Indications for: EVKEEZA
Adjunct to other LDL-C lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH).
Limitations of Use:
Safety and efficacy have not been established for other causes of hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Effects on cardiovascular morbidity and mortality have not been determined.
Adults and Children:
<5yrs: not established. Give by IV infusion over 60mins. ≥5yrs: 15mg/kg once monthly (every 4 weeks).
Discontinue if serious hypersensitivity reactions occur; monitor and treat appropriately. Assess LDL-C when clinically appropriate; effects may be measured as early as 2 weeks after initiation. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥5 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers.
Angiopoietin-like 3 (ANGPTL3) inhibitor.
Nasopharyngitis, influenza-like illness, dizziness, rhinorrhea, nausea, fatigue; hypersensitivity reactions.
Evinacumab-dgnb elimination is mediated via parallel linear and non-linear pathways. The elimination half-life is a function of serum evinacumab-dgnb concentrations, and is not a constant. Evinacumab-dgnb is not likely to undergo renal excretion.
Generic Drug Availability:
Single-dose vial (2.3mL, 8mL)—1