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adverse reactions
ADVERSE REACTIONS Peginterferon alfa-2a in combination with ribavirin tablets causes a broad variety of serious adverse reactions (see BOXED WARNING and WARNINGS ). The most common life-threatening or fatal events induced or aggravated by peginterferon alfa-2a and ribavirin tablets were depression, suicide, relapse of drug abuse/overdose, and bacterial infections, each occurring at a frequency of <1%. Hepatic decompensation occurred in 2% (10/574) of CHC/HIV patients (see WARNINGS: Hepatic Failure ). In all studies, one or more serious adverse reactions occurred in 10% of CHC monoinfected patients and in 19% of CHC/HIV receiving peginterferon alfa-2a alone or in combination with ribavirin tablets. The most common serious adverse event (3% in CHC and 5% in CHC/HIV) was bacterial infection (e.g., sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia). Other SAEs occurred at a frequency of <1% and included: suicide, suicidal ideation, psychosis, aggression, anxiety, drug abuse and drug overdose, angina, hepatic dysfunction, fatty liver, cholangitis, arrhythmia, diabetes mellitus, autoimmune phenomena (e.g., hyperthyroidism, hypothyroidism, sarcoidosis, systemic lupus erythematosus, rheumatoid arthritis), peripheral neuropathy, aplastic anemia, peptic ulcer, gastrointestinal bleeding, pancreatitis, colitis, corneal ulcer, pulmonary embolism, coma, myositis, cerebral hemorrhage, thrombotic thrombocytopenic purpura, psychotic disorder, and hallucination. Nearly all patients in clinical trials experienced one or more adverse events. The most commonly reported adverse reactions were psychiatric reactions, including depression, insomnia, irritability, anxiety, and flu-like symptoms such as fatigue, pyrexia, myalgia, headache and rigors. Other common reactions were anorexia, nausea and vomiting, diarrhea, arthralgias, injection site reactions, alopecia, and pruritus. Ten percent of CHC monoinfected patients receiving 48 weeks of therapy with peginterferon alfa-2a in combination with ribavirin tablets discontinued therapy; 16% of CHC/HIV coinfected patients discontinued therapy. The most common reasons for discontinuation of therapy were psychiatric, flu-like syndrome (e.g., lethargy, fatigue, headache), dermatologic and gastrointestinal disorders and laboratory abnormalities (thrombocytopenia, neutropenia, and anemia). Overall 39% of patients with CHC or CHC/HIV required modification of peginterferon alfa-2a and/or ribavirin tablets therapy. The most common reason for dose modification of peginterferon alfa-2a in CHC and CHC/HIV patients was for laboratory abnormalities; neutropenia (20% and 27%, respectively) and thrombocytopenia (4% and 6%, respectively). The most common reason for dose modification of ribavirin tablets in CHC and CHC/HIV patients was anemia (22% and 16%, respectively). Peginterferon alfa-2a dose was reduced in 12% of patients receiving 1000 mg to 1200 mg ribavirin tablets for 48 weeks and in 7% of patients receiving 800 mg ribavirin tablets for 24 weeks. Ribavirin tablet dose was reduced in 21% of patients receiving 1000 mg to 1200 mg ribavirin tablets for 48 weeks and in 12% of patients receiving 800 mg ribavirin tablets for 24 weeks. Chronic hepatitis C monoinfected patients treated for 24 weeks with peginterferon alfa-2a and 800 mg ribavirin tablets were observed to have lower incidence of serious adverse events (3% vs. 10%), hemoglobin <10 g/dL (3% vs. 15%), dose modification of peginterferon alfa-2a (30% vs. 36%) and ribavirin tablets (19% vs. 38%), and of withdrawal from treatment (5% vs. 15%) compared to patients treated for 48 weeks with peginterferon alfa-2a and 1000 mg or 1200 mg ribavirin tablets. On the other hand, the overall incidence of adverse events appeared to be similar in the two treatment groups. Because clinical trials are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug. Also, the adverse event rates listed here may not predict the rates observed in a broader patient population in clinical practice. Table 4 Adverse Reactions Occurring in ≥5% of Patients in Chronic Hepatitis C Clinical Trials (Study NV15801 Described as study 4 in the peginterferon alfa-2a package insert. ) Body System CHC Combination Therapy Study NV15801 Peginterferon alfa - 2a 180 mcg + 1000 mg or 1200 mg Ribavirin Tablets 48 week Interferon alfa - 2b + 1000 mg or 1200 mg Ribavirin Capsules 48 week N = 451 N = 443 % % Application Site Disorders Injection site reaction 23 16 Endocrine Disorders Hypothyroidism 4 5 Flu - like Symptoms and Signs Fatigue/Asthenia Pyrexia Rigors Pain 65 41 25 10 68 55 37 9 Gastrointestinal Nausea/Vomiting Diarrhea Abdominal pain Dry mouth Dyspepsia 25 11 8 4 6 29 10 9 7 5 Hematologic Severe hematologic abnormalities(lymphocyte <0.5 x 10 9/L; hemoglobin <10 g/dL; neutrophil <0.75 x 10 9/L; platelet <50 x 10 9/L). Lymphopenia Anemia Neutropenia Thrombocytopenia 14 11 27 5 12 11 8 <1 Metabolic and Nutritional Anorexia Weight decrease 24 10 26 10 Musculoskeletal , Connective Tissue and Bone Myalgia Arthralgia Back pain 40 22 5 49 23 5 Neurological Headache Dizziness (excluding vertigo) Memory impairment 43 14 6 49 14 5 Psychiatric Irritability/Anxiety/Nervousness Insomnia Depression Concentration impairment Mood alteration 33 30 20 10 5 38 37 28 13 6 Resistance Mechanism Disorders Overall 12 10 Respiratory , Thoracic and Mediastinal Dyspnea Cough Dyspnea exertional 13 10 4 14 7 7 Skin and Subcutaneous Tissue Alopecia Pruritus Dermatitis Dry Skin Rash Sweating Increased Eczema 28 19 16 10 8 6 5 33 18 13 13 5 5 4 Visual Disorders Vision Blurred 5 2 Common Adverse Reactions in CHC With HIV Coinfection The adverse event profile of coinfected patients treated with peginterferon alfa-2a and ribavirin tablets in Study NR15961 was generally similar to that shown for monoinfected patients in Study NV15801 (Table 4). Events occurring more frequently in coinfected patients were neutropenia (40%), anemia (14%), thrombocytopenia (8%), weight decrease (16%), and mood alteration (9%). Laboratory Test Values Anemia due to hemolysis is the most significant toxicity of ribavirin therapy. Anemia (hemoglobin <10 g/dL) was observed in 13% of all ribavirin tablets and peginterferon alfa-2a combination-treated patients in clinical trials. The maximum drop in hemoglobin occurred during the first 8 weeks of initiation of ribavirin therapy (see DOSAGE AND ADMINISTRATION : Dose Modifications ). Postmarketing Experience: The following adverse reactions have been identified and reported during post-approval use of peginterferon alfa-2a therapy: dehydration, hearing impairment, hearing loss, serious skin reactions (see WARNINGS: Hypersensitivity ), and serous retinal detachment. Additionally, pure red cell aplasia (PRCA) has been reported with ribavirin tablets in combination with peginterferone alfa 2a.