Inclisiran injection

WHY is this medicine prescribed?

Inclisiran injection is used along with diet alone or in combination with other cholesterol-lowering medications to decrease the amount of low-density lipoprotein (LDL) cholesterol ('bad cholesterol') in the blood in people with familial heterozygous hypercholesterolemia (HeFH) (an inherited condition in which cholesterol cannot be removed from the body normally). It is also used along with diet changes and other treatments to reduce the amount of low-density lipoprotein (LDL) cholesterol ('bad cholesterol') in the blood in people who have clinical atherosclerotic cardiovascular disease (ASCVD). Inclisiran injection is in a class of medications called proprotein convertase subtilisin kexin type 9 (PCSK9)-interfering mRNA. It works by decreasing the amount of LDL cholesterol in the blood to decrease the amount of cholesterol that may build up on the walls of the arteries and block 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. It is usually given once and then repeated 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 and pharmacist if you are allergic to inclisiran, any other medications, or any of the ingredients in inclisiran injection. Ask your pharmacist for a list of the ingredients.

• 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 administration 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 administration 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
• pain or burning on urination
• loose or frequent stools
• cough, shortness of breath, wheezing, low fever or chest tightness
• pain in arms or legs
• difficulty breathing

Inclisiran injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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 (http://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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.