페그인터페론베타-1a

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. PLEGRIDY is an interferon beta 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 ( 1 )

is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of PLEGRIDY [see Warnings and Precautions ( 5.3 )] . History of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of PLEGRIDY ( 4 )

Hepatic injury: monitor liver function tests; monitor patients for signs and symptoms of hepatic injury; consider discontinuation of PLEGRIDY if hepatic injury occurs ( 5.1 ) Depression and suicide: advise patients to report immediately any symptom of depression or suicidal ideation to their healthcare provider; consider discontinuation of PLEGRIDY if depression occurs ( 5.2 ) Anaphylaxis and other allergic reactions: Discontinue PLEGRIDY if a serious allergic reaction occurs ( 5.3 ) Injection site reactions: Do not administer PLEGRIDY into affected area until fully healed; if multiple lesions occur, change injection site or discontinue PLEGRIDY until healing of skin lesions ( 5.4 ) Congestive heart failure: monitor patients with pre-existing significant cardiac disease for worsening of cardiac symptoms ( 5.5 ) Decreased peripheral blood counts: monitor complete blood counts ( 5.6 ) Thrombotic Microangiopathy: Cases of thrombotic microangiopathy have been reported with interferon beta products. Discontinue PLEGRIDY if clinical symptoms and laboratory findings consistent with TMA occur ( 5.7 ) Pulmonary Arterial Hypertension: Cases of pulmonary arterial hypertension (PAH) have been reported in patients treated with interferon beta products, including PLEGRIDY. Discontinue PLEGRIDY if PAH is diagnosed ( 5.8 ) Autoimmune disorders: consider discontinuation of PLEGRIDY if a new autoimmune disorder occurs ( 5.9 ) 5.1 Hepatic Injury Severe hepatic injury, including hepatitis, …

8.1 Pregnancy Risk Summary Data from a large population-based cohort study, as well as other published studies over several decades, have not identified a drug-associated risk of major birth defects with the use of interferon beta products during early pregnancy. Findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta products in pregnancy have been inconsistent (see Data ). In a study in pregnant monkeys, administration of interferon beta during pregnancy resulted in an increased rate of abortion ( see Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized …