Description
Olezarsen 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 olezarsen 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 olezarsen 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 back of the 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.
Olezarsen injection may sometimes 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 on skin areas that are bruised, hard, red, damaged, or have scars.
Your doctor will ask you to stay on your low-fat diet while using this medicine.
Allow 30 minutes for the autoinjector to warm up to room temperature. Do not warm using heat sources (eg, hot water or microwave).
Check the liquid in the autoinjector. 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 it if it looks damaged or if the clear cap is missing or not attached.
To use the autoinjector:
- Wash your hands with soap and water before and after using this medicine.
- Hold the autoinjector in the middle with the clear cap facing away from you. Remove the clear cap by pulling it straight off. Do not twist if off.
- Do not recap the autoinjector. Do not push the orange needle shield against your hand or finger.
- Hold the autoinjector with one hand. Place the orange needle shield at 90 degree angle against your skin. Push firmly and hold the autoinjector straight against your skin. You will hear a click as the injection starts. You may hear a second click, which is normal. The injection is not finished.
- Hold the autoinjector against the skin for 10 seconds to make sure full dose has been given. Do not move, turn, or change the angle of the autoinjector during the injection.
- Check that the orange plunger rod has moved down to fill the entire viewing window. If you do not see the orange plunger rod, you may not have received the full dose.
- Remove the autoinjector by lifting it straight up. The orange needle shield will lock into place and cover the needle.
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 (autoinjector):
- To reduce triglycerides:
- Adults—80 milligrams (mg) injected under your skin once a month.
- 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 1 month from the date of your last dose to get back on your monthly scheduled time.
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 6 weeks. Throw away any unused medicine after 6 weeks.
Throw away used autoinjector 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.
This medicine may cause serious allergic reactions, including bronchospasm, erythema, and myalgias, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, chills, cough, difficulty in moving, facial swelling, joint pain, muscle aches, cramps, pains or stiffness, swollen joints, or trouble breathing.
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
- Unusual bleeding or bruising
Incidence not known
- Chest tightness
- chills
- cough
- difficulty in breathing or swallowing
- difficulty in moving
- fast heartbeat
- joint pain
- muscle aches, cramps, pains, or stiffness
- skin itching, rash, or redness
- swelling of the face, throat, or tongue
- swollen joints
- trouble breathing
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
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.
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