Thông tin thuốc của Inclisiran

Thông tin này không áp dụng cho tất cả các quốc gia. Vui lòng tham khảo thông tin kê toa lưu hành tại Việt Nam.

Thông tin thuốc gốc

Chỉ định và Liều dùng

Subcutaneous
Heterozygous familial hypercholesterolaemia, Mixed dyslipidaemia, Nonfamilial hypercholesterolaemia

Adult: Adjunct to diet: In combination with a statin or statin with other lipid-lowering treatments in patients unable to reach LDL-cholesterol (LDL-C) goals using maximum tolerated statin dose, or alone or in combination with other lipid-lowering treatments in statin-intolerant patients or when a statin is contraindicated: Initially, 284 mg as a single SC inj, repeated after 3 months, then every 6 months thereafter. Missed dose: <3 months from scheduled dose: Administer the dose as soon as possible then continue as originally scheduled; >3 months from scheduled dose: Skip the missed dose and restart with a new dosing schedule.

Subcutaneous
Cardiovascular risk reduction

Adult: Adjunct to diet and maximally tolerated statin treatment in patients with atherosclerotic CV disease who need additional reduction of LDL-C: Initially, 284 mg as a single SC inj, repeated after 3 months, then every 6 months thereafter. Missed dose: <3 months from scheduled dose: Administer the dose as soon as possible then continue as originally scheduled; >3 months from scheduled dose: Skip the missed dose and restart with a new dosing schedule. Treatment recommendations may vary among countries. Consider local treatment guidelines on the appropriate use or recommendations.

Thận trọng

Avoid performing haemodialysis for at least 72 hours following inclisiran dosing. Severe renal and hepatic impairment. There are no or limited data for the use of inclisiran in pregnant women; as a precaution, preferably avoid use during pregnancy. Lactation.

Tác dụng không mong muốn

Cardiac disorders: Angina pectoris.
Gastrointestinal disorders: Diarrhoea.
General disorders and administration site conditions: Inj site reactions (e.g. pain, rash, erythema).
Immune system disorders: Antibody development.
Metabolism and nutrition disorders: Diabetes mellitus.
Musculoskeletal and connective tissue disorders: Arthralgia, back pain, pain in extremity.
Nervous system disorders: Headache, dizziness.
Renal and urinary disorders: UTI.
Respiratory, thoracic and mediastinal disorders: Bronchitis, nasopharyngitis, cough, dyspnoea.

Phân loại thai kỳ (US FDA)

SC: Z (Avoid)

Chỉ số theo dõi

Obtain fasting or non-fasting lipid profile prior to treatment initiation. Monitor fasting lipid profile 4-12 weeks after therapy initiation and every 3-12 months thereafter; LDL-C 30 days after starting therapy and anytime thereafter (regardless of the timing of the dose).

Tác dụng

Description:
Mechanism of Action: Inclisiran is a cholesterol-lowering, double-stranded, small interfering ribonucleic acid (siRNA), conjugated on the sense strand with triantennary N-acetylgalactosamine (GalNAc) to enable uptake by hepatocytes. In hepatocytes, it uses the RNA interference mechanism and directs the catalytic breakdown of proprotein convertase subtilisin kexin type 9 (PCSK9) messenger RNA (mRNA). This activity increases the LDL-C receptor recycling and expression on the hepatocyte cell surface, thereby increasing the LDL-C uptake and decreasing the levels of LDL-C in the circulation.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: Approx 4 hours.
Distribution: Apparent volume of distribution: Approx 500 L. Plasma protein binding: 87%.
Metabolism: Metabolised mainly by nucleases to form shorter inactive nucleotides of varying lengths.
Excretion: Via urine (approx 16%). Terminal elimination half-life: Approx 9 hours.

Bảo quản

Store between 20-25°C. Do not freeze.

Phân loại MIMS

Thuốc trị rối loạn lipid máu

Phân loại ATC

C10AX16 - inclisiran ; Belongs to the class of other lipid modifying agents.

Tài liệu tham khảo

Anon. Inclisiran. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/06/2022.

Buckingham R (ed). Inclisiran. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/06/2022.

Joint Formulary Committee. Inclisiran. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/06/2022.

Leqvio 284 mg Solution for Injection in Pre-filled Syringe (Novartis Pharmaceuticals UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 06/06/2022.

Leqvio Injection, Solution (Novartis Pharmaceuticals Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 06/06/2022.

Leqvio Solution for Injection in Pre-filled Syringe 284 mg/1.5 mL (Novartis Pharmaceuticals [HK] Ltd). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 06/06/2022.

Sybrava 284 mg/1.5 mL Solution for Injection in Pre-filled Syringe (Novartis Corporation [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/06/2022.

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