Description
Plozasiran injection is used together with diet to reduce triglycerides (fat in the blood) in patients with familial chylomicronemia syndrome (FCS), a condition that keeps the body from breaking down fats.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of plozasiran injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of plozasiran injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Proper Use
A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the stomach, thighs, or upper arms.
This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Plozasiran injection may be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how to use the medicine.
You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are bruised, hard, red, tender, or have scars or stretch marks.
Your doctor will ask you to stay on your low-fat diet while using this medicine.
Allow 30 minutes for the prefilled syringe to warm up to room temperature. Do not warm using heat sources (eg, hot water or microwave).
Check the liquid in the prefilled syringe. It should be clear and colorless to yellow. Do not use it if it is cloudy, discolored, or has particles in it. Do not use the prefilled syringe if it looks damaged, cracked, or broken, if the gray cap is missing or not attached, or if it has been dropped.
To use the prefilled syringe:
- Wash your hands with soap and water before and after using this medicine.
- Do not remove the gray needle cap until you are ready to inject. Do not pick up or pull the prefilled syringe by the plunger rod or gray needle cap.
- Hold the prefilled syringe by the syringe barrel, with the needle facing away from you. Pull the gray needle cap straight up. Do not twist or bend the cap. Do not put the needle cap back on.
- Hold the prefilled syringe in one hand. Gently pinch the skin with your other hand. Insert the needle at a 45 to 90 degree angle. Keep the skin pinched while you are inserting the needle and during injection. Do not put your finger on the plunger head before injecting.
- Push the plunger head all the way down. Gently lift the syringe up and off the skin until the needle is completely removed. Do not pull the plunger head up. Lift the syringe straight up.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (prefilled syringe):
- To reduce triglycerides:
- Adults—25 milligrams (mg) injected under your skin once every 3 months.
- Children—Use and dose must be determined by your doctor.
- To reduce triglycerides:
Missed Dose
Call your doctor or pharmacist for instructions.
If you miss a dose, inject it as soon as possible. Then, inject the next dose 3 months from the date of your most recent dose to get back on the every-3-month dosing schedule.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
You may store this medicine at room temperature for up to 30 days. Throw away any unused medicine after 30 days.
Throw away used syringes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Blurred vision
- dry mouth
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- nausea
- stomach pain
- sweating
- trouble breathing
- unexplained weight loss
- unusual tiredness or weakness
- vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- headache
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80008538
