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PCSK9 Inhibitor (Human Monoclonal Antibody) Pregnancy: §4.6: 'There are no data from the use of Praluent in pregnant women. Alirocumab is a recombinant IgG1 antibody, therefore it is expected to cross the placental barrier.' Animal studies do not indicate direct or indirect harmful effects on maintenance of pregnancy or embryo-foetal development; maternal toxicity was noted in rats but not in monkeys at doses in excess of the human dose, and a weaker secondary immune response to antigen challenge was observed in the offspring of monkeys. 'The use of Praluent is not recommended during pregnancy unless the clinical condition of the woman requires treatment with alirocumab.' Breast-feeding: 'It is not known whether alirocumab is excreted in human milk. Human immunoglobulin G (IgG) is excreted in human milk, in particular in colostrum; the use of Praluent is not recommended in breast-feeding women during this period. For the remaining duration of breast-feeding, exposure is expected to be low.' Fertility: no adverse effects on surrogate markers of fertility in animals; no human data.

Alirocumab (PCSK9 Inhibitor — Post-ACS)

Brand names: Praluent

Alirocumab is a subcutaneous monoclonal antibody PCSK9 inhibitor used as a lipid-lowering agent to reduce LDL-cholesterol, including after acute coronary syndrome and in familial hypercholesterolaemia.

Adult dose

Dose: Adults (lipid lowering in hyperlipidaemia / mixed dyslipidaemia): 75 mg once every 2 weeks, or 150 mg once every 2 weeks, or 300 mg once every 4 weeks (monthly), given subcutaneously. 'All doses may be used for initiation of treatment.'
Route: Subcutaneous injection into the thigh, abdomen or upper arm; rotate the injection site with each injection. To give the 300 mg dose, 'either one 300 mg injection or two 150 mg injections should be given consecutively at two different injection sites.' Indication scope: adult hyperlipidaemia / mixed dyslipidaemia — §4.2 directs that secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g. nephrotic syndrome, hypothyroidism) be excluded before initiating.
Frequency: Every 2 weeks (75 mg or 150 mg) or every 4 weeks / monthly (300 mg). 'The dose of alirocumab can be individualised based on patient characteristics such as baseline LDL-C level, goal of therapy, and response to treatment.' If a dose is missed, 'the dose should be administered as soon as possible and thereafter, dosing should be resumed on the original schedule.'
Max: Maximum dose 150 mg once every 2 weeks. SPC §4.2 verbatim: 'Intense LDL-C reduction is expected with alirocumab 150 mg once every 2 weeks and 300 mg once every 4 weeks (monthly), where 150 mg once every 2 weeks is the maximum dose.'
No weight-based dosing in adults: 'No dose adjustment is needed in patients based on weight.' Elderly: 'No dose adjustment is needed for elderly patients.' Handling: each pre-filled pen is for single use only; 'The solution should be allowed to warm to room temperature prior to use'; do not inject into areas of active skin disease or injury (sunburn, rash, inflammation, skin infection); 'Alirocumab must not be co-administered with other injectable medicinal products at the same injection site.' Adults may self-inject after training, or a caregiver may administer. Interaction of note (§4.5): statins and other lipid-modifying therapy increase PCSK9 production, so exposure to alirocumab is about 40%, 15% and 35% lower with statins, ezetimibe and fenofibrate respectively — 'However, reduction of LDL-C is maintained during the dosing interval when alirocumab is administered every two weeks.' No CYP450 effects are anticipated.

Paediatric dose

Route: Subcutaneous injection into the thigh, abdomen or upper arm; rotate the site with each injection. Indication: heterozygous familial hypercholesterolaemia (HeFH) in paediatric patients 8 years of age and older.
Frequency: Once every 4 weeks; or once every 2 weeks if additional LDL-C reduction is needed.
Max: Maximum 300 mg once every 4 weeks, or 150 mg once every 2 weeks — the highest regimens in the SPC's paediatric HeFH table (body weight 50 kg or more). (The SPC's explicit 'maximum dose' wording — 150 mg once every 2 weeks — sits in the adult posology paragraph.)
Presentation: Source SPC is Praluent 150 mg solution for injection in pre-filled pen; a 300 mg dose is given as either one 300 mg injection or two 150 mg injections at two different sites. WEIGHT-BANDED, NOT PER-KG — dosePerKg is deliberately null; do not compute a mg/kg dose. SPC §4.2 table, 'HeFH in paediatric patients 8 years of age and older': body weight less than 50 kg — recommended dose 150 mg once every 4 weeks, or 75 mg once every 2 weeks if additional LDL-C reduction is needed; body weight 50 kg or more — recommended dose 300 mg once every 4 weeks, or 150 mg once every 2 weeks if additional LDL-C reduction is needed. 'Lipid levels can be assessed 8 weeks after treatment initiation or titration and dose adjusted accordingly.' Age limit: 'The safety and efficacy of Praluent in children less than 8 years of age have not been established. No data are available.' Administration: 'In adolescents 12 years of age and older, it is recommended that Praluent be administered by or under the supervision of an adult. In children less than 12 years of age, Praluent must be given by a caregiver.' The US label likewise establishes safety and effectiveness for HeFH in patients aged 8 years and older and states these are not established below 8 years or 'in pediatric patients with other types of hypercholesterolemia'.

Dose adjustments

Renal

§4.2: 'No dose adjustment is needed for patients with mild or moderate renal impairment. Limited data are available in patients with severe renal impairment.' §4.4: in clinical studies 'there was limited representation of patients with severe renal impairment (defined as eGFR < 30 mL/min/1.73 m2)... Alirocumab should be used with caution in patients with severe renal impairment.'

Hepatic

§4.2: 'No dose adjustment is needed for patients with mild or moderate hepatic impairment. No data are available in patients with severe hepatic impairment.' §4.4: 'Patients with severe hepatic impairment (Child-Pugh C) have not been studied... Alirocumab should be used with caution in patients with severe hepatic impairment.'

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients (§4.3 — the only contraindication listed)

Side effects

  • Local injection site reactions (erythema/redness, itching, swelling, pain/tenderness) — 6.1% of alirocumab-treated patients vs 4.1% on placebo injections; 'Most injection site reactions were transient and of mild intensity'; discontinuation rate 0.2% vs 0.3% (§4.8)
  • Upper respiratory tract signs and symptoms (mainly oropharyngeal pain, rhinorrhoea, sneezing) — 2.0%, common
  • Pruritus — 1.1%, common
  • Hypersensitivity, hypersensitivity vasculitis — rare
  • Urticaria, eczema nummular — rare
  • Angioedema — frequency not known (reported post-marketing)
  • Flu-like illness — frequency not known
  • 'No difference in the safety profile was observed between the two doses (75 mg and 150 mg) used in the Phase 3 programme'

Monitoring

  • Lipids: 'Lipid levels can be assessed 4 to 8 weeks after treatment initiation or titration, and dose adjusted accordingly (up-titration or down-titration)' in adults
  • 8 weeks after initiation or titration in paediatric HeFH patients.
  • Before initiating, exclude secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g. nephrotic syndrome, hypothyroidism).
  • Traceability: 'the name and the batch number of the administered product should be clearly recorded' (§4.4).
  • Allergic reactions: general allergic reactions including pruritus, and rare, sometimes serious reactions (hypersensitivity, nummular eczema, urticaria, hypersensitivity vasculitis) have been reported, with angioedema post-marketing — 'If signs or symptoms of serious allergic reactions occur, treatment with alirocumab must be discontinued and appropriate symptomatic treatment initiated.' Use with caution and monitor clinically in severe renal impairment and severe hepatic impairment.

Clinical monograph

How it works

It binds and inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), increasing the number of LDL receptors available to clear LDL-cholesterol from the circulation.

Prescribing in practice

  • It is an adjunct to maximally tolerated statin therapy and diet, not a replacement for statins, in patients not at LDL goal.
  • NICE restricts funded use to specific LDL thresholds and cardiovascular risk categories, so check current eligibility criteria.
  • Hypersensitivity and injection-site reactions can occur and warrant review.

Monitoring

Monitor the lipid profile to assess LDL-cholesterol response after initiation and dose adjustments.

Counselling the patient

  • Continue your statin and other heart-protective treatments unless told otherwise.
  • It is given by subcutaneous injection; rotate injection sites and report persistent skin reactions.
  • Keep using a healthy diet alongside the medicine.

Evidence & guidelines

The ODYSSEY OUTCOMES trial showed alirocumab reduced major adverse cardiovascular events in patients after recent acute coronary syndrome already on intensive statin therapy.

Reference: ODYSSEY OUTCOMES (Schwartz et al. NEJM 2018); NICE TA394/TA895; ESC Dyslipidaemia Guidelines 2019; MHRA SPC Praluent; 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).

Related

Curated clinical cross-links plus same-class fallbacks.

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