פרופ' אריק סטרואס
Long-lasting LDL-C lowering, Silence at last
פרופ' יעקב חנקין -
Israeli dyslipidemia guidelines 2020: rationale, Target goals and implementation
ד"ר ברק צפריר
Treatment gaps in Hyperlipidemia, Barriers, challenges and opportunities
Leqvio 284 mg, solution for injection in pre filled syringe
Important note: Before prescribing, consult full prescribing information.
Presentation: Solution for injection: Each pre‑filled syringe contains inclisiran sodium equivalent to 284 mg inclisiran in 1.5 ml solution.
Indications: Leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non‑familial) or mixed dyslipidaemia, as an adjunct to diet: a) 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 b) alone or in combination with other lipid‑lowering therapies in patients who are statin‑intolerant, or for whom a statin is contraindicated.
Posology and method of administration: 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). 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. There is limited experience with inclisiran in patients with severe renal impairment. Inclisiran should be used with caution in these patients. ¨ 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: Intended for administration by a healthcare professional. ¨For subcutaneous injection into the abdomen.¨ Each pre‑filled syringe is for single use only ¨Inclisiran should be inspected visually prior to administration. The solution should be clear, colourless to pale yellow and essentially free of particulates.
Contraindications: Hypersensitivity to the active substance or to any of the excipients.
Special warnings and precautions for use: 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.
Interactions: Not a substrate, inhibitor or inducer of CYP450 enzymes or common drug transporters. Not expected to have clinically significant interactions with other medicinal products. Based on the limited data available, clinically meaningful interactions with atorvastatin, rosuvastatin or other statins are not expected.
Fertility, pregnancy and lactation: Pregnancy: No available human data. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. It is preferable to avoid the use of inclisiran during pregnancy. ¨ Breast‑feeding: It is unknown whether inclisiran is excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of inclisiran in milk. A risk to newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast‑feeding or to discontinue/abstain from inclisiran therapy, taking into account the benefit of breast‑feeding for the child and the benefit of therapy for the woman. ¨ Fertility: No data on the effect of inclisiran on human fertility are available . Animal studies did not show any effects on fertility.
Undesirable effects: Common (≥1/100 to <1/10): The only adverse reactions associated with inclisiran were adverse reactions at the injection site (includes injection site reaction, injection site pain, injection site erythema and injection site rash).
Packs: one pre‑filled syringe.
Legal classification: Prescription only.
Leq 06.21 October 2021
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