Evolocumab: Difference between revisions
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== References == | == References == | ||
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[[Category:PCSK9 inhibitors]] | |||
[[Category:Lipid-lowering agents]] | |||
[[Category:Biologics]] | |||
[[Category:Monoclonal antibodies]] | |||
Latest revision as of 10:43, 23 May 2026
Evolocumab
Repatha
Experience
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Summary
Common uses
Hyperlipidemia not at LDL goal on maximally-tolerated statin ± ezetimibe0, Homozygous familial hypercholesterolemia0, Established ASCVD with elevated LDL despite statin (FOURIER trial)0
Pharmacy
Starting dose
140 mg SC every 2 weeks OR 420 mg SC monthly (3 consecutive injections 5 minutes apart due to volume)
Preparations
140 mg/mL single-use prefilled syringe and SureClick autoinjector; Pushtronex 420 mg/3.5 mL on-body infusor
US FDA Max
420 mg/month
Pharmacology
Routes
Subcutaneous
Onset
LDL reduction ~50-60% from baseline at 1-2 weeks
Duration
2-4 weeks per dose
Half-life
~11-17 days[1]
Bioavailability
~72% from SC depot[1]
Pregnancy
Limited data.[citation needed]
Legal status
Rx-only in US
Purported mechanism
Evolocumab is a fully human IgG2 monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9); PCSK9 normally binds the LDL receptor and targets it for lysosomal degradation, so blocking PCSK9 increases hepatic LDL receptor density, accelerates LDL clearance, and lowers serum LDL by ~50-60% on top of statin therapy.0 The FOURIER trial (2017) established cardiovascular event reduction on top of statin therapy, with no apparent floor below which further LDL reduction stopped helping. Cost (~$5,000/year US) and SC injection burden have limited uptake compared with statins[1].
References
- ↑ 1.0 1.1 1.2 FDA Prescribing Information, Repatha (evolocumab), Amgen, current revision. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125522s014lbl.pdf