Inclisiran works by helping the liver reduce levels of "bad" cholesterol (low-density lipoprotein, or LDL) circulating in your blood.

Inclisiran is used together with a low-fat diet and other cholesterol-lowering medications in adults with heterozygous familial hypercholesterolemia (inherited types of high cholesterol). These conditions can cause high blood levels of LDL cholesterol, and can also cause plaque to build up inside your arteries.

Inclisiran is also used in adults with atherosclerotic cardiovascular disease (ASCVD) needing additional lowering of LDL cholesterol.

Inclisiran may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Inclisiran is injected under the skin. A healthcare provider will give you this injection.

You should not stop using inclisiran without your doctor's advice, or your LDL cholesterol levels may increase.

Inclisiran is only part of a complete treatment program that also includes diet, statin medication, and regular blood testing. Follow your doctor's instructions very closely.

Usual Adult Dose for Hyperlipidemia:

Initial dose: 284 mg subcutaneously once, and repeat in 3 months
Maintenance dose (after initial dose): 284 mg subcutaneously every 6 months

Comments:
-Limitations of Use: The effect of this drug on cardiovascular morbidity and mortality has not been established.
-Low-density lipoprotein (LDL) cholesterol should be assessed when clinically indicated; the LDL-lowering effect of this drug may be measured as soon as 30 days after start and anytime thereafter without regard to the timing of the dose.

Use: As an adjunct to diet and maximally tolerated statin therapy for the treatment of patients with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL cholesterol

Tell your doctor if you have:

• end-stage kidney disease or severe liver disease.

May harm an unborn baby. Do not use if you are pregnant.

It may not be safe to breastfeed while using inclisiran. Ask your doctor about any risk.

Ask a doctor if it is safe to breastfeed while using this medicine.

Not approved for use by anyone younger than 18 years old.

Call your doctor for instructions if you miss an appointment for your inclisiran injection.

In a medical setting an overdose would be treated quickly.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives, severe itching; difficult breathing; swelling of your face, lips, tongue, or throat.

Inclisiran may cause serious side effects. Call your doctor at once if you have:

• pain and burning when you urinate.

Common side effects of inclisiran may include:

• 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 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 FDA at 1-800-FDA-1088.