Lipid-Lowering Agents Pregnancy: Data insufficient to evaluate drug-associated risk; as an IgG monoclonal antibody it crosses the placenta (increasingly near term).

Alirocumab

Brand names: Praluent

Alirocumab is a subcutaneously injected PCSK9-inhibitor monoclonal antibody used to lower LDL cholesterol in primary hypercholesterolaemia and to reduce cardiovascular risk, usually when statins are insufficient or not tolerated.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 75 mg once every 2 weeks OR 300 mg once every 4 weeks

Route: Subcutaneous (thigh, abdomen, or upper arm; rotate sites)

Frequency: Starting dosage for hypercholesterolaemia including HeFH; if LDL-C response inadequate, adjust to 150 mg once every 2 weeks

Product Praluent. HeFH undergoing LDL apheresis or HoFH: 150 mg once every 2 weeks. The 300 mg dose is given as two 150 mg injections consecutively at two different sites. Paediatric (HeFH, aged 8 years and older, weight-banded flat dose — not per-kg): under 50 kg 150 mg once every 4 weeks (may adjust to 75 mg every 2 weeks); 50 kg or more 300 mg once every 4 weeks (may adjust to 150 mg every 2 weeks).

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

History of a serious hypersensitivity reaction to alirocumab or any excipient (hypersensitivity vasculitis, angioedema, reactions requiring hospitalisation have occurred)

Side effects

Injection site reactions
Influenza
Myalgia (in patients with established CV disease)
Hypersensitivity reactions (hypersensitivity vasculitis, angioedema)

Clinical monograph

How it works

It binds PCSK9 and prevents it from degrading hepatic LDL receptors, so more receptors recycle to the cell surface and clear LDL cholesterol from the blood.

Prescribing in practice

NICE restricts alirocumab to specific LDL-cholesterol thresholds and risk categories, so eligibility should be confirmed against current NICE criteria before initiation.
It is given by subcutaneous injection on an intermittent schedule, typically as add-on to maximally tolerated statin and/or ezetimibe therapy.
Injection-site reactions are the most common adverse effect; it can be continued in patients who are statin-intolerant.

Monitoring

Check LDL cholesterol after initiation to confirm an adequate lipid-lowering response and guide ongoing therapy.

Counselling the patient

Teach the patient correct subcutaneous self-injection technique and to rotate injection sites.
Explain that it is added to, and does not replace, dietary measures and other lipid-lowering treatment unless statins are not tolerated.
Advise that mild injection-site redness or itching can occur and is usually transient.

Evidence & guidelines

The ODYSSEY OUTCOMES trial showed alirocumab reduced major adverse cardiovascular events after acute coronary syndrome, and NICE recommends it within defined eligibility criteria.

Reference: ODYSSEY OUTCOMES NEJM 2018; 379(22):2097-2107; NICE TA393; ESC/EAS Lipid Guidelines 2019; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

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