Hyperlipoproteinemias:

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).

EVKEEZA Warnings/Precautions:

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.

EVKEEZA Classification:

Angiopoietin-like 3 (ANGPTL3) inhibitor.

Adverse Reactions:

Nasopharyngitis, influenza-like illness, dizziness, rhinorrhea, nausea, fatigue; hypersensitivity reactions.

Metabolism:

The exact pathway through which evinacumab-dgnb is metabolized has not been characterized. As a human monoclonal IgG4 antibody, evinacumab-dgnb is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.

Drug Elimination:

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:

NO

How Supplied:

Single-dose vial (2.3mL, 8mL)—1