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 small interfering RNA (siRNA) therapeutic presented as a 284 mg/1 mL solution for subcutaneous injection. It is indicated for lowering low‑density lipoprotein cholesterol in adults with heterozygous familial hypercholesterolemia, clinical atherosclerotic cardiovascular disease, or primary hypercholesterolemia.

GNH India supplies Leqvio as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing products that meet EU regulatory standards.

Manufacturer / TM Owner

Novartis Europharm Limited

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Indications & Clinical Uses

Leqvio acts on the PCSK9 pathway to provide additional LDL‑cholesterol reduction for patients with established lipid disorders.

  • Heterozygous familial hypercholesterolemia: reduces LDL‑cholesterol levels when added to statin therapy.
  • Clinical atherosclerotic cardiovascular disease: provides further LDL‑cholesterol lowering to help lower cardiovascular risk.
  • Primary hypercholesterolemia: lowers LDL‑cholesterol in patients requiring additional lipid reduction beyond standard therapy.

How It Works

  • Inclisiran utilizes RNA interference to silence hepatic PCSK9 gene expression. By binding to PCSK9 messenger RNA, it prevents translation of the PCSK9 protein, which normally promotes degradation of LDL receptors. Reduced PCSK9 levels increase recycling of LDL receptors on hepatocyte surfaces, enhancing clearance of LDL‑cholesterol from the bloodstream.

Side Effects

Leqvio is generally well tolerated, but adverse reactions can occur.

Common Side Effects

  • Injection site pain or erythema.
  • Nasopharyngitis.
  • Headache.
  • Diarrhea.
  • Fatigue.

Serious or Rare Side Effects

  • Severe allergic reactions (anaphylaxis, angioedema).
  • Persistent elevation of liver enzymes.
  • Unexplained muscle pain or weakness that may indicate rhabdomyolysis.

Precautions & Warnings

Leqvio requires careful consideration of patient-specific factors before initiation.

  • Pregnancy: safety not established; avoid unless benefits outweigh risks.
  • Breastfeeding: unknown safety; consider potential effects on the infant.
  • Renal impairment: use with caution; monitor renal function.
  • Hepatic impairment: no dose adjustment required, but monitor liver enzymes.
  • Concomitant lipid‑lowering therapy: assess for additive LDL reduction and potential muscle symptoms.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Leqvio may interact with other therapies that affect lipid metabolism or immune function.

Major Interactions (Avoid)

  • Live vaccines: avoid simultaneous administration as immune response may be altered.
  • Strong immunosuppressants: may diminish therapeutic effect of inclisiran.

Moderate Interactions (Monitor Closely)

  • Statins: monitor for additive LDL‑cholesterol reduction and possible muscle-related side effects.
  • PCSK9 monoclonal antibodies: concurrent use generally not recommended; evaluate clinical necessity.
  • Anticoagulants: observe for any changes in bleeding risk when combined with lipid‑lowering therapy.

Frequently Asked Questions

Leqvio is prescribed to lower low‑density lipoprotein (LDL) cholesterol in adults with heterozygous familial hypercholesterolemia, clinical atherosclerotic cardiovascular disease, or primary hypercholesterolemia, typically as an adjunct to statin therapy.

Inclisiran is a small interfering RNA that targets the messenger RNA for proprotein convertase subtilisin/kexin type 9 (PCSK9) in liver cells. By silencing PCSK9 production, it increases the number of LDL receptors on hepatocytes, enhancing removal of LDL‑cholesterol from the bloodstream.

The dose of Leqvio is determined by the prescribing clinician. It is administered as a subcutaneous injection, and the prescribing information specifies the interval and amount based on the individual patient's clinical needs.

Safety of Leqvio during pregnancy and lactation has not been established. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, and the decision must be made by the treating physician.

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, and will request trade or institutional credentials before providing pricing, availability, shipping details (including cold‑chain if needed) and import documentation.

Leqvio belongs to the siRNA class that reduces PCSK9 synthesis, offering a dosing schedule that may be less frequent than monoclonal antibody PCSK9 inhibitors. Both classes lower LDL‑cholesterol, but inclisiran’s mechanism is intracellular gene silencing, whereas antibodies bind circulating PCSK9 protein.

Leqvio should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. Keep the product in its original packaging until use to maintain stability.

Leqvio is given as a subcutaneous injection into the abdomen, thigh, or upper arm. The injection is performed by a qualified healthcare professional according to the dosing schedule prescribed by the treating physician.

Serious adverse events include severe allergic reactions such as anaphylaxis or angioedema, significant elevations in liver enzymes, and rare cases of muscle injury that could indicate rhabdomyolysis. Patients should seek immediate medical attention if they experience symptoms of these conditions.

Leqvio is contraindicated in individuals with known hypersensitivity to inclisiran or any component of the formulation. Caution is also advised for patients with uncontrolled liver disease, and it should not be used in pregnancy or lactation unless the benefits outweigh the risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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