Infliximab

A to Z Drug Facts

 Action Neutralizes the biological activity of TNF by binding to its soluble and transmembrane forms and inhibits TNF receptor binding.

 Indications Reduce signs and symptoms and induce and maintain clinical remission of moderate to severe Crohn disease; reduce number of draining enterocutaneous fistulas in Crohn disease; in combination with methotrexate to reduce signs and symptoms, inhibit progression of structural damage, and improve physical function of rheumatoid arthritis in patients with inadequate response to methotrexate.

 Contraindications Hypersensitivity to murine proteins or other components of product; moderate or severe CHF.

 Route/Dosage

Rheumatoid Arthritis

ADULTS: IV 3 mg/kg infusion followed by additional 3 mg/kg doses at 2 and 6 wk after the first infusion, then q 8 wk thereafter.

Moderate to Severe Crohn Disease

ADULTS: IV 5 mg/kg as an induction regimen at 0.2 and 6 wk, followed by a maintenance regimen of 5 mg/kg q 8 wk. In patients who respond and then lose their response, consider treatment with 10 mg/kg.

Fistulizing Crohn Disease

ADULTS: IV 5 mg/kg initially followed by 5 mg/kg doses 2 and 6 wk after the first infusion.

 Interactions

Vaccines: Do not administer live vaccines concurrently. Incompatibilities: Do not infuse concomitantly with other agents in the same IV line.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Hypertension; hypotension; syncope; palpitation; tachycardia; cardiac failure; myocardial ischemia; brain infarction; pulmonary embolism; deep thrombophlebitis; chest pain. CNS: Headache; dizziness; upper motor neuron lesion; anxiety; confusion; delirium; depression; somnolence; suicide attempt. DERM: Urticaria; rash; furunculosis; sweating. EENT: Pharyngitis; ceruminosis. GI: Nausea; abdominal pain; vomiting; diarrhea; gastric ulcer; intestinal obstruction, perforation, and stenosis; pancreatitis; proctalgia. GU: UTI; azotemia; dysuria; hydronephrosis; kidney infection; renal failure; ureteral obstruction. HEMA: Splenic infarction; splenomegaly; lymphoma; thrombocytopenia; anemia; leukopenia; lymphadenopathy. HEPA: Elevated ALT and AST. META: Dehydration; pancreatic insufficiency; weight loss. RESP: Dyspnea; upper respiratory tract infection; coughing; sinusitis; rhinitis; adult respiratory distress syndrome; bronchitis; pleurisy; pneumonia; pulmonary infiltration; respiratory insufficiency. OTHER: Infusion reactions; infections; lupus-like syndrome; fatigue; fever; back pain; pain; pruritus; moniliasis; arthropathy; bone fracture; myalgia; tendon disorder and injury; abdominal hernia; falling; rheumatoid nodules; abscess; cellulitis; fever; sepsis; cholecystitis.

 Precautions

Pregnancy: Category B. Lactation: Undetermined. Children: Safety and efficacy not established. Elderly: Use with caution because of higher incidence of infection in the elderly. Autoimmunity: May result in autoantibody formation and, rarely, development of a lupus-like syndrome. CHF: Preliminary results of ongoing trials of patients with moderate to severe CHF have reported higher incidences of hospitalization and mortality for worsening heart failure in patients receiving infliximab. Infection: Serious infections including tuberculosis (frequently disseminated or extrapulmonary), invasive fungal infections, sepsis, and other opportunistic infections may occur. Neurologic events: Rarely, optic neuritis, seizure and new onset or exacerbation of clinical symptoms or radiographic evidence of CNS demyelinating disorders, including multiple sclerosis, may occur.

 Administration/Storage

• Reconstitute powder using 10 mL of sterile water only. Gently swirl solution to dissolve. Do not shake vial. Allow reconstituted solution to sit for 5 min. Solution should be colorless to light yellow and opalescent.
• Do not use if reconstituted solution is discolored or contains opaque particles.
• Prepare infusion solution by further diluting to a total volume of 250 mL with 0.9% Sodium Chloride Injection. Gently mix diluted solution.
• Use diluted solution within 3 hr of preparation.
• Administer via IV route only. Infuse slowly over a period of not less than 2 hr.
• Use in-line, sterile, low-protein filter of up to 1.2 mcm pore size.
• Do not infuse concomitantly in the same IV line with any other agents.
• Do not reuse or store any unused portion of the infusion solution.
• Store powder for injection in refrigerator. Do not freeze.
• Do not use beyond expiration date.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note history of allergic reactions to rats or mice.
• Assess patient for evidence of active infection. Report to health care provider if noted.
• Monitor patient for hypersensitivity reactions during and shortly after infusion.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Advise patient to notify health care provider immediately if any of the following occur: rash; hives; shortness of breath; swelling of the eyes, mouth, or throat.
• Advise patient to notify the health care provider if any of the following are noted: new or worsening joint or muscle pain; fever or other signs of infection; sore throat; difficulty swallowing; swelling of hands or face; headache.
• Advise women of child-bearing potential to inform health care provider if becoming pregnant or breastfeeding.
• Warn patient not to receive live vaccines while taking this drug.
• Instruct patient not to take any prescription or OTC medications or dietary supplements unless advised by health care provider.
• Advise patient that follow-up visits for examinations, blood tests, and additional doses of medication will be required; remind patient to keep appointments.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts