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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 proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors Inclisiran can be administered immediately after the last dose of a monoclonal antibody PCSK9 inhibitor.

To maintain low-density lipoprotein cholesterol (LDL-C) lowering it is recommended that inclisiran is administered within 2 weeks after the last dose of a monoclonal antibody PCSK9 inhibitor. 2). 3 Hepatic impairment No dose adjustments are necessary for patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.

2). Inclisiran should be used with caution in patients with severe hepatic impairment. 2). There is limited experience with inclisiran in patients with severe renal impairment. Inclisiran should be used with caution in these patients. 4 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.

2%). Tabulated list of adverse reactions Adverse reactions are presented by system organ class (Table 1). Frequency categories are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000) and not known (cannot be estimated from the available data).

8% of inclisiran and placebo patients, respectively, in the pivotal studies. 0%, respectively. All of these adverse reactions were mild or moderate in severity, transient and resolved without sequelae. 7%). 5 Special populations Elderly Of the 1 833 patients treated with inclisiran in the pivotal studies, 981 (54%) were 65 years of age or older, while 239 (13%) were 75 years of age or older.

No overall differences in safety were observed between these patients and younger patients. Immunogenicity In the pivotal studies 1 830 patients were tested for anti-drug antibodies. 9% (90/1 830) of patients during the 18 months of treatment with inclisiran.

No clinically significant differences in the clinical efficacy, safety or pharmacodynamic profiles of inclisiran were observed in the patients who tested positive for anti-inclisiran antibodies. 1%). These elevations did not progress to exceed the clinically relevant threshold of 3x ULN, were asymptomatic and were not associated with adverse reactions or other evidence of liver dysfunction.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Haemodialysis The effect of haemodialysis on inclisiran pharmacokinetics has not been studied. Considering that inclisiran is eliminated renally, haemodialysis should not be performed for at least 72 hours after inclisiran dosing. Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.

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