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.

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• 41-60 kg
• 61-70 kg
• 71-80 kg
• 81-90 kg
• 91-100 kg
• 101-110 kg
• 111-120 kg
• 121-130 kg
• 131-140 kg

If the adult patient

weighs:
41-60 kg

Multiply by
EMPLICITI dose:
10 mg/kg

For a total dose of: 410-600 mg

If the adult patient

weighs:
61-70 kg

Multiply by
EMPLICITI dose:
10 mg/kg

For a total dose of: 610-700 mg

If the adult patient

weighs:
71-80 kg

Multiply by
EMPLICITI dose:
10 mg/kg

For a total dose of: 710-800 mg

If the adult patient

weighs:
81-90 kg

Multiply by
EMPLICITI dose:
10 mg/kg

For a total dose of: 810-900 mg

If the adult patient

weighs:
91-100 kg

Multiply by
EMPLICITI dose:
10 mg/kg

For a total dose of: 91​0-1​000 mg

If the adult patient

weighs:
101-110 kg

Multiply by
EMPLICITI dose:
10 mg/kg

For a total dose of: 1010-1100 mg

If the adult patient

weighs:
111-120 kg

Multiply by
EMPLICITI dose:
10 mg/kg

For a total dose of: 1110-1200 mg

If the adult patient

weighs:
121-130 kg

Multiply by
EMPLICITI dose:
10 mg/kg

For a total dose of: 1210-1300 mg

If the adult patient

weighs:
131-140 kg

Multiply by
EMPLICITI dose:
10 mg/kg

For a total dose of: 1310-1400 mg

Depending on the weight-based dose, the full amount in the vials may not be used.

Determine the volume of SWFI needed for reconstitution¹

Strength
300-mg vial	400-mg vial
Amount of SWFI, USP required for reconstruction
13 mL	17 mL
Deliverable volume of reconstituted EMPLICITI in the vial
12 mL*	16 mL*
Post-reconstitution concentration
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.

Reconstitute lyophilized powder cake with appropriate volume of SWFI: reconstitute, mix, and let stand

Reconstitute¹

• 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

Mix¹

• 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 Stand¹

• 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.

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).