Pharmacy & Therapeutics - December 2008 - (Page 698)

PROFESSIONAL BRIEF SUMMARY—CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION CIMZIA® (certolizumab pegol) WARNING: RISK OF SERIOUS INFECTIONS Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation), invasive fungal infections, and other opportunistic infections, have been observed in patients receiving CIMZIA. Some of these infections have been fatal. Anti-tuberculosis treatment of patients with latent tuberculosis infection reduces the risk of reactivation in patients receiving treatment with TNF blockers such as CIMZIA. However, active tuberculosis has developed in patients receiving CIMZIA whose tuberculin test was negative. Evaluate patients for tuberculosis risk factors and test for latent tuberculosis infection prior to initiating CIMZIA and during therapy. Initiate treatment of latent tuberculosis infection prior to therapy with CIMZIA. Monitor patients receiving CIMZIA for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection (see WARNINGS AND PRECAUTIONS, Serious Infections, Tuberculosis and ADVERSE REACTIONS, Clinical Trials Experience). INDICATIONS AND USAGE CIMZIA is indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Serious Infections Serious infections, sepsis, and cases of opportunistic infections, including fatalities, have been reported in patients receiving TNF blockers, including CIMZIA. Many of the serious infections reported have occurred in patients on concomitant immunosuppressive therapy that, in addition to their Crohn’s disease, could predispose them to infections. In postmarketing experience with TNF blockers, infections have been observed with various pathogens including viral, bacterial, fungal, and protozoal organisms, and infections have been noted in all organ systems. Infections have been reported in patients receiving CIMZIA alone or in conjunction with immunosuppressive agents. Do not initiate treatment with CIMZIA in patients with active infections, including chronic or localized infections. Monitor patients for signs and symptoms of infection while on and after treatment with CIMZIA. Patients who develop a new infection while undergoing treatment with CIMZIA should be monitored closely. Discontinue administration of CIMZIA if a patient develops a serious infection. Exercise caution when considering the use of CIMZIA in patients with a history of recurrent infection, concomitant immunosuppressive therapy, or underlying conditions that may predispose them to infections, or patients who have resided in regions where tuberculosis and histoplasmosis are endemic.The benefits and risks of CIMZIA treatment should be carefully considered before initiation of CIMZIA therapy (see ADVERSE REACTIONS, Clinical Trials Experience). Tuberculosis As observed with other TNF blockers, tuberculosis associated with the administration of CIMZIA in clinical studies has been reported, including fatalities. Before initiation of therapy with CIMZIA, evaluate patients for tuberculosis risk factors and test for latent tuberculosis infection. Initiate treatment of latent tuberculosis infections prior to therapy with CIMZIA. When tuberculin skin testing is performed for latent tuberculosis infection, an induration size of 5 mm or greater should be considered positive, even if vaccinated previously with Bacille Calmette-Guerin (BCG). If latent infection is diagnosed, institute appropriate prophylaxis in accordance with the current guidelines from the Centers for Disease Control and Prevention. Consider the possibility of undetected latent tuberculosis, especially in patients who have immigrated from or traveled to countries with a high prevalence of tuberculosis or had close contact with a person with active tuberculosis. All patients treated with CIMZIA should have a thorough history taken prior to initiating therapy. Some patients who have previously received treatment for latent or active tuberculosis have developed active tuberculosis while being treated with TNF blockers. Consider anti-tuberculosis therapy prior to initiation of CIMZIA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Anti-tuberculosis therapy prior to initiating CIMZIA should also be considered in patients who have several, or highly significant, risk factors for tuberculosis infection and have a negative test for latent tuberculosis, but the decision to initiate anti-tuberculosis therapy in the patients should only be made after taking into account both the risk for latent tuberculosis infection and the risks of anti-tuberculosis therapy. If necessary, consult a physician with experience in the treatment of tuberculosis. Monitor patients receiving CIMZIA for signs and symptoms of active tuberculosis, particularly because tests for latent tuberculosis infection may be falsely negative. Instruct patients to seek medical advice if signs/symptoms (e.g., persistent cough, wasting, weight loss, low grade fever) suggestive of a tuberculosis infection occur. Hepatitis B Virus Reactivation Use of TNF blockers, including CIMZIA, may increase the risk of 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. The majority of reports have occurred in patients concomitantly receiving other medications that suppress the immune system, which may also contribute to HBV reactivation. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating CIMZIA therapy. Exercise caution in prescribing CIMZIA for patients identified as carriers of HBV. Adequate data are not available on the safety or efficacy of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF blocker therapy to prevent HBV reactivation. Patients who are carriers of HBV and require treatment with CIMZIA should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, discontinue CIMZIA and initiate effective anti-viral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of CIMZIA therapy in this situation and monitor patients closely. Malignancies In the controlled portions of clinical studies of some TNF blockers, more cases of malignancies have been observed among patients receiving TNF blockers compared to control patients. During controlled and open-labeled portions of CIMZIA studies of Crohn’s disease and other investigational uses, malignancies (excluding non-melanoma skin cancer) were observed at a rate (95% confidence interval) of 0.6 (0.4, 0.8) per 100 patient-years among 4,650 CIMZIA-treated patients versus a rate of 0.6 (0.2, 1.7) per 100 patient-years among 1,319 placebo-treated patients. The size of the control group and limited duration of the controlled portions of the studies preclude the ability to draw firm conclusions. In the controlled portions of clinical trials of all the TNF blockers, more cases of lymphoma have been observed among patients receiving TNF blockers compared to control patients. In controlled studies of CIMZIA for Crohn’s disease and other investigational uses, there was one case of lymphoma among 2,657 Cimzia-treated patients and one case of Hodgkin lymphoma among 1,319 placebo-treated patients. Rates in clinical studies for CIMZIA cannot be compared to the rates of clinical trials of other TNF blockers and may not predict the rates observed when CIMZIA is used in a broader patient population. Patients with Crohn’s disease or other diseases that require chronic exposure to immunosuppressant therapies may be at higher risk than the general population for the development of lymphoma, even in the absence of TNF blocker therapy. The potential role of TNF blocker therapy in the development of malignancies is not known. Hypersensitivity Reactions The following symptoms that could be compatible with hypersensitivity reactions have been reported rarely following CIMZIA administration to patients: angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria. If such reactions occur, discontinue further administration of CIMZIA and institute appropriate therapy. There are no data on the risks of using CIMZIA in patients who have experienced a severe hypersensitivity reaction towards another TNF blocker; in these patients caution is needed (see ADVERSE REACTIONS, Clinical Trials Experience). Neurologic Reactions Use of TNF blockers, including CIMZIA, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease. Exercise caution in considering the use of CIMZIA in patients with pre-existing or recent-onset central nervous system demyelinating disorders. Rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with CIMZIA; the causal relationship to CIMZIA remains unclear (see ADVERSE REACTIONS, Clinical Trials Experience). Hematological Reactions Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Adverse reactions of the hematologic system, including medically significant cytopenia (e.g., leukopenia, pancytopenia, thrombocytopenia) have been infrequently reported with CIMZIA (see ADVERSE REACTIONS, Clinical Trials Experience). The causal relationship of these events to CIMZIA remai

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Pharmacy & Therapeutics - December 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Interpreting Estimates of Treatment Effects Chemotherapy Foundation Symposium XXVI: Innovative Cancer Therapy for Tomorrow Third Annual Onmark National Payor/Provider Forum Fourth Annual Ophthalmic Drug Development and Delivery Summit Classification and Pharmacological Management Of Obesity CE Test and Forms Season’s Greetings: Thanks to Our Readers and Reviewers

Pharmacy & Therapeutics - December 2008

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