VFEND (Page 3 of 13)

2.7 Dosage Adjustment When Co-Administered With Phenytoin or Efavirenz

The maintenance dose of voriconazole should be increased when co-administered with phenytoin or efavirenz. Use the optimal method for titrating dosage [see Drug Interactions (7) and Dosage and Administration (2.3)].

2.8 Preparation and Intravenous Administration of VFEND for Injection

Reconstitution

The powder is reconstituted with 19 mL of Water For Injection to obtain an extractable volume of 20 mL of clear concentrate containing 10 mg/mL of voriconazole. It is recommended that a standard 20 mL (non-automated) syringe be used to ensure that the exact amount (19.0 mL) of Water for Injection is dispensed. Discard the vial if a vacuum does not pull the diluent into the vial. Shake the vial until all the powder is dissolved.

Dilution

VFEND must be infused over 1 to 3 hours, at a concentration of 5 mg/mL or less. Therefore, the required volume of the 10 mg/mL VFEND concentrate should be further diluted as follows (appropriate diluents listed below):

  1. Calculate the volume of 10 mg/mL VFEND concentrate required based on the patient’s weight (see Table 3).
  2. In order to allow the required volume of VFEND concentrate to be added, withdraw and discard at least an equal volume of diluent from the infusion bag or bottle to be used. The volume of diluent remaining in the bag or bottle should be such that when the 10 mg/mL VFEND concentrate is added, the final concentration is not less than 0.5 mg/mL nor greater than 5 mg/mL.
  3. Using a suitable size syringe and aseptic technique, withdraw the required volume of VFEND concentrate from the appropriate number of vials and add to the infusion bag or bottle. Discard Partially Used Vials.

The final VFEND solution must be infused over 1 to 3 hours at a maximum rate of 3 mg/kg per hour.

Table 3: Required Volumes of 10 mg/mL VFEND Concentrate
Body Weight(kg) Volume of VFEND Concentrate (10 mg/mL) required for:
3 mg/kg dose(number of vials) 4 mg/kg dose(number of vials) 6 mg/kg dose(number of vials) 8 mg/kg dose(number of vials) 9 mg/kg dose(number of vials)
10 4 mL (1) 8 mL (1) 9 mL (1)
15 6 mL (1) 12 mL (1) 13.5 mL (1)
20 8 mL (1) 16 mL (1) 18 mL (1)
25 10 mL (1) 20 mL (1) 22.5 mL (2)
30 9 mL (1) 12 mL (1) 18 mL (1) 24 mL (2) 27 mL (2)
35 10.5 mL (1) 14 mL (1) 21 mL (2) 28 mL (2) 31.5 mL (2)
40 12 mL (1) 16 mL (1) 24 mL (2) 32 mL (2) 36 mL (2)
45 13.5 mL (1) 18 mL (1) 27 mL (2) 36 mL (2) 40.5 mL (3)
50 15 mL (1) 20 mL (1) 30 mL (2) 40 mL (2) 45 mL (3)
55 16.5 mL (1) 22 mL (2) 33 mL (2) 44 mL (3) 49.5 mL (3)
60 18 mL (1) 24 mL (2) 36 mL (2) 48 mL (3) 54 mL (3)
65 19.5 mL (1) 26 mL (2) 39 mL (2) 52 mL (3) 58.5 mL (3)
70 21 mL (2) 28 mL (2) 42 mL (3)
75 22.5 mL (2) 30 mL (2) 45 mL (3)
80 24 mL (2) 32 mL (2) 48 mL (3)
85 25.5 mL (2) 34 mL (2) 51 mL (3)
90 27 mL (2) 36 mL (2) 54 mL (3)
95 28.5 mL (2) 38 mL (2) 57 mL (3)
100 30 mL (2) 40 mL (2) 60 mL (3)

VFEND I.V. for Injection is a single-dose unpreserved sterile lyophile. Therefore, from a microbiological point of view, once reconstituted, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C (36°F to 46°F). This medicinal product is for single use only and any unused solution should be discarded. Only clear solutions without particles should be used.

The reconstituted solution can be diluted with:

0.9% Sodium Chloride USP
Lactated Ringers USP
5% Dextrose and Lactated Ringers USP
5% Dextrose and 0.45% Sodium Chloride USP
5% Dextrose USP
5% Dextrose and 20 mEq Potassium Chloride USP
0.45% Sodium Chloride USP
5% Dextrose and 0.9% Sodium Chloride USPThe compatibility of VFEND I.V. with diluents other than those described above is unknown (see Incompatibilities below).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Incompatibilities

VFEND I.V. must not be diluted with 4.2% Sodium Bicarbonate Infusion. The mildly alkaline nature of this diluent caused slight degradation of VFEND after 24 hours storage at room temperature. Although refrigerated storage is recommended following reconstitution, use of this diluent is not recommended as a precautionary measure. Compatibility with other concentrations is unknown.

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