Vutrisiran Injection

Vutrisiran is used for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis (an inherited condition in which abnormal proteins build up and deposit in tissues, resulting in nerve damage) in adults. Vutrisiran is in a class of medications called small interfering RNAs (siRNAs). It works by decreasing the amount of abnormal proteins and the amount of abnormal protein deposited in the body's tissues, which decreases nerve damage.

Vutrisiran injection comes as a solution (liquid) to be given subcutaneously (under the skin). It is usually given by a doctor or a nurse in a clinic every 3 months.

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

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

Before receiving vutrisiran injection,

• tell your doctor and pharmacist if you are allergic to vutrisiran, any other medications, or any of the ingredients in vutrisiran 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 while taking vutrisiran. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had kidney disease, liver disease, or low vitamin A levels.
• Vutrisiran may decrease levels of vitamin A in your body. Your doctor may tell you to take a vitamin A supplement while you are receiving vutrisiran injection.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. The effects of vutrisiran on the fetus is unknown but low levels of vitamin A can affect development and therefore, benefits and risks of pregnancy while receiving vutrisiran should be discussed with your doctor. If you become pregnant while receiving vutrisiran injection, call your doctor.

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

If you missed a scheduled administration of vutrisiran injection, it should be given as soon as possible and then resume normal dosing schedule.

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

• joint pain
• shortness of breath
• bruising, pain, swelling, redness, itching and warmth at the site of injection

Some side effects can be serious. If you experience any of these symptoms while receiving vutrisiran, call your doctor immediately:

• difficulty seeing at night or in low light
• irregular heartbeat

Vutrisiran 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).

Keep all appointments with your doctor and the laboratory.

Ask your pharmacist any questions you have about vutrisiran.

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.

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