Vedolizumab -Entyvio®

1.1 Adult Ulcerative Colitis

ENTYVIO (vedolizumab) is indicated for:

•

inducing and maintaining clinical response,

•

inducing and maintaining clinical remission,

•

improving the endoscopic appearance of the mucosa, and

•

achieving corticosteroid-free remission

in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids.

1.2 Adult Crohn’s Disease

ENTYVIO (vedolizumab) is indicated for:

•

achieving clinical response,

•

achieving clinical remission, and

•

achieving corticosteroid-free remission

in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids.

2.1 Important Administration Instructions

Administer ENTYVIO as an intravenous infusion over 30 minutes. Do not administer as an intravenous push or bolus. ENTYVIO lyophilized powder must be reconstituted with Sterile Water for injection and diluted in 250 mL of sterile 0.9% Sodium Chloride injection prior to administration [see Dosage and Administration (2.4)]. After the infusion is complete, flush with 30 mL of sterile 0.9% Sodium Chloride injection.

ENTYVIO should be administered by a healthcare professional prepared to manage hypersensitivity reactions including anaphylaxis, if they occur. Appropriate monitoring and medical support measures should be available for immediate use. Observe patients during infusion and until the infusion is complete.

2.2 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.

2.3 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.

2.4 Reconstitution and Dilution Instructions

Reconstitution Instructions

Reconstitute ENTYVIO at room temperature. ENTYVIO should be reconstituted and prepared by a trained medical professional using aseptic technique by the following procedure:

1.

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, using a syringe with a 21 to 25 gauge needle.

2.

Insert the syringe needle into the vial through the center of the stopper and direct the stream of Sterile Water for injection to the glass wall of the vial to avoid excessive foaming.

3.

Gently swirl the vial for at least 15 seconds to dissolve the lyophilized powder. Do not vigorously shake or invert.

4.

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.

5.

Visually inspect the reconstituted ENTYVIO solution for particulate matter and discoloration prior to administration. 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.

6.

Prior to withdrawing the reconstituted ENTYVIO solution from the vial, gently invert vial three times.

7.

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 sterile 0.9% Sodium Chloride 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.

Storage

If necessary, the infusion solution may be stored for up to four hours at 2° to 8°C (36º to 46ºF). Do not freeze. Discard any unused portion of the infusion solution.