What is the most important information I should know about inclisiran?
Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.
What is inclisiran?
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.
What should I discuss with my healthcare provider before receiving inclisiran?
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 this medicine. 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.
How is this drug given?
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.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your inclisiran injection.
What happens if I overdose?
In a medical setting an overdose would be treated quickly.
What should I avoid while receiving inclisiran?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of inclisiran?
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.
Call your doctor at once if you have:
- pain and burning when you urinate.
Common side effects may include:
- redness, pain, or bruising where an injection was given;
- pain in your legs and arms;
- 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.
What other drugs will affect inclisiran?
Other drugs may affect inclisiran, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
Where can I get more information?
Your pharmacist can provide more information about inclisiran.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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