Alirocumab Injection
Alirocumab injection (Praluent) is a cholesterol-lowering medication used to reduce LDL ('bad') cholesterol and lower the risk of serious cardiovascular events in adults and certain children.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Alirocumab Injection: Patient Information Guide
A plain-language walkthrough of Alirocumab Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Alirocumab injection (Praluent) is approved for the following uses:
- High cholesterol (hypercholesterolemia): Praluent lowers LDL-C in adults as an addition to diet and exercise.
- Heterozygous familial hypercholesterolemia (HeFH): Praluent lowers LDL-C in adults and in children aged 8 and older with this inherited cholesterol disorder.
- Homozygous familial hypercholesterolemia (HoFH): Praluent lowers LDL-C in adults with this more severe inherited form of high cholesterol.
- Reducing cardiovascular risk: Praluent reduces the risk of major adverse cardiovascular events — including coronary heart disease death, heart attack, stroke, and hospitalization for unstable angina — in adults at increased risk for these events.
⚙️How it works▾
Alirocumab is a monoclonal antibody (a lab-made protein designed to target one specific substance in the body). It works by blocking a protein called PCSK9. Under normal conditions, PCSK9 binds to LDL receptors on liver cells and causes those receptors to break down — meaning fewer receptors are available to pull LDL cholesterol out of your blood. By blocking PCSK9, alirocumab keeps more LDL receptors active, so your liver can clear more LDL cholesterol from your bloodstream, lowering your LDL levels.
💊How it's taken▾
Praluent is given as a subcutaneous injection (just under the skin) into the thigh, abdomen, or upper arm. Depending on the prescriber's choice and your specific condition, it is given either every two weeks or once every four weeks. It can be taken with or without food. If you miss a dose, follow these guidelines:
- If you remember within 7 days of the missed dose, inject it and continue your original schedule.
- If more than 7 days have passed, the approach depends on your dosing schedule — ask your prescriber or pharmacist exactly what to do.
Your doctor may check your LDL cholesterol levels as early as 4 weeks after you start to see how well it is working.
🤒Side effects — in detail▾
The most commonly reported side effects with Praluent include:
- Injection site reactions — redness, itching, swelling, or pain where the shot was given
- Influenza (flu symptoms)
- Diarrhea
- Myalgia (muscle aches)
- Muscle spasms
- Bruising (contusion)
More serious reactions — including severe allergic responses such as angioedema (swelling under the skin) and hypersensitivity vasculitis (blood vessel inflammation from an immune reaction) — have been reported. If you have signs of a serious allergic reaction, such as trouble breathing, facial swelling, or severe rash, stop the injection and get emergency help right away.
⚠️Warnings & precautions▾
- Serious allergic reactions: Praluent has caused hypersensitivity vasculitis, angioedema, and other severe allergic reactions that required hospitalization. Stop using it and seek immediate care if these occur.
- Contraindication: Do not use Praluent if you have ever had a serious allergic reaction to alirocumab or any ingredient in the product.
- Pregnancy: Alirocumab crosses the placenta, especially later in pregnancy. The full impact on a developing baby is not known. A pregnancy safety registry exists — if you become pregnant while taking Praluent, contact Regeneron at 1-844-734-6643.
- Immune effects in animal studies: In animal studies, immune suppression was seen in infant animals born to mothers given alirocumab; the relevance to humans is not fully established.
🔀What it interacts with▾
Based on the available evidence, alirocumab does not appear to meaningfully interact with common statin medications (such as atorvastatin or rosuvastatin) — their blood levels were not significantly changed by alirocumab. Alirocumab is broken down by the body as a protein, not through the liver's usual drug-processing enzymes, so typical drug interactions seen with many medications are not expected.
- Statins (e.g., atorvastatin, rosuvastatin): No clinically meaningful interaction with alirocumab was observed; statin blood levels were unchanged. Praluent's apparent half-life is modestly shorter when taken with a statin, but this is not considered clinically important.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Prior serious allergic reaction to alirocumab: Do not take Praluent if you have had a serious hypersensitivity reaction to it or any of its ingredients.
- Pregnancy: Tell your doctor if you are pregnant or planning to become pregnant. Alirocumab crosses the placenta and the effects on babies are not fully known.
- Breastfeeding: It is unknown whether alirocumab passes into breast milk. Discuss the benefits and risks with your doctor.
- Children under 8: Praluent's safety and effectiveness have not been established in children younger than 8 years of age, or in children with cholesterol conditions other than HeFH.
- Older adults (65+): No meaningful difference in safety or effectiveness was found in older patients, though individual sensitivity may vary.
- Severe kidney disease: No dose adjustment is needed for mild or moderate kidney impairment, but there is no data for severe kidney impairment.
- Severe liver disease: No dose adjustment is needed for mild or moderate liver impairment, but there is no data for severe liver impairment.
📡Pharmacodynamics — effects in the body▾
Alirocumab reduces the amount of free PCSK9 circulating in the blood in a dose-dependent way — meaning higher doses block more PCSK9. After a single subcutaneous injection, PCSK9 suppression reaches its peak within 4 to 8 hours. PCSK9 levels return toward baseline once alirocumab levels drop below detectable amounts, which is why consistent dosing is important to maintain the cholesterol-lowering effect.
🔬Pharmacokinetics — how your body processes it▾
After a subcutaneous injection, alirocumab reaches its peak blood concentration in about 3 to 7 days, with approximately 85% of the dose being absorbed. The medication is distributed primarily within the bloodstream. Because alirocumab is a protein, it is broken down into small peptides and amino acids rather than being processed through the liver's typical drug-metabolizing enzymes — so it does not meaningfully interact with most other drugs through those pathways. At steady state (reached after 2 to 3 doses), the typical half-life is 17 to 20 days, though this shortens modestly to about 12 days when taken alongside a statin — a difference not considered clinically important. Factors such as age, body weight, sex, race, and kidney function do not significantly affect how the body handles alirocumab.
📦How to store it▾
Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not freeze.
📄 Written from Alirocumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Alirocumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Praluent supposed to do for me? ▾
How do I give myself the injection, and does it hurt? ▾
What side effects should I expect, and which ones should I call my doctor about? ▾
What happens if I miss a dose? ▾
Can I take Praluent with my statin (like atorvastatin or rosuvastatin)? ▾
Is it safe to use Praluent if I'm pregnant or trying to get pregnant? ▾
Is Alirocumab Injection available over the counter? ▾
When was Alirocumab Injection first available? ▾
Who makes Alirocumab Injection? ▾
💬 Answers drafted from Alirocumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Alirocumab Injection comes
Alirocumab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Praluent is used to reduce LDL cholesterol in adults with hypercholesterolemia (high cholesterol) as an adjunct to diet and exercise
- Praluent is used to reduce LDL cholesterol in adults and children aged 8 and older with heterozygous familial hypercholesterolemia (HeFH)
- Praluent is used to reduce LDL cholesterol in adults with homozygous familial hypercholesterolemia (HoFH)
- Praluent is used to reduce the risk of major cardiovascular events — including heart attack, stroke, and coronary heart disease death — in adults at increased cardiovascular risk
- Praluent is injected subcutaneously (just under the skin) into the thigh, abdomen, or upper arm; rotate the injection site each time and avoid areas that are tender, bruised, red, or hard
- Praluent should be allowed to warm to room temperature for 30 to 40 minutes if it has been refrigerated before injecting
- Praluent solution should be clear and colorless to pale yellow; do not use it if it looks cloudy, discolored, or contains particles
- For children aged 8 to 11, a caregiver must administer Praluent; children aged 12 to 17 should have an adult present during administration
📊 Alirocumab Injection across the U.S. market
How Alirocumab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Alirocumab Injection is used
A general measure of how commonly Alirocumab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Alirocumab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Alirocumab Injection prescribed? Of the 1,596 medications we measure, Alirocumab Injection ranks #751 by Medicaid prescriptions — more than 53% of them.
Utilization by Alirocumab Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
1 ML alirocumab 75 MG/ML Auto-Injector Most dispensed
Summed across the 1 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1659182
1 ML alirocumab 150 MG/ML Auto-Injector
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1659156
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Alirocumab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 14 listed Alirocumab Injection NDCs with Medicaid activity.
🔍 Compare Alirocumab Injection products
A representative set of FDA-listed product records for Alirocumab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 150 mg/mL | — | Regeneron Pharmaceuticals, Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| 75 mg/mL | Subcutaneous | Regeneron Pharmaceuticals, Inc. × 3 listings | BLA | View NDC → |
| 150 mg/mL | Subcutaneous | Regeneron Pharmaceuticals, Inc. × 3 listings | BLA | View NDC → |
| 75 mg/mL | Subcutaneous | Sanofi-Aventis U.S. LLC × 4 listings | BLA | View NDC → |
| 150 mg/mL | Subcutaneous | Sanofi-Aventis U.S. LLC × 4 listings | BLA | View NDC → |
| 75 mg/mL | Subcutaneous | Sanofi US Corporation | BLA | View NDC → |
| 150 mg/mL | Subcutaneous | Sanofi US Corporation | BLA | View NDC → |
Showing 17 of 17 products — FDA National Drug Code Directory. See every product, package size and price: browse all 17 Alirocumab Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Alirocumab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Alirocumab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Alirocumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1659152 2 dose forms · 2 strengths
-
Dose form (SCDF) Auto-Injector RxCUI 1659155In current FDA listingsClinical drug / strength (SCD) 1 ML alirocumab 150 MG/MLRxCUI 16591561 ML alirocumab 75 MG/MLRxCUI 1659182 -
Dose form (SCDF) Prefilled Syringe RxCUI 1659164No current FDA listing
Look up RxCUI 1659152 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Alirocumab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Sanofi-Aventis U.S. LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.