From the Guidelines
Leqvio (inclisiran) can cause several side effects, with the most common being reactions at the injection site, which were reported in 5.0% of patients in a pooled patient-level analysis of 3,660 patients in phase 3 trials, compared to 0.7% with placebo 1.
Common Side Effects
- Injection site reactions, such as pain, redness, and rash, which are typically mild and resolve within a few days
- Joint pain
- Urinary tract infections
- Diarrhea
- Bronchitis
- Mild to moderate muscle pain
- Headaches
- Back pain
- Flu-like symptoms
Serious Side Effects
- Serious allergic reactions are rare but possible
Management of Side Effects
It is essential to contact your healthcare provider immediately if you experience persistent or severe side effects while taking Leqvio. Regular follow-up appointments are crucial to monitor your response to the medication and manage any side effects that may occur.
Mechanism of Action
Leqvio works by inhibiting PCSK9 protein production in the liver, which increases LDL receptor availability and enhances the body's ability to remove LDL cholesterol from the bloodstream, as demonstrated in a pooled patient-level analysis of 3,660 patients in phase 3 trials, which showed a mean placebo-corrected change in LDL-C at day 510 of 50.7% 1.
From the FDA Drug Label
Adverse reactions reported in at least 3% of LEQVIO-treated patients, and more frequently than in placebo-treated patients, are shown in Table 1 Table 1: Adverse Reactions Occurring in Greater Than or Equal to 3% of LEQVIO-treated Patients and More Frequently than with Placebo (Studies 1,2, and 3) Adverse Reactions | Placebo (N = 1,822) % | LEQVIO (N = 1,833) % †includes related terms such as: injection site pain, erythema and rash Injection site reaction† | 28 | Arthralgia | 4 | 5 Bronchitis | 3 | 4
The common side effects of Leqvio include:
- Injection site reaction
- Arthralgia
- Bronchitis 2
From the Research
Leqvio Side Effects
- The safety and tolerability profile of Leqvio (inclisiran) was similar to placebo in clinical trials, although mild to moderate, transient injection-site adverse reactions were more frequent with inclisiran 3.
- Inclisiran has a good tolerability profile, with sustained and durable lowering of LDL cholesterol and twice-yearly application 4.
- The reduction of circulating low-density lipoprotein-cholesterol (LDL-C) is a primary target in cardiovascular risk reduction, and inclisiran decreases LDL-C levels by over 50% with one dose every 6 months, making it a simple and well-tolerated treatment strategy 5.
- Preclinical studies and Phase I and Phase II clinical trials of inclisiran have demonstrated its tolerability and efficacy in promoting long-term reduction of both PCSK9 protein and LDL cholesterol 6.
- Leqvio is a newly available option to further reduce LDL-cholesterol, and its use is characterized by an individual, "treat-to-target" approach 7.
Common Side Effects
- Mild to moderate, transient injection-site adverse reactions were more frequent with inclisiran 3.
- There is no mention of other common side effects in the provided studies.
Serious Side Effects
- There is no mention of serious side effects in the provided studies.