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新药ropeginterferon alfa-2b-njft（商品名：Besremi）获美国FDA批准，为首个治疗真性红细胞增多症(二)
vative monopegylated, long-acting interferon. With its unique pegylation technology, BESREMi has a long duration of activity in the body and is aimed to be administered once every two weeks or longer until hematologic parameters are stabilized, allowing flexible dosing that helps meet the individual needs of patients. After one year, patients with stable complete hematologic response (CHR) can be treated with BESREMi every four weeks.
BESREMi has orphan drug designation for treatment of PV in the United States. The product was approved by the European Medicines Agency (EMA) in 2019 and has received approval in Taiwan and South Korea. BESREMi was invented and is manufactured by PharmaEssentia.
Important Safety Information
IMPORTANT SAFETY INFORMATION AND INDICATIONS
WARNING: RISK OF SERIOUS DISORDERS
Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory eva luations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy.
CONTRAINDICATIONS
Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt
Hypersensitivity to interferons including interferon alfa-2b or any of the inactive ingredients of BESREMi.
Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
History or presence of active serious or untreated autoimmune disease
Immunosuppressed transplant recipients
WARNINGS AND PRECAUTIONS
Depression and Suicide: Life-threatening or fatal neuropsychiatric reactions have occurred in patients receiving interferon alfa-2b products, including BESREMi. These reactions may occur in patients with and without previous psychiatric illness. |
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