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Lipid-Lowering Agents Pregnancy: Avoid — insufficient data in pregnancy; discontinue if pregnancy occurs

Alirocumab

Brand names: Praluent

Adult dose

Dose: 75 mg every 2 weeks (starting dose); may increase to 150 mg every 2 weeks if response inadequate
Route: SC
Frequency: Every 2 weeks
Max: 150 mg every 2 weeks
Administer via pre-filled pen. Allow to warm to room temperature 30–40 minutes before injection. Reassess after 4–8 weeks and adjust dose.

Paediatric dose

Dose: Seek specialist opinion N/A/kg
Route: SC
Frequency: N/A
Max: N/A
Not established in children under 18; seek specialist paediatric lipidology opinion

Dose adjustments

Renal

No dose adjustment required — monoclonal antibody, not renally excreted

Hepatic

Use with caution in severe hepatic impairment — no dose adjustment data available

Paediatric weight-based calculator

Not established in children under 18; seek specialist paediatric lipidology opinion

Clinical pearls

  • Mechanism: fully human IgG1 monoclonal antibody against PCSK9 — same target as evolocumab; prevents PCSK9 from tagging LDL receptors for degradation; increases LDL-R surface expression on hepatocytes
  • ODYSSEY OUTCOMES trial (NEJM 2018): alirocumab post-ACS (1–12 months) vs placebo — LDL reduced by 62%; significant reduction in composite MACE (major adverse cardiovascular events) with 15% relative risk reduction; also significantly reduced all-cause mortality (pre-specified secondary endpoint)
  • Key differentiator vs evolocumab: ODYSSEY OUTCOMES showed all-cause mortality reduction (NNT 63 over 2.8 years) — this was a pre-specified secondary analysis; FOURIER did not show mortality benefit
  • NICE TA393: recommended on same basis as evolocumab — max tolerated statin + ezetimibe failure in high-risk patients; alirocumab and evolocumab have equivalent NICE recommendations
  • Statin intolerance: both PCSK9 inhibitors are alternatives when statins are not tolerated; GAUSS-3 trial confirmed evolocumab efficacy in statin-intolerant patients (alirocumab has similar evidence)
  • MHRA: licensed for hypercholesterolaemia (primary non-FH and FH) and mixed dyslipidaemia as adjunct to diet; available as 75 mg and 150 mg pre-filled pens

Contraindications

  • Known hypersensitivity to alirocumab or excipients

Side effects

  • Injection site reactions (bruising, erythema, pain)
  • Nasopharyngitis
  • Influenza
  • Urinary tract infection
  • Hypersensitivity reactions (including angioedema — rare)

Interactions

  • No clinically significant drug interactions — PCSK9 inhibitors do not affect CYP450 enzymes

Monitoring

  • Fasting lipid profile at 4–8 weeks post-initiation (LDL response assessment)
  • Hypersensitivity reactions — angioedema reported; discontinue if severe reaction
  • No hepatic or renal monitoring required

Reference: BNFc; BNF 90; ODYSSEY OUTCOMES NEJM 2018;379(22):2097-2107; NICE TA393; ESC/EAS Lipid Guidelines 2019. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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