Preparation for
EMPLICITI Infusion
PREPARATION:
Determine vial quantity based on patient weight
Because dosing for EMPLICITI is
EXAMPLES OF VIAL QUANTITIES NEEDED FOR WEIGHT-BASED DOSING OF EMPLICITI
*
Depending on the weight-based dose, the full amount in the vials may not be used.
How EMPLICITI is supplied and stored
SUPPLY
EMPLICITI is supplied in 300 and 400 mg single-dose vials. EMPLICITI is a sterile, nonpyrogenic, preservative-free lyophilized powder that is white to off-white, whole or fragmented cake that is provided in 2 strengths.
Carton contents
300 mg single-dose vial for IV infusion
10-digit-NDC
0003-2291-11
11-digit-NDC
00003-2291-11
Carton contents
400 mg single-dose vial for IV infusion
10-digit-NDC
0003-4522-11
11-digit-NDC
00003-4522-11
Storage of reconstituted solution
If not used immediately, the infusion solution may be stored under refrigeration conditions: 2°C to 8°C (36°F–46°F) 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 in room light
Storage of non-reconstituted vials
Refrigerate at 2°C to 8°C (36°F–46°F)
Protect EMPLICITI from light by storing in the original package until time of use
Do not freeze
Do not shake
Determine the volume of SWFI needed for reconstitution
*After reconstitution, each vial contains overfill to allow for withdrawal of 12 mL (300-mg) and 16 mL (400-mg), respectively.
SWFI, sterile water for injection; USP, United States Pharmacopeia.
How EMPLICITI is supplied and stored
SUPPLY
EMPLICITI is supplied in 300 and 400 mg single-dose vials. EMPLICITI is a sterile, nonpyrogenic, preservative-free lyophilized powder that is white to off-white, whole or fragmented cake that is provided in 2 strengths.
Carton contents
300 mg single-dose vial for IV infusion
10-digit-NDC
0003-2291-11
11-digit-NDC
00003-2291-11
Carton contents
400 mg single-dose vial for IV infusion
10-digit-NDC
0003-4522-11
11-digit-NDC
00003-4522-11
Storage of reconstituted solution
If not used immediately, the infusion solution may be stored under refrigeration conditions: 2°C to 8°C (36°F–46°F) 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 in room light
Storage of non-reconstituted vials
Refrigerate at 2°C to 8°C (36°F–46°F)
Protect EMPLICITI from light by storing in the original package until time of use
Do not freeze
Do not shake
Reconstitute lyophilized powder cake with appropriate volume of SWFI: reconstitute, mix, and let stand
RECONSTITUTE
- Aseptically reconstitute each EMPLICITI vial with a syringe of adequate size and a less than or equal to 18-gauge needle (eg,
17-gauge ) - A slight back pressure may be experienced during administration of the SWFI, which is considered normal
MIX
- 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
LET STAND
- 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
SWFI, sterile water for injection.
How EMPLICITI is supplied and stored
SUPPLY
EMPLICITI is supplied in 300 and 400 mg single-dose vials. EMPLICITI is a sterile, nonpyrogenic, preservative-free lyophilized powder that is white to off-white, whole or fragmented cake that is provided in 2 strengths.
Carton contents
300 mg single-dose vial for IV infusion
10-digit-NDC
0003-2291-11
11-digit-NDC
00003-2291-11
Carton contents
400 mg single-dose vial for IV infusion
10-digit-NDC
0003-4522-11
11-digit-NDC
00003-4522-11
Storage of reconstituted solution
If not used immediately, the infusion solution may be stored under refrigeration conditions: 2°C to 8°C (36°F–46°F) 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 in room light
Storage of non-reconstituted vials
Refrigerate at 2°C to 8°C (36°F–46°F)
Protect EMPLICITI from light by storing in the original package until time of use
Do not freeze
Do not shake
Dilute for infusion
- 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 (D5W), 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.
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.
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.
How EMPLICITI is supplied and stored
SUPPLY
EMPLICITI is supplied in 300 and 400 mg single-dose vials. EMPLICITI is a sterile, nonpyrogenic, preservative-free lyophilized powder that is white to off-white, whole or fragmented cake that is provided in 2 strengths.
Carton contents
300 mg single-dose vial for IV infusion
10-digit-NDC
0003-2291-11
11-digit-NDC
00003-2291-11
Carton contents
400 mg single-dose vial for IV infusion
10-digit-NDC
0003-4522-11
11-digit-NDC
00003-4522-11
Storage of reconstituted solution
If not used immediately, the infusion solution may be stored under refrigeration conditions: 2°C to 8°C (36°F–46°F) 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 in room light
Storage of non-reconstituted vials
Refrigerate at 2°C to 8°C (36°F–46°F)
Protect EMPLICITI from light by storing in the original package until time of use
Do not freeze
Do not shake