AHFS Class:
90:24.92 Disease-modifying Antirheumatic Drugs, Miscellaneous
Generic Name
Vedolizumab is available as a lyophilized powder or cake in preservative-free single-dose vials containing vedolizumab 300 mg with arginine hydrochloride 131.7 mg, histidine 23 mg, histidine monohydrochloride 21.4 mg, polysorbate 80 3 mg, and sucrose 500 mg.3512 Each vial should be reconstituted with 4.8 mL of sterile water for injection; sodium chloride 0.9%; or Ringer's injection, lactated at room temperature to yield 5 mL of solution containing vedolizumab 60 mg/mL.3512 Direct the stream of diluent against the vial wall to avoid excessive foaming and gently swirl the vial for at least 15 seconds to dissolve the contents; do not vigorously shake or invert.3512 Allow the vial to stand for up to 20 minutes at room temperature for dissolution and for any foam to settle; the vial can be swirled and inspected for dissolution during this time.3512 If the powder has not fully dissolved after 20 minutes, allow another 10 minutes for dissolution.3512 Once dissolved, gently invert vial 3 times.3512 Do not use if the drug is not dissolved within 30 minutes.3512 The reconstituted solution must be diluted in 250 mL of sodium chloride 0.9% or Ringer's injection, lactated and mixed gently.3512
Vedolizumab also is available as a preservative-free solution intended for subcutaneous injection in single-dose prefilled syringes or pens containing vedolizumab 108 mg in 0.68 mL.3512 Each 0.68-mL prefilled syringe or pen contains vedolizumab 108 mg, arginine hydrochloride 17.77 mg, citric acid monohydrate 0.18 mg, histidine 3.86 mg, histidine monohydrochloride 1.86 mg, polysorbate 80 1.35 mg, and sodium citrate dihydrate 4.71 mg in sterile water for injection.3512
pH
Reconstituted solution: Approximately 6.3.3512
Solution for subcutaneous injection: 6.5.3512
Trade Name(s)
Entyvio
Following reconstitution and dilution, vedolizumab is administered by intravenous infusion over approximately 30 minutes.3512 The infusion line should be flushed with 30 mL of sodium chloride 0.9% or Ringer's injection, lactated following infusion of vedolizumab.3512
Vedolizumab injection solution in prefilled syringes or pens is intended for subcutaneous injection.3512
Vedolizumab powder for injection is a white to off-white lyophilized powder or cake in vials.3512 The injection solution in prefilled syringes or pens is a clear to moderately opalescent, colorless to slightly yellow solution.3512
Intact vials, prefilled syringes, and prefilled pens should be stored at 2 to 8°C in the original packaging to protect from light.3512 Do not freeze.3512 Do not shake prefilled syringes or pens.3512
The injection solution in prefilled syringes or pens may be stored at room temperature up to 25°C in the original packaging for up to 7 days.3512 Do not use prefilled syringes or pens that have been left out of the refrigerator for more than 7 days.3512
Solutions reconstituted as recommended with sterile water for injection; sodium chloride 0.9%; or Ringer's injection, lactated may be stored in the vial for up to 8 hours at 2 to 8°C; if not refrigerated, reconstituted solutions at room temperature (20 to 25°C) should be diluted immediately.3512
The manufacturer states diluted solutions in sodium chloride 0.9%, if diluted immediately after reconstitution, may be stored for up to 12 hours at 20 to 25°C, or up to 24 hours at 2 to 8°C, which may include a period of up to 12 hours at 20 to 25°C.3512 If the reconstituted solution was not diluted immediately, any time the solution was held in the vial should be subtracted from the total time the solution may be stored in the infusion bag after dilution.3512 The combined storage time of reconstituted solution in the vial (which may include up to 8 hours at 2 to 8°C) and the solution diluted in sodium chloride 0.9% in the infusion bag should not exceed 12 hours at 20 to 25°C or 24 hours at 2 to 8°C.3512
The manufacturer states diluted solutions in Ringer's injection, lactated, if diluted immediately after reconstitution, may be stored for up to 6 hours at 2 to 8°C; if not refrigerated, solutions diluted in Ringer's injection, lactated should be used immediately after dilution.3512 If the reconstituted solution was not diluted immediately, any time the solution was held in the vial should be subtracted from the total time the solution may be stored in the infusion bag after dilution.3512 The combined storage time of reconstituted solution in the vial and the solution diluted in Ringer's injection, lactated in the infusion bag should not exceed 6 hours at 2 to 8°C.3512
Stability of vedolizumab (Takeda) diluted in sodium chloride 0.9% was evaluated in a study using a variety of methods to assess physicochemical stability (visual inspection, spectrophotometry, size exclusion chromatography, electrophoresis).4000 In addition, the drug's ability to bind to its target, a4ß7 integrin, was assessed.4000 Vedolizumab was reconstituted as recommended by the manufacturer with sterile water for injection at 20 to 25°C and immediately diluted in 250 mL sodium chloride 0.9% in polyolefin bags (Maco Pharma) and stored at 2 to 8°C for up to 30 days.4000 The solutions were physically and chemically stable without substantial loss of target binding affinity when stored refrigerated for 30 days.4000
Freezing Solutions
Vedolizumab in intact vials, prefilled syringes, prefilled pens should not be used if frozen.3512 Do not freeze reconstituted solutions or diluted solutions.3512
Light Effects
Intact vials, prefilled syringes, and prefilled pens should be protected from light until time of use.3512
For a list of references cited in the text of this monograph, search the monograph titled References.