Leqvio · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-099525 · has-adverse-reaction-information · PDF-Seite 4

Summary of the safety profile The only adverse reactions associated with inclisiran were adverse reactions at the injection site (8.2%). 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). 4 Table 1 Adverse reactions reported in patients treated with inclisiran System organ class Adverse reaction Frequency category Immune system disorders Hypersensitivity including Not known anaphylactic reaction, angioedema, rash, urticaria, pruritus General disorders and Adverse reactions at the Common administration site conditions injection site1 1 See section “Description of selected adverse reactions” Description of selected adverse reactions Adverse reactions at the injection site Adverse reactions at the injection site occurred in 8.2% and 1.8% of inclisiran and placebo patients, respectively, in the pivotal studies. The proportion of patients in each group who discontinued treatment due to adverse reactions at the injection site was 0.2% and 0.0%, respectively. All of these adverse reactions were mild or moderate in severity, transient and resolved without sequelae. The most frequently occurring adverse reactions at the injection site in patients treated with inclisiran were injection site reaction (3.1%), injection site pain (2.2%), injection site erythema (1.6%), and injection site rash (0.7%). Special populations Paediatric population The safety and efficacy of inclisiran were assessed in two phase III studies in paediatric patients. The first study was a 24-month, two-part study of 141 patients aged 12 to less than 18 years with HeFH, consisting of a 12-month double-blind, placebo-controlled part followed by a 12-month open-label part. The second study was a 24-month, two-part study of 13 patients aged 12 to less than 18 years with homozygous familial hypercholesterolaemia (HoFH), consisting of a 12-month double-blind, placebo-controlled part followed by a 12-month open-label par

Auszug; vollständigen Abschnitt im Original lesen.

HOS-099521 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-099520 · has-indication-information · PDF-Seite 2

Leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non- familial) or mixed dyslipidaemia, as an adjunct to diet, and in paediatric patients aged 12 years and older with heterozygous familial hypercholesterolaemia (HeFH): • 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.

HOS-099523 · has-interaction-information · PDF-Seite 4

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.

HOS-099524 · has-pregnancy-information · PDF-Seite 4

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 (see section 5.3). As a precautionary measure, it is preferable to avoid the use of inclisiran during pregnancy. Breast-feeding It is unknown whether inclisiran/metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of inclisiran in milk (see section 5.3). A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Leqvio 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 (see section 5.3).

HOS-099522 · has-warning-information · PDF-Seite 3

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”. 3