Usual Adult Dose for Hyperlipidemia

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

Comments:

• Low-density lipoprotein cholesterol (LDL-C) can be assessed when clinically appropriate; the LDL lowering effect may be measured as early as 4 weeks after initiation.
• For patients receiving 420 mg once a month, LDL-C should be measured just prior to next scheduled dose.
• When switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of prior regimen.

Uses:

• In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization.
• As an adjunct to diet, alone or in combination with other LDL-C lowering therapies for the treatment of primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C.

Usual Adult Dose for Heterozygous Familial Hypercholesterolemia

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

Comments:

• Low-density lipoprotein cholesterol (LDL-C) can be assessed when clinically appropriate; the LDL lowering effect may be measured as early as 4 weeks after initiation.
• For patients receiving 420 mg once a month, LDL-C should be measured just prior to next scheduled dose.
• When switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of prior regimen.

Uses:

• In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization.
• As an adjunct to diet, alone or in combination with other LDL-C lowering therapies for the treatment of primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C.

Usual Adult Dose for Cardiovascular Risk Reduction

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

Comments:

• Low-density lipoprotein cholesterol (LDL-C) can be assessed when clinically appropriate; the LDL lowering effect may be measured as early as 4 weeks after initiation.
• For patients receiving 420 mg once a month, LDL-C should be measured just prior to next scheduled dose.
• When switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of prior regimen.

Uses:

• In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization.
• As an adjunct to diet, alone or in combination with other LDL-C lowering therapies for the treatment of primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia

Initial dose: 420 mg subcutaneously once a month

• May increase to 420 mg every 2 weeks if clinically meaningful response is not achieved in 12 weeks

Concomitant Use with Lipid Apheresis:

• Patients on lipid apheresis may initiate treatment with 420 mg subcutaneously every 2 weeks to correspond with their apheresis schedule; administer after apheresis session is complete.

Comments:

• Low-density lipoprotein cholesterol (LDL-C) can be assessed when clinically appropriate; the LDL lowering effect may be measured as early as 4 weeks after initiation.
• For patients receiving 420 mg once a month, LDL-C should be measured just prior to next scheduled dose.

Use: As an adjunct to other LDL-lowering therapies for the treatment of homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.

Usual Pediatric Dose for Homozygous Familial Hypercholesterolemia

10 years or older:
Initial dose: 420 mg subcutaneously once a month

• May increase to 420 mg every 2 weeks if clinically meaningful response is not achieved in 12 weeks

Concomitant Use with Lipid Apheresis:

• Patients on lipid apheresis may initiate treatment with 420 mg subcutaneously every 2 weeks to correspond with their apheresis schedule; administer after apheresis session is complete.

Comments:

• Low-density lipoprotein cholesterol (LDL-C) can be assessed when clinically appropriate; the LDL lowering effect may be measured as early as 4 weeks after initiation.
• For patients receiving 420 mg once a month, LDL-C should be measured just prior to next scheduled dose.

Use: Uses: As an adjunct to other LDL-lowering therapies in pediatric patients 10 years or older for the treatment of homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.

Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia

10 years or older: 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously once a month

Comments:

• Low-density lipoprotein cholesterol (LDL-C) can be assessed when clinically appropriate; the LDL lowering effect may be measured as early as 4 weeks after initiation.
• For patients receiving 420 mg once a month, LDL-C should be measured just prior to next scheduled dose.
• When switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of prior regimen.

Use: As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients 10 years or older with HeFH, to reduce LDL-C.

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 or any product excipients; angioedema has occurred

Safety and efficacy have not been established in pediatric patients younger than 10 years

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; avoid injecting into areas with scars or stretch marks
• 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 5 minutes using the single-dose 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-dose 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:

• Within 7 days: The dose should be administered and the regular schedule should be resumed
• More than 7 days after the missed dose
• For an every 2-week dose, skip the missed dose and resume regular schedule
• For a once-monthly dose, administer missed dose and start a new schedule based on this date

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 [20C to 25C (68F to 77 F)] 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

General:

• The needle cover of the glass single-dose prefilled syringe and the single-dose prefilled autoinjector contain dry natural rubber (a derivative of latex) that may cause allergic reactions in individuals sensitive to latex.

Monitoring:

• LDL-C levels may be assess when clinically appropriate; LDL-lowering effect may be measured as early as 4 after starting treatment
• Note: for patients receiving 420 mg/month, the LDL-C can vary during the dosing interval in some patients; LDL-C should be measure just prior to next dose

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 prefilled 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.

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