In this edition of the Guidelines+ Monographs Series will delve into the medication alirocumab, marketed under the brand name Praluent® from Regeneron. Praluent (alirocumab) is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor indicated to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease, as adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C, as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, and as an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C. It was initially approved in 2015.
In the following sections, we will provide a comprehensive overview of alirocumab and analyze its positioning across various guidelines for its approved indications.
Note* – This Guidelines+ Monographs for alirocumab (Praluent) is current as of December 2024. Consult our clinical guidelines library and/or or medication information look up tool to ensure you are always accessing the most current information.
Without further delay, let’s jump in!
Medication Overview
- Brand name: Praluent
- Generic name: alirocumab
- Manufacturer(s): Regeneron
- Initial FDA Approval: 2015
Indications and FDA Approval Details
| Indicated Condition | Indicated | Age Range | Date Approved |
|---|---|---|---|
| Cardiovascular disease | To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. | Adults | April 26, 2019 |
Primary hyperlipidemia | As adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C. | Adults | July 24, 2015 |
Homozygous familial hypercholesterolemia | As an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C. | Adults | April 1, 2021 |
Heterozygous familial hypercholesterolemia | As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C. | 8 years of age and older | March 11, 2024 |
Dosage and Administration
- In adults with established cardiovascular disease or with primary hyperlipidemia, including HeFH:
- The recommended starting dosage of PRALUENT is either 75 mg once every 2 weeks or 300 mg once every 4 weeks administered subcutaneously.
- For patients receiving PRALUENT 300 mg every 4 weeks, measure LDL-C just prior to the next scheduled dosage, because LDL-C can vary between dosages in some patients.
- If the LDL-C response is inadequate, the dosage may be adjusted 150 mg subcutaneously every 2 weeks.
- In adults with HeFH undergoing LDL apheresis or in adults with HoFH:
- The recommended dosage of PRALUENT is 150 mg once every 2 weeks administered subcutaneously.
- PRALUENT can be administered without regard to the timing of LDL apheresis.
- In pediatric patients with HeFH:
- The recommended dosage of PRALUENT for patients with a body weight less than 50 kg is 150 mg once every 4 weeks administered subcutaneously.
- The recommended dosage of PRALUENT for patients with a body weight of 50 kg or more is 300 mg once every 4 weeks administered subcutaneously.
- If the LDL-C response is inadequate, the dosage may be adjusted for patients with a body weight less than 50 kg to 75 mg subcutaneously once every 2 weeks or for patients with a body weight of 50 kg or more to 150 mg subcutaneously once every 2 weeks.
- Assess LDL-C when clinically appropriate. The LDL-lowering effect of PRALUENT may be measured as early as 4 weeks after initiation.
- Administer PRALUENT subcutaneously into areas of the thigh, abdomen, or upper arm that are not tender, bruised, red, or indurated. Rotate injection sites for each administration.
- To administer the 300 mg dosage, give two 150 mg PRALUENT injections consecutively at two different injection sites.
Dosage Forms and Strengths
- Injection: 75 mg/mL or 150 mg/mL in a single-dose pre-filled pen
Contraindications
- History of a serious hypersensitivity reaction to alirocumab or any of the excipients in PRALUENT.
Warnings and Precautions
- Hypersensitivity reactions: hypersensitivity vasculitis, angioedema, and other hypersensitivity reactions requiring hospitalization, have been reported with PRALUENT treatment. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with PRALUENT, treat according to the standard of care, and monitor until signs and symptoms resolve.
Adverse Reactions
- Common (>5% of patients treated with PRALUENT and more frequently than placebo) adverse reactions in adults with: Primary hyperlipidemia: injection site reactions, and influenza. (6) Established cardiovascular disease: myalgia.
Now that we’ve covered the basic monograph information for Praluent, let’s take a closer look at how it is currently recommended in various clinical practice guidelines.
Specific Inclusions of Alirocumab in the Guidelines
- Management of Patients with Chronic Coronary Disease
- American College of Cardiology/American Heart Association
- Publication: July 18, 2023
- The ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment with Alirocumab) trial evaluated alirocumab use in patients with an ACS event 1 to 12 months earlier on maximal statin with or without ezetimibe. Cardiovascular events were significantly reduced by 15% with alirocumab, especially in those with additional high-risk clinical factors.
- Role of Nonstatin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk
- American College of Cardiology
- Publication: August 25, 2022
- Patients with ASCVD were categorized into 1 of 2 groups: not at very high risk or at very high risk. Very high-risk patients have a history of multiple major ASCVD events or 1 major ASCVD event and multiple high-risk conditions. Based on evidence from IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial), FOURIER, and ODYSSEY Outcomes, this very high-risk group of patients has demonstrated cardiovascular benefits from the addition of ezetimibe, evolocumab, and alirocumab.
- Lipid Management in Patients with Endocrine Disorders
- Endocrine Society
- Publication: September 18, 2020
- For additional LDL-C reduction in patients taking a statin, subcutaneous injection (every 2 weeks or once a month) of monoclonal antibodies to PCSK-9 (alirocumab and evolocumab) may be used either with the statin or with the statin plus ezetimibe. These medications block the effects of PCSK9 (a proprotein convertase) on degradation of LDL receptors in the liver. They are indicated as adjunct to diet, and either alone or in combination with other lipid lowering medications, for reducing CV events in people with ASCVD, and for reducing LDL-C in patients with FH (eg, heterozygous FH). Evolocumab also has an indication as adjunct to diet and lipid-lowering medications for treatment of homozygous FH. The cost of PCSK9 inhibitors may be prohibitive for some patients.
- Management of Blood Cholesterol
- American College of Cardiology/American Heart Association
- Publication: November 10, 2018
- Patients with clinical ASCVD who are judged to be very high risk include those with a history of multiple major ASCVD events or 1 major ASCVD event and multiple high-risk conditions. In these patients, additional net benefit from further LDL-C lowering when LDL-C is ≥70 mg/dL (≥1.8 mmol/L) or non–HDL-C ≥100 mg/dL (≥2.6 mmol/L) by ezetimibe and 2 PCSK9 inhibitors (evolocumab and alirocumab) has been demonstrated by 3 RCTs.
This concludes our Guidelines+ Monographs for alirocumab (Praluent). This list is current as of December 2024 and may be updated over time as new indications are approved and/or new guidelines published or updated. Sign up for alerts and stay informed on the latest published guidelines and articles.
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