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 PCSK9 inhibitor (siRNA) presented as a 284 mg/1 mL solution for injection use. It treats primary hypercholesterolemia (heterozygous familial hypercholesterolemia) and mixed dyslipidemia as an adjunct to diet and statins.

GNH India supplies Leqvio as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies, clinics, research institutions and procurement teams worldwide, providing reliable sourcing, regulatory support and cold‑chain logistics where required.

Manufacturer / TM Owner

Novartis Europharm Limited

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Indications & Clinical Uses

Leqvio is indicated for lipid‑lowering therapy in patients with elevated LDL‑cholesterol.

  • Primary hypercholesterolemia (heterozygous familial hypercholesterolemia): reduces LDL‑cholesterol as an adjunct to diet and statins.
  • Mixed dyslipidemia: lowers LDL‑cholesterol levels when added to standard therapy.

How It Works

  • Inclisiran is a small interfering RNA (siRNA) that specifically binds to messenger RNA encoding proprotein convertase subtilisin/kexin type 9 (PCSK9) in hepatocytes. By promoting degradation of PCSK9 mRNA, it reduces hepatic synthesis of PCSK9 protein, leading to decreased PCSK9‑mediated degradation of LDL receptors. The increased recycling of LDL receptors on liver cells enhances clearance of LDL‑cholesterol from the bloodstream, resulting in sustained LDL‑cholesterol reduction.

Side Effects

Leqvio may be associated with adverse reactions following subcutaneous administration.

Common Side Effects

  • Injection site reactions: pain, erythema or swelling at the injection site.
  • Nasopharyngitis: mild upper respiratory tract infection symptoms.
  • Headache: transient mild to moderate headache.
  • Diarrhoea: occasional loose stools.

Serious or Rare Side Effects

  • Severe hypersensitivity: anaphylaxis or angioedema requiring immediate medical attention.
  • Hepatic enzyme elevation: significant increase in ALT or AST levels.
  • Cardiovascular events: rare reports of myocardial infarction or stroke.

Precautions & Warnings

When prescribing Leqvio, clinicians should consider several precautionary measures to ensure safe use.

  • Assess baseline LDL‑cholesterol: evaluate lipid profile before initiating therapy.
  • Monitor hepatic function: check ALT/AST periodically during treatment.
  • Evaluate for hypersensitivity: inquire about prior allergic reactions to injectable medicines.
  • Use with statins cautiously: consider potential additive effects on liver enzymes.
  • Pregnancy and lactation: avoid use as safety data are insufficient.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Leqvio can interact with other medicines, primarily affecting lipid management and hepatic safety.

Major Interactions (Avoid)

  • PCSK9 monoclonal antibodies: concurrent use offers no additional LDL‑cholesterol benefit and may increase injection burden.
  • High‑dose statins with known hepatotoxicity: combined risk of liver enzyme elevation.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (warfarin, DOACs): monitor INR or bleeding risk as lipid changes may affect coagulation.
  • Immunosuppressants: observe for altered immune response.
  • Vaccines: schedule administration separately to avoid confounding injection site reactions.

Frequently Asked Questions

Leqvio is prescribed as an adjunct to diet and statin therapy for adults with primary hypercholesterolemia (heterozygous familial hypercholesterolemia) or mixed dyslipidemia. It helps lower low‑density lipoprotein cholesterol (LDL‑C) levels, reducing cardiovascular risk when used as part of a comprehensive lipid‑management plan.

Inclisiran is a small interfering RNA that targets the messenger RNA for PCSK9 in liver cells. By degrading this mRNA, it reduces the production of the PCSK9 protein, which normally promotes degradation of LDL receptors. Fewer PCSK9 molecules allow more LDL receptors to recycle to the cell surface, increasing clearance of LDL‑C from the bloodstream.

The dosing regimen for Leqvio is determined by the prescribing clinician based on the patient’s clinical profile and local guidelines. Typically, a single subcutaneous injection is administered at the start of therapy, followed by a second dose three months later, and then maintenance doses every six months, but the exact schedule must be confirmed by the prescriber.

Safety data for Inclisiran in pregnant or lactating women are limited, and the product is classified as having an unknown pregnancy category. Consequently, Leqvio should be avoided during pregnancy and breastfeeding unless the potential benefit justifies the potential risk, and the decision should be made by a qualified healthcare professional.

To request Leqvio, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details—including cold‑chain handling where required—and assistance with import documentation.

Leqvio (inclisiran) is a siRNA‑based PCSK9 inhibitor, whereas agents such as evolocumab and alirocumab are monoclonal antibodies. All lower LDL‑C by reducing PCSK9 activity, but Leqvio’s dosing interval is longer (initial dose, 3‑month follow‑up, then every six months), potentially improving adherence compared with bi‑weekly or monthly antibody injections.

Leqvio must be stored refrigerated at 2 °C to 8 °C. Keep the vial in its original packaging, protect it from light, and avoid freezing or shaking. If temporary exposure to higher temperatures occurs, discard the product as potency may be compromised.

Leqvio is given as a subcutaneous injection into the abdomen, thigh, or upper arm by a qualified healthcare professional. The injection is performed using a pre‑filled syringe or autoinjector, following the dosing schedule prescribed by the clinician, typically beginning with a loading dose, a second dose at three months, and then maintenance doses every six months.

The most serious adverse events reported with Leqvio include severe hypersensitivity reactions such as anaphylaxis or angioedema, significant elevations in liver enzymes (ALT/AST), and rare cardiovascular events like myocardial infarction or stroke. Patients should be monitored for these reactions, and any signs of severe allergy or liver dysfunction require immediate medical evaluation.

Leqvio is contraindicated in individuals with known hypersensitivity to inclisiran or any excipients in the formulation. It should also be avoided in pregnant or breastfeeding women, patients with severe active liver disease, and those who have experienced serious adverse reactions to prior PCSK9‑targeted therapies. Clinicians must assess each patient’s medical history before initiating treatment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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