mL/min

60 min or more

2 mL/min

-

-

Initiate EMPLICITI infusion rate at 3 mL per minute for 20 mg/kg dose. The infusion rate may be increased in a stepwise fashion as described in Table 4 if no infusion reactions develop. The maximum infusion rate should not exceed 5 mL per minute.

Patients who have escalated to 5 mL/min at 10 mg/kg dose must decrease the rate to 3 mL/min at the first infusion at 20 mg/kg.

Table 4: Infusion Rate for EMPLICITI 20 mg/kg

Dose 1

Dose 2 and all subsequent doses

Time Interval

Rate

Rate

0-30 min

3 mL/min

30 min or more

4 mL/min

5 mL/min

Adjust the infusion rate following a Grade 2 or higher infusion reaction [see Dosage and Administration (2.4)].

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.

Reconstitution and Preparation

Calculation of Dose

Calculate the dose (mg) and determine the number of vials needed for the 10 mg/kg and 20 mg/kg dosage based on patient weight.
Determine the volume of sterile water for injection (SWFI) needed for reconstitution as shown in Table 5.
Table 5: Reconstitution Instructions for EMPLICITI
Strength Amount of Sterile Water for Injection, USP Required for Reconstitution Deliverable Volume of Reconstituted EMPLICITI in the Vial Postreconstitution Concentration
* After reconstitution, each vial contains overfill to allow for withdrawal of 12 mL (300 mg) and 16 mL (400 mg), respectively.

300 mg vial

13 mL

12 mL*

25 mg/mL

400 mg vial

17 mL

16 mL*

25 mg/mL

Reconstitution

Aseptically reconstitute each EMPLICITI vial with a syringe of adequate size and a less than or equal to 18-gauge needle (e.g., 17-gauge). A slight back pressure may be experienced during administration of the Sterile Water for Injection, USP, which is considered normal.
Hold the vial upright and swirl the solution by rotating the vial to dissolve the lyophilized cake. Invert the vial a few times in order to dissolve any powder that may be present on top of the vial or the stopper. Avoid vigorous agitation. DO NOT SHAKE. The lyophilized powder should dissolve in less than 10 minutes.
After the remaining solids are completely dissolved, allow the reconstituted solution to stand for 5 to 10 minutes. The reconstituted preparation results in a colorless to slightly yellow, clear to slightly opalescent solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the solution if any particulate matter or discoloration is observed.

Dilution

Once the reconstitution is completed, withdraw the necessary volume for the calculated dose from each vial, up to a maximum of 16 mL from 400 mg vial and 12 mL from 300 mg vial.
Further dilute with either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP, into an infusion bag made of polyvinyl chloride or polyolefin. The final infusion concentration should range between 1 mg/mL and 6 mg/mL.
The volume of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP should be adjusted so as not to exceed 5 mL/kg of patient weight at any given dose of EMPLICITI.

Complete the EMPLICITI infusion within 24 hours of reconstitution of the EMPLICITI lyophilized powder. If not used immediately, the infusion solution may be stored under refrigeration conditions: 2ºC to 8ºC (36ºF-46ºF) and protected from light for up to 24 hours (a maximum of 8 hours of the total 24 hours can be at room temperature, 20°C to 25°C [68°F-77°F], and room light).

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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