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Infliximab
Infliximab (Remicade)
Infliximab
(in-FLIX-ih-mab)
Pregnancy Category: C
Remicade (Rx)
Classification:
Treatment for Crohn's disease
Action/Kinetics:
Chimeric IgG1K monoclonal antibody produced by a recombinant cell line to treat Crohn's disease. Acts by neutralizing the biological activity of TNFþ by high-affinity binding to its soluble and transmembrane forms and inhibits TNFþ receptor binding.
Uses:
Reduce signs and symptoms of moderate to severe Crohn's disease. To reduce the number of draining enterocutaneous fistulas in fistulizing Crohn's disease. With methotrexate to treat rheumatoid arthritis in those who do not respond adequately to methotrexate alone.
Contraindications:
Hypersensitivity to murine proteins. Lactation.
Special Concerns:
Safety and efficacy have not been determined for use in children or beyond a single dose in moderate to severe Crohn's disease or beyond three doses in fistulizing Crohn's disease. Use with caution in the elderly.
Side Effects:
Infusion-related (during infusion or within 2 hr post-infusion): Fever, chills, pruritus, urticaria, chest pain, hypotension, hypertension, dyspnea. Hypersensitivity: Urticaria, dyspnea, hypotension. Infections: Pneumonia, cellulitis, infection at CNS venous catheter, sepsis, cholecystitis, endophthalmitis, furunculosis. GI: N&V;, diarrhea, abdominal pain, constipation, dyspepsia, flatulence, intestinal obstruction, oral pain, ulcerative stomatitis, toothache. CNS: Dizziness, paresthesia, vertigo, anxiety, depression, insomnia. CV: Hypotension, hypertension, tachycardia. Dermatologic: Rash, pruritus, acne, alopecia, fungal dermatitis, eczema, erythema, erythematous rash, maculopapular rash, pruritus, papular rash, dry skin, increased sweating, urticaria, ecchymoses, flushing, hematoma. GU: Dysuria, micturition frequency, UTIs. Musculoskeletal: Myalgia, back pain, arthralgia, arthritis. Respiratory: URTI, pharyngitis, bronchitis, rhinitis, coughing, sinusitis, dyspnea, laryngitis, respiratory tract allergic reaction. Miscellaneous: Fatigue, fever, pain, moniliasis, chest pain, chills, peripheral edema, fall, hot flashes, malaise, anemia, abscess, flu syndrome, herpes simplex, herpes zoster, conjunctivitis.
Note: Possible formation of autoimmune antibodies (anti-dsDNA antibodies); development of lupus-like syndrome.
Note: Retreatment after an extended treatment-free period may cause delayed, potentially serious side effects. Symptoms include fever, myalgia, polyarthralgia, pruritus, rash and, less frequently, facial or hand edema, dysphagia, urticaria, sore throat, and headache. Use of acetaminophen, antihistamines, corticosteroids, or epinephrine helps the symptoms.
How Supplied:
Powder for injection: 100 mg
Dosage
•IV
Moderate to severe Crohn's disease
5 mg/kg as a single IV dose.
Fistulizing Crohn's disease.
Initial: 5 mg/kg IV followed by additional doses of 5 mg/kg at 2 and 6 weeks after the initial infusion.
With methotrexate to treat rheumatoid arthritis.
Infliximab, 3 mg/kg at 1, 2, and 6 weeks; then, q 8 weeks. During the first year, 8 infusions are given; in subsequent years, 6 infusions are given.
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