Leqvio

Leqvio is used in adults and children 12 years of age and older with high blood cholesterol levels (called primary hyperlipidemia), including heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH), to reduce low-density lipoprotein (LDL-C) levels alongside diet and exercise changes. It can be used first-line as monotherapy (by itself) or given with other cholesterol medications, including statins. Leqvio is administered by subcutaneous injection (under the skin), twice a year.

Leqvio works by using siRNA technology to block PCSK9 protein production by targeting its mRNA instructions. This prevents breakdown of liver receptors that remove LDL cholesterol from blood, allowing more receptors to function and enhancing LDL-C removal from the bloodstream. Leqvio belongs to the drug class called small interfering RNAs (siRNA).

Leqvio (inclisiran) first gained FDA approval on December 22, 2021. There is no generic.

Leqvio is a subcutaneous injection administered by a healthcare provider.

• After your first 2 doses of leqvio, you only need it every 6 months.
• It can be injected under the skin of the abdomen, upper arm, or thigh.
• It should not be injected into skin that is bruised, scarred, or broken. Tell your healthcare provider about any skin conditions or areas of injury you may have, such as psoriasis, eczema, sunburn, skin rashes, inflammation, or skin infections.
• See How is Leqvio injection administered? for more information.

This medicine is an add-on treatment to an improved diet and usually other cholesterol medications, such as statins.

Do not stop receiving this medication without talking to your healthcare provider, as your LDL cholesterol levels may increase.

Do not receive Leqvio if you are allergic to Leqvio, inclisiran, or any inactive ingredients in the Leqvio injection. See below for a complete list of ingredients.

Tell your healthcare provider about all the medical conditions you have, especially tell them if you have:

• severe kidney disease or are receiving dialysis
• severe liver disease
• arthritis
• asthma, COPD, or breathing problems
• a history of urinary tract infections
• skin conditions such as psoriasis or eczema
• are pregnant or intending to become pregnant
• are breastfeeding or intending to breastfeed.

Discuss with your healthcare provider if you should receive a Leqvio injection if you are pregnant. It is not approved for use in children under 12 years of age.

Pregnancy

Tell your healthcare provider immediately if you become pregnant or plan to become pregnant while receiving Leqvio to discuss if it should be discontinued. There is a pregnancy safety study that monitors outcomes in women exposed to Leqvio during pregnancy. You can report your pregnancy to Novartis at 1-888-669-6682 or [email protected].

Breastfeeding

It is not known if Leqvio passes into human breast milk. Talk to your healthcare provider about the best way to feed your baby if you are having treatment with Leqvio.

The most common side effects of Leqvio are:

• injection site reactions, such as redness, pain, or bruising, where the injection was given
• joint pain
• bronchitis, colds in your chest, or breathing problems
• headache (in children).

Weight gain has not been reported as a side effect of Leqvio in clinical trials.

Serious side effects and warnings

Leqvio may cause serious side effects, such as allergic reactions. 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.

Leqvio may increase your risk of urinary tract infections. Symptoms may include pain or burning while you are urinating, having to pass urine more frequently or more urgently than is usual for you, pelvic or rectal pain, or urine that is discolored or has a strong odor. Call your healthcare provider at once if you have any of these symptoms.

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.

Dose of Leqvio for hypercholesterolemia in adults and children 12 years and older:

• Initial, Dose 1: 284 mg SC
• 3 months later, Dose 2: 284 mg SC
• 6 months later and every 6 months thereafter, Dose 3: 284 mg SC.

Leqvio is available in a single-dose, prefilled syringe containing 284 mg/1.5 mL.

If you miss a dose of Leqvio 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.

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.

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.

Active ingredient: inclisiran sodium 284 mg (present as 300 mg inclisiran sodium salt).

Inactive ingredients: Water for Injection and may also contain sodium hydroxide or phosphoric acid for pH adjustment to a target pH of 7.0.

Leqvio is available as a 284 mg/1.5 mL (189 mg/mL) single-dose prefilled syringe.

Contains no preservatives.

Leqvio is manufactured by Novartis Pharmaceuticals Corporation, which is based in East Hanover, New Jersey, with global headquarters in Basel, Switzerland. The medication was developed under license from Alnylam Pharmaceuticals, Inc.

Novartis was formed in 1996 through the merger of Ciba-Geigy and Sandoz.