BETASERON® (interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.
IMPORTANT SAFETY INFORMATION
Contraindications. BETASERON (interferon beta-1b) is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, Albumin (Human), mannitol, or any other component of the formulation.
Hepatic Injury. Severe hepatic injury including cases of hepatic failure has been rarely reported in patients taking BETASERON. Consider the potential risk of BETASERON used in combination with known hepatotoxic drugs or other products (e.g., alcohol). Monitor liver function tests and monitor for signs and symptoms of hepatic injury. Consider discontinuing BETASERON if serum transaminase levels significantly increase, or if they are associated with clinical symptoms such as jaundice.
Anaphylaxis and Other Allergic-Reactions. Anaphylaxis has been reported as a rare complication of BETASERON use. Other allergic reactions have included dyspnea, bronchospasm, tongue edema, skin rash and urticaria. Discontinue BETASERON if anaphylaxis occurs.
Depression and Suicide. Depression and suicide have been reported to occur with increased frequency in patients receiving interferon compounds, including BETASERON. Patients treated with BETASERON should be advised to report immediately any symptoms of depression and/or suicidal ideation. Consider discontinuation of BETASERON if depression occurs.
Congestive Heart Failure. Monitor patients with pre-existing congestive heart failure (CHF) for worsening of their cardiac condition during initiation of and continued treatment with BETASERON. Consider discontinuation of BETASERON if worsening of CHF occurs with no other etiology.
Injection Site Necrosis and Reactions. Injection site reactions occurred in 78% of BETASERON patients receiving BETASERON (compared to 26% on placebo) in controlled clinical trials with injection site necrosis reported in 4% of BETASERON patients (compared to 0% on placebo). For patients who continue BETASERON after injection site necrosis has occurred, BETASERON should not be administered into the affected area until it is fully healed. If multiple lesions occur, therapy should be discontinued until healing occurs. Patients should be advised of the importance of the use of aseptic technique and rotating injection sites.
Leukopenia. Leukopenia has been reported in 18% of patients receiving BETASERON (compared to 6% on placebo) in controlled clinical trials leading to a reduction in dose in some patients. Monitoring of complete blood and differential white blood cell counts is recommended. Patients with myelosuppression may require more intensive monitoring.
Flu-like Symptom Complex. Flu-like symptom complex for patients on BETASERON was 57% (versus 37% on placebo) in controlled clinical trials. Analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms.
Seizures. Seizures have been temporally associated with the use of beta interferons.
Monitoring for Laboratory Abnormalities. In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts and blood chemistries including liver function tests are recommended at one, three and six months after introduction of BETASERON therapy, and periodically thereafter in the absence of clinical symptoms.
Pregnancy. Patients should be warned of the potential hazard to the fetus. BETASERON should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Most Common Adverse Reactions. The most commonly reported adverse reactions (at least 5% more frequent on BETASERON than on placebo) in controlled clinical trials were injection site reaction (78% vs 26% for placebo), lymphopenia (86% vs 66%), flu-like symptoms (57% vs 37%), myalgia (23% vs 14%), leukopenia (13% vs 4%), neutropenia (13% vs 5%), increased liver enzymes (SGPT to greater than five times baseline value [12% vs 4%], SGOT to greater than five times baseline value [4% vs 1%]), headache (50% vs 43%), hypertonia (40% vs 33%), pain (42% vs 35%), rash (21% vs 15%), insomnia (21% vs 16%), abdominal pain (16% vs 11%), and asthenia (53% vs 48%).
For additional important risk and use information, please see the full Prescribing Information.