Drug Detail:Entyvio (Vedolizumab [ ve-doe-liz-ue-mab ])
Generic Name: VEDOLIZUMAB 300mg in 5mL
Dosage Form: injection, powder, lyophilized, for solution
Drug Class: Selective immunosuppressants
Important Preparation and Administration Instructions
- Administer ENTYVIO as an intravenous infusion over 30 minutes. Do not administer as an intravenous push or bolus.
- Reconstitute ENTYVIO lyophilized powder with Sterile Water for Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP.
- Dilute the reconstituted ENTYVIO solution in 250 mL of 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, prior to administration [see Dosage and Administration (2.4)].
- After the infusion is complete, flush with 30 mL of 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP.
- ENTYVIO should be administered by a healthcare professional prepared to manage hypersensitivity reactions including anaphylaxis, if they occur [see Warnings and Precautions (5.1)]. Appropriate monitoring and medical support measures should be available for immediate use. Observe patients during infusion and until the infusion is complete.
Prior to Administration of ENTYVIO
Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines.
Dosage in Adults with Ulcerative Colitis or Crohn's Disease
The recommended dosage of ENTYVIO in adults with ulcerative colitis or Crohn's disease is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.
Discontinue therapy in patients who show no evidence of therapeutic benefit by Week 14.
Reconstitution and Dilution Instructions
Reconstitution Instructions
- Remove the flip-off cap from the single-dose vial and wipe with alcohol swab. Reconstitute ENTYVIO vial containing lyophilized powder with 4.8 mL of Sterile Water for Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, at room temperature (20°C to 25°C [68°F to 77°F]), using a syringe with a 21- to 25- gauge needle.
- Insert the syringe needle into the vial through the center of the stopper and direct the stream of Sterile Water for Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, to the glass wall of the vial to avoid excessive foaming.
- Gently swirl the vial for at least 15 seconds to dissolve the lyophilized powder. Do not vigorously shake or invert.
- Allow the solution to sit for up to 20 minutes at room temperature to allow for reconstitution and for any foam to settle; the vial can be swirled and inspected for dissolution during this time. If not fully dissolved after 20 minutes, allow another 10 minutes for dissolution. Do not use the vial if the drug product is not dissolved within 30 minutes.
- Visually inspect the reconstituted ENTYVIO solution for particulate matter and discoloration prior to dilution. Solution should be clear or opalescent, colorless to light brownish yellow and free of visible particulates. Do not administer reconstituted solution showing uncharacteristic color or containing particulates.
- Once dissolved, gently invert vial three times.
- Immediately, withdraw 5 mL (300 mg) of reconstituted ENTYVIO solution using a syringe with a 21- to 25- gauge needle. Discard any remaining portion of the reconstituted solution in the vial.
Dilution Instructions
Add the 5 mL (300 mg) of reconstituted ENTYVIO solution to 250 mL of 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, and gently mix the infusion bag. Do not add other medicinal products to the prepared infusion solution or intravenous infusion set. Once reconstituted and diluted, use the infusion solution as soon as possible.
Discard any unused portion of the infusion solution.
Storage
Specific storage conditions and timing for the reconstituted solution in vial and diluted solution in the infusion bag are outlined in Table 1.
Do not freeze the reconstituted solution in the vial or the diluted solution in the infusion bag.
| Storage Condition | ||
|---|---|---|
| Refrigeration (2°C to 8°C [36°F to 46°F]) |
Room temperature (20°C to 25°C [68°F to 77°F]) |
|
|
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| Reconstituted Solution (in Sterile Water for Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, inside vial) |
8 hours | Use immediately after reconstitution |
| Diluted Solution (in 0.9% Sodium Chloride Injection, USP) |
24 hours*,† | 12 hours* |
| Diluted Solution (in Lactated Ringer's Injection, USP) |
6 hours* | Use immediately after dilution |
The combined storage time of reconstituted ENTYVIO solution in the vial and the diluted solution in the infusion bag with 0.9% Sodium Chloride Injection, USP, is a total of 12 hours at room temperature (20°C to 25°C [68°F to 77°F]) or 24 hours refrigerated (2°C to 8°C [36°F to 46°F]). This combined storage time may include up to eight hours of the reconstituted solution in the vial at 2°C to 8°C.
The combined storage time of reconstituted ENTYVIO solution in the vial and the diluted solution in the infusion bag with Lactated Ringer's Injection, USP, is a total of six hours refrigerated (2°C to 8°C [36°F to 46°F]).
