Evolocumab

Pronunciation: ev-oh-LOK-yoo-mab.

Generic name
evolocumab
Drug class
PCSK9 inhibitor (monoclonal antibody)
Form
Pre-filled pen or syringe (140 mg/mL)
Route
Subcutaneous injection
Legal status
Prescription-only, specialist-initiated (cardiology/lipid clinic)

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia

Australia: Repatha (2) · Full directory

What evolocumab is and how it works

Evolocumab is a prescription-only injectable biologic (a PCSK9 inhibitor) used to lower LDL ('bad') cholesterol and reduce the risk of heart attack and stroke in people at increased cardiovascular risk. (1)

Evolocumab is given as an injection under the skin, either every 2 weeks or once a month, and is usually prescribed alongside a statin or for people who cannot tolerate statins. It does not replace diet, exercise, or other prescribed heart-health treatments.

Mechanism of action: how evolocumab works

Evolocumab is a fully human IgG2 monoclonal antibody that binds PCSK9, preventing it from degrading LDL receptors on liver cells -- this increases the liver's ability to clear LDL cholesterol from the blood. (1)

What evolocumab is used for

Reducing cardiovascular risk

Used in adults at increased risk to reduce the risk of major cardiovascular events -- cardiovascular death, heart attack, stroke, unstable angina requiring hospital admission, or a coronary revascularisation procedure. (1)

Lowering LDL cholesterol

Used alongside diet and exercise to lower LDL cholesterol in adults, and in adults and children aged 10 and older with heterozygous familial hypercholesterolemia (HeFH) or homozygous familial hypercholesterolemia (HoFH), inherited conditions that cause very high cholesterol. (1)

Before taking evolocumab

Do not take / not appropriate for

  • Do not use evolocumab if you have had a serious allergic reaction to evolocumab or any of its ingredients. (all countries) (1)

Tell your clinician about

  • Any previous allergic reaction to evolocumab or a similar injectable medicine.
  • A latex allergy -- some presentations' needle covers contain a latex derivative.
  • All other medicines you take, including statins.
  • Pregnancy, plans for pregnancy, or breastfeeding.
  • Any kidney or liver problems.
(1)

How to take evolocumab

  • Evolocumab is injected under the skin (subcutaneously) into the abdomen, thigh, or upper arm -- your care team will show you or a caregiver how to do this safely if you inject it yourself.
  • Rotate the injection site each time and avoid skin that is tender, bruised, red, hardened, scarred, or has stretch marks.
  • If refrigerated, let the pen or syringe warm to room temperature for at least 30 minutes before injecting.
  • Check that the solution is clear to slightly opalescent and colorless to pale yellow -- do not use it if it looks cloudy, discolored, or has particles in it.
  • The 420 mg dose requires three separate injections given within 30 minutes of each other.
(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4)

Missed dose

If you are within 7 days of your scheduled dose, give the injection as soon as possible and then continue your original schedule. If you are more than 7 days late on the every-2-weeks schedule, wait for your next scheduled dose. If you are more than 7 days late on the monthly schedule, give the dose now and start a new monthly schedule from that date. Contact your prescriber if you are unsure.

Overdose

Contact your prescriber or seek medical advice if you think too much evolocumab has been given. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Cold-like symptoms (nasopharyngitis) and upper respiratory tract infections.

What to notice: Cold-like symptoms (nasopharyngitis) and upper respiratory tract infections.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Flu-like symptoms and back pain.

What to notice: Flu-like symptoms and back pain.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Injection site reactions such as redness, pain, or bruising.

What to notice: Injection site reactions such as redness, pain, or bruising.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

In children with HeFH: headache and sore throat.

What to notice: In children with HeFH: headache and sore throat.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Signs of a serious allergic reaction (angioedema) — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing; widespread rash or hives.

Action: Seek emergency medical help immediately and ask the prescriber about stopping $1; your prescriber will decide whether it is safe to continue. (1)

Interactions

  • Taking a high-intensity statin alongside evolocumab slightly lowers evolocumab levels in the blood, but this is not considered a meaningful interaction and no dose change is generally needed. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

There is not enough human data to know the exact risk in pregnancy. Evolocumab does cross the placenta. Animal studies did not show harm at much higher exposures than used in humans. Tell your prescriber if you are pregnant or planning pregnancy; exposures during pregnancy can be reported to Amgen (1-800-77-AMGEN). (1) (2) (3) (4)

Breastfeeding

There is no data on whether evolocumab passes into human breast milk. Antibody medicines like this one do not generally pass into an infant's bloodstream in meaningful amounts via milk, but you and your prescriber should decide together whether to use it while breastfeeding. (1) (2) (3) (4)

Children

Approved for HeFH and HoFH in children aged 10 years and older, at the same dose as adults; not established for other uses in children. (1) (2) (3) (4)

Elderly

No specific dose adjustment based on age alone is described in the source reviewed. (1) (2) (3) (4)

Hepatic_impairment

Not established in the source reviewed for this dossier. (1) (2) (3) (4)

Renal_impairment

Not established in the source reviewed for this dossier. (1) (2) (3) (4)

Monitoring

Before starting

  • Cholesterol/lipid levels
  • Allergy history, including to injectable medicines and latex
  • Current statin or other lipid-lowering therapy

During treatment

  • Periodic cholesterol/lipid level checks to assess response.
  • Watch for signs of an allergic reaction after each injection.
(1)

Storage

Refrigerate at 36-46°F (2-8°C) in the original carton. May be kept at room temperature (68-77°F / 20-25°C) for up to 30 days if needed. Do not freeze. Do not shake. Keep out of the reach of children.

Study the drug class: PCSK9 inhibitors

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information and UK SmPC; verify against the current full label before prescribing.

United States

Indication: CV risk reduction / hypercholesterolemia / HeFH / HoFH

Dose summary: 140 mg SC every 2 weeks or 420 mg SC once monthly (clinically equivalent regimens); pediatric HeFH/HoFH 10+ years same dosing as adults. HoFH: initial 420 mg monthly, may increase to 420 mg every 2 weeks after 12 weeks if inadequate response; apheresis patients may start 420 mg every 2 weeks post-apheresis. 420 mg dose = 3 separate injections within 30 minutes.

Renal context: Not established in the source reviewed for this dossier. (1)

Mechanism of action

Hepatic guidance

Not established in the source reviewed for this dossier.

Overdose note

No specific antidote described in the source reviewed; manage supportively and seek prescriber guidance for suspected overdose. (1)

Frequently asked questions

Is evolocumab (Repatha) available in the US, UK, Europe, Canada, Australia, and New Zealand?

It is approved and available as Repatha in the US, UK, all EU countries, Canada, and Australia. In New Zealand, the funding body Pharmac has declined to publicly fund it, so it may only be accessible privately even where legally available -- check with a local prescriber or pharmacist for current access. (1) (2) (3) (4)

Is evolocumab a statin?

No. Evolocumab is a different type of cholesterol-lowering medicine called a PCSK9 inhibitor, given by injection. It is often prescribed alongside a statin, or for people who cannot tolerate statins. (1)

What should I do if I miss a dose of evolocumab?

If you are within 7 days of your scheduled dose, give it as soon as you remember and then continue your original schedule. If you are more than 7 days late on the every-2-weeks schedule, wait for your next scheduled dose. If you are more than 7 days late on the monthly schedule, give the dose now and start a new monthly schedule counting from that date. (1)

What is the mechanism of action of evolocumab?

Evolocumab is a fully human IgG2 monoclonal antibody that binds PCSK9, preventing it from degrading LDL receptors on liver cells -- this increases the liver's ability to clear LDL cholesterol from the blood. (1)

What is the generic name of Evolocumab?

The generic name is evolocumab. (1)

What class of drug is evolocumab?

Evolocumab is classed as: PCSK9 inhibitor (monoclonal antibody). (1)

References

  1. REPATHA (evolocumab) injection -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Amgen Inc. · United States · accessed 2026-07-29 · source 1
  2. Repatha (evolocumab) EU/Canada/Australia approval historyAmgen corporate press releases; TGA (Australia) product registration record · European Union / Canada / Australia · accessed 2026-07-29 · source 2
  3. Repatha SureClick -- Summary of Product Characteristics (SmPC)electronic medicines compendium (emc), United Kingdom -- Amgen Ltd · United Kingdom · accessed 2026-07-29 · source 3
  4. Pharmac funding application status for evolocumabPharmac (New Zealand government medicines funder) application tracker, via secondary search summary (direct page fetch failed -- JS-rendered) · New Zealand · accessed 2026-07-29 · source 4

Brand names by country

Single-ingredient evolocumab names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • REPATHA140 mg/mL · amgen usa inc.

United Kingdom

  • Repatha SureClick (3)MHRA marketing authorisation emc smpc confirmed · 140 mg · Amgen Ltd

Canada

  • REPATHA

Australia

  • Repatha (2)TGA ARTG registered 2015-12-09 · 140 mg/mL · Amgen Australia Pty Ltd
View brands in additional countries.

European Union

Repatha (2)

This page provides general reference information about evolocumab and is not a substitute for advice from the prescriber managing your treatment. Evolocumab is a specialist-initiated medicine; all dosing and treatment decisions should be made with your prescriber.

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