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Repatha
evolocumab
Adult Dosing .
Dosage forms: INJ (SureClick auto-injector): 140 mg; INJ (pre-filled syringe): 140 mg per mL
cardiovascular event risk reduction
- [140 mg SC q2wk]
- Alt: 420 mg SC qmo; Info: for pts w/ established CVD
primary hyperlipidemia
- [140 mg SC q2wk]
- Alt: 420 mg SC qmo
heterozygous familial hypercholesterolemia
- [140 mg SC q2wk]
- Alt: 420 mg SC qmo
homozygous familial hypercholesterolemia, adjunct tx
- [420 mg SC qmo or 420 mg SC q2wk]
- Start: 420 mg SC qmo, may incr. to 420 mg SC q2wk after 12wk if inadequate response; Info: may start 420 mg SC q2wk if pt on lipid apheresis
renal dosing
- [no adjustment]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
- Dosage forms: INJ (SureClick auto-injector): 140 mg; INJ (pre-filled syringe): 140 mg per mL
heterozygous familial hypercholesterolemia, adjunct tx
- [10 yo and older]
- Dose: 140 mg SC q2wk; Alt: 420 mg SC qmo
homozygous familial hypercholesterolemia, adjunct tx
- [10 yo and older]
- Dose: 420 mg SC qmo or 420 mg SC q2wk; Start: 420 mg SC qmo, may incr. to 420 mg SC q2wk after 12wk if inadequate response; Info: may start 420 mg SC q2wk if pt on lipid apheresis
renal dosing
- [no adjustment]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- caution: hypersensitivity to latex
Drug Interactions .
Overview
evolocumab
PCSK9 inhibitor
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
- angioedema
Common Reactions
- nasopharyngitis
- headache
- URI
- influenza
- diabetes mellitus (cardiovascular prevention use)
- oropharyngeal pain (peds pts)
- back pain
- hypersensitivity rxn
- injection site rxn
- cough
- UTI
- sinusitis
- myalgia
- dizziness
- musculoskeletal pain
- BP elevated
- diarrhea
- gastroenteritis
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy, esp. in 2nd and 3rd trimesters; no human data available, though likely to cross placenta in 2nd and 3rd trimesters based on human data w/ other monoclonal antibodies; no known risk of fetal harm based on animal data at up to 12x MRHD
Pregnancy Reporting
report any suspected fetal exposure to Amgen at 1-800-772-6436 or https://wwwext.amgen.com/products/global-patient-safety/adverse-event-reporting
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available, though risk of infant harm not expected based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: unknown; CYP450: none
Excretion: unknown; Half-life: 11-17 days
Subclass: Dyslipidemia: PCSK9 Inhibitors
Mechanism of Action
inhibits proprotein convertase subtilisin kexin type 9 (PCSK9) binding to LDL receptors, decreasing LDL receptor degradation and increasing LDL clearance (monoclonal antibody)
Formulary .
No Formulary Selected
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