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Posology: 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.
Special populations: Elderly (age ≥65 years): No dose adjustment is necessary in elderly patients.
Hepatic impairment: 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 Pharmacology: Pharmacokinetics under Actions). Inclisiran should be used with caution in patients with severe hepatic impairment.
Renal impairment: No dose adjustments are necessary for patients with mild, moderate or severe renal impairment or patients with end-stage renal disease (see Pharmacology: Pharmacokinetics under Actions). There is limited experience with inclisiran in patients with severe renal impairment. Inclisiran should be used with caution in these patients. See under Precautions for precautions to take in case of haemodialysis.
Paediatric population: The safety and efficacy of inclisiran in children aged less than 18 years have not yet been established. No data are available.
Method of administration: 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. For the instructions for use, see Instructions for use and handling for healthcare professionals under Cautions for Usage.
