Patients treated with REMICADE ® (infliximab) are at increased risk for developing serious infections that may fibrous histiocytoma skin lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants fibrous histiocytoma skin such as methotrexate or corticosteroids. Discontinue REMICADE ® if a patient develops a serious infection or sepsis.
• invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis, and cryptococcosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for fibrous histiocytoma skin invasive fungal infections who develop severe systemic illness.
The risks and benefits of treatment with REMICADE ® should be carefully considered prior to initiating therapy in patients fibrous histiocytoma skin with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms fibrous histiocytoma skin of infection during and after treatment with REMICADE ®, including the possible development of TB in patients who tested fibrous histiocytoma skin negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection.
Risk of infection may be higher in patients greater than fibrous histiocytoma skin 65 years of age, pediatric patients, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with REMICADE ® included pneumonia, cellulitis, abscess, and skin ulceration.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with fibrous histiocytoma skin TNF blockers, including REMICADE ®. Approximately half of these cases were lymphomas, including hodgkin’s and non-hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and fibrous histiocytoma skin malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after fibrous histiocytoma skin the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.
Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including REMICADE ®. These cases have had a very aggressive disease course and fibrous histiocytoma skin have been fatal. The majority of reported REMICADE ® cases have occurred in patients with crohn’s disease or ulcerative colitis and most were in adolescent fibrous histiocytoma skin and young adult males. Almost all of these patients had received treatment with azathioprine fibrous histiocytoma skin or 6-mercaptopurine concomitantly with REMICADE ® at or prior to diagnosis. Carefully assess the risks and benefits of treatment with REMICADE fibrous histiocytoma skin ®, especially in these patient types.
In clinical trials of all TNF inhibitors, more cases of lymphoma were observed compared with controls and fibrous histiocytoma skin the expected rate in the general population. However, patients with crohn’s disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing fibrous histiocytoma skin lymphoma. In clinical trials of some TNF inhibitors, including REMICADE ®, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with REMICADE fibrous histiocytoma skin ® was similar to that expected in the general population whereas fibrous histiocytoma skin the rate in control patients was lower than expected. Cases of acute and chronic leukemia have been reported with fibrous histiocytoma skin postmarketing TNF-blocker use. As the potential role of TNF inhibitors in the development fibrous histiocytoma skin of malignancies is not known, caution should be exercised when considering treatment of patients with fibrous histiocytoma skin a current or a past history of malignancy or other fibrous histiocytoma skin risk factors such as chronic obstructive pulmonary disease (COPD).
A population-based retrospective cohort study found a 2- to 3-fold increase in the incidence of invasive cervical cancer in fibrous histiocytoma skin women with rheumatoid arthritis treated with REMICADE ® compared to biologics-naïve patients or the general population, particularly those over 60 years of age. A causal relationship between REMICADE ® and cervical cancer cannot be excluded. Periodic screening should continue in women treated with REMICADE ®.
REMICADE ® is contraindicated in patients with moderate to severe (NYHA class III/IV) congestive heart failure (CHF) at doses greater than 5 mg/kg. Higher mortality rates at the 10 mg/kg dose and higher rates of cardiovascular events at the fibrous histiocytoma skin 5 mg/kg dose have been observed in these patients. REMICADE ® should be used with caution and only after consideration of fibrous histiocytoma skin other treatment options. Patients should be monitored closely. Discontinue REMICADE ® if new or worsening CHF symptoms appear. REMICADE ® should not be (re)administered to patients who have experienced a severe hypersensitivity reaction fibrous histiocytoma skin or to patients with hypersensitivity to murine proteins or other fibrous histiocytoma skin components of the product.
TNF inhibitors, including REMICADE ®, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating REMICADE fibrous histiocytoma skin ®. For patients who test positive, consult a physician with expertise in the treatment of hepatitis fibrous histiocytoma skin B. Exercise caution when prescribing REMICADE ® for patients identified as carriers of HBV and monitor closely fibrous histiocytoma skin for active HBV infection during and following termination of therapy fibrous histiocytoma skin with REMICADE ®. Discontinue REMICADE ® in patients who develop HBV reactivation and initiate antiviral therapy fibrous histiocytoma skin with appropriate supportive treatment. Exercise caution when considering resumption of REMICADE ® and monitor patients closely.
Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported in patients receiving REMICADE ® postmarketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver fibrous histiocytoma skin injury in many cases. Patients with symptoms or signs of liver dysfunction should be fibrous histiocytoma skin evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, REMICADE ® should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported. The causal relationship to REMICADE ® therapy remains unclear. Exercise caution in patients who have ongoing or a history fibrous histiocytoma skin of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop fibrous histiocytoma skin signs and symptoms of blood dyscrasias or infection. Consider discontinuation of REMICADE ® in patients who develop significant hematologic abnormalities.
Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hours fibrous histiocytoma skin of initiation of REMICADE ® infusion. Cases of transient visual loss have been reported during or fibrous histiocytoma skin within 2 hours of REMICADE ® infusion. Monitor patients during infusion and if a serious reaction occurs, discontinue infusion. Manage reactions according to signs and symptoms.
TNF inhibitors, including REMICADE ®, have been associated with CNS manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including guillain-barré syndrome. Exercise caution when considering REMICADE ® in patients with these disorders and consider discontinuation if these fibrous histiocytoma skin disorders develop.
Concomitant use of REMICADE ® with anakinra, abatacept, tocilizumab, or other biologics used to treat the same conditions as fibrous histiocytoma skin REMICADE ® is not recommended because of the possibility of an increased fibrous histiocytoma skin risk of infection. Care should be taken when switching from one biologic to fibrous histiocytoma skin another, since overlapping biological activity may further increase the risk of fibrous histiocytoma skin infection.
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