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Evolocumab Dosage

Medically reviewed on November 7, 2018.

Applies to the following strengths: 140 mg/mL; 420 mg/3.5 mL

Usual Adult Dose for Hyperlipidemia

140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously once a month

Comments:
-When switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of prior regimen.

Uses: Adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease requiring additional lowering of low density lipoprotein cholesterol (LDL-C)

Usual Adult Dose for Cardiovascular Risk Reduction

140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously once a month

Comments:
-When switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of prior regimen.

Uses: Adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease requiring additional lowering of low density lipoprotein cholesterol (LDL-C)

Usual Adult Dose for Homozygous Familial Hypercholesterolemia

420 mg subcutaneously once a month

Comments:
-Measure LDL-C levels 4 to 8 weeks after starting therapy; LDL-C can vary considerably during the dosing interval in some patients.
-Response to therapy depends on the degree of LDL-receptor function.

Uses: Adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) requiring additional LDL-C lowering.

Usual Pediatric Dose for Homozygous Familial Hypercholesterolemia

13 years or older:
420 mg subcutaneously once a month

Comments:
-Measure LDL-C levels 4 to 8 weeks after starting this drug; LDL-C can vary considerably during the dosing interval in some patients.
-Response to therapy depends on the degree of LDL-receptor function.

Uses: Adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) requiring additional LDL-C lowering.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Mild to moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended
Severe liver dysfunction: Data not available

Precautions

CONTRAINDICATIONS:
-Serious hypersensitivity to the active component; angioedema has occurred

Safety and efficacy have not been established in patients younger than 13 years with Homozygous Familial Hypercholesterolemia

Safety and efficacy have not been established in patients younger than 18 years with primary hyperlipidemia or Heterozygous Familial Hypercholesterolemia.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Administer subcutaneously into abdomen, thigh, or upper arm; rotate injection sites
-Do not administer into tender, bruised, red, or indurated areas
-Administer using a single-use prefilled syringe, single-use prefilled auto-injector, or single-use on-body infusor with prefilled cartridge
-For the 420 mg dose: Administer over 9 minutes using the single-use on-body infusor with prefilled cartridge OR give three injections (140 mg each) consecutively within 30 minutes using the single-use prefilled auto-injector or single-use prefilled syringe
-Provide proper training on how to prepare and administer

Preparation techniques: Allow to warm to room temperature:
-For single-use prefilled syringe and single-use prefilled auto-injector allow at least 30 minutes prior to use
-For single-use on-body infusor with prefilled cartridge allow at least 45 minutes prior to use
-Do not warm in any other way

Missed Dose:
-If an every 2-week dose is not administered within 7 days, skip the missed dose and resume regular schedule
-If a once-month dose is not administered within 7 days, administer the dose and start a new schedule

Storage requirements:
-Store refrigerated 2C to 8C (36F to 46F) in the original carton to protect from light; do not freeze; do not shake
-May store at room temperature [up to 25C (77F)] in the original carton for up to 30 days; discard if not used

Compatibilities: Do not co-administer with other injectable drugs at the same administration site

Monitoring:
-Measure LDL-C levels 4 to 8 weeks after starting treatment in patients with Homozygous Familial Hypercholesterolemia

Patient advice:
-Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
-If any signs or symptoms of serious allergic reactions occur, discontinue this drug and seek medical attention.
-The needle cover of the glass prefill syringe and the auto-injector contain dry natural rubber (a derivative of latex) that may cause allergic reactions in patients sensitive to latex; the single-use on-body infuser is not made with natural rubber latex.

Further information

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

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