Inclisiran: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Myanmar prescribing information.

Generic Medicine Info

Indications and Dosage

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.

Special Precautions

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.

Adverse Reactions

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.

Pregnancy Category (US FDA)

SC: Z (Avoid)

Monitoring Parameters

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).

Action

Description: 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.

Storage

Store between 20-25°C. Do not freeze.

MIMS Class

Dyslipidaemic Agents

ATC Classification

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

References

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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