Leqvio
Generic name: inclisiran
Dosage form: subcutaneous injection (284 mg/1.5 mL)
Drug class: Miscellaneous antihyperlipidemic agents
What is Leqvio?
Leqvio (inclisiran) is a prescription medicine used to lower LDL-C cholesterol levels for adults with certain types of high cholesterol (primary hyperlipidemia). Leqvio reduces ‘bad’ low-density lipoprotein cholesterol (LDL-C) and is used with diet and statin therapy.
Leqvio works by blocking a protein in the liver, this increasesLDL-C clearance, which lowers the amount of 'bad' cholesterol in your blood. The protein it blocks is proprotein convertase subtilisin kexin type 9 (PCSK9). Leqvio is a small interfering RNA (siRNA) and was the first medication of its class to be approved to lower 'bad' LDL cholesterol.
Leqvio is given as an injection under the skin (subcutaneous) as a first dose, then a second dose at 3 months, and then every 6 months after that.
What is Leqvio used for?
Leqvio is indicated for adults with primary hyperlipidemia, which is high cholesterol due to genetic abnormalities, including heterozygous familial hypercholesterolemia (HeFH). Leqvio should be used together with statin therapy and diet.
Leqvio originally received FDA approval on December 22, 2021, and the indications were expanded on July 10, 2023.
Leqvio side effects
Common Leqvio side effects
- redness, pain, or bruising where an injection was given;
- pain in your legs and arms;
- diarrhea;
- breathing problems, bronchitis;
- joint pain; or
- pain and burning when you urinate (this is a serious side effect - call your doctor)
Serious Leqvio side effects
Get emergency medical help if you have signs of an allergic reaction: hives, severe itching, difficulty breathing, swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- pain and burning when you urinate.
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Before taking this medicine
Do not receive this medicine if you are allergic to the active ingredient inclisiran or inactive ingredients in this medication. See below for a complete list of ingredients.
Tell your doctor if you use other medicines or have other medical conditions, including severe kidney disease, are receiving dialysis, or have severe liver disease.
You should not have this injection if you are under 18 years of age.
Pregnancy
Tell your doctor if you are pregnant, become pregnant, or plan to become pregnant. The use of this medicine should be avoided during pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not yet known whether this medicine passes into human breast milk. Your doctor will consider the potential benefits of treatment for you and the risks to your baby compared to the risks of breastfeeding for your baby.
How should I receive Leqvio?
- A healthcare professional will give you your injection, is injected under your skin (subcutaneously) into the abdomen, upper arm, or thigh. Do not inject in areas of active skin disease or injury, such as sunburn, skin rashes, inflammation, or skin infections.
- This medicine is an add-on treatment to an improved diet and the maximum tolerated statin dose.
- The injection is given as an initial dose, then repeated at 3 months, and then every 6 months after that.
- Do not stop receiving this medication without talking to your healthcare provider, as your LDL cholesterol levels may increase.
Dosing information
The recommended dosage of Leqvio:
- 284 mg given as a single subcutaneous injection initially, again at 3 months, and then every 6 months.
Leqvio is available in a single-dose prefilled syringe 284 mg/1.5 mL (189 mg/mL).
Inclisiran is only part of a complete treatment program that includes diet, statin medication, and regular blood testing.
What happens if I miss a dose?
If you miss a dose of this medicine and it has been less than 3 months, then see your healthcare provider for a dose and continue with your original dosing schedule.
If you miss a dose of this medicine and it has been more than 3 months, then see your healthcare provider and restart with a new dosing schedule - starting with an initial dose, then another dose at 3 months, and then every 6 months after that.
What happens if I overdose?
There is no specific treatment for an overdose of this medicine If you receive too much, your healthcare provider will check you for side effects and treat any side effects as required.
Interactions
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Leqvio is not expected to cause drug-drug interactions or to be affected by inhibitors or inducers of cytochrome P450 enzymes or transporters.
Storage
- Store at 20°C to 25°C (68°F to 77°F).
- Excursions are permitted between 15°C and 30°C (59°F and 86°F).
- Do not freeze
- Discard after single use.
- Keep out of sight and reach of children.
Ingredients
Active ingredient: inclisiran sodium
Inactive ingredients: water, sodium hydroxide, phosphoric acid
Contains no preservatives. Not made with natural rubber latex.
Company
Manufactured by: Sandoz GmbH, Langkarnpfen, Austria.
Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936.
Popular FAQ
What is the difference between Leqvio and Repatha?
Leqvio and Repatha are both injectable medicines that are used for the treatment of high cholesterol, by specifically lowering low density lipoprotein (LDL) levels. Although they both inhibit PCSK9 they work by different mechanisms. Repatha is a monoclonal antibody that binds directly to PCSK9 in the liver preventing it from binding to LDL receptors. Leqvio blocks the PCSK9 protein by interfering with the translation of PCSK9 messenger RNA. Both have the same result – and that is freeing up LDL receptors on the surface of liver cells which allows LDL cholesterol to be removed from the blood. Continue reading
What are PCSK9 Inhibitors and how do they work?
The PCSK9 inhibitors are used for the treatment of high-risk patients with elevated cholesterol, especially when statins aren't adequate. They work by blocking PCSK9, leaving more receptors available to capture your "bad" cholesterol (LDL) for break down and removal from the blood. Continue reading
Can Leqvio be taken without a statin?
Leqvio may be used alone or with other medications, such as statins, to treat high cholesterol, in addition to a heart-healthy diet. But it can be prescribed without a statin if statins are not tolerated or contraindicated. Continue reading
Does Leqvio cause weight gain?
Weight gain is not reported as a side effect of Leqvio in the product information and neither does it seem to be a topic of discussion on blog sites. Weight gain has also not been reported with other PCSK9 inhibitors, such as Repatha. Continue reading
How is Leqvio injection administered?
Leqvio is administered subcutaneously, which means just under the skin. Your healthcare provider will sit or lie you down and then inject Leqvio just under the skin of your abdomen, upper arm, or thigh. This may cause slight pain and redness around the site of the injection. You cannot administer Leqvio yourself. Continue reading
What is the mechanism of action for Leqvio (inclisiran)?
Leqvio works by blocking production of the PCSK9 protein which means more LDL receptors are present on liver cells which increases the uptake of LDL cholesterol and lowers LDL cholesterol in the blood, reducing cholesterol levels. Continue reading
Is Leqvio FDA approved as a high cholesterol treatment?
Leqvio is FDA approved as a high-cholesterol treatment and it specifically lowers LDL cholesterol levels (sometimes referred to as "bad" cholesterol. It is approved for people with atherosclerosis (hardening and narrowing of the arteries caused by a build-up of fatty plaques) or heterozygous familial hypercholesterolemia (a genetic condition that causes high levels of LDL cholesterol). Leqvio may be prescribed alone or in addition to statins or other cholesterol-lowering medications. Continue reading
Who is the actor in the Leqvio commercial?
The actor in the Leqvio commercial "Forging on" is Robert Leardi an actor who was born in Southington, Connecticut, USA on 4 November 1961. He has also played Lt. Schrank in the 2008 production of West Side Story in London’s West End and performed in several TV series such as The Thing (2012) and Ladies Revenge Club (2014). Continue reading
Where can I find the Leqvio FDA package insert?
You can find the Leqvio FDA package insert on the FDA Access Data website, or read the prescribing information for Leqvio that has been published by drugclasses.com which is derived from the product information. Continue reading
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