ENTYVIO

Similar pharmacokinetics were observed in ulcerative colitis and Crohn's disease patients administered 300 mg ENTYVIO as a 30-minute intravenous infusion on Weeks 0, 2, and 6, and then every eight weeks up to Week 52 (Table 3) . Table 3. Mean ± SD Vedolizumab Concentrations in Patients Data from patients in UC Trials I and II and CD Trials I and III with pharmacokinetic data available; data from patients with anti-vedolizumab antibody were excluded. with Ulcerative Colitis and Crohn's Disease Pa...

14.1 Clinical Studies in Ulcerative Colitis Intravenous Administration The safety and efficacy of intravenous ENTYVIO were evaluated in two randomized, double-blind, placebo-controlled trials (UC Trials I and II) in adult patients with moderately to severely active ulcerative colitis (UC) defined as Mayo score of 6 to 12 with endoscopy subscore of two or three. The Mayo score ranges from 0 to 12 and has four subscales that are each scored from zero (normal) to three (most severe): stool frequency, rectal bleeding, findings on endoscopy, and physician global assessment. An endoscopy subscore of...

The following topics are also discussed in detail in the Warnings and Precautions section: Infusion-Related Reactions and Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.3) ] Liver Injury [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence ≥3% and ≥1% higher than placebo) are: nasopharyngitis, headache, arthralgia, nausea, pyrexi...

ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients (such as dyspnea, bronchospasm, urticaria, flushing, rash and increased heart rate) [see Warnings and Precautions (5.1) ] . Patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients. ( 4 )

Infusion-Related Reactions and Hypersensitivity Reactions : Discontinue ENTYVIO and initiate appropriate treatment if serious reactions occur. ( 5.1 ) Infections : Treatment with ENTYVIO should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. If a serious infection develops, ENTYVIO should not be administered until the infection resolves. ( 5.2 ) Progressive Multifocal Leukoencephalopathy (PML) : Although unlikely, a...

7 DRUG INTERACTIONS 7.1 Natalizumab Products Because of the potential for increased risk of PML and other infections, avoid the concomitant use of ENTYVIO with natalizumab products. 7.2 TNF Blockers Because of the potential for increased risk of infections, avoid the concomitant use of ENTYVIO with TNF blockers. 7.3 CYP450 Substrates The formation of CYP450 enzymes may be suppressed by increased l...