克隆氏症、潰瘍性結腸炎、慢性結腸袋炎 Crohn disease; Ulcerative colitis; pouchitis
For patients with primary or secondary nonresponse to tumor necrosis factor (TNF)-alpha inhibitors
<20240410>

Monoclonal Antibody, Selective Adhesion-Molecule Inhibitor
Vedolizumab is a humanized monoclonal antibody that binds to the alpha4beta7 integrin and blocks the interaction of alpha4beta7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue. The interaction of the alpha4beta7 integrin with MAdCAM-1 has been implicated as an important contributor to the chronic inflammation that is a hallmark of ulcerative colitis and Crohn disease.

Distribution
Vd: 5 L
Half-life elimination:
25 days (serum, at 300 mg dosage)

1. Serious or severe hypersensitivity to vedolizumab or any component of the formulation
2. Patients with active severe infections or opportunistic infections

1. Information related to the use of vedolizumab in pregnancy is available.
2. The safety of administering live vaccines to infants exposed to vedolizumab in utero is not known. Vaccination with live vaccines (eg, rotavirus vaccine) should be avoided for the first 6 months of life if exposure to a biologic agent occurs during the third trimester of pregnancy.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk and benefits.
However, available guidelines note maternal use of vedolizumab is considered compatible with breastfeeding.

Headache, antibody development, arthralgia, nasopharyngitis

Use:
1. Prior to initiating treatment, all patients should be brought up to date with all immunizations according to current immunization guidelines.
2. Observe patients during infusion (until complete) and monitor for hypersensitivity reactions; discontinue if a reaction occurs.
Administration:
1. Prior to use, reconstitute Entyvio with 4.8mL sterile water for injection under 20 to 25 degree C, then dilute it with 250mL sterile 0.9% sodium chloride injection or LR <2021/10/13>
2. IV Infuse over 30 minutes. Do not administer by IV push or bolus.
3. Following infusion, flush with 30 mL of sterile 0.9% sodium chloride injection or LR <2021/10/13>
Dosage:
Crohn disease; Ulcerative colitis
1. General: 300mg at 0, 2, and 6 weeks and then every 8 weeks thereafter.
2. For patients with lower to non-response: 300mg every 4 weeks; may show therapeutic benefit by week 10 <2021/10/13>
3. Discontinue:
  1) Discontinue therapy In patients who show no evidence of therapeutic benefit by week 14.
  2) Consider treatment of 300mg every 4 weeks for patients restarting therapy. <2021/10/13>
Pouchitis
1. General:300 mg administered by intravenous infusion at 0, 2, and 6 weeks, and then every 8 weeks thereafter.
2.Vedolizumab should be initiated concomitantly with standard antibiotic therapy.
3.Discontinue therapy In patients who show no evidence of therapeutic benefit by week 14.
<20240410>

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Discontinue use with jaundice or signs / symptoms of hepatic injury.

未開啟之藥瓶應冷藏於 2°至 8°C。請放在原始包裝內，以防止光照。