Updated May 30, 2026, 4:23 PM
Monoclonal antibodyUS FDA Database Verified

inFLIXimab (Rx)

Generic: InFLIXimab

Brand: Remicade

(in-fliks'ih-mab)

Pregnancy Category: B

Pharmacological Action

Monoclonal antibody that neutralizes the activity of tumor necrosis factor α (TNFα) that has been found in Crohn’s disease; decreased infiltration of inflammatory cells

Therapeutic outcome: Decreased cramping and blood in stools

Uses

Crohn’s disease, fistulizing, moderate to severe; rheumatoid arthritis given with methotrexate, plaque psoriasis, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, psoriasis Unlabeled uses: Behçet’s syndrome, uveitis, juvenile arthritis

Contraindications

Hypersensitivity to murines, moderate to severe CHF (NYHA class III/IV)

Precautions: Pregnancy B, breastfeeding, children, geriatric, COPD, hepatotoxicity, hematologic abnormalities, hepatitis B, Guillain-Barré syndrome, seizures, multiple sclerosis

BLACK BOX WARNING: Infection, neoplastic disease, TB

Dosage & Routes

Crohn’s disease (moderate to severe/fistulizing) Adult/adolescent/child ≥6 yr: IV INF 5 mg/kg initially, then repeat dose 2, 6 wk, q8 wk thereafter, may increase to 10 mg/kg if needed (adults) Rheumatoid arthritis

Adult: IV 3 mg/kg initially, and 2, 6 wk and q8 wk thereafter, max 10 mg/kg/dose

Available forms: Powder for inj 100 mg

Implementation Intermittent IV infusion route - Administer immediately after reconstitution; reconstitute each vial with 10 ml of sterile water for inj, further dilute total dose/250 ml of 0.9% NaCl inj to a total conc of between 0.4 and 4 mg/ml; use 21-G or smaller needle for reconstitution, direct sterile water at glass wall of vial, gently swirl, do not shake, may foam; allow to stand for 5 min, give within 3 hr - Give over ≥2 hr, use polyethylene-lined inf with in-line, sterile, low-protein-bind filter - Do not admix - Provide refrigerated storage, do not freeze

Adverse Effects

CNS: Headache, dizziness, depression, vertigo, fatigue, anxiety, fever, seizures, chills, flulike symptoms, demyelinating disease

CV: Chest pain, hypo/hypertension, tachycardia, CHF, acute coronary syndrome

GI: Nausea, vomiting, abdominal pain, stomatitis, constipation, dyspepsia, flatulence

GU: Dysuria, frequency

HEMA: Anemia, leukopenia, thrombocytopenia, pancytopenia

INTEG: Rash, dermatitis, urticaria, dry skin, sweating, flushing, hematoma, pruritus, keratoderma blennorrhagicum

MS: Myalgia, back pain, arthralgia

RESP: URI, pharyngitis, bronchitis, cough, dyspnea, sinusitis

SYST: Anaphylaxis, fatal infections, sepsis, malignancies, immunogenicity, Stevens-Johnson syndrome, toxic epidermal necrolysis

Pharmacokinetics

Absorption: Unknown

Distribution: Vascular compartment

Metabolism: Unknown

Excretion: Unknown

Half-life: 9½ days

Pharmacodynamics

Unknown

Interactions

Drug classifications Live virus vaccines: do not administer live vaccines concurrently TNF blockers (abatacept, anakinra, golimumab, rilonacept): increased infections, neutropenia; avoid concurrent use

Nursing Considerations

Assessment - Assess GI symptoms: nausea, vomiting, abdominal pain - Take periodic blood counts: CBC - Assess CV status: B/P, pulse, chest pain - Assess for allergic reaction, anaphylaxis: rash, dermatitis, urticaria, fever, chills, dyspnea, hypotension; discontinue if severe; administer epinephrine, corticosteroids, antihistamines; assess for allergy to murine proteins before starting therapy

BLACK BOX WARNING: Fatal infections: discontinue if infection occurs, do not administer to patients with active infections; identify TB before beginning treatment, a TB test should be obtained; if present, TB should be treated before giving infliximab; exercise caution when switching one DMARD to another - Report suspected adverse reactions to the FDA (1-800-FDA-1088)

BLACK BOX WARNING: Assess for neoplastic disease in those <18 yr, including heptosplenic T-cell lymphoma, usually occurs in those with inflammatory bowel disease

Patient/family education - Instruct patient to report infusion reaction immediately - Instruct patient to notify prescriber immediately if infection occurs - Advise patient not to breastfeed while taking this product - Advise patient to notify prescriber of GI symptoms, hypersensitivity reactions - Advise patient not to operate machinery or drive if dizziness, vertigo occurs - Teach patient to avoid live virus vaccinations, bring up to date prior to use

Evaluation

Positive therapeutic outcome: Absence of blood in stool, Reported improvement in comfort, Weight gain

Reference

Mosby's Drug Guide; Davis Drug Guide

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