Understanding Leqvio (Inclisiran) for High Cholesterol
Leqvio (inclisiran) is a prescription medication designed to assist in the treatment of specific types of high cholesterol. It is administered as an injection under the skin using a prefilled syringe.
Healthcare providers typically prescribe Leqvio to reduce low-density lipoprotein (LDL) cholesterol, often referred to as “bad” cholesterol, in adults diagnosed with hypercholesterolemia. This includes individuals with heterozygous familial hypercholesterolemia (HeFH), an inherited condition where a person receives the gene for high cholesterol from one parent. Leqvio is always prescribed in conjunction with a balanced diet and regular exercise.
How Leqvio Works and Its Uses
Leqvio contains the active ingredient inclisiran. It is used to lower LDL cholesterol in adults with hypercholesterolemia, including HeFH. Hypercholesterolemia signifies an excess of cholesterol in the blood. Cholesterol, a type of lipid, is vital for building and maintaining cells, hormones, and certain vitamins. However, excessive cholesterol levels can elevate the risk of serious cardiovascular events like heart attack and stroke.
High cholesterol often presents without symptoms, meaning many individuals are unaware of their condition until a significant complication arises. For those with HeFH, untreated high cholesterol can manifest as gray-white cholesterol deposits around the corneas (corneal arcus), chest pain during activity, xanthomas (fat deposits on knees, elbows, buttocks, and tendons), and xanthelasmas (cholesterol deposits around the eyelids).
Leqvio operates through a unique mechanism of action. The liver naturally produces the PCSK9 protein, which contributes to increased LDL cholesterol levels. Leqvio works by decreasing the amount of PCSK9 the liver produces, thereby lowering LDL cholesterol levels. While some cholesterol-lowering drugs have demonstrated a reduction in the risk of death and complications such as heart attack and stroke, it is not yet established whether Leqvio offers these same risk reductions. Consequently, Leqvio may be prescribed alongside other cholesterol-lowering medications to help mitigate these risks.
Potential Side Effects of Leqvio
Like most medications, Leqvio can cause side effects, which may be mild or serious. The occurrence and nature of side effects can vary based on factors such as age, existing health conditions, and other medications being taken.
Mild Side Effects
Common mild side effects associated with Leqvio may include a mild reaction at the injection site (such as pain, warmth, rash, or skin discoloration), joint pain, and bronchitis (a type of lung infection). These mild effects often resolve within a few days to a couple of weeks. If they become bothersome, it is advisable to consult a healthcare professional.
Serious Side Effects
Serious side effects from Leqvio are less common but can occur. Clinical studies have reported severe injection site reactions as a serious side effect. In the event of serious side effects, immediate medical attention is recommended.
Allergic Reactions
Although not reported in initial studies, allergic reactions to Leqvio have been observed since its approval. Symptoms of a mild allergic reaction, such as a rash, should prompt a call to a doctor. Severe allergic reactions, characterized by swelling or difficulty breathing, require immediate emergency medical care as they can be life-threatening.
Leqvio Dosage and Administration
The specific dosage of Leqvio will be determined by a healthcare provider. Leqvio is supplied as a liquid in a prefilled syringe, with each syringe containing a single dose of 284 milligrams (mg) in 1.5 milliliters (mL) of solution.
The recommended dosing schedule begins with an initial injection, followed by a second injection three months later. Subsequently, injections are administered once every six months. Leqvio is given as a subcutaneous injection in a healthcare provider’s office, typically in the upper arm, thigh, or abdomen. Injection sites with rashes, infections, inflammation, or sunburned skin are avoided.
If a dose is missed, it is important to contact the doctor’s office promptly to reschedule. If the missed dose is received within three months, the regular treatment schedule can continue. However, if more than three months have passed since the missed dose, treatment will need to be restarted with two doses three months apart.
Leqvio is generally intended for long-term use if it proves safe and effective for the individual. It begins to work shortly after the first dose, with some individuals showing lower cholesterol levels within two weeks of starting treatment.
Leqvio and Other Medications
Leqvio is often prescribed alongside a statin medication to further reduce cholesterol levels. Common statins include atorvastatin, rosuvastatin, and simvastatin. For individuals unable to take statins, Leqvio may be prescribed with other cholesterol-lowering drugs, such as ezetimibe.
Leqvio is not known to interact with other medications, herbs, supplements, foods, or alcohol. However, it is always recommended to inform healthcare providers about all prescription, over-the-counter, and supplemental drugs being taken to prevent potential interactions.
Cost of Leqvio
The cost of Leqvio can vary significantly based on insurance coverage. Patient assistance programs may be available to help manage prescription costs.
Important Considerations Before Starting Leqvio
Before initiating treatment with Leqvio, several factors should be discussed with a healthcare provider.
Pregnancy and Breastfeeding
The safety of Leqvio during pregnancy is not established, as studies in pregnant individuals are lacking. Given that cholesterol is essential for fetal development and Leqvio lowers cholesterol, it could potentially harm a fetus. Therefore, Leqvio is typically not prescribed during pregnancy. Individuals who are pregnant or planning pregnancy should discuss alternative treatment options. If pregnancy occurs while using Leqvio, discontinuation of treatment is usually recommended.
It is also unknown whether Leqvio passes into breast milk or affects a breastfed child. Individuals who are breastfeeding or planning to breastfeed should consult their doctor about their options.
Precautions
Individuals with a history of allergic reaction to Leqvio or its ingredients will likely not be prescribed the medication. Additionally, Leqvio has not been studied in individuals with severe liver problems, so its safety and effectiveness in this population are unknown. Those with severe liver issues should discuss with their doctor whether Leqvio is appropriate for them.
Leqvio vs. Repatha and Statins
Leqvio and evolocumab (Repatha) are both used to lower cholesterol, particularly in adults with HeFH, but they work in slightly different ways and have different dosing schedules. Repatha may also be prescribed for children aged 10 and older with HeFH, and for adults and certain children with homozygous familial hypercholesterolemia (HoFH). Repatha is also approved to reduce the risk of heart attack and stroke in adults with specific heart conditions. Leqvio injections are given every six months after the initial two doses, while Repatha injections are typically administered every two or four weeks and can be self-administered at home.
Leqvio is not a statin. Statins are a distinct class of cholesterol-lowering drugs that operate differently. Leqvio can be used in combination with statins to enhance cholesterol reduction.
It is generally not recommended to use Leqvio with other PCSK9 inhibitors like Repatha or alirocumab (Praluent), as the safety and effectiveness of such combinations have not been studied. If current treatment with Repatha or Praluent is insufficient, a doctor may suggest switching to Leqvio, or vice versa, if Leqvio is not adequately effective.
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