Evolocumab Injection
Evolocumab is an injectable cholesterol-lowering medicine used to reduce LDL ('bad') cholesterol in adults and children with certain cholesterol conditions, and to lower the risk of serious cardiovascular events in adults at increased risk.
🧬 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 1 clinical label set 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 →
📖 Evolocumab Injection: Patient Information Guide
A plain-language walkthrough of Evolocumab 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▾
Evolocumab injection (brand: Repatha) is approved for several cholesterol-related and cardiovascular conditions:
- Cardiovascular risk reduction: Repatha is used in adults at increased risk to reduce the chance of major cardiovascular events, including heart attack, stroke, unstable angina requiring hospitalization, coronary revascularization procedures, and cardiovascular death.
- High cholesterol (hypercholesterolemia): Repatha is used alongside diet and exercise to lower LDL ('bad') cholesterol in adults.
- Heterozygous familial hypercholesterolemia (HeFH): Repatha is approved for adults and children aged 10 and older with this inherited cholesterol condition, used with diet and other LDL-lowering therapies.
- Homozygous familial hypercholesterolemia (HoFH): Repatha is approved for adults and children aged 10 and older with this more severe inherited cholesterol condition, used with diet and other LDL-lowering therapies.
⚙️How it works▾
Your liver removes LDL cholesterol from your blood using special receptors on its surface. A protein called PCSK9 normally destroys those receptors, reducing the liver's ability to clear LDL. Evolocumab is a monoclonal antibody — a targeted protein drug — that binds to PCSK9 and blocks it from breaking down those receptors. With more receptors available, the liver pulls more LDL out of the bloodstream, lowering your cholesterol levels.
💊How it's taken▾
Repatha is given as an under-the-skin (subcutaneous) injection, either every two weeks or once a month, depending on the condition being treated and your prescriber's guidance. It does not need to be taken with food. If refrigerated, let Repatha warm to room temperature for at least 30 minutes before injecting.
- Inject into the abdomen, thigh, or upper arm — rotate sites each time.
- If you miss a dose within 7 days, inject it and resume your original schedule; if it's been more than 7 days, follow the missed-dose instructions on the label or ask your pharmacist.
- Your LDL levels can be checked as early as 4 weeks after starting treatment.
🤒Side effects — in detail▾
Most people tolerate Repatha well. The most common side effects include:
- Nasopharyngitis (cold symptoms)
- Upper respiratory tract infection
- Influenza (flu)
- Back pain
- Injection site reactions — redness, pain, or bruising where you inject
- Headache
- Muscle pain or spasms
- Cough
- Diarrhea or gastroenteritis (stomach upset)
More serious reactions are rare but important: if you develop swelling of the face, lips, tongue, or throat, hives, or trouble breathing, stop using Repatha and get emergency medical help right away — these are signs of a serious allergic reaction called angioedema.
⚠️Warnings & precautions▾
- Serious allergic reactions (including angioedema): Repatha can cause severe allergic reactions. Swelling of the face or throat, hives, or difficulty breathing require immediate medical attention. Anyone who has had a serious allergic reaction to evolocumab or any Repatha ingredient must not use this medication.
- Latex sensitivity: Some Repatha autoinjectors and syringes contain dry natural rubber (derived from latex) in the needle cover. If you have a latex allergy, tell your prescriber — a latex-free version is available.
🔀What it interacts with▾
The FDA label for Repatha identifies limited drug interactions. There is one interaction of note:
- High-intensity statins (e.g., atorvastatin, rosuvastatin at high doses): Taking Repatha alongside a high-intensity statin reduces evolocumab levels slightly, but this difference is not considered clinically meaningful — both medications can be used together as prescribed.
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 evolocumab: Do not use Repatha if you have had a serious hypersensitivity reaction to evolocumab or any Repatha ingredient — this is a contraindication.
- Latex allergy: Tell your doctor or pharmacist — some Repatha devices contain natural rubber latex in the needle cover.
- Pregnancy: There is not enough data to fully assess the risk to a developing baby. Evolocumab crosses the placenta. Discuss the risks and benefits with your doctor if you are pregnant or planning to become pregnant. Healthcare providers should report Repatha exposure during pregnancy to Amgen.
- Breastfeeding: It is unknown whether evolocumab passes into breast milk. Discuss with your doctor whether to continue breastfeeding while using Repatha.
- Children under 10: Repatha's safety and effectiveness have not been established in children younger than 10, or in children with cholesterol conditions other than HeFH or HoFH.
- Older adults: No meaningful differences in safety or effectiveness were found in patients 65 and older compared to younger adults, though individual sensitivity may vary.
- Liver impairment: Mild to moderate liver impairment results in lower evolocumab exposure, but no dose adjustment is recommended. No data exist for severe liver impairment.
- Kidney impairment: No dose adjustment is needed; kidney function does not meaningfully affect how the drug works.
📡Pharmacodynamics — effects in the body▾
After a subcutaneous injection, Repatha begins suppressing free PCSK9 protein in the blood within about 4 hours, reaching maximum suppression quickly. LDL cholesterol levels start to fall noticeably within 2 to 3 weeks of the first dose. The LDL-lowering effect is tied directly to evolocumab concentrations — when drug levels drop, PCSK9 activity and LDL levels begin to return toward where they started.
🔬Pharmacokinetics — how your body processes it▾
After a subcutaneous injection, evolocumab reaches peak blood levels in about 3 to 4 days, with approximately 72% of the dose absorbed. It has an effective half-life of 11 to 17 days, meaning it stays active in the body for nearly two weeks or longer. The drug is eliminated through two pathways: at lower concentrations it binds to its PCSK9 target (which becomes saturated), and at higher concentrations it is broken down through the body's normal protein-degradation process. Steady drug levels in the blood are reached by about 12 weeks of regular dosing. Age, sex, race, and kidney function do not meaningfully change how the body handles evolocumab; body weight has a modest effect that is not considered clinically significant.
📦How to store it▾
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze.
📄 Written from Evolocumab 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 Evolocumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Repatha used for? ▾
How do I give myself this injection, and does it hurt? ▾
What side effects should I actually watch for? ▾
Can I still take my statin while using Repatha? ▾
Is Repatha safe to use during pregnancy or while breastfeeding? ▾
What if I miss a dose? ▾
Is Evolocumab Injection available over the counter? ▾
When was Evolocumab Injection first available? ▾
Who makes Evolocumab Injection? ▾
💬 Answers drafted from Evolocumab 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 Evolocumab Injection comes
Evolocumab 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
- Repatha is used to reduce the risk of heart attack, stroke, unstable angina requiring hospitalization, coronary procedures, and cardiovascular death in adults at increased cardiovascular risk
- Repatha is used alongside diet and exercise to lower LDL cholesterol in adults with hypercholesterolemia
- Repatha is used to lower LDL cholesterol in adults and children aged 10 and older with heterozygous familial hypercholesterolemia (HeFH) or homozygous familial hypercholesterolemia (HoFH)
- Repatha is injected subcutaneously (under the skin) into the abdomen, thigh, or upper arm — avoid areas that are tender, bruised, red, or scarred, and rotate injection sites each time
- Repatha should be warmed to room temperature for at least 30 minutes if it has been refrigerated before injecting
- Repatha is available as prefilled single-dose SureClick autoinjectors and prefilled single-dose syringes; some presentations contain dry natural rubber (latex) in the needle cover — ask for a latex-free option if needed
- Repatha doses of 420 mg can be given as three consecutive injections completed within 30 minutes using the prefilled pen, SureClick autoinjector, or prefilled syringe
📊 Evolocumab Injection across the U.S. market
How Evolocumab 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 Evolocumab Injection is used
A general measure of how commonly Evolocumab 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 Evolocumab 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 Evolocumab Injection prescribed? Of the 1,596 medications we measure, Evolocumab Injection ranks #347 by Medicaid prescriptions — more than 78% of them.
Utilization by Evolocumab 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 evolocumab 140 MG/ML Auto-Injector Most dispensed
Summed across the 2 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1665895
1 ML evolocumab 140 MG/ML Prefilled Syringe
Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1665904
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 Evolocumab 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 4 of 10 listed Evolocumab Injection NDCs with Medicaid activity.
🔍 Compare Evolocumab Injection products
A representative set of FDA-listed product records for Evolocumab 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 | ||||
| 140 mg/mL | Subcutaneous | Amgen Inc × 4 listings | BLA | View NDC → |
| 140 mg/mL | Subcutaneous | Amgen USA Inc. × 23 listings | BLA | View NDC → |
| 140 mg/mL | — | Patheon Italia S.p.A. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 420 mg/3.5 mL | — | Patheon Italia S.p.A. | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 29 of 29 products — FDA National Drug Code Directory. See every product, package size and price: browse all 29 Evolocumab 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 Evolocumab 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 Evolocumab 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 Evolocumab 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 1665684 3 dose forms · 3 strengths
-
Dose form (SCDF) Auto-Injector RxCUI 1665894In current FDA listingsClinical drug / strength (SCD) 1 ML evolocumab 140 MG/MLRxCUI 1665895 -
Dose form (SCDF) Cartridge RxCUI 1801318No current FDA listingClinical drug / strength (SCD) 3.5 ML evolocumab 120 MG/MLRxCUI 1801319 -
Dose form (SCDF) Prefilled Syringe RxCUI 1665903No current FDA listingClinical drug / strength (SCD) 1 ML evolocumab 140 MG/MLRxCUI 1665904
Look up RxCUI 1665684 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 Evolocumab 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
RxNorm drug class
Evolocumab Injection belongs to the PCSK9 Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 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 1 FDA-filed SPL label set 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. Amgen USA Inc. 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.