Olezarsen Injection

Olezarsen injection comes as a solution (liquid) in a prefilled autoinjector to be given subcutaneously (under the skin). It is usually given once a month at home. Use olezarsen injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You or your caregiver will be shown how to use the autoinjector by your doctor or nurse. You will be given instructions for use with the medicine. This will tell you how to inject it. Read it carefully. Ask your doctor or pharmacist if you have any questions on how to inject the medicine.

If the autoinjector has been refrigerated, place on a flat surface to warm to room temperature for 30 minutes before you plan to use it. Do not try to warm it by heating it in a microwave, placing it in hot water, leaving it in sunlight, or through any other method.

Always look at the autoinjector before using. Check that the expiration date has not passed and the liquid is clear and colorless to yellow. Do not use it if the liquid is cloudy, discolored, or contains particles.

You can inject olezarsen injection anywhere on the front of your thighs (upper leg) or stomach except the area 2 inches (5 centimeters) around your navel (belly button). If a caregiver injects the medication, the back of the upper arm may also be used. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.

Use each autoinjector device only once. Dispose of used devices in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

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 using olezarsen injection,

• tell your doctor and pharmacist if you are allergic to olezarsen, any other medications, or any of the ingredients in olezarsen 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 have or have ever had diabetes or liver problems.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using olezarsen injection, call your doctor.

Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. You can also visit the National Cholesterol Education Program (NCEP) website for additional dietary information at: https://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf

Inject the missed dose as soon as you remember it and start a new monthly dosing schedule based on this date. Do not inject a double dose to make up for a missed dose. Call your doctor if you miss a dose and have questions about what to do.

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

• redness, itching, swelling, pain, or tenderness at the injection site
• joint pain

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

• rash; hives; itching; redness; difficulty breathing or swallowing; swelling of the face, throat, tongue, lips, and eyes; chills; or muscle pain

Olezarsen 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator in the original carton. It may also be stored at room temperature for up to 6 weeks in the original carton. Do not freeze and protect from light.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.