Concise Prescribing Info
Moderately to severely active ulcerative colitis & Crohn's disease who have had an inadequate response w/, lost response to, or were intolerant to either conventional therapy or tumour necrosis factor-α (TNFα) antagonist in adult patients.
Dosage/Direction for Use
Ulcerative colitis 300 mg IV infusion at 0, 2 & 6 wk & then every 8 wk, thereafter. Continue therapy & should be observed by wk 10. May increase dosing frequency to 300 mg every 4 wk. Retreatment: Dosing at every 4 wk & extended treatment period up to 1 yr. Crohn's disease 300 mg IV infusion at 0, 2 & 6 wk & then every 8 wk thereafter. Continue therapy every 8 wk from wk 14 in responding patients. Retreatment: Dosing at every 4 wk & extended treatment period up to 1 yr.
Hypersensitivity. Active severe infections eg, TB, sepsis, cytomegalovirus, listeriosis & opportunistic infections eg, progressive multifocal leukoencephalopathy.
Special Precautions
Acute hypersensitivity reactions including anaphylaxis. Screen patients for TB prior to therapy &/or discontinue therapy if diagnosed w/ TB; appropriate anti-TB treatment should be started & therapy may be continued until infection is resolved. Discontinue if severe infusion-related, anaphylactic & hypersensitivity reactions occur. Patients w/ controlled chronic or history of recurring severe infection; previously treated w/ natalizumab or rituximab (min of 12 wk prior to initiation of therapy); severe active disease at baseline not previously treated w/ TNFα antagonists. May increase the risk of malignancy. Concomitant use w/ live vaccines. Renal or hepatic impairment. May have minor influence on the ability to drive or operate machines. Women of childbearing potential. Pregnancy & lactation. Childn 0-17 yr.
Adverse Reactions
Nasopharyngitis, headache, arthralgia. Bronchitis, gastroenteritis, upper resp tract infection, flu, sinusitis, pharyngitis; paraesthesia, HTN, oropharyngeal pain, nasal congestion, cough; anal abscess/fissure, nausea, dyspepsia, constipation, abdominal distension, flatulence, haemorrhoids; rash, pruritus, eczema, erythema, night sweats, acne; muscle spasms, back pain, muscular weakness, fatigue, pain in the extremity.
ATC Classification
L04AA33 - vedolizumab ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Entyvio infusion conc 300 mg
20 mL x 1's
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