Ribavirin is a nucleoside analogue indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with Pegasys in patients 5 years of age and older with compensated liver disease which was not treated in past with the interferon alpha, and in adult chronic hepatitis C patients coinfected with HIV.
Warning & Precautions
Patients should be monitored for the following serious conditions, some of which may become life threatening. Patients with persistently severe or worsening signs or symptoms should have their therapy withdrawn.
Significant adverse reactions associated with Ribavirin/Pegylated interferon alfa-2a combination therapy include severe depression and suicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, ophthalmologic disorders, cerebrovascular disorders, pulmonary dysfunction, colitis, pancreatitis, and diabetes.
Pregnancy: Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Patients are instructed to use at least two forms of effective contraception during the treatment and also for 180 days after the interruption of the treatment. Pregnancy testing should take place monthly during Ribavirin 200 mg therapy and for 6 months after therapy has stopped.
Anemia: Anemia associated with Ribavirin capsules occurs within 1 to 2 weeks of initiation of therapy. Because the starting drop in hemoglobin could be significant, it is advised that hemoglobin or hematocrit be obtained pretreatment and at week 2 and week 4 of therapy or more frequently if clinically indicated. Caution needs to be exercised in the beginning of the treatment in any patient with baseline risk of severe anemia.
Pulmonary Disorders: Dyspnea, pulmonary infiltrates, pneumonitis, pulmonary hypertension, and pneumonia have been reported during therapy with ribavirin and interferon. Occasional cases of fatal pneumonia have occurred. In addition,
sarcoidosis or the exacerbation of sarcoidosis has been reported. If in the case of existing pulmonary infiltrates or pulmonary function impairment, patients must be precisely monitored and, if appropriate, combination
Ribavirin/Pegylated interferon alfa-2a treatment should be discontinued.
Pancreatitis: Ribavirin and Pegylated interferon alfa-2a therapy should be suspended in patients with signs and symptoms of pancreatitis, and discontinued in patients with confirmed pancreatitis.
Hypersensitivity: Hypersensitivity reactions have been observed during the alpha interferon and ribavirin therapy such as angioedema, bronchoconstriction, urticaria and anaphylaxis. If such a reaction occurs, therapy with Pegylated interferon alfa-2a and Ribavirin should be discontinued immediately and appropriate medical therapy instituted. Several skin reactions such as vesiculobullous eruptions, erythema multiforme major with erythroderma have been observed in patients receiving Pegylated interferon alfa-2a with and without ribavirin. Patients during the alpha interferon and ribavirin therapy should interrupt (discontinue) the therapy.
Bone Marrow Suppression: Pancytopenia (marked decreases in RBCs, neutrophils and platelets) and bone marrow suppression have been reported in the literature to occur within 3 to 7 weeks after the concomitant administration of pegylated interferon/ribavirin and azathioprine. Ribavirin, Azathioprine and Pegylated interferon alfa-2a must be interrupted for pancytopenia, and pegylated interferon/ribavirin should not be re-introduced with concomitant azathioprine.
Impact on Growth in Pediatric Patients: Pediatric subjects treated with Pegylated interferon alfa-2a plus Ribavirin combination therapy showed a delay in weight and height increases after 48 weeks of therapy compared with baseline.
Cardiovascular Disorders: Hypertension, supraventricular arrhythmias, chest pain, and myocardial infarction have been observed in patients treated with Pegylated interferon alfa-2a. Pegasys must be given with caution to those patients who are with pre-existing cardiac disease. Patients with the cardiac diseases may be worsened by ribavirin-induced anemia. Patients who carry a history of unstable or significant cardiac disease are advised to not take Ribavirin/Pegylated interferon alfa-2a.
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