Entyvio

Moderately to severely active ulcerative colitis or Crohn's disease in adults who have had an inadequate response w/, lost response to, or were intolerant to either conventional therapy or tumour necrosis factor-α (TNFα) antagonist.

IV Ulcerative colitis 300 mg IV infusion over 30 min at 0, 2 & 6 wk, & then every 8 wk thereafter. May increase dose frequency to 300 mg every 4 wk in patient who has experienced decrease in response. Discontinue therapy if no evidence of therapeutic benefit is observed by wk 10. Retreatment: Consider dosing at every 4 wk if therapy is interrupted & there is need to restart treatment. Crohn's disease 300 mg IV infusion over 30 min at 0, 2 & 6 wk, & then every 8 wk thereafter. Continue therapy every 8 wk from wk 14 in responding patients. May increase dose frequency to 300 mg every 4 wk in patient who has experienced decrease in response. Discontinue therapy if no evidence of therapeutic benefit is observed by wk 14. Retreatment: Consider dosing at every 4 wk if therapy is interrupted & there is need to restart treatment.

Hypersensitivity. Active severe infections eg, TB, sepsis, cytomegalovirus, listeriosis, & opportunistic infections eg, progressive multifocal leukoencephalopathy.

For IV use only. Observe all patients continuously during each infusion, for approx 2 hr following completion of the 1st 2 infusion for signs & symptoms of acute hypersensitivity reactions, & for approx 1 hr following completion of all subsequent infusions. Immediately discontinue treatment if severe infusion-related reaction (IRR), anaphylactic reaction, or other severe reaction occurs. Consider pre-treatment (eg, w/ antihistamine, hydrocortisone &/or paracetamol) prior to next infusion for patients w/ history of mild to moderate IRR. Not to be initiated in patients w/ active, severe infections until the infections are controlled, & consider w/holding treatment in patients who develop severe infection while on chronic treatment. Caution in patients w/ controlled chronic severe infection or history of recurring severe infections. Closely monitor patients for infections before, during & after treatment. Screen for TB before starting treatment. Discontinue therapy in patients diagnosed w/ TB during therapy until TB infection has been resolved. Monitor patients for any new onset or worsening of neurological signs & symptoms. Increased risk of malignancy in patients w/ ulcerative colitis & Crohn's disease. Caution in patients previously treated w/ natalizumab or rituximab. Not recommended in concomitant use w/ biologic immunosuppressants. Administer w/ other live vaccines only if the benefits clearly outweigh the risks. Consider patients w/ severe active disease at baseline not previously treated w/ TNFα antagonists during induction of remission in Crohn's disease. May have minor influence on ability to drive or operate machines. Has not been studied in patients w/ renal or hepatic impairment. Women of childbearing potential are strongly recommended to use adequate contraception & continue its use for at least 18 wk after the last treatment. Pregnancy & lactation. Safety & efficacy in childn 0-17 yr have not been established.

Nasopharyngitis; headache; arthralgia. Bronchitis, gastroenteritis, URTI, 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; pyrexia.

Caution w/ live vaccines, particularly live oral vaccines.

GIT Regulators, Antiflatulents & Anti-Inflammatories

L04AG05 - vedolizumab ; Belongs to the class of monoclonal antibodies. Used as immunosuppressants.

Rx