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Medically reviewed on Nov 15, 2018


(e voe LOK ue mab)

Index Terms

  • AMG145

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Auto-injector, Subcutaneous [preservative free]:

Repatha SureClick: 140 mg/mL (1 mL) [contains mouse (murine) and/or hamster protein, polysorbate 80]

Solution Cartridge, Subcutaneous [preservative free]:

Repatha Pushtronex System: 420 mg/3.5 mL (3.5 mL) [contains polysorbate 80]

Solution Prefilled Syringe, Subcutaneous [preservative free]:

Repatha: 140 mg/mL (1 mL) [contains mouse (murine) and/or hamster protein, polysorbate 80]

Brand Names: U.S.

  • Repatha
  • Repatha Pushtronex System
  • Repatha SureClick

Pharmacologic Category

  • Antilipemic Agent, PCSK9 Inhibitor
  • Monoclonal Antibody


Evolocumab is a human monoclonal antibody (IgG2 isotype) that binds to proprotein convertase subtilisin kexin type 9 (PCSK9). PCSK9 binds to the low-density lipoprotein receptors (LDLR) on hepatocyte surfaces to promote LDLR degradation within the liver. LDLR is the primary receptor that clears circulating LDL; therefore, the decrease in LDLR levels by PCSK9 results in higher blood levels of LDL-cholesterol (LDL-C). By inhibiting the binding of PCSK9 to LDLR, evolocumab increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.


IV: Vd: ~3.3 L


Nonsaturable proteolysis

Onset of Action

Peak effect: Proprotein convertase subtilisin kexin type 9 (PCSK9) suppression: 4 hours

Time to Peak

SubQ: 3 to 4 days

Half-Life Elimination

11 to 17 days

Special Populations: Hepatic Function Impairment

In patients with mild or moderate hepatic impairment, a 20% to 30% lower mean Cmax and 40% to 50% lower mean AUC occurs.

Use: Labeled Indications

Homozygous familial hypercholesterolemia: Adjunct to diet and other LDL-lowering therapies (eg, statins, ezetimibe, LDL apheresis) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C

Hyperlipidemia, primary (including heterozygous familial hyperlipidemia): Adjunct to diet, alone or in combination with other lipid-lowering therapies (eg, maximum tolerated dose of statins), for the treatment of adults with primary hyperlipidemia, including heterozygous familial hyperlipidemia (HeFH), to reduce LDL-C (Sabatine 2015)

Prevention of cardiovascular events in patients with established cardiovascular disease: To reduce the risk of MI, stroke, and coronary revascularization in adults with established cardiovascular disease (CVD). Note: Use in combination with an optimized regimen of lipid-lowering therapy (eg, high-intensity statin) (Sabatine 2017).


Serious hypersensitivity to evolocumab or any component of the formulation.

Documentation of allergenic cross-reactivity for PCSK9 inhibitors is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Homozygous familial hypercholesterolemia (HoFH): SubQ: 420 mg once monthly. Note: Use in combination with diet and other lipid-lowering therapies (eg, statin, ezetimibe, LDL apheresis).

Off-label dosing: 420 mg once every 2 weeks (after 12 weeks, may decrease to 420 mg once a month) in conjunction with lipid apheresis has been studied in a limited number of patients (Bruckert 2014). The European Atherosclerosis Society recommends administration directly after lipid apheresis (EAS [France 2016]).

Hyperlipidemia, primary (including heterozygous familial hyperlipidemia [HeFH]): SubQ: 140 mg every 2 weeks or 420 mg once monthly. Note: Use in combination with diet and an optimized regimen of lipid-lowering therapy (eg, maximum tolerated dose of statin) (Sabatine 2015).

Switching regimens: Administer the first dose of the new regimen on the next scheduled day of the prior regimen.

Prevention of cardiovascular events in patients with established CVD: SubQ: 140 mg every 2 weeks or 420 mg once monthly. Note: Use in combination with an optimized regimen of lipid-lowering therapy (eg, high-intensity statin) (Sabatine 2017).

Switching regimens: Administer the first dose of the new regimen on the next scheduled day of the prior regimen.

Missed dose: Administer within 7 days from the missed dose and resume original schedule. If an every-2-week dose is not administered within 7 days, wait until the next dose on the original schedule. If a once-monthly dose is not administered within 7 days, administer the dose and start a new schedule based on this date.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Homozygous familial hypercholesterolemia: Adolescents 13 to 17 years: SubQ: Refer to adult dosing

Missed dose: Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment necessary.

Dosing: Hepatic Impairment

Mild to moderate impairment (Child Pugh classes A and B): No dosage adjustment necessary.

Severe impairment (Child Pugh class C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).


For SubQ administration. Do not shake. If refrigerated, allow to stand at room temperature for at least 30 minutes (single-use prefilled autoinjector or single-use prefilled syringe) or at least 45 minutes (single-use on-body infusor with prefilled cartridge) prior to use (do not warm with heat or hot water). Administer into areas of the abdomen (except for the 2-inch area around the navel), thigh, or upper arm; only use areas that are not tender, bruised, red, or indurated. Do not coadminister with other injectable drugs at the same injection site. Rotate the injection site with each injection.

Once-monthly dose (ie, 420 mg): Administer SubQ over 9 minutes using the single-use infusor with prefilled cartridge or give 3 separate SubQ 140 mg injections consecutively within a 30-minute period using the single-use prefilled autoinjector or single-use prefilled syringe.


Store between 2°C to 8°C (36°F to 46°F) in the original carton. May also store at room temperature (at 20°C to 25°C [68°F to 77°F]) in the original carton; however, under these conditions, must use within 30 days (discard if not used within 30 days). Protect from direct light and do not expose to temperatures above 25°C (77°F). Do not freeze.

Drug Interactions

Belimumab: Monoclonal Antibodies may enhance the adverse/toxic effect of Belimumab. Avoid combination

Adverse Reactions

>10%: Respiratory: Nasopharyngitis (6% to 11%)

1% to 10%:

Cardiovascular: Hypertension (3%)

Central nervous system: Dizziness (4%), fatigue (2%)

Dermatologic: Skin rash (1%)

Gastrointestinal: Gastroenteritis (3% to 6%), nausea (2%)

Genitourinary: Urinary tract infection (5%)

Hematologic & Oncologic: Bruise (1%)

Infection: Influenza (8% to 9%)

Local: Injection site reaction (including erythema, pain, bruising: 6%)

Neuromuscular & Skeletal: Myalgia (4%)

Respiratory: Upper respiratory tract infection (9%), cough (1% to 5%), sinusitis (4%)

<1%, postmarketing, and/or case reports: Antibody development, decreased LDL cholesterol (<25 mg/dL), hypersensitivity, urticaria


Concerns related to adverse effects:

• Hypersensitivity reactions: Hypersensitivity reactions (eg, angioedema, rash, urticaria) have been reported, some requiring discontinuation. Discontinue treatment and initiate supportive treatment in patients who develop signs/symptoms of serious allergic reaction; monitor until symptoms resolve.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Latex: The packaging (needle cap of prefilled syringe and autoinjector) may contain dry natural rubber, which is a derivative of latex.

Monitoring Parameters

Lipid profile; in patients with homozygous familial hypercholesterolemia, measure LDL-C levels 4 to 8 weeks after initiation (response to evolocumab will depend on degree of LDL-receptor function); signs/symptoms of hypersensitivity reactions.

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. IgG antibodies are known to cross the placenta in increasing amounts during the second and third trimesters; exposure of the fetus to evolocumab is expected.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience pharyngitis, rhinitis, flu-like symptoms, signs of common cold, back pain, or injection site irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.