Valid Ghana · FDA Ghana

SYBRAVA 248mg/1.5ml SOLUTION FOR INJECTION

inclisiran

FDA/SD.245-081333 inclisiran 284 mg cardiovascular system INN generic

What it does

Inclisiran is a medication used to lower cholesterol levels in the blood.

Commonly used for: high cholesterol (hyperlipidemia), familial hypercholesterolemia

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/SD.245-081333
Registration date
2024-09-18
Expiry date
2029-11-01
Status
Valid
Active ingredient
inclisiran
Dosage form
inclisiran
Strength
284 mg
Pack size
-
Therapeutic class
-
ATC class (WHO)
C10AX - Other lipid modifying agents
RxNorm RxCUI
2588243
Manufacturer / MAH
Corden Pharma
Country of origin
-
Manufacturer location
Viale dell'Industria, 3, 20867 Caponago MB, Italy

Source: Food and Drugs Authority · fetched 2026-04-18 08:33:09 · updated 2026-09-18 04:00:07

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Inclisiran is a medication used to lower cholesterol levels in the blood.

What it treats

  • high cholesterol (hyperlipidemia)
  • familial hypercholesterolemia

How it works

Inclisiran helps the body reduce the amount of cholesterol produced in the liver.

Who it's for

This medication is for adults who have high cholesterol levels and need additional help to manage it.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Inclisiran

BNF-referenced

Inclisiran is a small interfering RNA that targets and inhibits the production of proprotein convertase subtilisin/kexin type 9 (PCSK9). By reducing PCSK9 levels, Inclisiran enhances the ability of the liver to clear low-density lipoprotein (LDL) cholesterol from the bloodstream, thereby effectively lowering LDL cholesterol levels. It is administered via subcutaneous injection and is used primarily in the management of hyperlipidaemia, particularly in patients with familial hypercholesterolaemia.

Indications

  • Primary hypercholesterolaemia
  • Mixed dyslipidaemia
  • Homozygous familial hypercholesterolaemia

Dosage

Children: null

Adults: 420 mg every 2 weeks, or for specific cases, 284 mg initially for 1 dose, followed by 284 mg after 3 months for 1 dose, then 284 mg every 6 months.

Mechanism of action

Inclisiran acts by interfering with the messenger RNA (mRNA) for PCSK9, leading to a decrease in PCSK9 protein production. This action results in increased uptake of LDL cholesterol by the liver and a reduction in circulating LDL cholesterol levels. The inhibition of PCSK9 enhances the recycling of LDL receptors, which further contributes to lowering LDL cholesterol in the bloodstream.

Pharmacodynamics

The pharmacodynamic effects of Inclisiran include significant reductions in LDL cholesterol levels, observed within weeks of administration. The drug's effects are sustained over time, with maintenance doses leading to persistent reductions in LDL cholesterol. The efficacy of Inclisiran can be seen in various patient populations, including those with familial hypercholesterolaemia and those at high cardiovascular risk.

Pharmacokinetics

Inclisiran is administered subcutaneously, with peak plasma concentrations occurring approximately 2 to 4 hours post-injection. It has a long half-life, allowing for less frequent dosing. The drug is primarily eliminated by the liver, with renal excretion playing a minimal role in its pharmacokinetics. The pharmacokinetic profile is not significantly altered in patients with liver or renal impairment, but caution is advised in severe cases.

Contra-indications

  • Hypersensitivity to inclisiran or any excipients
  • Severe hepatic impairment
  • Severe renal impairment

Adverse effects

  • Arthralgia
  • Back pain
  • Increased risk of infection
  • Nausea
  • Skin reactions
  • Influenza-like illness
  • Angioedema

Precautions

  • Caution in patients with moderate hepatic impairment
  • Caution in patients with moderate to severe renal impairment
  • Patients should be trained in subcutaneous injection technique

Pregnancy

Avoid unless potential benefit outweighs risk-limited information available.

Breast-feeding

Avoid-present in milk in animal studies.

Storage

Store in a refrigerator (2–8°C)-consult product literature for further information regarding storage outside refrigerator.

Formulations

  • Solution for injection
BNF 85 (British National Formulary) p.247 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.