Leqvio Injection: Uses, Dosage, Side Effects, Warnings (2024)

Generic name: inclisiran
Dosage form: subcutaneous injection (284 mg/1.5 mL)
Drug class: Miscellaneous antihyperlipidemic agents

Medically reviewed by Melisa Puckey, BPharm. Last updated on Sep 3, 2023.

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 increases LDL-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.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circ*mstances.

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