Active Ingredient and Strength	INCLISIRAN SODIUM EQV INCLISIRAN - 284 MG
Dosage Form	INJECTION, SOLUTION
Manufacturer and Country	CORDEN PHARMA S.P.A - ITALY NOVARTIS PHARMACEUTICAL MANUFACTURING GMBH - AUSTRIA
Registration Number	SIN16295P
Licence Holder	NOVARTIS (SINGAPORE) PTE LTD
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	C10AX16

3 Indications

Treatment in adults with primary hypercholesterolaemia (including 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.

4 Dosage regimen and administration

Dosage regimen

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

Missed dose

If a planned dose of Leqvio is missed by less than 3 months, Leqvio should be administered and dosing maintained according to the patient’s original schedule.
If a planned dose of Leqvio is missed by more than 3 months, a new dosing schedule should be started – Leqvio should be administered initially, again at 3 months, followed by every 6 months.

Treatment Transition from PCSK9 Inhibitor Monoclonal Antibody

Leqvio can be administered immediately after the last dose of a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor monoclonal antibody. To maintain LDL-C lowering, it is recommended that Leqvio is administered within 2 weeks after the last dose of a PCSK9 inhibitor monoclonal antibody.

Special populations

Renal impairment

No dose adjustment is necessary for patients with renal impairment (mild, moderate or severe) or end-stage renal disease. There is limited experience with inclisiran in patients with severe renal impairment. Inclisiran should be used with caution in these patients. If administering Leqvio to patients on hemodialysis, hemodialysis should not be performed for at least 72 hours after Leqvio dosing (see section 11 Clinical pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

No dose adjustment is necessary for patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. Patients with severe hepatic impairment (Child-Pugh class C) have not been studied.

Pediatric patients (below 18 years)

The safety and efficacy of Leqvio in patients below 18 years of age have not been established.

Geriatric patients (65 years of age or above)

No dose adjustment is necessary in patients 65 years of age or above.

Method of administration

Leqvio is intended for administration by a healthcare professional.

Leqvio is for subcutaneous injection into the abdomen. Injections should not be given into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, or skin infections.

Leqvio should be inspected visually for particulate matter prior to administration. If the solution contains visible particulate matter, the solution should not be used.

Each 284 mg dose is administered using a single pre-filled syringe. Each pre-filled syringe is for single use only.

There are two types of pre-filled syringes (one with needle guard, one without needle guard). For the instructions for use for the pre-filled syringe with needle guard, see section 14 Pharmaceutical information – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Not all presentations are available in all countries.

5 Contraindications

Hypersensitivity to the active substance or to any of the excipients.