Preparation: Step 1
Determine vial quantity based on patient weight
Because dosing for EMPLICITI is weight-based, the dose of EMPLICITI will vary by patient, and may be provided through a combination of vial sizes1
Select patient weight below to calculate
recommended EMPLICITI dose.
Depending on the weight-based dose, the full amount in the vials may not be used.
Preparation: Step 2
Determine the volume of SWFI needed for reconstitution1
|300-mg vial||400-mg vial|
|Amount of SWFI, USP required
|13 mL||17 mL|
|Deliverable volume of reconstituted
EMPLICITI in the vial
|12 mL*||16 mL*|
|25 mg/mL||25 mg/mL|
*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.
Preparation: Step 3
Reconstitute lyophilized powder cake with appropriate volume of SWFI: reconstitute, mix, and let stand
- 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 SWFI, 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
SWFI=sterile water for injection.
Preparation: Step 4
Dilute for infusion1
- 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
230 mL of either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection (D5W), USP, into an infusion bag made of polyvinyl chloride or polyolefin
- The volume of 0.9% Sodium Chloride Injection, USP or D5W can 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: 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 room light).
IMPORTANT SAFETY INFORMATION ABOUT PREGNANCY/FEMALES AND MALES OF REPRODUCTIVE POTENTIAL
- There are no studies with EMPLICITI with pregnant women to inform any drug associated risks.
- There is a risk of fetal harm, including severe life-threatening human birth defects associated with lenalidomide and it is contraindicated for use in pregnancy. Refer to the lenalidomide full prescribing information for requirements regarding contraception and the prohibitions against blood and/or sperm donation due to presence and transmission in blood and/or semen and for additional information.
Please see additional Important Safety Information below.