Indicated for:

Crohn’s Disease:

• Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response to conventional therapy.

• Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD.

Pediatric Crohn’s Disease:

• Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active CD who have had an inadequate response to conventional therapy.

Ulcerative Colitis:

• Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy. 

Pediatric Ulcerative Colitis:

• Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

Rheumatoid Arthritis:

• REMICADE, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA).

Ankylosing Spondylitis:

• Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS).

Psoriatic Arthritis:

• Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients with psoriatic arthritis (PsA).

Plaque Psoriasis:

• Treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis (Ps) who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. REMICADE should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Treatment for latent infection should be initiated prior to REMICADE use.

Before starting Remicade and periodically during therapy patients should be evaluated for active tuberculosis and tested for latent infection.Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

Patients treated with REMICADE are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. REMICADE should be discontinued if a patient develops a serious infection or sepsis.

Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before REMICADE use and during therapy.

Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.

Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.

REMICADE and other agents that inhibit TNF have been associated with CNS manifestation of systemic vasculitis, seizure and new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome.

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including REMICADE. 

Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including REMICADE. Almost all had received azathioprine or 6 mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. The majority of REMICADE cases were reported in patients with Crohn’s disease or ulcerative colitis, most of whom were adolescent or young adult males.

The use of REMICADE at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure.

In a randomized study evaluating REMICADE in patients with moderate to severe heart failure (New York Heart Association [NYHA] Functional Class III/IV), REMICADE treatment at 10 mg/kg was associated with an increased incidence of death and hospitalization due to worsening heart failure.

Severe hepatic reactions, including acute liver failure, jaundice, hepatitis and cholestasis, have been reported in postmarketing data in patients receiving REMICADE. Autoimmune hepatitis has been diagnosed in some of these cases.

Treatment with REMICADE should not be initiated in patients with an active infection, including clinically important localized infections. Patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants such as corticosteroids or methotrexate may be at greater risk of infection. The risks and benefits of treatment should be considered prior to initiating therapy 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 endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis or
• with underlying conditions that may predispose them to infection

Malignancies, some fatal, have been reported among children, adolescents and young adults who received treatment with TNF-blocking agents (initiation of therapy ≤ 18 years of age), including REMICADE. Approximately half of these cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma.

Psoriasis patients should be monitored for nonmelanoma skin cancers (NMSCs), particularly those patients who have had prior prolonged phototherapy treatment.

Use of TNF blockers, including REMICADE, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.

Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia, some with a fatal outcome, have been reported in patients receiving REMICADE.

Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hours of initiation of REMICADE infusion. Cases of transient visual loss have been reported during or within 2 hours of infusion of REMICADE.

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including REMICADE.

A population-based retrospective cohort study using data from Swedish national health registries found a 2 to 3 fold increase in the incidence of invasive cervical cancer in women with rheumatoid arthritis treated with infliximab compared to biologics-naïve patients or the general population, particularly those over 60 years of age. A causal relationship between infliximab and cervical cancer cannot be excluded. Periodic screening should continue in women treated with REMICADE.

The combination of REMICADE and anakinra or abatacept is not recommended.

Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.

The concurrent administration of live vaccines with REMICADE is not recommended.

The use of tocilizumab in combination with biological DMARDs such as TNF antagonists, including REMICADE, should be avoided because of the possibility of increased immunosuppression and increased risk of infection.

The combination of REMICADE with other biological therapeutics used to treat the same conditions as REMICADE is not recommended.

As with other IgG antibodies, infliximab crosses the placenta. Infliximab has been detected in the serum of infants up to 6 months following birth. Consequently, these infants may be at increased risk of infection, including disseminated infection which can become fatal. At least a six month waiting period following birth is recommended before the administration of live vaccines (e.g., BCG vaccine or other live vaccines, such as the rotavirus vaccine) to these infants. Cases of agranulocytosis in infants exposed in utero have also been reported.

Women should not breastfeed their infants while taking REMICADE.

GoToSource

• Use for pediatric crohn’s disease in children under the age of 6. GoToSource

• Use for pediatric ulcerative colitis in children under the age of 6. GoToSource

• Use for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis in patients under the age of 18. GoToSource

• Sarcoidosis, sjögren’s syndrome, behcet’s syndrome and graft versus host disease. GoToSource

• Eosinophilic esophagitis. GoToSource

• Idiopathic hypereosinophilic syndrome. GoToSource

• Use with gemcitabine for cancer cachexia. GoToSource

• Idiopathic orbital inflammation. GoToSource

• Vogt-koyanagi-harada’s disease. GoToSource

• Birdshot retinochoroidopathy. GoToSource

• Use with prednisolone for acute alcoholic hepatitis. GoToSource

• Cap polyposis. GoToSource

• Kawasaki disease. GoToSource

• Blau syndrome. GoToSource

• Familial mediterranean fever-related amyloidosis. GoToSource

• Still’s disease. GoToSource

• Disc herniation-induced sciatica. GoToSource

• Chronic leg ulcers. GoToSource

• Severe undifferentiated spondyloarthropathy. GoToSource

Serious infections including tuberculosis and disseminated histoplasmosis, fungal infections (coccidioidomycosis, blastomycosis, aspergillosis and candidiasis) resulting in hospitalization and death. GoToSource

Lymphoma and other cancers. GoToSource

Central nervous system disorders, including multiple sclerosis, myelitis, optic neuritis and peripheral demyelinating disorders including guillain-barré syndrome. GoToSource

Serious hematologic events, including leukopenia, neutropenia, thrombocytopenia and pancytopenia. GoToSource 

Worsening congestive heart failure. GoToSource

Free bowel perforation. GoToSource 

Chilblain lupus. GoToSource

Lawsuits filed for cancer and serious infections.