Product image of Leqvio (Inclisiran) supplied by GNH India

Leqvio

Active Ingredient:
Inclisiran
Origin:
EU

Leqvio (Inclisiran)

Inclisiran, the active ingredient in Leqvio, is a siRNA therapeutic presented as a subcutaneous injection for subcutaneous use. It lowers LDL‑cholesterol in adults with primary hypercholesterolemia, heterozygous familial hypercholesterolemia, or mixed dyslipidemia, typically as an adjunct to diet and statin therapy.

GNH India supplies Leqvio as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Novartis Europharm Limited

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Indications & Clinical Uses

  • Leqvio is a lipid‑lowering agent that targets elevated LDL‑cholesterol across several dyslipidemic conditions.
  • Primary hypercholesterolemia: reduces LDL‑cholesterol levels when added to diet and statin therapy.
  • Heterozygous familial hypercholesterolemia: provides additional LDL‑cholesterol reduction in genetically predisposed patients.
  • Mixed dyslipidemia: improves overall lipid profile as part of a comprehensive cardiovascular risk‑reduction strategy.

How It Works

  • Inclisiran is a small interfering RNA that binds specifically to hepatic PCSK9 messenger RNA, leading to its degradation. By decreasing PCSK9 protein synthesis, the drug enhances recycling of LDL receptors on liver cells, which increases clearance of LDL‑cholesterol from the bloodstream and results in sustained reductions in plasma LDL‑cholesterol concentrations.

Side Effects

Leqvio is generally well tolerated, but adverse reactions have been reported.

Common Side Effects

  • Injection site pain or erythema.
  • Mild headache.
  • Upper respiratory tract infection symptoms.
  • Transient increase in liver enzymes.
  • Fatigue.
  • Nausea.

Serious or Rare Side Effects

  • Severe allergic reactions (anaphylaxis, angioedema).
  • Persistent injection site reactions (abscess, cellulitis).
  • Significant hepatic injury.
  • Unexplained hypotension.
  • Immune-mediated thrombocytopenia.

Precautions & Warnings

  • Before initiating therapy, clinicians should evaluate patient suitability and monitor for potential risks.
  • Pregnancy and lactation: use only if the potential benefit justifies the potential risk to the fetus or infant.
  • Renal impairment: assess renal function; dose adjustment may be required.
  • Hepatic disease: monitor liver enzymes regularly.
  • Concomitant statin therapy: watch for additive muscle-related symptoms.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Inclisiran may interact with other agents that affect lipid metabolism or immune response.

Major Interactions (Avoid)

  • Concurrent use of strong PCSK9‑targeting monoclonal antibodies (may lead to excessive LDL‑cholesterol lowering).
  • Live vaccines administered within 4 weeks of injection (potentially reduced vaccine efficacy).

Moderate Interactions (Monitor Closely)

  • Statins (monitor for muscle toxicity).
  • CYP‑modulating drugs (although inclisiran is not metabolized by CYP enzymes, monitor overall lipid‑lowering effect).
  • Anticoagulants (watch for bleeding if severe injection site reactions occur).

Frequently Asked Questions

Leqvio is indicated for adults with primary hypercholesterolemia, heterozygous familial hypercholesterolemia, or mixed dyslipidemia, particularly when additional LDL‑cholesterol reduction is needed alongside diet, statins, or other lipid‑lowering therapies.

Inclisiran is a small interfering RNA that specifically binds to PCSK9 messenger RNA in liver cells, causing its degradation. Reduced PCSK9 protein leads to increased recycling of LDL receptors, which enhances removal of LDL‑cholesterol from the bloodstream, resulting in sustained cholesterol lowering.

The dosing schedule for Leqvio is determined by the prescribing healthcare professional. Typically, the medication is administered by subcutaneous injection at intervals recommended by the prescriber based on the patient’s clinical profile and treatment goals.

Safety data for inclisiran in pregnancy and lactation are limited. The drug should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant, and the decision should be made by a qualified healthcare provider.

To order Leqvio, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain handling if needed) and required import documentation.

Leqvio (inclisiran) uses RNA interference to reduce PCSK9 production, whereas monoclonal antibodies bind circulating PCSK9 protein. Both lower LDL‑cholesterol, but inclisiran is administered less frequently (typically twice yearly) and may offer a different safety and convenience profile compared with antibody therapies that require more frequent dosing.

Leqvio should be stored at 2‑8 °C (refrigerated). Keep the product in its original packaging, protect it from light, and avoid freezing or shaking the vial to maintain stability and potency.

Leqvio is given as a subcutaneous injection, usually performed by a healthcare professional. The injection is administered into the abdomen or thigh, following the dosing schedule prescribed by the treating clinician.

Serious risks include severe allergic reactions such as anaphylaxis or angioedema, persistent injection‑site infections, significant liver enzyme elevations, and rare immune‑mediated conditions like thrombocytopenia. Patients should be monitored for these events and seek immediate medical attention if they occur.

Leqvio is contraindicated in individuals with known hypersensitivity to inclisiran or any of its excipients. Patients with uncontrolled severe liver disease, active infections at the injection site, or those who cannot receive subcutaneous injections should avoid using this medication.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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