Plozasiran

Plozasiran is used along with a low-fat diet to lower triglycerides (a kind of fat in the blood) in adults with familial chylomicronemia syndrome (a condition that makes it hard for the body to break down fats).

Plozasiran may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Plozasiran is injected under the skin in the stomach or thigh, usually once every 3 months. This medicine may also be injected into your upper arm only if given by a healthcare provider or caregiver.

A healthcare provider will teach you or your caregiver how to properly use this medicine.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand how to use an injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Do not inject within 2 inches of your navel (belly button) or areas where the skin is hard, tender, red, bruised, cut, or has scars or stretch marks.

Throw away a prefilled syringe after one use, even if there is still medicine left inside.

Do not reuse a prefilled syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Your treatment will also include a special diet. Follow your doctor's instructions very carefully.

Store this medicine in the original carton in a refrigerator.

Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before using.

Do not warm the medicine with hot water, sunlight, or a microwave.

You may store this medicine at room temperature in the original carton for up to 30 days. Throw the medicine away if not used within 30 days.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

It is not known if plozasiran will harm an unborn baby. Tell your doctor if you are pregnant or planning to become pregnant.

Ask a doctor if it is safe to breastfeed while using plozasiran.

Get emergency medical help if you notice signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Less serious side effects may happen more often, or you may have none at all.

Common side effects of plozasiran may include:

• high blood sugar;
• headache;
• nausea; or
• pain, redness, or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Hypertriglyceridemia:

25 mg subcutaneously once every 3 months Comments:-Treatment should be adjunct to a low-fat diet (less than or equal to 20 grams of fat per day).Use: To reduce triglycerides in adults with familial chylomicronemia syndrome (FCS)

Use the medicine as soon as you remember and take your next dose 3 months after your last dose, then return to your regular schedule. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, drinks, or activities.

Other drugs may affect plozasiran, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.