【藥品訊息】 保脂通注射劑 75mg 中文仿單 保脂通注射劑 75mg 衛教單張

降血脂 (其他) Primary heterozygous familial hypercholesterolemia, On maximally tolerated statin therapy, Adjunct.
Primary hypercholesterolemia, In patients with atherosclerotic cardiovascular disease; on maximally tolerated statin therapy; Adjunct.

Alirocumab is a monoclonal antibody that inhibits the binding of Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) to low-density lipoprotein receptors (LDLRs) on hepatocytes, thus reducing degradation of the LDLR. Increased LDLRs are then available to clear LDL-C from circulation and lower LDL-C levels.

Absorption:
Bioavailability, subQ: 85%; Tmax, subQ: 3 to 7 days.
Distribution:
Vd: 0.04 to 0.05 L/kg.
Metabolism:
Protein degradation: Primary.
Excretion:
Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) binding: Primarily at lower concentrations.
Proteolytic pathway (nonsaturable): Primarily at higher concentrations.
Elimination Half Life: 17 to 20 days

History of serious hypersensitivity to alirocumab.

Infant risk cannot be ruled out.

Common:
Dermatologic:Injection site reaction (7.2% to 16.6%).
Respiratory: Nasopharyngitis (11.3%).
Other: Influenza (5.7%).
Serious:
Immunologic: Allergic reaction (8.6%)

Primary heterozygous familial hypercholesterolemia, On maximally tolerated statin therapy; Adjunct:
Initial (once-every-2-weeks regimen), 75 mg subQ once every 2 weeks; may increase after 4 to 8 weeks to max 150 mg every 2 weeks.
Initial (once-every-4-weeks regimen), 300 mg subQ once every 4 weeks; if LDL-C response inadequate just prior to next scheduled dose, may adjust to 150 mg every 2 weeks starting on the next scheduled dosing date.
Primary hypercholesterolemia, In patients with atherosclerotic cardiovascular disease; on maximally tolerated statin therapy;

Adjunct:
Initial (once-every-2-weeks regimen), 75 mg subQ once every 2 weeks; may increase after 4 to 8 weeks to MAX 150 mg every 2 weeks.
Initial (once-every-4-weeks regimen), 300 mg subQ once every 4 weeks; if LDL-C response inadequate just prior to next scheduled dose, may adjust to 150 mg every 2 weeks starting on the next scheduled dosing date.