Inflectra Disease Interactions

In a study of patients with moderate to severe heart failure (New York Heart Association [NYHA] Functional Class III/IV), an increase incidence of death and hospitalization due to worsening of heart failure was observed after treatment with infliximab at 10 mg/kg. Infliximab at doses > 5 mg/kg is contraindicated in patients with moderate to severe heart failure.

Severe hepatic reactions, including acute liver failure, jaundice, hepatitis and cholestasis, have been reported with the use of infliximab. Infliximab should be discontinued if jaundice and/or marked liver enzyme elevations (e.g., greater than or equal to 5 times the upper limit of normal) develop and a thorough investigation of the abnormality should be undertaken.

There have been reports of serious infections, including sepsis and opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis and tuberculosis with TNF blockers. Treatment with these agents should not be initiated in patients with an active infection, including clinically important localized infections. Caution and close monitoring is recommended when considering their use in patients with a history of recurrent infections, underlying conditions which may predispose them to infections, or chronic, latent, or localized infections. Administration of these agents should be discontinued if a patient develops a serious infection or sepsis.

In clinical trials malignancies have been observed in patients receiving TNF-blockers agents. Patients with psoriasis should be monitored for non-melanoma skin cancers (NMSCs), particularly those patients who have had prior prolonged phototherapy treatment. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers. Caution should be exercised when considering these agents in the treatment of patients with a history of malignancies or in continuing treatment in patients who develop malignancies while receiving these agents.

The use of TNF blocking agents has been associated with rare cases of CNS manifestations 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. Care should be exercised when considering the use of these agents in patients with neurologic disorders and discontinuing the agent is recommended if these disorders develop during therapy.

Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving TNF blocking agents, including patients who have previously received treatment for latent or active tuberculosis. Cases of active tuberculosis have also occurred in patients being treated with these agents during treatment for latent tuberculosis. Prior to initiating TNF blocking agents, patients should be screened for latent tuberculosis infection with a tuberculin skin test and periodically during therapy. Patients testing positive in tuberculosis screening should be treated by standard medical practice prior to therapy with TNF blocking agents. Anti-tuberculosis therapy should also be considered prior to initiation of therapy in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Tuberculosis should be strongly considered in patients who develop a new infection during treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis.

In studies, patients with moderate to severe chronic obstructive pulmonary disease (COPD) treated with infliximab developed more malignancies, the majority of lung or head and neck origin than those treated with placebo. Caution should be exercised when considering the use of infliximab in patients with moderate to severe COPD.

Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia, some with a fatal outcome, have been reported in patients treated with TNF blocking agents. Caution should be exercised when treating patients who have ongoing or a history of significant hematologic abnormalities. Discontinuation of therapy should be considered in patients with confirmed significant hematologic abnormalities.

The use of TNF blockers has been associated with reactivation of hepatitis B, in some cases fatal, in patients who were previously infected with the hepatitis B virus (HBV). Therefore, screening for viral hepatitis should be performed in accordance with published guidelines before starting therapy with these agents. Monitor patients at risk or with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation. Prescribers should exercise caution in prescribing TNF blockers in patients previously infected with HBV. It is recommended to monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following therapy. In patients who develop HBV reactivation, therapy should be stopped and antiviral therapy with appropriate supportive treatment should be initiated. The safety of resuming these agents after HBV reactivation is controlled is not known. Therefore, prescribers should weigh the risks and benefits when considering resumption of therapy.