Infliximab Dosage

This dosage information may not include all the information needed to use Infliximab safely and effectively. See additional information for Infliximab.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for Crohn's Disease - Acute

Moderately to severely active Crohn's disease or fistulizing Crohn's disease: 5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter; treatment with 10 mg/kg may be considered for patients who respond and then lose their response

Study (n=14)
Fistula therapy:
Infliximab in combination with azathioprine: 5 mg/kg IV in 250 mL of normal saline infused over 2 hours, then repeated at weeks 2 and 6, plus oral azathioprine 2 to 2.5 mg/kg started within 2 days of initial infliximab infusion

Usual Adult Dose for Ulcerative Colitis

Moderately to severely active ulcerative colitis: 5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter

Study (n=8)
Refractory ulcerative colitis: 5 mg/kg ABW, single IV dose infused over 2 hours

Usual Adult Dose for Rheumatoid Arthritis

Moderately to severely active rheumatoid arthritis: 3 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 3 mg/kg every 8 weeks thereafter; adjusting the dose up to 10 mg/kg or treating as often as every 4 weeks may be considered for patients who have an incomplete response

Infliximab should be given in combination with methotrexate.

Usual Adult Dose for Ankylosing Spondylitis

5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 6 weeks thereafter

Usual Adult Dose for Psoriatic Arthritis

5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter

Infliximab may be used with or without methotrexate.

Study (n=10)
5 mg/kg as an IV infusion over 2 hours, at weeks 0, 2, and 6, thereafter for weeks 10 to 54, patients received 3 mg/kg every 8 weeks

Study (n=16)
3 mg/kg IV at weeks 0, 2, 6, 14, 22, and 30, given to patients with at least 6 months of methotrexate at stable dosage

Usual Adult Dose for Psoriasis

Chronic severe (i.e., extensive and/or disabling) plaque psoriasis: 5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter

Studies - Moderate to severe plaque psoriasis: 5 to 10 mg/kg via IV infusion at weeks 0, 2, and 6

Case reports (n=2)
Plaque psoriasis: 5 to 10 mg/kg as a single IV infusion administered over 3 hours

Case reports (n=3)
Pustular psoriasis: 5 to 10 mg/kg via IV infusion at weeks 0, 2, and 6

Usual Adult Dose for Sarcoidosis

5 mg/kg ideal body weight via IV infusion then repeated at weeks 2, and every 4 to 8 weeks thereafter

Usual Adult Dose for Behcet's Disease

Study (n=5)
5 mg/kg as a single IV infusion over 3 hours

Usual Adult Dose for Giant Cell Arteritis

Study (n=4)
3 mg/kg at weeks 0, 2, and 6, as an IV infusion over 2 hours

Usual Adult Dose for Uveitis

Case (n=1)
5 mg/kg as a single IV infusion at weeks 0, 2, and 6, then every 2 months thereafter

Case (n=10)
5 mg/kg as a single IV infusion administered over 3 hours

Usual Adult Dose for SAPHO Syndrome

Case (n=1)
3 mg/kg ABW, via IV infusion every 4 weeks

Usual Adult Dose for Polychondritis

Cases (n=2)
5 mg/kg ABW, via IV infusion at weeks 0, 2, 6, 14, 22, 30, and 38, concomitantly with oral prednisone

Usual Adult Dose for Sjogren's Syndrome

Pilot study (n=16)
3 mg/kg via IV infusion at weeks 0, 2, and 6

Case (n=1)
3 mg/kg via IV infusion at weeks 0, 2, and 6, and every 12 weeks thereafter

Usual Adult Dose for Celiac Disease

Case (n=1)
5 mg/kg via IV infusion, as a single dose, over 2 hours

Usual Adult Dose for Toxic Epidermal Necrolysis

Case (n=1)
5 mg/kg via IV infusion, as a single dose therapy

Usual Adult Dose for Subcorneal Pustular Dermatosis

Case (n=1)
5 mg/kg as an IV infusion, as a single dose, over 2 hours

Usual Adult Dose for Pyoderma Gangrenosum

Cases (n=3)
5 mg/kg via IV infusion at weeks 0, 2, 4, 8 and 10, then every 6 to 8 weeks thereafter

Usual Adult Dose for Pulmonary Fibrosis

Case (n=1)
3 mg/kg via IV infusion at week 0, 2 and 6, and every other 8 weeks thereafter

Usual Pediatric Dose for Crohn's Disease - Acute

Moderately to severely active Crohn's disease:
6 years or older: 5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks

Usual Pediatric Dose for Crohn's Disease - Maintenance

Moderately to severely active Crohn's disease:
6 years or older: 5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks

Usual Pediatric Dose for Ulcerative Colitis

Moderately to severely active ulcerative colitis:
6 years or older: 5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks

Usual Pediatric Dose for Juvenile Idiopathic Arthritis

Cases (n=2)
10 years or older: 3 mg/kg via IV infusion at weeks 0, 2, and 6, followed by infusions every 8 weeks

Usual Pediatric Dose for Kawasaki Disease

Case (n=1)
Refractory Kawasaki disease:
3 years or older: 5 mg/kg via IV infusion, then repeated on days 45, 59, and 89

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Dosage greater than 5 mg/kg should not be used in patients with congestive heart failure. Use caution when using infliximab in patients with mild heart failure (NYHA Class I/II). All patients should be closely monitored and infliximab stopped if patient develops new or worsening symptoms of heart failure.

Patients with Crohn's disease or fistulizing Crohn's disease who do not respond to infliximab therapy by week 14 are unlikely to respond to continued dosing; drug discontinuation should be considered in these patients.

Precautions

Patients treated with infliximab are at increased risk for developing serious infections involving multiple organ systems and sites that may progress to hospitalization or death. Such infections have included tuberculosis, invasive fungal infections, and bacterial, viral, and other opportunistic infections. Infliximab should not be started in patients with an active infection, including clinically important localized infections. Patients greater than 65 years of age, patients with comorbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection. The risks and benefits of therapy should be considered before starting treatment in patients with chronic or recurrent infection, who have been exposed to tuberculosis, with a history of an opportunistic infection, who have resided or traveled in areas of endemic tuberculosis or mycosis, or with underlying conditions that may predispose them to infection. Patients should be closely monitored for signs and symptoms of infection during and after treatment with infliximab, including the possible development of tuberculosis in patients testing negative for latent tuberculosis prior to starting treatment. Patients developing new infections should be closely monitored, have prompt and complete diagnostic workups appropriate for immunocompromised patients, and have appropriate antimicrobial therapy started. Infliximab should be discontinued in patients developing a serious infection or sepsis.

Tuberculosis has been observed in patients receiving infliximab. Patients should be evaluated for active tuberculosis and tuberculosis risk factors and tested for latent tuberculosis infection prior to initiating infliximab and during therapy. Treatment of latent tuberculosis should be initiated prior to therapy with infliximab. Treatment of latent tuberculosis in patients with a reactive tuberculin test reduces the risk of tuberculosis reactivation in patients receiving infliximab. Some patients who tested negative for latent tuberculosis prior to receiving infliximab have developed active tuberculosis. Physicians should monitor patients receiving infliximab for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection. Tests for latent tuberculosis may be falsely negative during treatment with infliximab.

Pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis, and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor alfa blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients taking TNF blockers who present with signs and symptoms of possible systemic fungal infection, healthcare professionals should ascertain if patients live in or have traveled to areas of endemic mycoses. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antibody and antigen testing for histoplasmosis may be negative in some patients with active infection. For patients at risk of invasive fungal infections who develop severe systemic illness, clinicians should consider empiric antifungal treatment.

Lymphoma and other malignancies, some fatal, have been reported in children and young adults treated with TNF blockers, including infliximab. Reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immunosuppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine in most patients), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease, or other diseases. About half the cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphomas, while the other cases were a variety of malignancies (including rare malignancies usually associated with immunosuppression and malignancies not usually reported in children and adolescents). These cases were reported during postmarketing experience.

A higher risk of developing malignancies (excluding lymphoma and nonmelanoma skin cancer) has been observed among patients receiving tumor necrosis factor blockers when compared to controls. Caution should be exercised when considering infliximab treatment in patients with a history of malignancy or in continuing treatment in patients who develop malignancy while on infliximab.

Psoriasis patients should be monitored for nonmelanoma skin cancers (NMSC), particularly those patients who have had prior prolonged phototherapy treatment. In clinical trials, NMSCs were more common in patients with previous phototherapy.

More malignancies, the majority of lung or head and neck origin, were reported in infliximab-treated patients diagnosed with moderate-to-severe chronic obstructive pulmonary disease (COPD) compared with control patients. All patients had a history of heavy smoking. Caution should be exercised when considering the use of infliximab in these patients.

Infliximab at doses greater than 5 mg/kg is contraindicated for use in patients with moderate to severe congestive heart failure. An increased incidence of death and hospitalization due to worsening heart failure has been observed in patients with heart failure (NYHA Class III/IV) who received infliximab 10 mg/kg. Caution should be exercised when using infliximab in patients with mild heart failure (NYHA Class I/II). Postmarketing reports include cases of new onset heart failure, including heart failure in patients without known preexisting cardiovascular disease. Treatment should be discontinued in patients who develop new or worsening symptoms of heart failure.

Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis, have been reported rarely in postmarketing data in patients receiving infliximab. Severe hepatic reactions occurred between 2 weeks to more than a year after initiation of infliximab. Autoimmune hepatitis has been diagnosed in some of these cases. Some of these cases were fatal or necessitated liver transplantation. Infliximab should be discontinued if jaundice and/or marked liver enzyme elevations (e.g., 5 times the upper limit of normal) develops.

Infliximab has been associated with reactivation of hepatitis B in patients who are chronic carriers of this virus (e.g., surface antigen positive). Prior to the initiation of and during treatment with infliximab, chronic carriers should be appropriately evaluated. HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal. Patients who are carriers of HBV and require treatment with TNF blockers should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. Caution should be exercised when considering resumption of TNF blocker therapy in these patients, since safety data are lacking, and the patients should be monitored closely.

Infliximab has been associated with hypersensitivity reactions that vary in time of onset and required hospitalization in some cases. Most hypersensitivity reactions (including urticaria, dyspnea, and/or hypotension) have occurred during or within 2 hours of infliximab infusion. Serum sickness-like reactions (fever, rash, headache, sore throat, myalgias, polyarthralgias, hand and facial edema, and/or dysphagia) have been reported in patients after initiation of therapy (as early as following the second dose) and after reintroduction of infliximab therapy following an extended period without therapy. These reactions have been associated with marked increases in antibodies to infliximab, loss of detectable serum concentrations of infliximab, and possible loss of drug efficacy. Infliximab should be discontinued if severe hypersensitivity reactions arise and the appropriate medications to treat hypersensitivity reactions should be available for prompt administration.

During rheumatoid arthritis, Crohn's disease, and psoriasis clinical trials, reinstitution of infliximab after a period without therapy resulted in a higher rate of infusion reactions relative to regular maintenance therapy. Careful consideration of the benefit-risk of infliximab reintroduction after a period without therapy is generally recommended, especially when reintroduced with a regimen given at weeks 0, 2, and 6. If maintenance therapy for psoriasis is interrupted, infliximab should be restarted as a single dose followed by maintenance therapy.

When treating inflammatory bowel disease patients, especially in adolescents and young adults, consideration of whether to use infliximab alone or in combination with other immunosuppressants should take into account a possibility that there is a higher risk of hepatosplenic T-cell lymphoma with combination therapy versus, from clinical trial data, an observed increased risk of immunogenicity and hypersensitivity reactions with infliximab alone. Patients should be monitored for the development of sign and symptoms of malignancies including splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, and weight loss.

Development of autoimmune antibodies has resulted in the rare occurrence of a lupus-like syndrome. Infliximab therapy should be discontinued in patients who develop symptoms suggestive of a lupus-like syndrome and who are positive for double-stranded antibodies. Resolution of lupus-like symptoms and disappearance of antibodies has occurred following discontinuation of infliximab.

Infliximab and other agents that inhibit TNF have been associated in rare cases with central nervous system (CNS) manifestation 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-Barre syndrome). Caution is recommended when considering the use of infliximab in patients with these neurologic disorders and discontinuation of infliximab should be considered if these disorders develop.

Caution should be exercised in patients receiving infliximab therapy who have ongoing or a history of significant hematologic abnormalities. Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia, some with a fatal outcome, have been reported in patients receiving infliximab. A causal relationship has not been established. All patients should be advised to seek immediate attention at the first signs and symptoms suggestive of blood dyscrasias or infection while on infliximab. Discontinuation of therapy should be considered in patients who develop significant hematologic abnormalities.

Heart block has been reported in 2 patients during infliximab infusion. Clinicians reporting these cases recommend that heart rhythm be continuously monitored in all subjects during infliximab infusion.

The manufacturer recommends against the use of live vaccines during therapy with infliximab.

Niacin-like reaction developed in 3 children treated with infliximab for refractory systemic juvenile rheumatoid arthritis. Symptoms resolved after the infusion rate was decreased or the drug stopped. Aspirin (10 mg/kg/dose, with a maximum of 325 mg) and diphenhydramine (1 mg/kg/dose) may be administered 1 hour before infusion of the drug.

Safety and effectiveness for the treatment of Crohn's disease have not been established in pediatric patients less than 6 years of age. Infliximab has been studied only in combination with conventional immunosuppressive therapy in pediatric Crohn's disease. The longer term (over 1 year) safety and efficacy in pediatric Crohn's disease patients have not been established.

Safety and effectiveness for the treatment of ulcerative colitis have not been established in pediatric patients less than 6 years of age. Safety and effectiveness for reducing signs and symptoms and inducing and maintaining clinical remission have been established in pediatric patients aged 6 years or older with moderately to severely active ulcerative colitis; however, the effectiveness in inducing and maintaining mucosal healing could not be established in these patients. The longer term (over 1 year) safety and effectiveness in pediatric ulcerative colitis patients have not been established.

Safety and effectiveness for the treatment of plaque psoriasis have not been established in pediatric patients (less than 18 years of age). The effectiveness of infliximab in the treatment of juvenile rheumatoid arthritis has not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

The infusion solution should be administered over a period of not less than 2 hours through an infusion set with an inline, sterile, non-pyrogenic, low-protein-binding filter (pore size of 1.2 microns or less).

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