LEQVIO

4 Administration 08/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................

2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................

4 INDICATIONS ............................................................................................................... 4 CONTRAINDICATIONS .................................................................................................

4 DOSAGE AND ADMINISTRATION ................................................................................. 6 OVERDOSAGE..............................................................................................................

). 7%). 6% (102/1833) inclisiran-treated subjects discontinued the treatment in pivotal studies. The most common TEAEs that occurred more frequently in the inclisiran-treated subjects were: diabetes mellitus, nasopharyngitis, arthralgia, back pain, urinary tract infection, diarrhea, bronchitis, cough, headache, angina pectoris, dizziness, pain in extremity, dyspnea, and injection site reaction.

7% (12/1833) discontinuations in inclisiran-treated subjects from the pivotal studies due to adverse events. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to LEQVIO® (inclisiran) Product Monograph Page 9 of 34 the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The safety of LEQVIO was evaluated in 3 Phase III placebo-controlled trials that included 3,655 patients with atherosclerotic cardiovascular disease (ASCVD), ASCVD risk equivalents, or heterozygous familial hypercholesterolemia, treated with maximally tolerated statins and LEQVIO or placebo, including 1,833 patients exposed to 4 injections of inclisiran for up to 18 months (mean treatment duration of 526 days).

Adverse events (regardless of causality) reported for ≥ 1% of patients treated with inclisiran in the pivotal trials are listed by MedDRA system organ class in Table 2. 8% of LEQVIO-treated and placebo-treated patients, respectively, in the pivotal trials.

0%, respectively. All of these adverse drug reactions were mild or moderate in severity, transient and resolved without sequelae. 1%). 5%) patients treated with placebo for AST. 65 mmol/L (25 mg/dL) at two consecutive occasions. 1 mmol/L (81 mg/dL) at baseline were identified as the factors influencing most the likelihood of having low LDL-C levels upon inclisiran treatment.