인터페론베타-1b(숙주:E.coli strain MM294-1, 벡터:pSY2501)

is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BETASERON is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )

is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, Albumin (Human), or any other component of the formulation. History of hypersensitivity to natural or recombinant interferon beta, albumin or mannitol ( 4 )

• Hepatic Injury: Monitor liver function tests and signs and symptoms of hepatic injury; consider discontinuing BETASERON if serious hepatic injury occurs. ( 5.1 , 5.11 ) • Anaphylaxis and Other Allergic Reactions: Discontinue if anaphylaxis occurs. ( 5.2 ) • Depression and Suicide: Advise patients to immediately report any symptom of depression and/or suicidal ideation; consider discontinuation of BETASERON if depression occurs. ( 5.3 ) • Congestive Heart Failure (CHF): Monitor patients with CHF for worsening of cardiac symptoms; consider discontinuation of BETASERON if worsening of CHF occurs. ( 5.4 ) • Injection Site Reactions Including Necrosis: Do not administer BETASERON into affected area until fully healed; if multiple lesions occur, change injection site or discontinue BETASERON until healing of skin lesions. ( 5.5 ) • Leukopenia: Monitor complete blood count. ( 5.6 , 5.12 ) • Thrombotic Microangiopathy: Cases of thrombotic microangiopathy (TMA) have been reported. Discontinue BETASERON if clinical symptoms and laboratory findings consistent with TMA occur and a relationship to BETASERON is suspected. ( 5.7 ) • Pulmonary Arterial Hypertension: Cases of pulmonary arterial hypertension (PAH) have been reported in patients treated with interferon beta products, including BETASERON. Discontinue BETASERON if PAH is diagnosed. ( 5.8 ) • Flu-like Symptom Complex: Consider analgesics and/or antipyretics on injection days. ( 5.9 ) • Drug-induced Lupus Erythematosus: Cases of …

8.1 Pregnancy Risk Summary Although there have been no well-controlled studies in pregnant women, available data, which includes prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. Administration of BETASERON to monkeys during gestation resulted in increased embryo-fetal death at or above exposures greater than 3 times the human therapeutic dose ( see Animal Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage …