Evolocumab

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.

• REPATHA 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.ICD-10: E78.00, I20.9, I21.9, I63.9

• REPATHA 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 [see Warnings and Precautions (5.1) ] .contraindicated

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. ( 2.1 ) If switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of the prior regimen. ( 2.1 ) 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. ( 2.1 ) If switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of the prior regimen. ( 2.1 ) In adults and pediatric patients aged 10 years and older with HoFH : The initial recommended dosage of REPATHA is 420 mg once monthly administered subcutaneously. ( 2.1 ) The dosage can be increased to 420 mg every 2 weeks if a clinically meaningful response is not achieved in 12 weeks. ( 2.1 ) Patients on lipid apheresis may initiate treatment with 420 mg every 2 weeks to correspond with their apheresis schedule. Administer REPATHA after the apheresis session is complete. ( 2.1 ) Assess LDL-C when clinically appropriate. The LDL-lowering effect of REPATHA may be measured as early as 4 weeks after initiation. ( 2.1 ) REPATHA is available as prefilled single-dose SureClick ® autoinjectors and prefilled single-dose syringes that either contain dry natural rubber (a derivative of latex) in the needle cover or are not made with natural rubber latex.

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. ( 5.1 ) 5.1 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. REPATHA is contraindicated in patients with a history of serious hypersensitivity reactions to evolocumab or any excipient in REPATHA [see Contraindications (4) ] . The prefilled single-dose SureClick ® autoinjector and prefilled single-dose syringe presentations of REPATHA that contain dry natural rubber (a derivative of latex) in the needle cover may cause an allergic reaction in individuals sensitive to latex. Instruct patients to inform their healthcare provider if they are sensitive to latex. Consider prescribing a presentation of REPATHA that does not contain dry natural rubber for individuals that are sensitive to latex [see How Supplied/Storage and Handling (16) ] .

The following adverse reactions are also discussed in other sections of the label: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Common (> 5% of patients treated with REPATHA and more frequently than placebo) adverse reactions in adults with: Primary hypercholesterolemia: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions. ( 6 ) Established CVD: diabetes mellitus, nasopharyngitis and upper respiratory tract infection. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions in Adults with Primary Hypercholesterolemia The data described below reflect exposure to REPATHA in 8 placebo-controlled trials that included 2651 patients treated with REPATHA, including 557 exposed for 6 months and 515 exposed for 1 year (median treatment duration of 12 weeks) . The mean age of the population was 57 years, 49% of the population were women, 85% White, 6% Black, 8% Asians, and 2% other races.

8.1 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. In animal reproduction studies, there were no effects on pregnancy or neonatal/infant development when monkeys were subcutaneously administered evolocumab from organogenesis through parturition at dose exposures up to 12 times the exposure at the maximum recommended human dose of 420 mg every month. In a similar study with another drug in the PCSK9 inhibitor antibody class, humoral immune suppression was observed in infant monkeys exposed to that drug in utero at all doses. The exposures where immune suppression occurred in infant monkeys were greater than those expected clinically. No assessment for immune suppression was conducted with evolocumab in infant monkeys. Measurable evolocumab serum concentrations were observed in the infant monkeys at birth at comparable levels to maternal serum, indicating that evolocumab, like other IgG antibodies, crosses the placental barrier. Monoclonal antibodies are transported across the placenta in increasing amounts especially near term; therefore, evolocumab has the potential to be transmitted from the mother to the developing fetus.

Metabolism

Evolocumab exhibits non-linear kinetics as a result of binding to PCSK9. Administration of the 140 mg dose in healthy volunteers resulted in a C max mean of 18.6 µg/mL and AUC last mean of 188 day∙µg/mL.

• Aug 27, 2015BLABLA125522Amgen Inc

1. 1Device Difficult To Use32,60121%
2. 2Drug Dose Omission By Device24,42116%
3. 3Wrong Technique In Product Usage Process22,05314%
4. 4Accidental Exposure To Product16,45010%
5. 5Injection Site Pain10,5466.7%
6. 6Product Storage Error6,6474.2%
7. 7Back Pain5,4973.5%
8. 8Myalgia5,3323.4%
9. 9Drug Dose Omission4,9293.1%
10. 10Injection Site Bruising4,6322.9%
11. 11Device Use Error4,1192.6%
12. 12Arthralgia3,9792.5%
13. 13Fatigue3,9272.5%
14. 14Injection Site Haemorrhage3,8932.5%
15. 15Off Label Use3,8652.5%

The 10 most recently updated of 162 ClinicalTrials.gov registrations naming Evolocumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Efficacy and Safety of Early Combined Therapy With PCSK9 Inhibitors and Statins in Acute Ischemic Stroke
  Completed · Phase 2 · Phase 3 · Interventional · 429 enrolled · Xiang Luo
  NCT06696820updated 2026-06-09
• CAPRA-EVO: a Randomized Serial PCCT Trial of Early Evolocumab After ACS
  Recruiting · Phase 4 · Interventional · 233 enrolled · West China Hospital
  NCT07612774updated 2026-06-09
• Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior STEMI Undergoing Primary PCI
  Terminated · Phase 4 · Interventional · 119 enrolled · Henan Institute of Cardiovascular Epidemiology
  NCT05613426updated 2026-05-22
• A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)
  Terminated · Phase 1 · Phase 2 · Interventional · 314 enrolled · Hoffmann-La Roche
  NCT03337698updated 2026-05-12
• Early Administration of PCSK9 Inhibitors After Thrombectomy for Atherosclerotic Acute Ischemic Stroke: A Randomized Controlled Trial
  Completed · Phase 4 · Interventional · 60 enrolled · The Affiliated Hospital of Xuzhou Medical University
  NCT07295366updated 2026-05-07
• A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC
  Terminated · Phase 2 · Interventional · 19 enrolled · Eziafa Oduah, MD, PhD, MPH
  NCT05144529updated 2026-05-05
• Evolocumab in Acute Coronary Syndrome
  Completed · Phase 2 · Interventional · 60 enrolled · Johns Hopkins University
  NCT03515304updated 2026-05-01
• Evaluation Study of Early Administration of Evolocumab After Thrombolysis in Patients With Atherosclerotic Acute Ischemic Stroke
  Completed · Phase 4 · Interventional · 132 enrolled · The Affiliated Hospital of Xuzhou Medical University
  NCT07301372updated 2026-04-30
• The Effects of Evolocumab in Patients With Diabetes and Atherosclerotic Vascular Disease
  Completed · Phase 4 · Interventional · 41 enrolled · Robert Rosenson
  NCT03829046updated 2026-04-28
• The Effect of InTensive Statin in Ischemic Stroke With inTracranial Atherosclerotic Plaques
  Recruiting · Phase 4 · Interventional · 100 enrolled · General Hospital of Shenyang Military Region
  NCT03753555updated 2026-04-27

Frequently asked questions

How does Evolocumab work?

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.

What is Evolocumab used for?

According to FDA labeling, Evolocumab carries indications including: REPATHA 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Evolocumab?

Evolocumab is classified as Other lipid modifying agents, PCSK9 Inhibitor, PCSK9 Inhibitors, Increased Lipolysis.

What are the brand names for Evolocumab?

Evolocumab is marketed under brand names including Repatha.

What are the contraindications for Evolocumab?

Evolocumab labeling lists contraindications including: REPATHA 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 [see Warnings and Precautions (5.1) ] .. Always consult the full prescribing information and a clinician.