Evkeeza

— THERAPEUTIC CATEGORIES —
  • Hyperlipoproteinemias
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Evkeeza Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Evinacumab-dgnb 150mg/mL; soln for IV infusion after dilution; preservative-free.

    Pharmacological Class

    Angiopoietin-like 3 (ANGPTL3) inhibitor.

    How Supplied

    Single-dose vial (2.3mL, 8mL)—1

    Manufacturer

    Regeneron

    Generic Availability

    NO

    Mechanism of Action

    Evinacumab-dgnb inhibition of ANGPTL3 leads to reduction in LDL-C, HDL-C, and triglycerides (TG). It reduces LDL-C independent of the presence of LDL receptor by promoting VLDL processing and clearance upstream of LDL formation. The blockade of ANGPTL3 lowers TG and HDL-C by rescuing lipoprotein lipase and endothelial lipase activities, respectively.

    Evkeeza Indications

    Indications

    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.

    Evkeeza Dosage and Administration

    Adults and Children

    <5yrs: not established. Give by IV infusion over 60mins. ≥5yrs: 15mg/kg once monthly (every 4 weeks).

    Administration

    Give by IV infusion over 60mins. Do not mix with other medications or administer other medications concomitantly via the same infusion line.

    Evkeeza Contraindications

    Not Applicable

    Evkeeza Boxed Warnings

    Not Applicable

    Evkeeza Warnings/Precautions

    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 Pharmacokinetics

    Absorption

    Mean (standard deviation) steady-state trough concentration: 266 (120) mg/L in adults. Mean (standard deviation) Cmax at the end of infusion: 718 (183) mg/L in adults.

    Distribution

    Steady-state volume of distribution: ~4.7 L in adults.

    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.

    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.

    Evkeeza Interactions

    Not Applicable

    Evkeeza Adverse Reactions

    Adverse Reactions

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

    Evkeeza Clinical Trials

    See Literature

    Evkeeza Note

    Not Applicable

    Evkeeza Patient Counseling

    See Literature

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