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adverse reactions
ADVERSE REACTIONS Depression, suicidal ideation, and new or worsening other psychiatric disorders have been observed to be increased in patients using interferon compounds including AVONEX ® (see WARNINGS: Depression and Suicide ). Anaphylaxis and other allergic reactions have been reported in patients using AVONEX ® (see WARNINGS: Anaphylaxis ). Decreased peripheral blood counts have been reported in patients using AVONEX ® (see WARNINGS: Decreased Peripheral Blood Counts ). Hepatic injury, including hepatic failure, hepatitis, and elevated serum hepatic enzyme levels, has been reported in post-marketing experience (see WARNINGS: Hepatic Injury ). Seizures, cardiovascular adverse events, and autoimmune disorders also have been reported in association with the use of AVONEX ® (see Precautions ). The adverse reactions most commonly reported in patients associated with the use of AVONEX ® were flu-like and other symptoms occurring within hours to days following an injection. Symptoms can include myalgia, fever, fatigue, headaches, chills, nausea, and vomiting. Some patients have experienced paresthesias, hypertonia and myasthenia. The most frequently reported adverse reactions resulting in clinical intervention (e.g., discontinuation of AVONEX ® , or the need for concomitant medication to treat an adverse reaction symptom) were flu-like symptoms and depression. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of AVONEX ® cannot be directly compared to rates in clinical trials of other drugs and may not reflect the rates observed in practice. The data described below reflect exposure to AVONEX ® in 351 patients, including 319 patients exposed for 6 months, and 288 patients exposed for greater than one year in placebo-controlled trials. The mean age of patients receiving AVONEX ® was 35 years, 74% were women and 89% were Caucasian. Patients received either 30 mcg AVONEX ® or placebo. Table 3 enumerates adverse events and selected laboratory abnormalities that occurred at an incidence of at least 2% higher frequency in AVONEX ® -treated subjects than was observed in the placebo group. Reported adverse events have been classified using standard COSTART terms. Table 3 Adverse Events and Selected Laboratory Abnormalities in the Placebo-Controlled Studies Adverse Event Placebo (N = 333) AVONEX ® (N = 351) Body as a Whole Headache 55% 58% Flu-like symptoms (otherwise unspecified) 29% 49% Pain 21% 23% Asthenia 18% 24% Fever 9% 20% Chills 5% 19% Abdominal pain 6% 8% Injection site pain 6% 8% Infection 4% 7% Injection site inflammation 2% 6% Chest pain 2% 5% Injection site reaction 1% 3% Toothache 1% 3% Nervous System Depression 14% 18% Dizziness 12% 14% Respiratory System Upper respiratory tract infection 12% 14% Sinusitis 12% 14% Bronchitis 5% 8% Digestive System Nausea 19% 23% Musculoskeletal System Myalgia 22% 29% Arthralgia 6% 9% Urogenital Urinary tract infection 15% 17% Urine constituents abnormal 0% 3% Skin and Appendages Alopecia 2% 4% Special Senses Eye disorder 2% 4% Hemic and Lymphatic System Injection site ecchymosis 4% 6% Anemia 1% 4% Cardiovascular System Migraine 3% 5% Vasodilation 0% 2% No AVONEX ® -treated patients attempted suicide in the two placebo-controlled studies. In Study 2, AVONEX ® -treated patients were more likely to experience depression than placebo-treated patients (20% in AVONEX ® group vs. 13% in placebo group). The incidences of depression in the placebo-treated and AVONEX ® -treated patients in Study 1 were similar. In Study 1, suicidal tendency was seen more frequently in AVONEX ® -treated patients (4% in AVONEX ® group vs. 1% in placebo group) (see WARNINGS ). Seizures Seizures have been reported in 4 of 351 AVONEX ® -treated patients in the placebo-controlled studies, compared to none in the placebo-treated patients (see Precautions: Seizures ). Post-Marketing Experience The following adverse events have been identified and reported during post-approval use of AVONEX ® : New or worsening other psychiatric disorders, and anaphylaxis (see WARNINGS ). Autoimmune disorders including autoimmune hepatitis, idiopathic thrombocytopenia, hyper- and hypothyroidism, and seizures in patients without prior history (see Precautions ). Infrequent reports of congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure with rare cases being temporally related to the administration of AVONEX ® (see Precautions: Cardiomyopathy and Congestive Heart Failure ). Decreased peripheral blood counts in all cell lines, including rare pancytopenia and thrombocytopenia (see WARNINGS: Decreased Peripheral Blood Counts ). Some cases of thrombocytopenia have had nadirs below 10,000/μL. Some of these cases reoccur upon rechallenge. Hepatic injury, including hepatic failure and elevated serum hepatic enzyme levels, some of which have been severe, has been reported post-marketing (see WARNINGS: Hepatic Injury ). Meno- and metrorrhagia, rash (including vesicular rash), and rare cases of injection site abscess or cellulitis that may require surgical intervention have also been reported in post-marketing experience. Because reports of these reactions are voluntary and the population is of an uncertain size, it is not always possible to reliably estimate the frequency of the event or establish a causal relationship to drug exposure. Adverse Reactions Associated with Subcutaneous Use AVONEX ® has also been evaluated in 290 patients with diseases other than multiple sclerosis, primarily chronic viral hepatitis B and C, in which the doses studied ranged from 15 mcg to 75 mcg, given SC, 3 times a week, for up to 6 months. Inflammation at the site of the subcutaneous injection was observed in 52% of treated patients in these studies. Subcutaneous injections were also associated with the following local reactions: injection site necrosis, injection site atrophy, injection site edema and injection site hemorrhage. None of the above was observed in the multiple sclerosis patients participating in Study 1. Injection site edema and injection site hemorrhage were observed in multiple sclerosis patients participating in Study 2. Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. In recent studies assessing immunogenicity in multiple sclerosis patients administered AVONEX ® for at least 1 year, 5% (21 of 390 patients) showed the presence of neutralizing antibodies at one or more times. The clinical significance of neutralizing antibodies to AVONEX ® is unknown. These data reflect the percentage of patients whose test results were considered positive for antibodies to AVONEX ® using a two-tiered assay (ELISA binding assay followed by an antiviral cytopathic effect assay), and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of neutralizing activity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to AVONEX ® with the incidence of antibodies to other products may be misleading. Anaphylaxis has been reported as a rare complication of AVONEX ® use. Other allergic reactions have included dyspnea, orolingual edema, skin rash and urticaria (see WARNINGS: Anaphylaxis ).