Alirocumab

Pronunciation: al-ir-OH-kyoo-mab.

Generic name
alirocumab
Drug class
PCSK9 inhibitor (monoclonal antibody)
Form
Pre-filled pen (75 mg, 150 mg, 300 mg)
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: Praluent (4) · Full directory

What alirocumab is and how it works

Alirocumab 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)

Alirocumab is given as an injection under the skin every 2 or 4 weeks, usually 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 alirocumab works

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

What alirocumab is used for

Reducing cardiovascular risk

Used in adults at increased risk to reduce the risk of major cardiovascular events, including heart attack, stroke, and unstable angina requiring hospital admission. (1)

Lowering LDL cholesterol

Used alongside diet and exercise to lower LDL cholesterol in adults, including those with heterozygous familial hypercholesterolemia (HeFH) or homozygous familial hypercholesterolemia (HoFH), and in children aged 8 and older with HeFH. (1)

Before taking alirocumab

Do not take / not appropriate for

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

Tell your clinician about

  • Any previous allergic reaction to alirocumab or a similar injectable medicine.
  • All other medicines you take, including statins.
  • Pregnancy, plans for pregnancy, or breastfeeding.
  • If the medicine is for a child, their exact weight (dosing is weight-based for children).
(1)

How to take alirocumab

  • Alirocumab is injected under the skin (subcutaneously) into the abdomen, thigh, or upper arm.
  • Rotate the injection site each time.
  • If refrigerated, let the pen warm to room temperature for 30-40 minutes before injecting.
  • The 300 mg dose may be given as one 300 mg injection or as two separate 150 mg injections at different sites.
(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 it has been longer than 7 days, contact your prescriber for guidance.

Overdose

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

Side effects

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

Injection site reactions such as redness, itching, swelling, or pain.

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

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

Flu-like symptoms.

What to notice: Flu-like symptoms.

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

Muscle pain.

What to notice: Muscle pain.

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

Serious warnings

Signs of a serious allergic reaction — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash, hives, or skin blood vessel inflammation.

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

  • No clinically meaningful interaction has been found between alirocumab and statins. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

There is not enough human data to know the exact risk in pregnancy. Animal studies at high exposures showed effects on the immune system of infant primates. Tell your prescriber if you are pregnant or planning pregnancy; exposures during pregnancy can be reported to a pregnancy registry (1-844-734-6643). (1) (2) (3) (4)

Breastfeeding

Antibody medicines like this one are present in breast milk but are generally expected to be absorbed only in limited amounts by a breastfeeding infant. Discuss with your prescriber. (1) (2) (3) (4)

Children

Approved for HeFH in children aged 8 years and older, with weight-based dosing; 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 to injectable medicines
  • Current statin or other lipid-lowering therapy

During treatment

  • Cholesterol/lipid levels may be checked as early as 4 weeks after starting, to assess response.
  • Watch for signs of an allergic reaction after each injection.
(1)

Storage

Refrigerate at 36-46°F (2-8°C). May be kept at room temperature (up to 77°F / 25°C) for a maximum of 30 days. 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: Adults: 75 mg SC every 2 weeks or 300 mg every 4 weeks; may increase to 150 mg every 2 weeks. HoFH/apheresis: 150 mg every 2 weeks. Pediatric HeFH (8+ years): <50kg 150mg every 4 weeks (may adjust to 75mg every 2 weeks); >=50kg 300mg every 4 weeks (may adjust to 150mg every 2 weeks). Assess LDL-C as early as 4 weeks after starting.

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 alirocumab (Praluent) available in the US, UK, Europe, Canada, and Australia?

Yes, it is approved in all of these regions. New Zealand-specific approval was not found in this research and should be confirmed locally. (1) (2) (3) (4)

Is alirocumab the same as evolocumab (Repatha)?

No. Both are PCSK9 inhibitors and work similarly, but they are different specific medicines from different manufacturers, with their own dosing schedules and prescribing details. (1)

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

If you are within 7 days of your scheduled dose, give it as soon as you remember and then resume your normal injection schedule. If more than 7 days have passed, contact your prescriber or pharmacist for guidance on when to give your next dose. (1)

What is the mechanism of action of alirocumab?

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

What is the generic name of Alirocumab?

The generic name is alirocumab. (1)

What class of drug is alirocumab?

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

References

  1. PRALUENT (alirocumab) injection -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Regeneron Pharmaceuticals, Inc. · United States · accessed 2026-07-29 · source 1
  2. Praluent (alirocumab) EU and global approval historyRegeneron/Sanofi corporate press releases · European Union / Canada · accessed 2026-07-29 · source 2
  3. Praluent 75mg/150mg/300mg solution for injection -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Sanofi · United Kingdom · accessed 2026-07-29 · source 3
  4. PRALUENT -- ARTG registrationTherapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-29 · source 4

Brand names by country

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

Priority countries

United States

  • Praluent75 mg/mL, 150 mg/mL · sanofi-aventis u.s. llc

United Kingdom

  • Praluent (3)MHRA licensed emc smpc confirmed · 75 mg, 150 mg, 300 mg · Sanofi

Canada

  • PRALUENT

Australia

  • Praluent (4)TGA ARTG registered 2022-10-17 · 300 mg/2 mL · Sanofi-Aventis Australia Pty Ltd
View brands in additional countries.

European Union

Praluent (2)