Drug Detail:Alirocumab (Alirocumab)
Drug Class: PCSK9 inhibitors
Usual Adult Dose for Hyperlipidemia
75 mg subcutaneously every 2 weeks OR 300 mg subcutaneously once every 4 weeks
- For inadequate LDL-C (low density lipoprotein) response, may adjust dose to 150 mg subcutaneously every 2 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:
- Assess LDL-C when clinically appropriate, the LDL-C lowering effect may be measured as early as 4 weeks after initiating therapy.
- In some patients, LDL-C can vary considerably during 4-week dosing intervals, therefore measure LDL-C just prior to the next scheduled dose.
- If LDL-C reduction is inadequate, consider adjusting dose to 150 mg every 2 weeks starting new dose on the next scheduled dosing date.
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 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
75 mg subcutaneously every 2 weeks OR 300 mg subcutaneously once every 4 weeks
- For inadequate LDL-C (low density lipoprotein) response, may adjust dose to 150 mg subcutaneously every 2 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:
- Assess LDL-C when clinically appropriate, the LDL-C lowering effect may be measured as early as 4 weeks after initiating therapy.
- In some patients, LDL-C can vary considerably during 4-week dosing intervals, therefore measure LDL-C just prior to the next scheduled dose.
- If LDL-C reduction is inadequate, consider adjusting dose to 150 mg every 2 weeks starting new dose on the next scheduled dosing date.
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 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
75 mg subcutaneously every 2 weeks OR 300 mg subcutaneously once every 4 weeks
- For inadequate LDL-C (low density lipoprotein) response, may adjust dose to 150 mg subcutaneously every 2 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:
- Assess LDL-C when clinically appropriate, the LDL-C lowering effect may be measured as early as 4 weeks after initiating therapy.
- In some patients, LDL-C can vary considerably during 4-week dosing intervals, therefore measure LDL-C just prior to the next scheduled dose.
- If LDL-C reduction is inadequate, consider adjusting dose to 150 mg every 2 weeks starting new dose on the next scheduled dosing date.
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 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 Homozygous Familial Hypercholesterolemia
150 mg subcutaneously once every 2 weeks
Comments:
- Assess LDL-C when clinically appropriate, the LDL-C lowering effect may be measured as early as 4 weeks after initiating therapy.
Uses:
- As an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH), to reduce low density lipoprotein cholesterol (LDL-C).
Renal Dose Adjustments
Mild to moderate renal dysfunction: No adjustment recommended
Severe renal dysfunction: Data not available
Liver Dose Adjustments
Mild to moderate hepatic dysfunction: No adjustment recommended
Severe hepatic dysfunction: Data not 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
- Administer into areas that are not tender, bruised, red, or indurated
Missed Dose:
WITHIN 7 DAYS: If dose is missed within 7 days of scheduled dose, administer the missed dose and resume regular dosing schedule
MORE THAN 7 DAYS:
- For every 2-week dosing regimen: Skip the missed dose and resume regular dosing schedule
- For every 4-week dosing regimen: Administer dose 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:
- If refrigerated, allow 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:
- Assess LDL-C when clinically appropriate; LDL-lowering effects may be measured as early as 4 weeks after initiating therapy
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.
Frequently asked questions
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