Praluent (Alirocumab)
PCSK9 Inhibitor for High Cholesterol & Cardiovascular Risk Reduction
Quick Facts About Praluent
Key Takeaways About Praluent
- Powerful cholesterol reduction: Praluent lowers LDL cholesterol by 45–60% when added to statin therapy, significantly exceeding what statins achieve alone
- Proven cardiovascular benefit: The ODYSSEY OUTCOMES trial showed a 15% reduction in major cardiovascular events in high-risk patients
- Self-administered at home: Praluent is injected under the skin using an easy-to-use pre-filled pen every 2 or 4 weeks
- Well tolerated: The most common side effects are mild injection site reactions and upper respiratory symptoms; serious side effects are rare
- For statin-intolerant patients: Praluent can be used alone when patients cannot tolerate statins, offering an effective alternative for cholesterol management
What Is Praluent and What Is It Used For?
Praluent (alirocumab) is a monoclonal antibody that targets the PCSK9 protein, increasing the liver's ability to remove LDL cholesterol from the blood. It is prescribed for adults and children aged 8 and older with high cholesterol, and for adults with cardiovascular disease to reduce the risk of heart attack, stroke and unstable angina.
Praluent contains the active substance alirocumab, a fully human monoclonal antibody. Monoclonal antibodies are specialized proteins designed to recognize and bind to specific target substances in the body. Alirocumab binds to a protein called PCSK9 (proprotein convertase subtilisin/kexin type 9), which plays a central role in cholesterol regulation.
Under normal circumstances, PCSK9 is secreted by liver cells and attaches to LDL receptors on the liver surface. These receptors act as “docking stations” that capture and remove LDL cholesterol from the bloodstream. When PCSK9 binds to these receptors, it causes them to be broken down, reducing the liver's capacity to clear LDL cholesterol. By blocking PCSK9, alirocumab prevents this receptor destruction, thereby increasing the number of active LDL receptors and significantly lowering blood levels of LDL cholesterol.
In clinical trials, Praluent has demonstrated the ability to reduce LDL cholesterol by approximately 45–60% from baseline when used in combination with maximally tolerated statin therapy. This level of reduction is particularly important for patients who remain at high cardiovascular risk despite conventional treatment.
Approved indications
Praluent is approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for the following uses:
- Primary hypercholesterolemia and mixed dyslipidemia in adults: Including heterozygous familial hypercholesterolemia (HeFH) and non-familial hypercholesterolemia, when diet and maximally tolerated statin therapy do not achieve adequate LDL-C reduction
- Heterozygous familial hypercholesterolemia in children and adolescents aged 8 and older: When diet and statin therapy are insufficient
- Cardiovascular risk reduction in adults: In patients with established atherosclerotic cardiovascular disease, to reduce the risk of myocardial infarction, stroke and unstable angina requiring hospitalization
Praluent is given together with a statin (or statin plus other lipid-lowering therapies) when maximum statin doses are insufficient. It can also be given alone or with other lipid-lowering medicines when statins cannot be used or are not tolerated. Patients should continue following a cholesterol-lowering diet throughout treatment.
Statins work by blocking the enzyme HMG-CoA reductase in the liver, reducing cholesterol production. Praluent works through an entirely different mechanism – by blocking PCSK9, it increases the number of LDL receptors available to clear cholesterol from the blood. This complementary action is why the two drug classes are often used together for maximum effect. For patients who cannot tolerate statins (due to muscle pain or other side effects), Praluent offers a powerful alternative.
What Should You Know Before Taking Praluent?
Do not use Praluent if you are allergic to alirocumab or any of its excipients. Tell your doctor about any kidney or liver disease before starting treatment. Praluent is not recommended during pregnancy or breastfeeding. Serious allergic reactions, though rare, have been reported.
Before starting Praluent, your healthcare provider will evaluate your overall health status, current medications, and treatment goals. Several important factors should be considered to ensure the safe and effective use of this medication.
Contraindications
Praluent must not be used if you have a known allergy (hypersensitivity) to alirocumab or any of the inactive ingredients in the formulation, including histidine, sucrose, polysorbate 20, and water for injections. If you have experienced a previous allergic reaction to Praluent, do not use it again.
Warnings and Precautions
Inform your doctor before using Praluent if you have any of the following conditions:
- Kidney disease: Praluent has been studied in only a limited number of patients with severe kidney impairment. Your doctor may need to monitor your kidney function more closely
- Liver disease: Praluent has not been studied in patients with severe hepatic impairment. Use with caution and only under close medical supervision
Serious allergic reactions have been reported in some patients using Praluent, including hypersensitivity, angioedema (swelling of the face, lips, throat or tongue), nummular eczema (coin-shaped red patches, sometimes with blisters), and allergic vasculitis (inflammation of blood vessels with symptoms such as diarrhea, rash or purplish skin spots). If you develop any signs of a serious allergic reaction, stop using Praluent immediately and seek emergency medical attention.
Children and Adolescents
Praluent is approved for use in children and adolescents aged 8 years and older with heterozygous familial hypercholesterolemia. It should not be used in children under 8 years of age, as there is no clinical experience in this age group. For adolescents aged 12 and older, Praluent should be administered by or under the supervision of an adult. For children under 12, a caregiver should administer the injection.
Pregnancy and Breastfeeding
Praluent is not recommended during pregnancy or breastfeeding. There is limited data on the use of alirocumab in pregnant women, and it is not known whether the drug passes into breast milk. If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your healthcare provider before using this medicine. Women of childbearing potential should use effective contraception during treatment.
Driving and Operating Machinery
Praluent is not expected to affect your ability to drive or operate machinery. No studies on this topic have shown any impairment.
How Does Praluent Interact with Other Drugs?
Praluent has no known clinically significant drug interactions. It is commonly used alongside statins and other lipid-lowering therapies. Always inform your healthcare provider about all medications you are taking, including over-the-counter medicines and supplements.
Because alirocumab is a monoclonal antibody, it is not metabolized by liver cytochrome P450 enzymes, which are responsible for processing most conventional drugs. This means Praluent has a low potential for pharmacokinetic drug-drug interactions. However, it is important to tell your doctor about all medications you use to ensure proper monitoring and dose adjustment.
| Drug / Drug Class | Interaction Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Statins (atorvastatin, rosuvastatin, etc.) | Complementary effect | Additive LDL-C lowering | Standard combination; no dose adjustment needed |
| Ezetimibe | Complementary effect | Additional LDL-C lowering | Can be used together safely |
| Fibrates (fenofibrate, gemfibrozil) | No pharmacokinetic interaction | May be used for combined dyslipidemia | Can be used together; monitor lipid panel |
| Warfarin and other anticoagulants | No known interaction | No effect on coagulation parameters | No dose adjustment needed |
| Antihypertensives | No known interaction | No effect on blood pressure | No dose adjustment needed |
Statin therapy may influence the level of PCSK9 in the blood. Statins increase circulating PCSK9 levels as a compensatory response to their cholesterol-lowering effect. This is one reason why adding a PCSK9 inhibitor like Praluent to statin therapy produces such significant additional benefit – it counteracts the statin-induced PCSK9 increase. Your doctor may adjust your Praluent dose based on your LDL-C response when starting or changing statin therapy.
What Is the Correct Dosage of Praluent?
The standard starting dose for adults is 75 mg injected under the skin every two weeks. If LDL cholesterol reduction is insufficient, the dose may be increased to 150 mg every two weeks, or 300 mg every four weeks. Your doctor will determine the right dose based on your cholesterol levels and treatment response.
Always use Praluent exactly as your healthcare provider has instructed. The dose, frequency, and duration of treatment are individualized based on your cholesterol levels, cardiovascular risk profile, and treatment goals. Your doctor will monitor your LDL cholesterol levels regularly and may adjust the dose accordingly.
Adults
Standard Dosing for Adults
- Starting dose: 75 mg subcutaneously every 2 weeks (Q2W)
- Dose escalation: If additional LDL-C reduction is needed, increase to 150 mg Q2W
- Monthly alternative: 300 mg subcutaneously every 4 weeks (Q4W), administered as one 300 mg injection or two 150 mg injections at different sites
When the 300 mg dose is prescribed as two 150 mg injections, both injections should be given consecutively at two different injection sites (for example, one in each thigh). Your doctor will check your cholesterol levels 4–8 weeks after starting treatment or after any dose change to evaluate your response.
Children and Adolescents (8 years and older with HeFH)
Pediatric Dosing (Age 8+)
- Option 1: 75 mg subcutaneously every 2 weeks
- Option 2: 150 mg subcutaneously every 2 weeks (if greater LDL-C reduction needed)
- Option 3: 150 mg or 300 mg subcutaneously every 4 weeks
For adolescents aged 12 and older, injections should be given by or under the supervision of an adult. For children under 12 years, a caregiver must administer the injection.
How to Inject Praluent
Praluent is injected under the skin (subcutaneously) in the thigh, abdomen (avoiding the area within 5 cm of the navel), or the outer area of the upper arm. Before your first injection, your healthcare provider will demonstrate the proper technique. Key points to remember:
- Allow the pen to reach room temperature for 30–45 minutes before injection
- Check that the solution is clear, colorless to slightly yellow, and free of particles
- Clean the injection site with an alcohol swab
- Rotate injection sites with each injection
- Do not inject into skin that is tender, bruised, red, or hard
- After injection, dispose of the pen in a sharps container; do not replace the cap
Missed Dose
If you miss a dose, inject the missed dose as soon as possible. Then take your next dose at the regularly scheduled time. This will help you return to your original injection schedule. If you are unsure about when to inject your next dose, consult your healthcare provider.
Overdose
If you inject more Praluent than prescribed, contact your healthcare provider or seek medical advice. In clinical trials, no significant adverse effects were observed with doses up to 12 mg/kg administered intravenously. Treatment of overdose should be symptomatic and supportive.
If you stop using Praluent, your cholesterol levels may increase. Do not discontinue treatment without discussing it with your healthcare provider first. Consistent use is essential for maintaining the cardiovascular benefits of the medication.
What Are the Side Effects of Praluent?
The most common side effects of Praluent are injection site reactions (redness, itching, swelling, pain) and upper respiratory tract symptoms (sore throat, nasal congestion, sneezing). Serious allergic reactions are rare but require immediate medical attention. Most side effects are mild and resolve on their own.
Like all medicines, Praluent can cause side effects, although not everyone experiences them. The majority of reported side effects are mild to moderate in severity and do not require treatment discontinuation. Clinical trials involving over 6,000 patients have established the following safety profile.
Common
May affect up to 1 in 10 people
- Injection site reactions: redness, itching, swelling, pain or tenderness where the medicine is injected
- Upper respiratory tract symptoms: sore throat, nasal congestion, sneezing (signs of upper respiratory infection)
- Itching (pruritus) at sites other than the injection area
Rare
May affect up to 1 in 1,000 people
- Urticaria (hives) – red, itchy welts on the skin
- Hypersensitivity reactions including angioedema (swelling of face, lips, throat or tongue)
- Nummular eczema (coin-shaped red patches, sometimes with blisters)
- Allergic vasculitis (inflammation of blood vessels with diarrhea, rash or purplish skin spots)
Not Known Frequency
Reported after marketing; frequency cannot be estimated
- Influenza-like illness
- Difficulty breathing or swelling of face, lips, throat or tongue (angioedema)
Injection site reactions are the most frequently reported side effect, occurring in approximately 6–7% of patients in clinical trials. These reactions are typically mild, last only a few days, and do not require treatment discontinuation. Rotating the injection site with each dose can help minimize discomfort.
In the large-scale ODYSSEY OUTCOMES trial involving over 18,000 patients followed for a median of 2.8 years, the overall safety profile of alirocumab was comparable to placebo, with no significant increase in serious adverse events, liver enzyme elevations, or neurocognitive events.
Stop using Praluent and contact your doctor or seek emergency medical care immediately if you experience signs of a serious allergic reaction: difficulty breathing, swelling of the face, lips, tongue or throat, severe skin rash with blistering, or dizziness and feeling faint. These reactions are very rare but can be life-threatening.
How Should You Store Praluent?
Store Praluent in a refrigerator (2°C to 8°C). Do not freeze. If needed, individual pens may be stored at room temperature (up to 25°C) for up to 30 days, protected from light. Do not use after the expiration date or if the solution appears discolored, cloudy, or contains particles.
Proper storage is essential to maintain the effectiveness and safety of Praluent. The medication is a biological product that must be handled carefully to preserve its integrity.
- Refrigerate: Store at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light
- Do not freeze: If the pen has been frozen, do not use it
- Room temperature storage: If necessary, individual pens may be kept at up to 25°C (77°F), protected from light, for a single continuous period of up to 30 days. Once removed from refrigeration, use within 30 days or discard
- Before injection: Allow the pen to reach room temperature for 30–45 minutes. Do not heat it artificially (do not use a microwave or warm water)
- Inspect before use: Check that the solution is clear, colorless to slightly yellow, and free of flakes or particles. Do not use if the solution appears discolored or cloudy
- Keep out of reach of children
- After use: Dispose of the pen in a sharps container. Do not dispose of in household waste or sewage
What Does Praluent Contain?
Praluent contains the active substance alirocumab (a human monoclonal antibody) and excipients including histidine, sucrose, polysorbate 20, and water for injections. It is available as 75 mg, 150 mg, and 300 mg pre-filled pens.
The active substance in Praluent is alirocumab, a fully human IgG1 monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Each pen delivers a precise dose of alirocumab in a clear, colorless to slightly yellow solution.
Available Strengths and Presentations
| Strength | Volume | Pen Type | Pack Sizes |
|---|---|---|---|
| 75 mg | 1 mL | Green button pen or button-free pen | 1, 2, 3 or 6 pens |
| 150 mg | 1 mL | Grey button pen or button-free pen | 1, 2, 3 or 6 pens |
| 300 mg | 2 mL | Button-free pen | 1 or 3 pens |
Inactive Ingredients (Excipients)
- Histidine: Buffer to maintain pH stability
- Sucrose: Stabilizer to protect the protein structure
- Polysorbate 20: Surfactant to prevent protein aggregation
- Water for injections: Solvent
Not all pack sizes or strengths may be available in every market. Your pharmacist can advise you on which presentations are available in your region.
Frequently Asked Questions About Praluent
Praluent (alirocumab) is primarily used to lower high LDL (“bad”) cholesterol in adults and children aged 8 and older with hypercholesterolemia when diet and maximum statin therapy are not sufficient. It is also prescribed to reduce the risk of heart attack, stroke and unstable angina in adults with established cardiovascular disease. Praluent works by blocking the PCSK9 protein, which allows the liver to remove more LDL cholesterol from the blood.
Praluent is given as a subcutaneous (under the skin) injection using a pre-filled pen. After training from a healthcare professional, patients can self-administer at home. The injection can be given in the thigh, abdomen (avoiding the area near the navel), or the outer area of the upper arm. The pen should be allowed to warm to room temperature for 30–45 minutes before injection.
The most common side effects include injection site reactions (redness, itching, swelling, pain or tenderness), upper respiratory tract infections (sore throat, nasal congestion, sneezing), and general itching. These side effects are generally mild to moderate and tend to resolve on their own without treatment. Serious allergic reactions are very rare but can occur – seek immediate medical attention if you experience difficulty breathing, swelling of the face, lips, or throat.
In clinical trials, Praluent reduced LDL cholesterol by approximately 45–60% from baseline when used in combination with statins. The landmark ODYSSEY OUTCOMES trial, involving over 18,000 patients with recent acute coronary syndrome, demonstrated that alirocumab reduced the composite endpoint of major cardiovascular events (coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or hospitalization for unstable angina) by 15% compared to placebo.
Praluent is not recommended during pregnancy or breastfeeding. There is limited data on the use of alirocumab in pregnant women, and it is not known whether it passes into breast milk. Women who are pregnant, may be pregnant, or are planning to become pregnant should consult their healthcare provider before starting or continuing Praluent. Effective contraception is recommended during treatment.
Praluent and statins both lower LDL cholesterol but through different mechanisms. Statins inhibit HMG-CoA reductase, reducing cholesterol production in the liver. Praluent is a PCSK9 inhibitor that increases the number of LDL receptors on liver cells, allowing more LDL cholesterol to be cleared from the blood. The two are often used together because their mechanisms are complementary. Praluent is particularly valuable for patients who cannot tolerate statins or who need additional LDL-C lowering beyond what statins alone can achieve.
References
- Schwartz GG, Steg PG, Szarek M, et al. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. N Engl J Med. 2018;379(22):2097-2107. doi:10.1056/NEJMoa1801174
- European Medicines Agency (EMA). Praluent (alirocumab) – Summary of Product Characteristics. Last updated 2025.
- U.S. Food and Drug Administration (FDA). Praluent (alirocumab) – Prescribing Information. Revised 2025.
- Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020;41(1):111-188. doi:10.1093/eurheartj/ehz455
- Robinson JG, Farnier M, Krempf M, et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015;372(16):1489-1499. doi:10.1056/NEJMoa1501031
- Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. Circulation. 2019;139(25):e1082-e1143.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023.
- Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017;376(18):1713-1722. [Comparative PCSK9 inhibitor data]
Medical Editorial Team
This article has been written and reviewed by iMedic’s Medical Editorial Team, comprising specialists in cardiology, clinical pharmacology and lipidology. Our team follows international guidelines from the ESC, EMA, FDA and WHO, and adheres to the GRADE evidence framework to ensure the highest quality of medical information.
All medical claims are supported by peer-reviewed research and international guidelines. Evidence level: 1A – based on systematic reviews and randomized controlled trials.
iMedic receives no pharmaceutical company funding or advertising revenue. Our editorial content is completely independent and free from commercial influence.