Praluent® (Alirocumab)

Praluent® (Alirocumab)

Description

Alirocumab 75mg/mL and 150mg/mL Injection — PCSK9 Inhibitor for Hypercholesterolemia and Cardiovascular Risk Reduction

Additional Information

Praluent® (Alirocumab) — PCSK9 Inhibitor for LDL Cholesterol Management

A Sourcing Guide for Hospitals and Cardiology Clinics

Praluent® (Alirocumab) is a human monoclonal antibody indicated, according to its approved prescribing information, as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL cholesterol. As with all lipid-lowering biologic therapies, the decision to prescribe Praluent, including patient selection and dose titration, rests entirely with the treating physician, in accordance with the approved label. This page provides sourcing and procurement information for hospitals and pharmacies, not clinical or treatment guidance.

As both a trusted medicine distributor in Delhi and a licensed pharmaceutical distributor in Delhi, A.K. Pharma supplies genuine Praluent (Alirocumab) to hospitals, cardiology clinics, and pharmacies across India, manufactured by Regeneron Pharmaceuticals and Sanofi. Hospitals managing broader cardiovascular risk reduction caseloads can also source companion medicines through A.K. Pharma’s full product range.


What is Praluent (Alirocumab)?

Praluent contains Alirocumab, a human IgG1 monoclonal antibody that targets proprotein convertase subtilisin kexin type 9 (PCSK9), a protein involved in regulating LDL cholesterol clearance from the bloodstream.

PCSK9’s Role in Cholesterol Regulation:

According to published cardiology and lipidology literature, LDL receptors (LDLR) on liver cell surfaces are responsible for clearing LDL cholesterol from the blood. PCSK9 binds to LDL receptors and promotes their degradation, reducing the number of receptors available to clear LDL cholesterol, which contributes to elevated blood LDL levels.

Alirocumab’s Mechanism: By binding to and inhibiting PCSK9, Alirocumab prevents PCSK9 from binding to LDL receptors, according to the manufacturer’s prescribing information. This preserves a greater number of LDL receptors on the liver cell surface, increasing LDL cholesterol clearance from the blood and lowering circulating LDL-C levels — a mechanism distinct from statins, which work primarily by inhibiting cholesterol synthesis in the liver, and complementary to therapies such as Repatha (Evolocumab), another PCSK9 inhibitor available from A.K. Pharma.

Full prescribing information is available at the FDA label for Alirocumab, with additional background on cholesterol management available via the American Heart Association and the National Lipid Association.


Clinical Studies and Evidence

ODYSSEY Outcomes Trial (Alirocumab in Post-Acute Coronary Syndrome)
Published in the New England Journal of Medicine (2018), the ODYSSEY Outcomes trial evaluated Alirocumab in patients with a recent acute coronary syndrome who remained on maximally tolerated statin therapy. Key findings demonstrated a significant reduction in major adverse cardiovascular events, including death from coronary heart disease, non-fatal myocardial infarction, fatal or non-fatal ischemic stroke, and unstable angina requiring hospitalisation, compared to placebo, supporting Alirocumab’s role in secondary cardiovascular prevention.

ODYSSEY FH I and FH II Trials (Alirocumab in Heterozygous Familial Hypercholesterolemia)
These trials evaluated Alirocumab in patients with heterozygous familial hypercholesterolemia inadequately controlled on maximally tolerated statin therapy, demonstrating significant LDL-C reductions compared to placebo, supporting its approval in this genetically-driven high cholesterol population.

For broader clinical guidance on lipid management and cardiovascular risk reduction, the American College of Cardiology (ACC) and European Society of Cardiology publish ongoing treatment guidelines.


Available Strengths

Praluent is supplied as:

PresentationStrengthAdministration
Praluent Pre-Filled Pen/Syringe75mg/mLSubcutaneous injection, once every 2 weeks
Praluent Pre-Filled Pen/Syringe150mg/mLSubcutaneous injection, once every 2 weeks

The starting dose is typically 75mg every 2 weeks, with titration to 150mg every 2 weeks if LDL-C response is inadequate, per the approved prescribing information.


Indications — What Praluent is Used For

Primary Hyperlipidemia, Including Heterozygous Familial Hypercholesterolemia:

  • As an adjunct to diet and maximally tolerated statin therapy, for additional LDL cholesterol lowering in adults with HeFH

Clinical Atherosclerotic Cardiovascular Disease (ASCVD):

  • As an adjunct to diet and maximally tolerated statin therapy, for additional LDL cholesterol lowering in adults with established ASCVD

Reduction of Cardiovascular Risk:

  • To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalisation in adults with established cardiovascular disease

For detailed indication information refer to MedlinePlus Alirocumab and the Familial Hypercholesterolemia Foundation.


Key Benefits of Praluent

Demonstrated Cardiovascular Outcome Benefit
The ODYSSEY Outcomes trial demonstrated a significant reduction in major adverse cardiovascular events in patients following a recent acute coronary syndrome, providing outcome-level evidence beyond LDL-C reduction alone.

Effective in Genetically-Driven High Cholesterol
For patients with heterozygous familial hypercholesterolemia who often do not achieve adequate LDL-C control with statins alone, Praluent provides a targeted additional treatment pathway.

Two Dosing Strengths for Flexible Titration
Available in both 75mg and 150mg strengths, allowing physicians to titrate therapy based on individual LDL-C response, per the approved label.

Convenient Biweekly Dosing
Administered once every 2 weeks via self-administered subcutaneous injection, offering a more infrequent dosing schedule compared to daily oral lipid-lowering therapies.


Dosage and Administration — General Reference

Dosing of Praluent is determined by the prescribing physician according to the approved label. General administration information from the manufacturer’s prescribing information includes:

  • Administered as a subcutaneous injection into the thigh, abdomen, or upper arm
  • Starting dose typically 75mg every 2 weeks, with titration to 150mg every 2 weeks if needed, based on LDL-C response assessed 4 to 8 weeks after initiation or dose adjustment
  • Allow the pre-filled pen or syringe to warm to room temperature for 30 to 40 minutes before injection
  • Visually inspect for particulate matter and discoloration before use

Monitoring (per manufacturer prescribing information):

  • LDL-C level assessment 4 to 8 weeks after initiating or adjusting therapy, to determine response and need for further dose adjustment
  • Monitoring for hypersensitivity reactions, given reported allergic reactions with this therapeutic class
  • General cardiovascular risk factor monitoring as part of comprehensive lipid management

Full dosing guidelines are available in the manufacturer’s official prescribing information and should always be followed exactly as directed by the treating physician.


Who Should Use Praluent

Praluent is prescribed by cardiologists, lipidologists, and physicians managing cardiovascular risk for:

  • Adults with heterozygous familial hypercholesterolemia inadequately controlled on maximally tolerated statin therapy
  • Adults with established atherosclerotic cardiovascular disease requiring additional LDL-C lowering
  • Adults with established cardiovascular disease where reduction of cardiovascular event risk is a treatment goal

Praluent is prescribed as an adjunct to diet and statin therapy, not as a replacement. A.K. Pharma supplies Praluent to hospitals and cardiology clinics across Delhi and India.


Possible Side Effects

Common side effects reported in clinical trials include injection site reactions, nasopharyngitis, and influenza.

Serious side effects include:

Hypersensitivity Reactions: Allergic reactions, including hypersensitivity vasculitis, have been reported; discontinuation may be required for severe hypersensitivity reactions, per the approved prescribing information.

Injection Site Reactions: Reported commonly, generally mild to moderate in severity.

Neurocognitive Events: Some post-marketing surveillance has monitored for reported neurocognitive events associated with PCSK9 inhibitor therapy as a class.

Full side effect information is available at FDA Alirocumab Safety Information.


Precautions

  • Hypersensitivity reactions — monitor for signs of allergic reaction; discontinue if severe hypersensitivity occurs
  • Not a substitute for statin therapy — used as an adjunct to diet and maximally tolerated statin therapy, per approved label
  • Effect on cardiovascular morbidity and mortality in patients without established cardiovascular disease has not been fully determined for all populations
  • Severe hepatic impairment — limited data available; use per physician assessment
  • Pregnancy — use per physician assessment of benefit versus risk, in accordance with the approved label
  • Refer to manufacturer prescribing information and ACC/AHA cholesterol management guidelines for complete management context

Storage and Handling

  • Store in a refrigerator (2°C to 8°C)
  • Do not freeze
  • Protect from light
  • Keep out of reach of children

As a responsible medicine distributor in Delhi, A.K. Pharma stores all cardiology biologics including Praluent under manufacturer-recommended cold chain conditions ensuring product integrity for every supply.


Manufacturer Information

Praluent (Alirocumab) is manufactured by Regeneron Pharmaceuticals and Sanofi. Alirocumab received FDA approval in July 2015 as the first PCSK9 inhibitor approved in the United States, with subsequent approval for cardiovascular risk reduction following the ODYSSEY Outcomes trial. A.K. Pharma supplies only genuine Praluent sourced from authorised distributors. Learn more about Sanofi’s cardiovascular portfolio directly from the manufacturer.


Related Cardiology Medicines Available at A.K. Pharma


Frequently Asked Questions

Q. What is Praluent used for?
Praluent (Alirocumab) is used as an adjunct to diet and maximally tolerated statin therapy to lower LDL cholesterol in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease, and to reduce cardiovascular event risk in patients with established cardiovascular disease.

Q. What is the generic name and strength of Praluent?
The generic name of Praluent is Alirocumab, available in 75mg/mL and 150mg/mL pre-filled pen or syringe strengths, manufactured by Regeneron Pharmaceuticals and Sanofi.

Q. How is Praluent different from statins?
Statins lower cholesterol primarily by inhibiting cholesterol synthesis in the liver, while Praluent works by inhibiting PCSK9, preserving LDL receptors on liver cells to increase clearance of LDL cholesterol from the blood — a complementary rather than replacement mechanism, used alongside statin therapy.

Q. How often is Praluent administered?
Praluent is administered as a subcutaneous injection once every 2 weeks, starting at 75mg with potential titration to 150mg based on LDL-C response.

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

Q. What is the price of Praluent in India?
Praluent price in India varies by strength and 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 Praluent 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 Praluent in bulk?
Yes. A.K. Pharma supplies Praluent in bulk to hospitals and cardiology clinics across Delhi and India.


Why Order Praluent from A.K. Pharma?

  • Licensed medicine distributor in Delhi and pharmaceutical distributor in Delhi with all required drug licenses
  • 100% genuine Praluent sourced from authorised Regeneron/Sanofi distributors
  • Both 75mg and 150mg strengths available
  • Cold chain-compliant storage and delivery for biologic integrity
  • Available alongside companion cardiology medicines — Repatha, Sybrava, Vymada — simplifying procurement
  • Bulk supply available for hospitals and cardiology clinics
  • Prompt response to all quote requests
  • Serving cardiologists and lipidologists across Delhi NCR and India

Contact A.K. Pharma for Praluent Supply

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


Disclaimer: This page is intended for informational and sourcing/procurement purposes only and does not constitute medical or clinical advice. All treatment decisions, including drug selection and dosing, should be made by a qualified healthcare professional in accordance with the approved prescribing information. A.K. Pharma is a licensed medicine distributor and does not provide clinical guidance.

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