Mipomersen Injection
Mipomersen injection may cause liver damage. Tell your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had liver disease, including liver damage that developed while you were taking another medication. Your doctor will probably tell you not to use mipomersen injection if you have liver disease. Tell your doctor and pharmacist if you regularly take acetaminophen (Tylenol, in other medications for pain) and if you are taking amiodarone (Cordarone, Pacerone); other medications for high cholesterol; methotrexate (Rheumatrex, Trexall); tamoxifen (Soltamox); or tetracycline antibiotics such as doxycycline (Doryx, Vibra-Tabs, Vibramycin), minocycline (Dynacin, Minocin), and tetracycline (Sumycin). If you experience any of the following symptoms, call your doctor immediately: nausea, vomiting, loss of appetite, stomach pain, excessive tiredness, yellowing of the skin or eyes, dark urine, or itching.
Drinking alcohol increases the risk that you will develop liver damage during your treatment with mipomersen injection. Do not drink more than one alcoholic beverage per day while you are using this medication.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before and during your treatment to check your body’s response to mipomersen injection.
Because of the risk of liver damage, a program has been set up to monitor patients using mipomersen injection. Your doctor will need to complete training and register with the program before prescribing this medication. You will only be able to receive your medication from a pharmacy that has been certified to dispense mipomersen injection. Ask your doctor for more information about how to get your medication.
Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with mipomersen injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.
Talk to your doctor about the risks of using mipomersen injection.
🔔 Why is this medication prescribed?
Mipomersen injection is used to decrease levels of cholesterol and other fatty substances in the blood in people who have homozygous familial hypercholesterolemia (HoFH; a rare inherited condition that causes very high levels of cholesterol in the blood, increasing the risk of serious heart disease). Some people with HoFH may be treated with LDL apheresis (a procedure that removes LDL from the blood), but mipomersen injection should not be used along with this treatment. Mipomersen injection should not be used to decrease cholesterol levels in people who do not have HoFH. Mipomersen injection is in a class of medications called antisense oligonucleotide (ASO) inhibitors. It works by preventing certain fatty substances from forming in the body.
🔔 How should this medicine be used?
Mipomersen injection comes as a solution to inject under the skin. It is usually injected once a week. Inject mipomersen injection on the same day of the week and at around the same time of day every time you inject it. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use mipomersen injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.
Mipomersen injection may help control your cholesterol but will not cure your condition. It may take 6 months or longer for your cholesterol level to decrease significantly. Continue to use mipomersen injection even if you feel well. Do not stop using mipomersen injection without talking to your doctor.
You can inject mipomersen yourself or have a friend or relative inject the medication for you. Your doctor will show you or the person who will be injecting the medication how to give the injection. You and the person who will be injecting the medication should read the manufacturer’s instructions for use that come with the medication. Ask your doctor if you have any question or do not understand how to inject mipomersen.
Mipomersen injection comes in pre-filled syringes and in vials. If you are using vials of mipomersen injection, your doctor will tell you what type of syringe you should use and how you should draw the medication into the syringe. Do not mix any other medications in the syringe with mipomersen injection.
Take mipomersen injection out of the refrigerator at least 30 minutes before you plan to inject it to allow the medication to come to room temperature. Keep the syringe in its packaging to protect it from light during this time. Do not try to warm the syringe by heating it in any way.
Always look at mipomersen injection before injecting it. Be sure that the packaging is sealed, undamaged and labeled with the correct name of the medication and an expiration date that has not passed. Check that the solution in the vial or syringe is clear and colorless or slightly yellow. Do not use a vial or syringe if it is damaged, expired, discolored, or cloudy or if it contains particles.
You can inject mipomersen anywhere on the outer part of your upper arms, your thighs, or your stomach, except your navel (belly button) and the area 2 inches around it. Choose a different spot each time you inject the medication. Do not inject into skin that is red, swollen, infected, scarred, tattooed, sunburned or that is affected by a rash or a skin disease such as psoriasis.
Each pre-filled syringe or vial only contains enough mipomersen injection for one dose. Do not try to use vials or syringes more than once. Dispose of used syringes in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture-resistant container.