Infliximab

DEA Class; Rx

Common Brand Names; Remicade, Inflectra, infliximab-dyyb, Renflexis, infliximab-abda, Ixifi, infliximab-qbtx, Avsola, infliximab-axxq

• Antipsoriatics, Systemic; 
• DMARDs, TNF Inhibitors; 
• Immunosuppressants; 
• Monoclonal Antibodies; 
• Inflammatory Bowel Disease Agents

TNF blocker; given as an intravenous infusion
Used for Crohn’s disease and ulcerative colitis in adult and pediatric patients 6 years and older; also used in adults with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis
Boxed warnings for increased risk of serious infections and potential risk of malignancy

Indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately-to-severely active rheumatoid arthritis in combination with methotrexate

Indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis

Indicated for the treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate

Remicade, Inflectra, Renflexis, Ixifi, Avsola

Indicated for moderately-to-severely active Crohn disease in patients who have had inadequate response to conventional therapy

Also, indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn disease

Indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adults with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy

Indicated for reducing signs and symptoms in patients with active ankylosing spondylitis

Active serious infections

Documented hypersensitivity

Doses >5 mg/kg in patients with moderate-to-severe heart failure (NYHA Class III/IV)

• Development of antinuclear antibodies (50%)
• Infection (36%)
• Upper respiratory tract infection (32%)
• Abdominal pain (12%; 26% with Crohn disease)
• Nausea (21%)
• Infusion-related reaction (20%)
• Headache (18%)
• Development of antibodies to double-stranded DNA (17%)
• Other respiratory infection (eg, sinusitis, cough) (12-14%)
• Diarrhea (12%)
• Elevated alanine transaminase (ALT), >1 to <3 ULN (12-34%)
• Bronchitis (10%)
• Dyspepsia (10%)
• Rash (1-10%)
• Elevated ALT, ≥3 ULN (2-10%)
• Fatigue (9%)
• Back pain (8%)
• Rhinitis (8%)
• Urinary tract infection (8%)
• Arthralgia (1-8%)
• Fever (7%)
• Hypertension (7%)
• Pruritus (7%)
• Dyspnea (6%)
• Candidiasis (5%)
• Lupuslike symptoms (<5%)
• Elevated ALT, ≥5 ULN (<1-4%)

Patients should be closely monitored for development of signs and symptoms of infection during and after treatment

Hypersensitivity reactions reported; most hypersensitivity reactions, which include anaphylaxis, urticaria, dyspnea, and/or hypotension, have occurred during or within 2 hr of infusion

Caution in neurologic disorder

Moderate-to-severe chronic obstructive pulmonary disease

Monitor closely for signs and symptoms of demyelinating disease (eg, confusion, numbness, vision changes); consider termination of therapy if significant CNS reactions develop

Risk of tuberculosis, histoplasmosis, and other opportunistic infections, as well as hepatitis B reactivation; test for HBV infection before starting infliximab; monitor HBV carriers during and several months after therapy

Consider discontinuance if hematologic disorder occurs (eg, leukopenia, thrombocytopenia, neutropenia, pancytopenia)

Consider discontinuance if lupuslike symptoms occur

Readministration after period of no treatment resulted in higher incidence of infusion reactions than was seen with regular maintenance treatment (4% vs <1%)

Consider empiric antifungal therapy for patients who develop a systemic illness on infliximab and reside or travel to regions where mycoses are endemic

Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hr of initiation of infliximab infusion; cases of transient visual loss have been reported during or within 2 hr of infliximab infusion; monitor patients during infusion and if serious reaction occurs, discontinue infusion

Use caution in patients with history of seizures; discontinue therapy if significant adverse reactions develop

Use caution in patients with mild heart failure (NYHA Class I, II) or decreased left ventricular function; worsening and new-onset heart failure reported

Before initiating therapy in pediatric and adult patients, update vaccinations in accordance with current vaccination guidelines

Available observational studies in pregnant women exposed to infliximab products showed no increased risk of major malformations among live births as compared to those exposed to non- biologics

Published literature show that infliximab is present at low levels in human milk

Infliximab

injection, lyophilized powder for reconstitution

• 100mg/vial (Remicade, Inflectra, Renflexis, Ixifi, Avsola)

Biosimilars to Remicade

• Inflectra (infliximab-dyyb)
• Renflexis (infliximab-abda)
• Ixifi (infliximab-qbtx)
• Avsola (infliximab-axxq)