Repatha® (Evolocumab)

Repatha® (Evolocumab)

Description

Evolocumab 140mg Injection — PCSK9 Inhibitor for Hypercholesterolaemia and Cardiovascular Risk Reduction

Additional Information

Repatha® (Evolocumab) — PCSK9 Inhibitor for Cholesterol Lowering and Cardiovascular Protection

The Most Extensively Studied PCSK9 Inhibitor with Proven Cardiovascular Outcomes Benefit

Repatha® (Evolocumab) is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) — a protein that degrades LDL receptors on liver cells. By blocking PCSK9, Repatha increases the number of LDL receptors available to clear LDL cholesterol from the bloodstream — reducing LDL-C by up to 60% on top of statin therapy and significantly reducing the risk of cardiovascular events including heart attack and stroke.

A.K. Pharma is a trusted medicine distributor in Delhi supplying genuine Repatha (Evolocumab) to hospitals, cardiology centres, lipid clinics, and pharmacies across India. Manufactured by Amgen, Repatha is the most extensively studied PCSK9 inhibitor — with proven cardiovascular outcomes benefit demonstrated in the landmark FOURIER trial.


What is Repatha (Evolocumab)?

Repatha contains Evolocumab — a fully human IgG2 monoclonal antibody that specifically binds to PCSK9 with high affinity. PCSK9 is a serine protease produced primarily in the liver that binds to LDL receptors (LDLR) and directs them for lysosomal degradation — reducing the liver’s capacity to clear LDL cholesterol from the circulation.

By neutralising PCSK9, Repatha prevents LDLR degradation — increasing LDLR recycling to the hepatocyte surface — dramatically increasing hepatic LDL uptake and clearance. This results in significant LDL-C reductions of 50-60% beyond the effect of statin therapy alone.

Full prescribing information is available at the FDA label for Evolocumab.


Clinical Studies and Evidence

FOURIER Trial (Evolocumab Cardiovascular Outcomes) Published in the New England Journal of Medicine (2017), the landmark FOURIER trial — involving 27,564 patients with established cardiovascular disease on statin therapy — demonstrated that Evolocumab significantly reduced the risk of the primary composite cardiovascular endpoint (cardiovascular death, MI, stroke, hospitalisation for unstable angina, or coronary revascularisation) by 15%, and the key secondary endpoint (cardiovascular death, MI, or stroke) by 20%. The trial established Repatha as the first PCSK9 inhibitor with proven cardiovascular outcomes benefit.

GLAGOV Trial (Evolocumab and Atherosclerosis Regression) Published in JAMA (2016), the GLAGOV trial demonstrated that Evolocumab added to statin therapy significantly reduced coronary atherosclerotic plaque volume — with 64.3% of Evolocumab-treated patients showing plaque regression vs 47.3% with placebo — the first evidence that aggressive LDL lowering with a PCSK9 inhibitor can regress atherosclerosis.

PROFICIO Programme (Phase 3 LDL Lowering Trials) The PROFICIO programme — comprising LAPLACE-2, RUTHERFORD-2, GAUSS-3, TESLA, and DESCARTES trials — demonstrated consistent LDL-C reductions of 50-60% with Evolocumab across all patient populations including heterozygous familial hypercholesterolaemia (HeFH), homozygous familial hypercholesterolaemia (HoFH), and statin-intolerant patients.

TESLA Trial (Homozygous FH) Published in The Lancet (2014), the TESLA trial demonstrated Evolocumab significantly reduced LDL-C by 30.9% in patients with homozygous familial hypercholesterolaemia — a condition where statins have limited efficacy.

Long-Term Safety Extension The OSLER extension studies demonstrated sustained LDL-C lowering and a favourable safety profile over 2+ years of continuous Evolocumab treatment — supporting long-term use.


Available Strengths

Repatha is available in the following formulations:

  • 140mg/mL prefilled syringe — single dose for every-2-week dosing
  • 140mg/mL SureClick autoinjector — single dose for every-2-week dosing
  • 420mg/3.5mL Pushtronex system — monthly dosing device (delivers 3 x 140mg)

The standard dosing options are:

  • 140mg subcutaneously every 2 weeks, OR
  • 420mg subcutaneously once monthly

Indications — What Repatha is Used For

Primary Hyperlipidaemia and Mixed Dyslipidaemia:

  • Adjunct to diet and maximally tolerated statin therapy for adults with primary hyperlipidaemia (including HeFH) requiring additional LDL-C lowering
  • Adjunct to other LDL-lowering therapies in adults with HeFH or clinical ASCVD requiring additional LDL-C lowering

Homozygous Familial Hypercholesterolaemia (HoFH):

  • Adjunct to diet and other LDL-lowering therapies in adults and paediatric patients (≥13 years) with HoFH requiring additional LDL-C lowering

Established Cardiovascular Disease:

  • To reduce the risk of MI, stroke, and coronary revascularisation in adults with established cardiovascular disease
  • Based on FOURIER trial evidence — cardiovascular outcomes benefit proven

For detailed indication information refer to MedlinePlus Evolocumab.


Key Benefits of Repatha

Proven Cardiovascular Outcomes Benefit The FOURIER trial demonstrated a 15% reduction in primary MACE and 20% reduction in the key secondary endpoint (CV death, MI, stroke) — establishing Repatha as a proven cardiovascular protective therapy beyond LDL lowering alone.

Powerful LDL-C Reduction Repatha reduces LDL-C by 50-60% on top of maximally tolerated statin therapy — enabling patients to achieve very low LDL-C targets (≤55 mg/dL or ≤1.4 mmol/L) as recommended by current guidelines for very high cardiovascular risk patients.

Atherosclerosis Regression The GLAGOV trial demonstrates Repatha can actually regress existing atherosclerotic plaque — going beyond preventing progression to actively reducing plaque burden.

Effective in Familial Hypercholesterolaemia Repatha is effective in both HeFH and HoFH — providing meaningful LDL-C reduction even in HoFH where statins have limited efficacy due to absent or dysfunctional LDL receptors.

Convenient Dosing Options Choice of every-2-week or once-monthly dosing — with multiple device options (syringe, autoinjector, monthly Pushtronex system) — maximising patient convenience and adherence.

Statin-Intolerant Patients Repatha provides meaningful LDL-C reduction in statin-intolerant patients where statins cannot be used at effective doses — addressing a significant unmet clinical need.


How Repatha Works

LDL cholesterol is cleared from the bloodstream primarily by LDL receptors (LDLR) on hepatocytes. After binding LDL, LDLR is internalised and recycled back to the cell surface — ready to bind more LDL molecules. PCSK9 interferes with this recycling process:

  • PCSK9 is produced and secreted by hepatocytes
  • Secreted PCSK9 binds to LDLR on the hepatocyte surface
  • The PCSK9-LDLR complex is internalised and directed to lysosomes for degradation
  • LDLR is destroyed rather than recycled — reducing hepatic LDL clearance capacity
  • LDL accumulates in the bloodstream — elevated LDL-C levels

Repatha works by:

  • Binding with high affinity to circulating PCSK9
  • Preventing PCSK9 from binding to LDLR on hepatocyte surface
  • Allowing LDLR to be recycled back to the cell surface after LDL internalisation
  • Dramatically increasing hepatocyte LDLR density
  • Increasing hepatic LDL uptake and clearance
  • Reducing circulating LDL-C by 50-60%

For a detailed mechanism overview refer to the European Society of Cardiology Dyslipidaemia Guidelines and American College of Cardiology Cholesterol Guidelines.


LDL-C Targets — Current Guidelines

Current ESC/EAS and ACC/AHA guidelines recommend aggressive LDL-C targets for high and very high risk patients:

Risk Category LDL-C Target Common Patients
Very High Risk <55 mg/dL (<1.4 mmol/L) Established CVD, recent ACS, FH with CVD
High Risk <70 mg/dL (<1.8 mmol/L) Diabetes with organ damage, severe CKD, FH
Moderate Risk <100 mg/dL (<2.6 mmol/L) Multiple risk factors

Many patients cannot achieve these targets on statins alone — making Repatha an essential add-on therapy to reach guideline-recommended LDL-C goals.


Repatha vs Sybrava — PCSK9 Inhibition Compared

Feature Repatha (Evolocumab) Sybrava (Inclisiran)
Mechanism Anti-PCSK9 monoclonal antibody siRNA PCSK9 inhibitor
LDL-C Reduction 50-60% 50-55%
Cardiovascular Outcomes Proven (FOURIER) Proven (ORION-4)
Dosing Every 2 weeks or monthly Twice yearly
Route SC injection SC injection
Available at A.K. Pharma Request Quote Request Quote

Dosage and Administration

Primary Hyperlipidaemia / Established CVD:

  • 140mg SC every 2 weeks, OR
  • 420mg SC once monthly

Homozygous FH:

  • 420mg SC once monthly — may increase to 420mg every 2 weeks if inadequate response after 12 weeks

Administration:

  • Subcutaneous injection — abdomen, thigh, or upper arm
  • Rotate injection sites
  • Allow prefilled syringe or SureClick to reach room temperature — 30 minutes before injection
  • Do not shake device
  • Inject immediately after removing from refrigerator once at room temperature

Full dosing guidelines available at Drugs.com Evolocumab Dosage.


Who Should Use Repatha

Repatha is prescribed for:

  • Adults with established cardiovascular disease (post-MI, stroke, peripheral arterial disease) on maximally tolerated statin therapy not achieving LDL-C targets
  • Adults with heterozygous or homozygous familial hypercholesterolaemia requiring additional LDL-C lowering
  • Statin-intolerant patients with high cardiovascular risk requiring LDL-C reduction
  • Patients with very high cardiovascular risk requiring LDL-C <55 mg/dL

Repatha is prescribed by cardiologists, lipidologists, endocrinologists, and general physicians. A.K. Pharma supplies Repatha to hospitals, cardiology centres, and pharmacies across Delhi and India.


Possible Side Effects

Common side effects include nasopharyngitis, upper respiratory tract infection, injection site reactions, back pain, and arthralgia.

Serious side effects include:

  • Hypersensitivity reactions including angioedema and rash — rare
  • Neurocognitive effects — rare reports of confusion and memory impairment

Full side effect information available at FDA Evolocumab Safety Information.


Precautions

  • Monitor LDL-C levels 4-8 weeks after initiation and after dose adjustments
  • Consider reducing or stopping Repatha if LDL-C falls below guideline minimum thresholds
  • Not recommended during pregnancy — effective contraception required
  • Refer to ESC Dyslipidaemia Guidelines for complete management context

Storage and Handling

  • Store in refrigerator between 2°C and 8°C
  • Do not freeze
  • Protect from light — keep in original carton
  • Allow to reach room temperature before injection — approximately 30 minutes
  • Can be stored at room temperature below 25°C for up to 30 days if needed
  • Single use device — discard after use

As a responsible medicine distributor in Delhi, A.K. Pharma maintains full cold chain requirements during storage and supply of Repatha ensuring product integrity for every unit supplied.


Manufacturer Information

Repatha (Evolocumab) is manufactured by Amgen Inc., a global biotechnology company. Evolocumab received FDA approval in August 2015 for hyperlipidaemia and HoFH, with cardiovascular outcomes indication added in 2017 following the FOURIER trial. A.K. Pharma supplies only genuine Repatha sourced from authorized Amgen distributors.


Related Heart Medicines Available at A.K. Pharma


Frequently Asked Questions

Q. What is Repatha used for? Repatha (Evolocumab) is used to lower LDL cholesterol in patients with primary hyperlipidaemia, familial hypercholesterolaemia, and established cardiovascular disease — and to reduce the risk of heart attack, stroke, and coronary revascularisation. More information available at MedlinePlus.

Q. What is the generic name of Repatha? The generic name of Repatha is Evolocumab. It is a fully human anti-PCSK9 monoclonal antibody belonging to the PCSK9 inhibitor class of cholesterol-lowering medicines.

Q. How much does Repatha lower LDL cholesterol? Repatha reduces LDL-C by 50-60% on top of maximally tolerated statin therapy — enabling most patients to achieve guideline-recommended LDL-C targets of <55 mg/dL for very high cardiovascular risk.

Q. Is Repatha available in India? Repatha can be supplied to hospitals, cardiology centres, and pharmacies across India through licensed pharmaceutical distributors. Contact A.K. Pharma — medicine distributor in Delhi — for availability and pricing.

Q. What is the difference between Repatha and Sybrava? Both inhibit PCSK9 and reduce LDL-C by 50-60%. Repatha is a monoclonal antibody injected every 2 weeks or monthly while Sybrava (Inclisiran) is an siRNA that silences PCSK9 production — injected only twice yearly after initiation. Both have proven cardiovascular outcomes benefits.

Q. What is the price of Repatha in India? Repatha price in India varies by pack size. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.

Q. How to order Repatha from A.K. Pharma? You can request a quote directly from this page, call us at 011 4172 6999, or WhatsApp us at +91 9810034827 with your requirements and we will respond promptly.

Q. Does A.K. Pharma supply Repatha in bulk? Yes. A.K. Pharma supplies Repatha in bulk to hospitals, cardiology centres, and pharmacies across Delhi and India. Contact us for bulk pricing and availability.


Why Order Repatha from A.K. Pharma?

  • Licensed medicine distributor in Delhi with all required drug licenses
  • 100% genuine Repatha sourced from authorized Amgen distributors
  • Cold chain maintained throughout storage and delivery
  • Bulk supply available for hospitals and cardiology centres
  • Prompt response to all quote requests
  • Serving cardiologists and lipidologists across Delhi NCR and India

Contact A.K. Pharma for Repatha Supply 📍 E-2/257A, 2nd Floor, Shastri Nagar, New Delhi 110052 📞 011 4172 6999 📱 WhatsApp: +91 9810034827 🌐 akpharma.in

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