Concise Prescribing Info
Adult patients w/ moderately to severely active ulcerative colitis or Crohn's disease who have had an inadequate response w/, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-α (TNFα) antagonist.
Dosage/Direction for Use
Administer as an IV infusion over 30 min. 300 mg at 0, 2 & 6 wk, & then every 8 wk thereafter. May increase to 300 mg every 4 wk if there is decrease in response. Ulcerative colitis Retreatment: Every 4 wk. Crohn's disease Continue therapy every 8 wk from wk 14 in responding patients. Retreatment: Every 4 wk.
Hypersensitivity. Active severe infections eg, TB, sepsis, cytomegalovirus, listeriosis & opportunistic infections eg, progressive multifocal leukoencephalopathy (PML).
Special Precautions
Observe patients continuously during each infusion; first 2 infusion should be observed for approx 2 hr following completion of infusion for signs & symptoms of acute hypersensitivity reactions; for subsequent infusions, observe for approx 1-hr following completion of infusion. Discontinue in case of severe infusion-related & anaphylactic reactions. Consider pre-treatment prior to next infusion in patients w/ a history of mild to moderate infusion-related reactions. Do not initiate treatment in patients w/ active, severe infections. Patients w/ controlled chronic severe infections or history of recurring severe infections. Monitor for any new onset or worsening of neurological signs & symptoms. Withhold treatment if PML is suspected, & discontinue permanently if confirmed. Increased risk of malignancy. Patients previously treated w/ natalizumab or rituximab. Concomitant use w/ biologic immunosuppressants. Live & oral vaccines. Patients w/ severe active disease at baseline not previously treated w/ TNFα antagonists. May have minor influence on the ability to drive or operate machines. Women of childbearing potential should use adequate contraception during & for 18 wk after treatment. Pregnancy & lactation.
Adverse Reactions
Nasopharyngitis; headache; arthralgia. Bronchitis, gastroenteritis, upper resp tract infection, influenza, 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; pyrexia.
Drug Interactions
MIMS Class
GIT Regulators, Antiflatulents & Anti-Inflammatories / Immunosuppressants
ATC Classification
L04AA33 - vedolizumab ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Entyvio powd for infusion 300 mg
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