Understanding Leqvio (Inclisiran) and Its Purpose
Leqvio, with the generic name inclisiran, is an injectable prescription medicine used to lower low-density lipoprotein cholesterol (LDL-C), often called "bad" cholesterol [1.6.2, 1.4.7]. It is approved for adults with primary hyperlipidemia, including a genetic condition called heterozygous familial hypercholesterolemia (HeFH), and for those with atherosclerotic cardiovascular disease (ASCVD) who require additional help lowering their cholesterol [1.6.2]. Atherosclerotic cardiovascular disease involves the buildup of cholesterol plaque in the arteries and includes conditions like heart attacks and strokes [1.6.2].
Leqvio is typically used as an adjunct to a healthy diet and alongside statin therapy, the most common type of cholesterol-lowering medication [1.6.1]. After an initial dose and a follow-up dose at three months, Leqvio is administered by a healthcare professional just twice a year [1.6.1].
How Leqvio Works: A Unique Mechanism
Leqvio is the first and only small interfering RNA (siRNA) therapy for lowering LDL-C [1.6.4]. It works differently from statins or other cholesterol drugs like Repatha [1.4.5, 1.5.6]. Leqvio uses a process called RNA interference [1.4.1]. It targets and directs the breakdown of the messenger RNA (mRNA) for a protein called PCSK9 [1.4.6]. By preventing the PCSK9 protein from being produced in the liver, more LDL receptors remain on the surface of liver cells. These receptors are then able to capture and remove LDL-C from the bloodstream, leading to lower overall cholesterol levels [1.4.1, 1.4.2].
What is the Side Effect of Leqvio? Common and Mild Reactions
While effective, all medications can cause side effects. For Leqvio, the most reported side effects are generally mild and temporary [1.2.3, 1.2.4].
Most Common Side Effects:
- Injection Site Reactions: This is the most frequent side effect noted in clinical trials [1.2.2]. These reactions occur where the shot was given and can include pain, redness, itching, swelling, bruising, rash, or tenderness [1.2.1, 1.3.1]. These symptoms are typically mild to moderate and resolve on their own within a few days [1.3.3].
- Joint Pain (Arthralgia): Pain in joints like the elbows or knees was another common side effect reported in studies [1.2.4, 1.3.2].
- Urinary Tract Infection (UTI): In some cases, UTIs were reported in clinical studies [1.2.2]. Symptoms can include a burning sensation during urination or pelvic pain [1.2.2, 1.3.4].
- Diarrhea: Some patients taking Leqvio may experience diarrhea [1.2.2].
- Bronchitis: Inflammation of the tubes that carry air to the lungs, causing cold or flu-like symptoms, was also noted [1.3.2].
- Pain in Extremity: Some people reported experiencing pain in their arms or legs [1.2.3].
Serious Side Effects and Allergic Reactions
Serious side effects with Leqvio are considered uncommon, and none were officially reported during the main clinical trials [1.3.1, 1.3.2]. However, severe reactions are still possible.
Potential Serious Side Effects:
- Severe Injection Site Reactions: While most reactions are mild, a severe and persistent reaction at the injection site could occur [1.3.1].
- Severe Allergic Reaction (Hypersensitivity): Though not reported in initial studies, as with most drugs, a severe allergic reaction is a potential risk [1.2.2, 1.3.2]. Symptoms demand immediate medical attention (call 911) and include:
- Trouble breathing or wheezing [1.2.7]
- Swelling of the face, lips, tongue, or throat (angioedema) [1.2.1, 1.2.7]
- Hives or severe skin rash [1.2.1]
- Dizziness or fainting [1.2.7]
Patients who have had a previous serious hypersensitivity reaction to inclisiran or any of its ingredients should not use Leqvio [1.6.5].
Comparison of Side Effects: Leqvio vs. Other Cholesterol Medications
It's helpful to compare Leqvio to other common cholesterol treatments, such as statins and another PCSK9 inhibitor, Repatha.
| Feature/Side Effect | Leqvio (Inclisiran) | Repatha (Evolocumab) | Statins (e.g., Atorvastatin) |
|---|---|---|---|
| Administration | Subcutaneous injection by a healthcare professional, twice a year (after starting doses) [1.6.1] | Self-administered subcutaneous injection, every 2 or 4 weeks [1.4.5] | Oral pill, typically taken daily |
| Mechanism | siRNA; prevents PCSK9 protein production [1.4.6] | Monoclonal antibody; blocks existing PCSK9 protein [1.5.6] | HMG-CoA reductase inhibitor; stops liver from making cholesterol [1.4.5] |
| Common Side Effects | Injection site reactions, joint pain, UTI, diarrhea, bronchitis [1.2.2] | Injection site reactions, runny nose, sore throat, back pain, muscle pain [1.5.2] | Muscle pain, joint pain, digestive problems |
| Specific Side Effects | Bronchitis, hand/foot pain [1.5.2] | Back pain, muscle pain, dizziness, high blood pressure [1.5.1, 1.5.2] | Liver enzyme elevations, increased blood sugar |
Leqvio and Repatha share some side effects like injection site reactions and joint pain [1.5.2]. However, Repatha is also associated with back pain and muscle pain, while bronchitis has been noted more with Leqvio [1.5.2]. Statins are well-known for causing muscle pain, a side effect not commonly linked directly to Leqvio, though it is often taken with a statin [1.2.2].
Managing Side Effects and Patient Considerations
For mild injection site reactions, a cold pack can help soothe the area [1.2.8]. These reactions typically resolve within a day or two [1.2.8]. If side effects like joint pain or diarrhea are persistent or bothersome, it is important to speak with a healthcare provider. They can help determine if Leqvio is the cause and suggest management strategies [1.2.4].
Long-Term Safety: Clinical trials have not shown evidence of long-term side effects from Leqvio. No new safety concerns emerged in extension trials where patients were followed for nearly five years [1.3.3]. The development of antibodies against the drug that might reduce its effectiveness has been rare and not associated with increased side effects [1.3.3].
Conclusion
Leqvio offers a convenient and effective way to lower LDL cholesterol with a twice-a-year dosing schedule administered by a healthcare professional [1.4.5]. The primary side effects of Leqvio are mild and transient, with the most common being reactions at the injection site and joint pain [1.2.4, 1.3.1]. While serious side effects are rare, patients should be aware of the signs of a severe allergic reaction [1.2.7]. As with any medication, the decision to use Leqvio should be made in consultation with a doctor who can weigh the benefits of significant cholesterol reduction against the potential for side effects.
For authoritative and detailed prescribing information, please refer to the official FDA label for Leqvio [1.6.5].
