Leqvio

/ Novartis

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 section 5.2). 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 section 5.2). There is limited experience with inclisiran in patients with severe renal impairment. Inclisiran should be used with caution in these patients.
Paediatric population
The drug is not indicated for children and adolescents under 18 years old. The safety and efficacy of inclisiran in children aged less than 18 years have not yet been established. No data are available.
See prescribing information for full details.

For adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet.
In combination with a statin or statin with other lipid-lowering therapy in patients unable to reach LDL-C goals with maximal tolerated dose of a statin.
Alone or in combination with other lipid-lowering therapy in patients who are statin-intolerant, or for whom statin is contraindicated

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

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”. Please refer to the license holder for further details.

The only adverse reactions associated with inclisiran were adverse reactions at the injection site (8.2%). Please refer to the license holder for further details.

Inclisiran is not a substrate for common drug transporters and, although in vitro studies were not conducted, it is not anticipated to be a substrate for cytochrome P450. Inclisiran is not an inhibitor or inducer of cytochrome P450 enzymes or common drug transporters. Therefore, inclisiran is 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.

Pregnancy
There are no or limited amount of data from the use of inclisiran in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, 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 (see section 5.3). 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

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.

Store below 30°c. Do not freeze.