Clinical Information
Gen. Code and Des.
72362 vedolizumab INTRAVEN VIAL 300 MG
GCN and Des.
36544 vedolizumab INTRAVEN VIAL 300 MG
Strength
300MG
Dose Form
VIAL (EA)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
56920000 GI DRUGS, MISCELLANEOUS
92200000 IMMUNOMODULATORY AGENTS
Active Ingredients
15531 vedolizumab 943609663
Inactive Ingredients
2551 polysorbates 9005645
2598 sucrose 57501
ENTYVIO- vedolizumab injection, powder, lyophilized, for solution
Takeda Pharmaceuticals America, Inc.
1 INDICATIONS AND USAGE
1.1 Adult Ulcerative Colitis
ENTYVIO (vedolizumab) is indicated for:
�
inducing and maintaining clinical response,
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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 DOSAGE AND ADMINISTRATION
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.
(6765)(6199)
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.
