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Alirocumab Dosage

Medically reviewed by Drugs.com. Last updated on May 31, 2019.

Applies to the following strengths: 75 mg/mL; 150 mg/mL

Usual Adult Dose for Hyperlipidemia

Initial dose: 75 mg subcutaneously every 2 weeks
-Measure LDL-C levels within 4 to 8 weeks, if the LDL-C response is inadequate, adjust dose and reassess LDL-C within 4 to 8 weeks
Maximum dose: 150 mg subcutaneously every 2 weeks

Alternatively,
Initial dose: 300 mg subcutaneously once every 4 weeks
-Measure LDL-C just prior to the next scheduled dose, if LDL-C reduction is inadequate, may adjust dose to 150 mg every 2 weeks (start new dose on the next scheduled dosing date); reassess LDL-C within 4 to 8 weeks

Patients with heterozygous familial hypercholesterolemia (HeFH) undergoing LDL apheresis: 150 mg subcutaneously once every 2 weeks
-Dose may be administered without regard to the timing of apheresis

Comments:
-In some patients, LDL-C can vary considerably during dosing intervals when dosed once every 4 weeks; in such patients, the dosing interval should be adjusted to every 2 weeks.

Uses:
-As an adjunct to diet, alone or in combination with other lipid-lowering therapies for the treatment of primary hyperlipidemia including (HeFH), to reduce low density lipoprotein cholesterol (LDL-C).
-To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.

Usual Adult Dose for Heterozygous Familial Hypercholesterolemia

Initial dose: 75 mg subcutaneously every 2 weeks
-Measure LDL-C levels within 4 to 8 weeks, if the LDL-C response is inadequate, adjust dose and reassess LDL-C within 4 to 8 weeks
Maximum dose: 150 mg subcutaneously every 2 weeks

Alternatively,
Initial dose: 300 mg subcutaneously once every 4 weeks
-Measure LDL-C just prior to the next scheduled dose, if LDL-C reduction is inadequate, may adjust dose to 150 mg every 2 weeks (start new dose on the next scheduled dosing date); reassess LDL-C within 4 to 8 weeks

Patients with heterozygous familial hypercholesterolemia (HeFH) undergoing LDL apheresis: 150 mg subcutaneously once every 2 weeks
-Dose may be administered without regard to the timing of apheresis

Comments:
-In some patients, LDL-C can vary considerably during dosing intervals when dosed once every 4 weeks; in such patients, the dosing interval should be adjusted to every 2 weeks.

Uses:
-As an adjunct to diet, alone or in combination with other lipid-lowering therapies for the treatment of primary hyperlipidemia including (HeFH), to reduce low density lipoprotein cholesterol (LDL-C).
-To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.

Usual Adult Dose for Cardiovascular Risk Reduction

Initial dose: 75 mg subcutaneously every 2 weeks
-Measure LDL-C levels within 4 to 8 weeks, if the LDL-C response is inadequate, adjust dose and reassess LDL-C within 4 to 8 weeks
Maximum dose: 150 mg subcutaneously every 2 weeks

Alternatively,
Initial dose: 300 mg subcutaneously once every 4 weeks
-Measure LDL-C just prior to the next scheduled dose, if LDL-C reduction is inadequate, may adjust dose to 150 mg every 2 weeks (start new dose on the next scheduled dosing date); reassess LDL-C within 4 to 8 weeks

Patients with heterozygous familial hypercholesterolemia (HeFH) undergoing LDL apheresis: 150 mg subcutaneously once every 2 weeks
-Dose may be administered without regard to the timing of apheresis

Comments:
-In some patients, LDL-C can vary considerably during dosing intervals when dosed once every 4 weeks; in such patients, the dosing interval should be adjusted to every 2 weeks.

Uses:
-As an adjunct to diet, alone or in combination with other lipid-lowering therapies for the treatment of primary hyperlipidemia including (HeFH), to reduce low density lipoprotein cholesterol (LDL-C).
-To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.

Renal Dose Adjustments

Mild to moderate renal dysfunction: No adjustment recommended
Severe renal dysfunction: No data available

Liver Dose Adjustments

Mild to moderate hepatic dysfunction: No adjustment recommended
Severe hepatic dysfunction: No data available

Precautions

CONTRAINDICATIONS:
-History of a serious hypersensitivity to active substance or any product excipients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Administer subcutaneously into the thigh, abdomen, or upper arm
-Rotate the injection sites
-To administer the 300 mg dose, give two 150 mg injections consecutively at 2 different injection sites
-Do not administer into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, or skin infections

Missed Dose:
-Every 2-week dosing regimen: If a dose is missed, administer within 7 days and then resume regular dosing schedule; if missed dose is not administered within 7 days, skip the missed dose and give the next dose on the regular schedule
-Every 4-week dosing regimen: If a dose is missed, administer within 7 days and then resume regular dosing schedule; if missed dose is not administered within 7 days, give the missed dose and and start a new schedule based on this date.

Storage requirements:
-Store refrigerated 36F to 46F (2C to 8C); protect from light
-May be kept at room temperature (77F [25C]) for up to 30 days; keep in original carton to protect from light
-After removal from refrigerator, must be used within 30 days or discarded
-Do not freeze; do not expose to extreme heat; do not shake

Reconstitution/preparation techniques:
-Allow this drug to warm to room temperature for 30 to 40 minutes prior to use
-Provide proper training to patients and/or caregivers on the preparation and administration of this drug prior to use; instruct patients and/or caregivers to read and follow the Instructions for Use each time they use this drug.

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

General:
-In a large clinical trial, this drug showed a significant reduction in the composite endpoint (risk for time to first occurrence of coronary heart disease death, non-fatal myocardial infarction, fatal and non-fatal ischemic stroke, or unstable angina requiring hospitalization) compared to placebo in patients who had had a recent acute coronary syndrome event (4 to 52 weeks prior) and were receiving lipid-modifying-therapy (LMT) regimen that was statin-intensive (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or were at maximally tolerated statin doses with or without other LMT.

Monitoring:
-Patients on every 2-week schedule: Obtain LDL-C levels 4 to 8 weeks after initiation or dose adjustment
-Patients on every 4-week schedule: Obtain LDL-C level just prior to next dose as LDL-C can vary considerably between doses with this regimen

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.

Further information

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

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