Remicade

Infliximab

Reducing signs & symptoms, & inducing & maintaining clinical remission in adults & ped patients ≥6 yr w/ moderately to severely active Crohn's disease (CD) who have had an inadequate response to conventional therapy. Reducing the number of draining enterocutaneous & rectovaginal fistulas & maintaining fistula closure in adult patients w/ fistulizing CD. Reducing signs & symptoms, inducing & maintaining clinical remission & mucosal healing, & eliminating corticosteroid use in adult patients w/ moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy. Reducing signs & symptoms, & inducing & maintaining clinical remission in ped patients ≥6 yr w/ moderately to severely active UC who have had an inadequate response to conventional therapy. In combination w/ methotrexate, for reducing signs & symptoms, inhibiting the progression of structural damage, & improving physical function in adult patients w/ moderately to severely active RA. Reducing signs & symptoms in adult patients w/ active ankylosing spondylitis (AS). Reducing signs & symptoms of active arthritis, inhibiting the progression of structural damage, & improving physical function in adult patients w/ psoriatic arthritis (PsA). Treatment of adult patients w/ chronic severe (ie, extensive &/or disabling) plaque psoriasis (Ps) who are candidates for systemic therapy & when other systemic therapies are medically less appropriate.

IV infusion Adult Moderate to severe active CD or fistulizing CD 5 mg/kg as IV induction regimen at 0, 2 & 6 wk followed by a maintenance regimen of 5 mg/kg every 8 wk thereafter. Moderate to severe active UC 5 mg/kg as IV induction regimen at 0, 2 & 6 wk followed by a maintenance regimen of 5 mg/kg every 8 wk thereafter. Moderate to severe active RA 3 mg/kg given as an IV induction regimen at 0, 2 & 6 wk followed by a maintenance regimen of 3 mg/kg every 8 wk thereafter. AS 5 mg/kg as IV induction regimen at 0, 2 & 6 wk followed by a maintenance regimen of 5 mg/kg every 6 wk thereafter. PsA 5 mg/kg as IV induction regimen at 0, 2 & 6 wk followed by a maintenance regimen of 5 mg/kg every 8 wk thereafter. Chronic severe Ps 5 mg/kg as IV induction regimen at 0, 2 & 6 wk followed by a maintenance regimen of 5 mg/kg every 8 wk thereafter. Ped patient Moderate to severe active CD 5 mg/kg as IV induction regimen at 0, 2 & 6 wk followed by a maintenance regimen of 5 mg/kg every 8 wk. Moderate to severe active UC 5 mg/kg as IV induction regimen at 0, 2 & 6 wk followed by a maintenance regimen of 5 mg/kg every 8 wk.

Hypersensitivity to infliximab or any murine proteins. Doses of >5 mg/kg in patients w/ moderate or severe heart failure.

Increased risk of developing serious infections. Discontinue if patient develops serious infection or sepsis. Evaluate patient for TB risk factors & test for latent infection prior to & periodically during therapy. Reports of malignancies (lymphomas, hepatosplenic T-cell lymphoma, skin cancer, cervical cancer or other malignancies of the lung or head & neck origin). Hepatotoxicity & hepatitis B reactivation. Discontinue in case of new/worsening symptoms of heart failure; significant hematologic abnormalities; severe hypersensitivity reactions; neurologic disorders; lupus-like symptoms. Reports of CV & cerebrovascular reactions during & after infusion. May result in the formation of autoantibodies & development of a lupus-like syndrome. Concurrent use w/ anakinra, abatacept or other biological products used to treat the same conditions as Remicade is not recommended. Care should be taken when switching between biologic disease-modifying antirheumatic drugs (DMARDs). Concurrent administration of live vaccines or therapeutic infectious agents is not recommended. Live vaccines should not be given to infants after in utero exposure to infliximab for at least 6 mth following birth. Pregnancy & lactation. Elderly. Ped patients.

Adult: Infusion-related reactions eg, dyspnea, flushing, headache, rash; infections eg, resp tract infections, UTI; development of positive antinuclear antibody (ANA); malignancies; worsening of heart failure in patients w/ moderate/severe heart failure receiving 10 mg/kg dose; severe liver injury including acute liver failure & autoimmune hepatitis; HBV reactivation; nausea, sinusitis, diarrhea, abdominal pain, pharyngitis, coughing, bronchitis, dyspepsia, fatigue, pain, arthralgia, pruritus, fever, HTN, moniliasis. Paed: Anemia, leukopenia, flushing, bacterial or viral infection, neutropenia, bone fracture, resp tract allergic reaction, upper resp tract infection, pharyngitis, abscess, abdominal pain, fever, headache.

Increased risk of serious infections w/ anakinra, abatacept, tocilizumab. Concomitant methotrexate use may decrease the incidence of anti-infliximab Ab production & increase infliximab conc. Patients w/ CD who received immunosuppressants tended to experience fewer infusion reactions compared to patients not on immunosuppressants. Monitor effects/drug conc of CYP450 substrates w/ narrow therapeutic index (warfarin, cyclosporine or theophylline) upon initiation or discontinuation of Remicade. Risk of clinical infections including disseminated infections w/ live vaccines or therapeutic infectious agents.

Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants

L04AB02 - infliximab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.

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