Primary hypercholesterolaemia

Active Ingredient: Inclisiran

Indication for Inclisiran

Population group: only adults (18 years old or older)

Inclisiran is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

  • in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or
  • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

For this indication, competent medicine agencies globally authorize below treatments:

284 mg once every 3-6 months

Route of admnistration

Subcutaneous

Defined daily dose

284 - 284 mg

Dosage regimen

From 284 To 284 mg once every 90 day(s)

Detailed description

The recommended dose is 284 mg inclisiran administered as a single subcutaneous injection: initially, again at 3 months, followed by every 6 months.

Missed doses

If a planned dose is missed by less than 3 months, inclisiran should be administered and dosing continued according to the patient’s original schedule.

If a planned dose is missed by more than 3 months, a new dosing schedule should be started – inclisiran should be administered initially, again at 3 months, followed by every 6 months.

Treatment transition from monoclonal antibody PCSK9 inhibitors

Inclisiran can be administered immediately after the last dose of a monoclonal antibody PCSK9 inhibitor. To maintain LDL-C lowering it is recommended that inclisiran is administered within 2 weeks after the last dose of a monoclonal antibody PCSK9 inhibitor.

Dosage considerations

Inclisiran is for subcutaneous injection into the abdomen; alternative injection sites include the upper arm or thigh. Injections should not be given into areas of active skin disease or injury such as sunburns, skin rashes, inflammation or skin infections.

Active ingredient

Inclisiran

Inclisiran is a cholesterol-lowering, double-stranded, small interfering ribonucleic acid (siRNA), conjugated on the sense strand with triantennary N-acetylgalactosamine (GalNAc) to facilitate uptake by hepatocytes. It is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet.

Read more about Inclisiran

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