Indication and Important Safety Information
Indication
- EXTAVIA (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. EXTAVIA 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 EXTAVIA. Consider the potential risk of EXTAVIA used in combination with known hepatotoxic drugs or other products (eg, alcohol). Monitor liver function tests and monitor for signs and symptoms of hepatic injury. Consider discontinuing EXTAVIA 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 interferon beta-1b use. Other allergic reactions have included dyspnea, bronchospasm, tongue edema, skin rash and urticaria. Discontinue EXTAVIA if anaphylaxis occurs. The removable rubber cap of the diluent pre-filled syringe contains natural rubber latex and should not be used by latex-sensitive individuals as it may cause allergic reactions.
- Depression and Suicide. Depression and suicide have been reported to occur with increased frequency in patients receiving interferon compounds, including interferon beta-1b. Patients treated with EXTAVIA should be advised to report immediately any symptoms of depression and/or suicidal ideation. Consider discontinuation of EXTAVIA 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 EXTAVIA. Consider discontinuation of EXTAVIA if worsening of CHF occurs with no other etiology.
- Injection Site Necrosis and Reactions. Injection site reactions occurred in 78% of patients receiving interferon beta-1b (compared to 26% on placebo) in controlled clinical trials with injection site necrosis reported in 4% of interferon beta-1b patients (compared to 0% on placebo). For patients who continue on EXTAVIA after injection site necrosis has occurred, EXTAVIA 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 was reported in 18% of patients receiving interferon beta-1b (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.
- Thrombotic Microangiopathy. Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, have been reported with interferon beta products, including EXTAVIA. Cases have been reported several weeks to years after starting interferon beta products. Discontinue EXTAVIA if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated.
- Flu-Like Symptom Complex. Flu-like symptom complex for patients on interferon beta-1b was 57% (vs 37% on placebo) in controlled clinical trials. Analgesics and/or antipyretics may help ameliorate flu-like symptoms.
- Seizures. Seizures have been temporally associated with the use of beta interferons.
- Drug-induced Lupus Erythematosus. Cases of drug-induced lupus erythematosus have been reported with some interferon beta products, including EXTAVIA. Signs and symptoms of drug-induced lupus reported in patients treated with EXTAVIA have included rash, serositis, polyarthritis, nephritis, and Raynaud’s phenomenon. EXTAVIA therapy should be stopped if patients develop new signs and symptoms of this syndrome.
- 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 EXTAVIA therapy, and periodically thereafter in the absence of clinical symptoms.
- Pregnancy. Patients should be warned of the potential hazard to the fetus. EXTAVIA 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 interferon beta-1b 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%).
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