- Injection, lyophilized powder for solution 100 mg
Neutralizes the biological activity of tumor necrosis factor (TNF)–alpha by binding to its soluble and transmembrane forms, and inhibits TNF-alpha receptor binding.
Single IV infusions show a linear relationship between the dose administered and the C max .
Distributed primarily within the vascular compartment.
The half-life is 7.7 to 9.5 days.
Special PopulationsRenal Function Impairment
It is not known if there are differences in Cl or Vd in patients with marked renal impairment.Hepatic Function Impairment
It is not known if there are differences in Cl or Vd in patients with marked hepatic impairment.Elderly
No major differences in Cl or Vd were observed in subgroups defined by age.Children
Peak and trough concentrations were similar in children 6 to 17 y of age and adults with Crohn disease.Gender
No major differences in Cl or Vd were observed in subgroups defined by gender.Weight
No major differences in Cl or Vd were observed in subgroups defined by weight.
Indications and Usage
Reduce signs and symptoms and induce and maintain clinical remission of moderate to severe active Crohn disease in patients who have had inadequate response to conventional therapy; reduce number of draining enterocutaneous and rectovaginal fistulas, and maintain fistula closure in fistulizing Crohn disease; in combination with methotrexate to reduce signs and symptoms, inhibit progression of structural damage, and improve physical function in patients with moderately to severely active rheumatoid arthritis; reduce signs and symptoms of active ankylosing spondylitis; reduce signs and symptoms of active psoriatic arthritis, inhibit progression of structural damage, and improve physical function of patients with active psoriatic arthritis; treatment of chronic, severe plaque psoriasis in patients who are candidates for systemic therapy; reduce signs and symptoms, achieve clinical remission and mucosal healing, and eliminate corticosteroid use in patients with moderately to severely active ulcerative colitis who have an inadequate response to conventional therapy.
Adjunctive therapy for active Wegener granulomatosis in refractory patients; management of Behçet syndrome uveitis; management of hidradenitis suppurativa; treatment of erythrodermic psoriasis; treatment of steroid-resistant graft-versus-host disease; treatment of juvenile idiopathic arthritis; treatment of pustular psoriasis; treatment of pyoderma gangrenosum; treatment of refractory cases of celiac sprue; treatment of sarcoidosis; treatment of uveitis.
Hypersensitivity to murine proteins or other components of product; previous severe hypersensitivity reaction to infliximab; administration of doses more than 5 mg/kg to patients with moderate or severe heart failure.
Dosage and AdministrationAnkylosing Spondylitis
IV 5 mg/kg as an induction regimen at 0, 2, and 6 wk, followed by a maintenance regimen of 5 mg/kg every 6 wk.Crohn Disease
IV 5 mg/kg as an induction regimen at 0, 2, and 6 wk, followed by a maintenance regimen of 5 mg/kg every 8 wk. In patients who respond and then lose response, consider treatment with 10 mg/kg. Consider discontinuation of therapy in patients who do not respond by wk 14.Children 6 y and older
IV 5 mg/kg as an induction regimen at 0, 2, and 6 wk, followed by a maintenance regimen of 5 mg/kg every 8 wk.Psoriatic Arthritis, Plaque Psoriasis
IV 5 mg/kg as an induction regimen at 0, 2, and 6 wk, followed by a maintenance regimen of 5 mg/kg every 8 wk. Can be used in combination with methotrexate in the treatment of psoriatic arthritis.Rheumatoid Arthritis
IV 3 mg/kg as an induction regimen at 0, 2, and 6 wk, followed by a maintenance regimen of 3 mg/kg every 8 wk in combination with methotrexate. For patients with incomplete response, may administer up to 10 mg/kg or treat as often as every 4 wk.Ulcerative Colitis
IV 5 mg/kg as an induction regimen at 0, 2, and 6 wk followed by a maintenance regimen of 5 mg/kg every 8 wk thereafter.
- For administration by IV infusion only. Not for intradermal, subcutaneous, IM, IV bolus, or intra-arterial administration.
- Reconstitute each vial with 10 mL of sterile water for injection with a syringe equipped with a 21-gauge or smaller needle. Gently swirl by rotating the vial to dissolve the lyophilized powder. Avoid prolonged or vigorous agitation; do not shake. Foaming of the solution on reconstitution is not unusual; allow to stand for 5 min.
- Further dilute the total volume of reconstituted solution to 250 mL with sodium chloride 0.9% injection. The infusion solution concentration should be between 0.4 and 4 mg/mL.
- Administer by IV infusion over a period of no less than 2 h through an infusion set with an in-line, sterile, nonpyrogenic, low–protein-binding filter with a pore size of 1.2 micrometers or less.
- Do not infuse infliximab concomitantly in the same IV line with any other agent.
- Premedication may be administered at the health care provider's discretion. Premedication could include antihistamines, acetaminophen, and/or corticosteroids.
- Slow or suspend infusion for mild to moderate infusion reactions; upon resolution of the reaction, reinitiate at a lower infusion rate and/or administer acetaminophen, antihistamines, and/or corticosteroids. Discontinue infliximab in patients who do not tolerate the infusion after these interventions.
- Discontinue further infliximab treatment in patients who experience severe infusion-related hypersensitivity reactions.
Store vials in refrigerator (36° to 46°F). Discard any unused reconstituted solution or infusion solution.
Drug InteractionsAbatacept, anakinra
Risk of serious infection and neutropenia may be increased. Coadministration of infliximab and abatacept or anakinra is not recommended.Azathioprine and 6-mercaptopurine
Rare, aggressive, and often fatal postmarketing cases of hepatosplenic T-cell lymphoma have been reported in adolescent and young adult patients with Crohn disease treated with infliximab. All of these hepatosplenic T-cell lymphomas with infliximab have occurred in patients on concomitant treatment with azathioprine or 6-mercaptopurine.TNF blockers (eg, adalimumab, certolizumab, etanercept, golimumab)
Risk of serious infection may be increased. Avoid coadministration of infliximab and another TNF blocker.Tocilizumab
Coadministration may increase the risk of serious infection. Avoid coadministration.Vaccines
Do not coadminister live vaccines.
Hypertension (7%); chest pain, hypotension (1%); bradycardia; thrombophlebitis; myocardial infarction/ischemia, pericardial effusion, systemic and cutaneous vasculitis (postmarketing).
Headache (18%); fatigue (9%); neuropathies, peripheral demyelinating disorders (including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy), seizure (postmarketing).
Rash (10%); flushing (9%); pruritus (7%); erythema multiforme, new-onset and worsening psoriasis, Stevens-Johnson syndrome, TEN (postmarketing).
Transient visual loss (postmarketing).
Abdominal pain (26%); nausea (21%); diarrhea (12%); dyspepsia, blood in stool (10%); intestinal obstruction.
Anemia (11%); leukopenia (9%); neutropenia (7%); hemolytic anemia, lymphadenopathy, lymphoma, pancytopenia, thrombocytopenia; idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura (postmarketing).
Elevated ALT (51%); elevated AST; hepatitis; severe liver injury, including acute liver failure and autoimmune hepatitis; cholestasis, jaundice (postmarketing).
Antibodies to infliximab (51%); respiratory tract allergic reaction (6%); delayed hypersensitivity reported as serum sickness or a combination of arthralgia and/or myalgia with fever and or rash (1%); allergic reaction, anaphylactic-like reactions, including laryngeal/pharyngeal edema and severe bronchospasm (postmarketing).
Arthralgia (8%); bone fracture (7%); transverse myelitis (postmarketing).
Upper respiratory tract infection (32%); sinusitis (14%); coughing, pharyngitis (12%); bronchitis (10%); dyspnea (1%); pulmonary edema; pleurisy; pneumonia; interstitial lung disease, including interstitial pneumonitis/pulmonary fibrosis (postmarketing).
Infections (56%); infusion reactions (20%); pain, viral infections (8%); fever (7%); bacterial infection (6%); moniliasis (5%); chills (3%); cellulitis; malignancies, including non-Hodgkin lymphoma and Hodgkin disease; sepsis; serum sickness (postmarketing).
Serious, life-threatening infections leading to hospitalization and death may occur. Infections include active tuberculosis (TB), including disseminated or extrapulmonary disease or reactivation of latent TB. Test patients for latent TB before and during treatment. Start treatment for latent infection before infliximab use. Other infections include invasive fungal infections (eg, histoplasmosis, aspergillosis, pneumocystosis), which may be disseminated rather than localized diseases. Consider empiric antifungal therapy in patients at risk of invasive fungal infections who develop severe systemic illness. In addition, bacterial, viral, and other infections caused by opportunistic pathogens, including Legionella and Listeria , may occur. Discontinue infliximab in patients developing a serious infection or sepsis. Most patients who develop these infections are taking concurrent immunosuppressants, such as corticosteroids or methotrexate.Malignancies
Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers, including infliximab. Rare cases of hepatosplenic T-cell lymphoma have been reported in adolescent and young adult patients with Crohn disease or ulcerative colitis treated with infliximab. All the hepatosplenic T-cell lymphomas with infliximab have occurred in patients on concomitant treatment with azathioprine or 6-mercaptopurine.
Closely monitor patients for signs and symptoms of infection during or after infliximab treatment. Monitor long-term carriers of hepatitis B. Test patients for latent TB before and during treatment. If patients with heart failure are treated, closely monitor during treatment and discontinue infliximab if new or worsening symptoms of heart failure occur. Monitor patients with psoriasis for nonmelanoma skin cancers, especially those who have had prolonged phototherapy treatment. Evaluate patients with signs and symptoms of liver dysfunction for evidence of liver injury.
Category B .
Undetermined. Lactating women should not breast-feed while taking infliximab.
Not studied in children younger than 6 y with Crohn disease; safety and efficacy not established in children for other indications.
Use with caution because of higher incidence of infection in elderly patients.
Reactions vary in their time of onset. Urticaria, dyspnea, and hypotension have occurred during or within 2 h of infliximab infusion; however, serum sickness–like reactions have been observed as early as after the second dose and when infliximab was reinstituted following an extended period without infliximab treatment.
May result in autoantibody formation and, rarely, development of a lupus-like syndrome.
Treatment has been associated with adverse outcomes in patients with heart failure; use in patients with heart failure only after other treatment options have been considered. Worsening heart failure and new-onset heart failure have been reported during postmarketing experience.
Leukopenia, neutropenia, pancytopenia, and thrombocytopenia, sometimes fatal, have been reported. Use with caution in patients with ongoing or a history of significant hematologic abnormalities.
Hepatitis B virus reactivation
Has occurred in patients who are long-term carriers of hepatitis B; some cases were fatal.
Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis, have been reported; some cases were fatal or necessitated liver transplant.
Treatment can be associated with development of antibodies to infliximab. The incidence is approximately 10% in patients given a 3-dose induction regimen followed by maintenance dosing.
Rarely, CNS manifestations of systemic vasculitis, seizure, and new-onset or exacerbation of clinical symptoms and/or radiographic evidence of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome, may occur.
Bring children with Crohn disease up to date with all vaccinations prior to starting infliximab therapy. It is recommended that live vaccines not be given concurrently.
Single doses of up to 20 mg/kg have been administered without toxic effects.
- Advise patient or caregiver to review the Medication Guide before each treatment infusion session.
- Advise patients to report any signs of new or worsening medical conditions, such as heart disease, neurological disease, or autoimmune disorders.
- Advise patient to notify health care provider immediately of any of the following: bleeding or unusual bruising; change in vision; dark, brown-colored urine; difficulty breathing or unexplained shortness of breath; difficulty swallowing; fever or other signs of infection; flu-like symptoms; new or worsening headache; new or worsening joint or muscle pain; numbness or tingling in any part of the body; paleness; rash, hives, or itching; right upper stomach pain; sore throat; swelling of hands or face; unexplained cough; unexplained tiredness; weakness in arms or legs; or yellowing of the skin or eyes.
- Advise patient with heart failure to notify health care provider immediately if new or worsening symptoms of heart failure (eg, shortness of breath, swelling of ankles or feet) develop.
- Warn patient not to receive live vaccines while undergoing infliximab therapy. Children with Crohn disease should be brought up to date with all vaccinations prior to initiating infliximab therapy.
Copyright © 2009 Wolters Kluwer Health.
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