GNH USA

Europe — EMA

Leqvio

GNH USA supplies Leqvio (Inclisiran), a PCSK9 inhibitor for heterozygous familial hypercholesterolemia, primary hypercholesterolemia and mixed dyslipidemia.

Inclisiran

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What is Inclisiran?

Inclisiran, the active ingredient in Leqvio, is a PCSK9 inhibitor (siRNA) presented as a 284 mg injectable solution (prefilled syringe) for subcutaneous use. It treats heterozygous familial hypercholesterolemia, primary hypercholesterolemia and mixed dyslipidemia in adults. GNH USA supplies Leqvio as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality and regulatory compliance across markets.

What is Inclisiran used for?

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

- Heterozygous familial hypercholesterolemia: reduces LDL‑cholesterol levels when added to statin therapy. - Primary hypercholesterolemia: lowers LDL‑cholesterol in patients at high cardiovascular risk. - Mixed dyslipidemia: improves lipid profile by decreasing LDL‑cholesterol alongside other lipid parameters.

What are the side effects of Inclisiran?

Leqvio may be associated with adverse reactions, most of which are mild to moderate.

Common Side Effects: - Injection site reactions: pain, erythema, or swelling at the injection site. - Nasopharyngitis: mild upper respiratory tract infection symptoms. - Headache: transient mild headache. - Diarrhea: occasional loose stools.

Serious or Rare Side Effects: - Allergic reactions: urticaria, angioedema, or anaphylaxis. - Hepatic enzyme elevation: increased ALT or AST levels. - Severe injection site necrosis: rare tissue damage at injection site. - Immune-mediated events: rare systemic hypersensitivity responses.

What precautions apply to Inclisiran?

When prescribing Leqvio, clinicians should consider several safety and handling precautions.

- Cardiovascular monitoring: assess LDL‑cholesterol response and overall risk. - Concomitant statin therapy: continue statins as recommended to maximize LDL reduction. - Pregnancy and lactation: avoid use as safety has not been established. - Renal impairment: use with caution in patients with severe renal dysfunction. - Hepatic disease: monitor liver enzymes in patients with existing liver conditions. - Store at 2-8 °C: keep refrigerated, protect from light, do not freeze or shake.

What does Inclisiran interact with?

Leqvio can interact with other medicines, primarily affecting lipid management and immune response.

Major Interactions (Avoid): - PCSK9 monoclonal antibodies: concurrent use may lead to redundant PCSK9 inhibition. - Live vaccines: potential altered immune response; avoid simultaneous administration.

Moderate Interactions (Monitor Closely): - Statins: monitor for additive LDL‑cholesterol lowering and rare myopathy. - Cytochrome P450 substrates: no direct effect, but monitor if hepatic function is compromised. - Anticoagulants: observe for any changes in coagulation parameters.

Frequently asked questions

What is Leqvio used for?+
Leqvio is prescribed to lower low‑density lipoprotein cholesterol (LDL‑C) in adults with heterozygous familial hypercholesterolemia, primary hypercholesterolemia, or mixed dyslipidemia, often as an adjunct to statin therapy to reduce cardiovascular risk.
How does Inclisiran work?+
Inclisiran is a small interfering RNA that specifically binds to the messenger RNA that codes for PCSK9 in liver cells. By degrading this mRNA, it reduces PCSK9 protein production, allowing more LDL receptors to recycle to the cell surface and clear LDL‑C from the blood.
What is the usual dose of Leqvio?+
The prescribed dose of Leqvio is determined by the treating physician. Typically, a single 284 mg subcutaneous injection is administered, followed by a second dose three months later and then every six months thereafter, but exact scheduling is individualized.
Is Leqvio safe in pregnancy or breastfeeding?+
Safety of Leqvio during pregnancy and lactation has not been established. It is generally advised to avoid use in pregnant or nursing women unless the potential benefit justifies the potential risk, and decisions should be made by a qualified healthcare professional.
How do I order Leqvio from GNH USA?+
To order Leqvio, submit an enquiry on the product page at gnh-usa.com specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, cold‑chain shipping details and necessary import documentation.
How does Leqvio compare with other PCSK9 inhibitors?+
Leqvio uses siRNA technology to silence PCSK9 production, offering dosing only twice yearly after the initial loading period, whereas monoclonal antibody PCSK9 inhibitors require injections every two to four weeks. Both classes lower LDL‑C, but Leqvio’s infrequent dosing may improve adherence for some patients.
How should Leqvio be stored and handled?+
Leqvio must be stored refrigerated between 2 °C and 8 °C. Keep the prefilled syringe in its original packaging, protect it from light, and do not freeze or shake the product. If temporary temperature excursions occur, consult the product label before use.
How is Leqvio administered?+
Leqvio is given as a subcutaneous injection using the prefilled syringe provided. The injection is typically performed by a healthcare professional in a clinical setting. The recommended injection sites are the abdomen or thigh, rotating sites with each administration.
What are the most serious risks to watch for?+
Serious adverse events associated with Leqvio include severe allergic reactions such as anaphylaxis, significant injection‑site necrosis, and marked elevations in liver enzymes. Patients should be monitored for signs of hypersensitivity, persistent injection‑site problems, or abnormal liver function tests.
Who should not use Leqvio?+
Leqvio should not be used in individuals with known hypersensitivity to inclisiran or any component of the formulation. It is also contraindicated in pregnant or breastfeeding women until safety is established, and caution is advised in patients with severe hepatic impairment.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Inclisiran
Route
Subcutaneous Use
Manufacturer
Novartis Europharm Limited
Origin
EU

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