Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
The recommended dose is 284 mg inclisiran administered as a single subcutaneous injection: initially, again at 3 months, followed by every 6 months.
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.
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.
No dose adjustment is necessary in elderly patients.
No dose adjustments are necessary for patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. No data are available in patients with severe hepatic impairment (Child-Pugh class C) (see section 5.2). Inclisiran should be used with caution in patients with severe hepatic impairment.
No dose adjustments are necessary for patients with mild, moderate or severe renal impairment or patients with end-stage renal disease (see section 5.2). There is limited experience with inclisiran in patients with severe renal impairment. Inclisiran should be used with caution in these patients. See section 4.4 for precautions to take in case of haemodialysis.
The safety and efficacy of inclisiran in children aged less than 18 years have not yet been established. No data are available.
Subcutaneous use.
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.
Each 284 mg dose is administered using a single pre-filled syringe. Each pre-filled syringe is for single use only.
Inclisiran is intended for administration by a healthcare professional.
No clinically relevant adverse reactions were observed in healthy volunteers who received inclisiran at doses up to three times the therapeutic dose. No specific treatment for inclisiran overdose is available. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
2 years.
This medicinal product does not require any special storage conditions. Do not freeze.
1.5 ml solution in a pre-filled syringe (Type I glass) with plunger stopper (bromobutyl, fluorotec coated rubber) with needle and rigid needle shield.
Pack size of one pre-filled syringe.
Leqvio should be inspected visually prior to administration. The solution should be clear, colourless to pale yellow and essentially free of particulates. If the solution contains visible particulate matter, the solution should not be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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