PCSK9 Inhibitor (Monoclonal Antibody) Pregnancy: US label 8.1: available data from clinical trials and post-marketing reports in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. No effects on pregnancy or neonatal/infant development were seen in monkeys at exposures up to 12 times the exposure at the maximum recommended human dose of 420 mg monthly. Evolocumab, like other IgG antibodies, crosses the placenta, in increasing amounts especially near term.

Evolocumab

Brand names: Repatha

Evolocumab is a subcutaneously injected monoclonal antibody (a PCSK9 inhibitor) used to lower LDL cholesterol in primary hypercholesterolaemia, mixed dyslipidaemia and established cardiovascular disease.

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: 140 mg every 2 weeks OR 420 mg once monthly (adults at increased risk of cardiovascular events or with hypercholesterolaemia)

Route: Subcutaneous injection into the abdomen, thigh or upper arm (rotate injection sites)

Frequency: Every 2 weeks (140 mg) or once monthly (420 mg)

From US prescribing information for REPATHA (no UK SPC in the fetched bundle) — verify against UK labelling before use. Heterozygous familial hypercholesterolaemia (HeFH), adults and paediatric patients aged 10 years and older: 140 mg every 2 weeks or 420 mg once monthly subcutaneously. Homozygous familial hypercholesterolaemia (HoFH), adults and paediatric patients aged 10 years and older: initial dosage 420 mg once monthly subcutaneously, which can be increased to 420 mg every 2 weeks if a clinically meaningful response is not achieved in 12 weeks; patients on lipid apheresis may initiate 420 mg every 2 weeks to correspond with their apheresis schedule, giving evolocumab after the apheresis session is complete. If switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of the prior regimen. The 420 mg dose can be given over 5 minutes using the single-dose on-body infusor with prefilled cartridge, or as 3 injections given consecutively within 30 minutes using the prefilled single-dose autoinjector or syringe. Assess LDL-C when clinically appropriate — the LDL-lowering effect may be measured as early as 4 weeks after initiation; for patients on 420 mg once monthly, LDL-C can vary during the dosing interval, so measure just prior to the next scheduled dose. Missed dose: within 7 days, administer and resume the original schedule; more than 7 days after a missed dose, for every-2-week dosing wait until the next dose on the original schedule, and for once-monthly dosing administer the dose and start a new schedule from that date. If refrigerated, allow to warm to room temperature for at least 30 minutes (autoinjector or syringe) or at least 45 minutes (on-body infusor). Some presentations contain dry natural rubber (a latex derivative) in the needle cover — consider a presentation without it for latex-sensitive individuals. Paediatric: safety and effectiveness established for HeFH and HoFH in patients aged 10 years and older at the same fixed doses (no per-kg dosing is stated); not established below 10 years of age or for other types of hyperlipidaemia.

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 evolocumab or to any of the excipients — serious hypersensitivity reactions including angioedema have occurred

Side effects

Nasopharyngitis and upper respiratory tract infection
Influenza
Back pain
Injection site reactions
Diabetes mellitus (reported in patients with established cardiovascular disease)
Hypersensitivity reactions including angioedema

Clinical monograph

How it works

It binds and inhibits proprotein convertase subtilisin/kexin type 9, preventing degradation of hepatic LDL receptors so more receptors recycle to the cell surface and clear LDL cholesterol from the blood.

Prescribing in practice

It is contraindicated in patients with a known hypersensitivity to the product, and injection-site reactions and occasional hypersensitivity are the main safety concerns.
It is used as an adjunct to diet and maximally tolerated statin therapy, or alone or with other agents when statins are not tolerated.
NICE restricts use to defined LDL thresholds depending on cardiovascular risk category.

Monitoring

Lipid profile is checked to confirm response, but routine ongoing laboratory monitoring of the drug itself is not generally required.

Counselling the patient

Rotate injection sites and allow the pen or syringe to reach room temperature before injecting.
Continue your statin and lifestyle measures unless told otherwise.
Store in the refrigerator and protect from light.

Evidence & guidelines

The FOURIER trial showed evolocumab reduced cardiovascular events on top of statin therapy, underpinning its NICE-approved cardiovascular indications.

Reference: FOURIER trial (Sabatine et al. NEJM 2017); NICE TA394; MHRA SPC Repatha; ESC/EAS Dyslipidaemia 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.

Calculators

Pathways