INFLIXIMAB

INFLIXIMAb (in-flix'i-mab) Remicade Classifications: biologic response modifier; monoclonal antibody (igg); tumor necrosis factor modifier; Therapeutic: tumor necrosis factor (tnf) modifier; disease-modifying antirheumatic drug (dmard) Pregnancy Category: B

Availability

100 mg powder for injection

Action

IgG₁-K is a monoclonal antibody that binds specifically to tumor necrosis factor-alpha (TNF-alpha), a cytokine, preventing TNF-alpha from binding to its receptors. TNF-alpha induces proinflammatory cytokines. Infliximab reduces infiltration of inflammatory cells and TNF-alpha production in inflamed areas of the intestine, as seen in Crohn's disease.

Therapeutic Effect

Infliximab reduces concentrations of TNF-alpha production in Crohn's disease and related diseases. It is also a disease-modifying antirheumatic drug (DMARD).

Uses

Moderately to severely active Crohn's disease, including fistulizing Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis.

Contraindications

Hypersensitivity to infliximab; CHF; infection, sepsis; murine protein hypersensitivity; lactation.

Cautious Use

History of allergic phenomena or untoward responses to monoclonal antibody preparation; renal or hepatic impairment; multiple sclerosis (potential exacerbation); fungal infection; heart failure, human antichimeric antibody (HACA); leukopenia, thrombocytopenia; immunosuppressed patients; neoplastic disease; tuberculosis; vaccination; vasculitis; neurological disease; neutropenia; seizure disorder, seizures; older adults; pregnancy (category B).

Route & Dosage

Crohn's Disease Adult: IV 5 mg/kg infused over at least 2 h, repeat at 2 and 6 wk for fistulizing disease, then q8wk Child: IV 5 mg/kg at weeks 0, 2, and 6, then 5 mg/kg q8wk Rheumatoid Arthritis Adult: IV 3 mg/kg at weeks 0, 2, and 6, then q8wk Ulcerative Colitis Adult: IV 5 mg/kg at weeks 0, 2, and 6, then 5 mg/kg q8wk Ankylosing Spondylitis Adult: IV 5 mg/kg at weeks 0, 2, and 6, then 5 mg/kg q6wk

Administration

• Note: Do not administer to a patient who has known or suspected sepsis.

Intravenous PREPARE: IV Infusion: • Reconstitute each vial with 10 mL of sterile water for injection using a 21-gauge or smaller syringe. Inject sterile water against wall of vial, then gently swirl to dissolve but do not shake.• Let stand for 5 min.• Solution should be colorless to light yellow with a few translucent particles. Discard if particles are opaque.• Further dilute by first removing from a 250-mL IV bag of NS a volume of NS equal to the volume of reconstituted infliximab to be added to the IV bag. Slowly add the total volume of reconstituted infliximab solution to the 250-mL infusion bag and gently mix.• Infusion concentration should be 0.4 to 4 mg/mL.• Begin infusion within 3 h of preparation.  ADMINISTER: IV Infusion: •  Give over at least 2 h using a polyethylene-lined infusion set with an in-line, low-protein-binding filter (pore size 1.2 micron or less).• Flush infusion set before/after with NS to ensure delivery of total drug dose.• Discard unused infusion solution.  INCOMPATIBILITIES Y-site: Do not infuse with any other drugs.

• Store unopened vials at 2°–8° C (36°–46° F).

Adverse Effects (≥1%)

Body as a Whole: Fatigue, fever, pain, myalgia, back pain, chills, hot flashes, arthralgia; infusion-related reactions (fever, chills, pruritus, urticaria, chest pain, hypotension, hypertension, dyspnea). Increased risk of opportunistic infections, including tuberculosis. CNS: Headache, dizziness, involuntary muscle contractions, paresthesias, vertigo, anxiety, depression, insomnia. CV: Chest pain, peripheral edema, hypotension, hypertension, tachycardia, anemia, CHF, pericardial effusion, systemic and cutaneous vasculitis. GI: Nausea, diarrhea, abdominal pain, vomiting, constipation, dyspepsia, flatulence, intestinal obstruction, ulcerative stomatitis, increased hepatic enzymes. Hematologic: Leukopenia, neutropenia, thrombocytopenia, pancytopenia. Respiratory: URI, pharyngitis, bronchitis, rhinitis, coughing, sinusitis, dyspnea. Skin: Rash, pruritus, acne, alopecia, fungal dermatitis, eczema, dry skin, increased sweating, urticaria. Other: Infections, development of autoantibodies, lupus-like syndrome, conjunctivitis, dysuria, urinary frequency.

Interactions

Drug: May blunt effectiveness of vaccines given concurrently.

Pharmacokinetics

Distribution: Distributed primarily to the vascular compartment. Half-Life: 9.5 d.

Nursing Implications

Assessment & Drug Effects

• Discontinue IV infusion and notify physician for fever, chills, pruritus, urticaria, chest pain, dyspnea, hypo/hypertension.
• Monitor for and immediately report S&S of local IV site or more generalized infection.

Patient & Family Education

• Report any infection to your physician promptly.

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Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug