Inclisiran injection

pronounced as (in' kli sir' an)

Brand Name(s): Leqvio®

Why is this medicine prescribed?

Inclisiran injection is used to decrease the amount of cholesterol (a fat-like substance that can build up and clog blood vessels causing heart attacks or strokes or other health problems). Inclisiran injection is in a class of medications called proprotein convertase subtilisin kexin type 9 (PCSK9)-interfering mRNA. It lowers LDL (bad) cholesterol in the blood, which helps keep cholesterol from blocking blood flow to the heart, brain, and other parts of the body.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Inclisiran injection comes as a solution (liquid) to be given subcutaneously (under the skin) into abdomen, upper am, or thigh. Give once and then repeat again in 3 months and then every 6 months after that. Inclisiran injection is given by a doctor or nurse at a doctor's office or clinic.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What special precautions should I follow?

Before taking inclisiran,

  • tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking inclisiran injection, call your doctor.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget to take a dose?

If a scheduled dose is missed by less than 3 months, inclisiran injection should be given as soon as possible and continued on the regular schedule. If a scheduled dose is missed by more than 3 months, inclisiran injection dosing schedule should be restarted by giving a dose now and then another in 3 months and then every 6 months thereafter.

What side effects can this medicine cause?

Inclisiran injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • pain, swelling, redness at injection site
  • joint pain
  • cough, shortness of breath, wheezing, low fever or chest tightness

Some side effects can be serious. If you experience any of these symptoms, stop using inclisiran injection and call your doctor immediately or get emergency medical treatment:

  • itching, rash, hives
  • difficulty breathing or swallowing
  • swelling of the face, throat, tongue, lips, and eyes
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to inclisiran.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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