Leqvio
Generic name: inclisiran
Dosage form: subcutaneous injection
Drug class: Miscellaneous antihyperlipidemic agents
What is Leqvio?
Leqvio (inclisiran) is an injectable medication administered every six months to lower levels of 'bad' cholesterol called low-density lipoprotein (LDL) cholesterol. High cholesterol can lead to heart disease and blood circulation problems.
Leqvio was the first medication of its class - small interfering RNA (siRNA) - to be approved to lower 'bad' LDL cholesterol.
Leqvio is an siRNA designed to block a protein made in the liver called PCSK9 (proprotein convertase subtilisin kexin type 9). PCSK9 reduces the number of receptors available to clear 'bad' LDL cholesterol from your blood.
Leqvio works by interfering with the translation of PCSK9 messenger RNA (mRNA). This limits the amount of PCSK9 produced, which helps to lower the amount of 'bad' cholesterol in your blood.
Leqvio is used as an add-on to diet and statin therapy (another type of medication used to treat high cholesterol), to treat high LDL levels in certain adults with high cholesterol or atherosclerosis.
Leqvio was approved by the US Food and Drug Administration in 2021.
What is Leqvio used for?
Leqvio is used as an add-on (adjunct) to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL cholesterol.
The effect of this medication on cardiovascular morbidity and mortality has not been determined.
Who should not receive Leqvio?
Do not receive Leqvio if you are allergic to inclisiran or any the other ingredients in this medication. See below for a complete list of ingredients.
Do not receive Leqvio if you are under 18 years of age.
What should I tell my doctor before receiving Leqvio?
Before receiving Leqvio tell your healthcare provider about all of your medical conditions, including if you:
- are receiving dialysis
- have severe liver disease
- have severe kidney disease
How should I receive Leqvio?
- Leqvio will be administered by a healthcare professional. It is injected under your skin (subcutaneously) into the abdomen, upper arm, or thigh.
- Leqvio is used as an add-on to diet and maximally tolerated stating therapy.
- Leqvio is injected initially, then again at 3 months and then every 6 months after that.
- Do not stop receiving this medication without talking to your healthcare provider.
What happens if I miss a dose?
If you miss a dose of Leqvio and it has been less than 3 months then see your healthcare provider for a dose of this medication and continue with your original dosing schedule.
If you miss a dose of Leqvio 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 Leqvio overdose. If you receive too much, your healthcare provider will check you for side effects and will treat any side effects as required.
Dosing information
The recommended dosage of Leqvio, in combination with maximally tolerated statin therapy, is 284 mg administered as a single subcutaneous injection initially, again at 3 months, and then every 6 months.
What are the side effects of Leqvio?
Common side effect of Leqvio include:
- injection site reactions, such as pain, redness or a rash
- joint pain (arthralgia)
- urinary tract infections
- diarrhea
- bronchitis
- pain in extremities
- shortness of breath (dyspnea)
These are not all of the possible side effects of this medication. Call your healthcare provider for medical advice about side effects.
To report suspected adverse reactions, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
Tell your healthcare provider about all 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.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. The use of Leqvio should be avoided during pregnancy.
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not yet known whether Leqvio passes into human breast milk. Your doctor will help you to decide whether to continue breastfeeding or to start treatment with this medication. Your doctor will consider the potential benefits of treatment for you, compared with the health benefits and risks of breast-feeding for your baby.
Storage
- Store at 20°C to 25°C (68°F to 77°F).
- Excursions permitted between 15°C and 30°C (59°F and 86°F).
- Do no freeze
- Discard after single use.
- Keep out of sight and reach of children.
What are the ingredients in Leqvio?
Active ingredient: inclisiran sodium
Inactive ingredients: water, sodium hydroxide, phosphoric acid
Contains no preservatives. Not made with natural rubber latex.
Leqvio is manufactured by Sandoz GmbH, Langkarnpfen, Austria and distributed by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936
Popular FAQ
Leqvio and Repatha are both injectable medicines that are used for the treatment of high cholesterol, by specifically lowering low density lipoprotein (HDL) 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
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
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
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
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
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
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
References
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