Evolocumab

What it is and how it works

Mechanism of Action Evolocumab is a human monoclonal IgG2 directed against human proprotein convertase subtilisin kexin type 9 (PCSK9). PCSK9 binds to the low-density lipoprotein receptor (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. By inhibiting the binding of PCSK9 to LDLR, evolocumab increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.

Mechanism class: PCSK9 Inhibitors

Indications

is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). REPATHA is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in : adults with hypercholesterolemia.

Dosage and administration (summary)

In adults at increased risk for CV events or with hypercholesterolemia : The recommended dosage of REPATHA is either 140 mg every 2 weeks OR 420 mg once monthly administered subcutaneously. If switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of the prior regimen. In adults and pediatric patients aged 10 years and older with HeFH : The recommended dosage of REPATHA is either 140 mg every 2 weeks OR 420 mg once monthly administered subcutaneously. If switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of the prior regimen.

Contraindications

is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in REPATHA. Serious hypersensitivity reactions including angioedema have occurred in patients treated with REPATHA . Patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in REPATHA.

Warnings and precautions

Hypersensitivity Reactions : Angioedema has occurred. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with REPATHA, treat according to the standard of care, and monitor until signs and symptoms resolve. Hypersensitivity Reactions Hypersensitivity reactions, including angioedema, have been reported in patients treated with REPATHA. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with REPATHA, treat according to the standard of care, and monitor until signs and symptoms resolve.

Pregnancy

Pregnancy Risk Summary Available data from clinical trials and postmarketing reports on REPATHA use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

Storage and supply

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake. REPATHA prefilled single-dose pen, prefilled single-dose SureClick ® autoinjector, or prefilled single-dose syringe may also be kept at room temperature at 68°F to 77°F (20°C to 25°C) in the original carton for 30 days.

Source: Evolocumab (Repatha) — US FDA prescribing information, 2026-08-19, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.