Plozasiran Injection

Plozasiran injection is used to reduce triglycerides (a type of fat that your body uses for energy but can cause heart disease, strokes or problems with your pancreas if levels get too high) in patients with familial chylomicronemia syndrome(FCS; a rare genetic disorder where the body does not break down fats which leads to increased triglyceride levels). Plozasiran injection is in a class of medications called apolipoprotein C-III inhibitors. It works by decreasing the production of apoC-III, which increases the breakdown and removal of triglycerides from the body.

Plozasiran injection comes as a solution (liquid) in a prefilled syringe to be given subcutaneously (under the sin). Give every 3 months.

Use plozasiran injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You or a caregiver will be shown how to inject the medicine before your first dose. You will also be given the instructions for use. Read these carefully. Talk to your doctor or pharmacist if you have any questions on how to use the medicine.

Before using plozasiran injection, look closely at the prefilled syringe to make sure the solution is not cloudy or has particulates or is discolored. The solution should be clear to yellow.

You can inject plozasiran into the front of the thighs or abdomen. If a caregiver is injecting it, you can use the outer area of the upper arm. Do not inject into an area where the skin is bruised, tender, red, hard, or cut. Do not inject into areas with scars or stretch marks.

Plozasiran injection controls FCS but does not cure it. Continue to use plozasiran injection even if you feel well. Do not stop using plozasiran injection without talking to your doctor.

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

Before using plozasiran injection,

• 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 have or have ever had kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using plozasiran injection, call your doctor.

You should eat a low-fat diet with plozasiran injection therapy. Try to target 20 grams of fat or less a day.

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

Inject the missed dose as soon as you remember it and then resume giving every 3 months after that. Do not take a double dose to make up for a missed one.

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

• headache
• nausea
• pain, redness, or bruising at the site of injection

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

• increased thirst, increased urinating, tiredness, blurred vision, weight loss

Plozasiran 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 or at room temperature and away from excess heat and moisture (not in the bathroom) for 30 days.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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

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

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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