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
100 mg powder for injection
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.
Infliximab reduces concentrations of TNF-alpha production in Crohn's disease and related diseases. It is also a disease-modifying
antirheumatic drug (DMARD).
Moderately to severely active Crohn's disease, including fistulizing Crohn's disease, rheumatoid arthritis, ankylosing spondylitis,
Hypersensitivity to infliximab; CHF; infection, sepsis; murine protein hypersensitivity; lactation.
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
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
Adult: IV 3 mg/kg at weeks 0, 2, and 6, then q8wk
Adult: IV 5 mg/kg at weeks 0, 2, and 6, then 5 mg/kg q8wk
Adult: IV 5 mg/kg at weeks 0, 2, and 6, then 5 mg/kg q6wk
- Note: Do not administer to a patient who has known or suspected sepsis.
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
Headache, dizziness, involuntary muscle contractions, paresthesias, vertigo, anxiety, depression
Chest pain, peripheral edema, hypotension, hypertension, tachycardia, anemia
, CHF, pericardial effusion, systemic and cutaneous
, abdominal pain, vomiting, constipation
, dyspepsia, flatulence, intestinal obstruction, ulcerative stomatitis
enzymes. Hematologic: Leukopenia
URI, pharyngitis, bronchitis
, rhinitis, coughing, sinusitis
Rash, pruritus, acne
, fungal dermatitis, eczema
, dry skin, increased sweating, urticaria. Other:
Infections, development of autoantibodies, lupus-like syndrome
, dysuria, urinary frequency.
May blunt effectiveness of vaccines
Distributed primarily to the vascular compartment. Half-Life:
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.