Orencia for the treatment of patients with rheumatoid arthritis and polyarticular juvenile idiopathic arthritis
Orencia ( Abatacept ) SC ( subcutaneous ) and IV ( intravenous ) is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Orencia may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs ( DMARDs ) other than tumor necrosis factor ( TNF ) antagonists.
Orencia IV is indicated for reducing signs and symptoms in pediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis. Orencia IV may be used as monotherapy or concomitantly with Methotrexate. Orencia SC has not been studied in pediatric patients.
Orencia should not be administered concomitantly with TNF antagonists. Orencia is not recommended for use concomitantly with other biologic rheumatoid arthritis ( RA ) therapy, such as Anakinra ( Kineret ).
Important safety information
Concomitant use with TNF antagonists - Concurrent therapy with Abatacept and a biologic DMARD is not recommended. In controlled clinical trials, adult patients receiving concomitant intravenous Abatacept and TNF antagonist therapy experienced more infections ( 63% ) and serious infections ( 4.4% ) compared to patients treated with only TNF antagonists ( 43% and 0.8%, respectively ), without an important enhancement of efficacy.
Hypersensitivity - Less than 1% of adult patients treated with Abatacept experienced hypersensitivity reactions, including some cases of anaphylaxis or anaphylactoid reactions. Other events potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in less than 0.9% of patients treated with Abatacept and generally occurred within 24 hours of infusion. There was 1 case of a hypersensitivity reaction with Abatacept in JIA clinical trials ( 0.5%; n =190 ). Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use in the event of a reaction.
Infections - Serious infections, including sepsis and pneumonia, have been reported in patients receiving Abatacept. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which in addition to their underlying disease, could further predispose them to infection. Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections. Treatment with Abatacept should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis, and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with Abatacept.
Immunizations - Live vaccines should not be given concurrently with Abatacept or within 3 months of its discontinuation as it may blunt the effectiveness of some immunizations. It is recommended that JIA patients be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating therapy with Abatacept.
Use in patients with chronic obstructive pulmonary disease ( COPD ) - Adult COPD patients treated with Abatacept developed adverse events more frequently than those treated with placebo ( 97% vs. 88%, respectively ). Respiratory disorders occurred more frequently in patients treated with Abatacept compared to those on placebo ( 43% vs 24%, respectively ), including COPD exacerbations, cough, rhonchi, and dyspnea. A greater percentage of patients treated with Abatacept developed a serious adverse event compared to those on placebo ( 27% vs. 6% ), including COPD exacerbation [ 3 of 37 patients ( 8% ) ] and pneumonia [ 1 of 37 patients ( 3% ) ]. Use of Abatacept in patients with rheumatoid arthritis and COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.
Blood glucose testing - Abatacept for intravenous administration contains maltose, which may result in falsely elevated blood glucose readings on the day of infusion when using blood glucose monitors with test strips utilizing glucose dehydrogenase pyrroloquinolinequinone ( GDH-PQQ ). Consider using monitors and advising patients to use monitors that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide ( GDH-NAD ), glucose oxidase, or glucose hexokinase test methods. Abatacept for subcutaneous administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring.
Pregnant and nursing mothers - Abatacept should be used during pregnancy only if clearly needed. The risk for development of autoimmune diseases in humans exposed in utero to Abatacept has not been determined. Nursing mothers should be informed of the risk/benefit of continued breast-feeding or discontinuation of the drug.
Most serious adverse reactions - Serious infections ( 3% Abatacept vs 1.9% placebo ) and malignancies ( 1.3% Abatacept vs 1.1% placebo ). In general, adverse events in pediatric and adolescent patients were similar in frequency and type to those seen in adult patients.
Malignancies - The overall frequency of malignancies was similar between adult patients treated with Abatacept or placebo. However, more cases of lung cancer were observed in patients treated with Abatacept ( 0.2% ) than those on placebo ( 0% ). A higher rate of lymphoma was seen compared to the general population; however, patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of Abatacept in the development of malignancies in humans is unknown.
Most frequent adverse events ( greater than or equal to 10% ) - Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events in the adult rheumatoid arthritis clinical studies. ( Xagena )
Source: BMS, 2013
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