What is Mipomersen?
Mipomersen is a medicine that lowers cholesterol. It decreases the levels in the blood of "bad" cholesterol, such as low-density lipoprotein (LDL), apolipoprotein B (apo-B), and non-high-density lipoprotein (non-HDL).
Mipomersen can be used in conjunction with a low-fat diet as well as other methods to decrease the level of total cholesterol for those suffering from homozygous familial hypercholesterolemia (a kind of genetically inherited elevated cholesterol). Mipomersen should not be administered to people who suffer from heterozygous familial hypercholesterolemia.
There is no way to determine if mipomersen reduces your chance of developing a heart condition.
Mipomersen is only available through a licensed pharmacy that is part of an exclusive program known as Kynamro REMS. Your physician must be registered with the program to recommend Mipomersen to you.
Mipomersen is also used to treat conditions not covered in the medication guide.
Side effects of Mipomersen
See a doctor immediately. Are You Suffering From an Allergic Reaction? Symptoms May Include Hives, Difficult Breathing and Facial or Tongue Swelling
Mipomersen may cause serious side effects. Take off Mipomersen immediately, and contact your physician immediately in case you experience:
- The flu-like symptoms can be seen within two days of an injection: the fever chills, the body is aching, fatigue, and joint or muscular
- Redness, pain, swelling, itching, swelling, tenderness, or pain where an injection was made;
- nausea nausea, abdominal pains, itching weight loss, dark urine, clay-colored stool, jaundice (yellowing of eyes or skin).
A common adverse effect associated with mipomersen could be:
- Nausea;
- Headache;
- Flu signs and symptoms.
This is not an exhaustive list of possible side effects, and other side effects could occur. Consult your physician to seek medical advice on adverse negative effects. It is possible to report any side effects to the FDA by calling 1-800-FDA-1088.
Similar or related medications
atorvastatin, rosuvastatin, simvastatin, lipitor, ezetimibe, Crestor, and Zetia
Warnings
Mipomersen can only be purchased at a licensed pharmacy.
Mipomersen should not be used in the event of an active liver illness or unusual liver function tests. Contact your physician immediately if you notice liver-related symptoms like vomiting, nausea, fever, and fatigue. You may also experience itching, bloody urine, or jaundice (yellowing of the eyes or skin).
Mipomersen could cause liver enzymes to become too high. Your blood needs to be checked frequently. The treatment you receive could be stopped in the event of results from the tests.
Before you take this drug
It is not recommended to use mipomersen. If you're allergic to it or suffer from:
- Active liver disease
- Unusual test of liver function.
To ensure that mipomersen is suitable for you, inform your doctor that you are suffering from:
- Cirrhosis or another liver disease;
- Kidney disease (or kidney disease if you're taking dialysis);
- When you drink alcohol.
The doctor you see will conduct tests on your blood to ensure there are no problems that hinder you from using mipomersen.
Mipomersen used during pregnancy can affect the unborn baby. Consult your doctor if you are pregnant or get pregnant while taking mipomersen. Make sure you are using the most effective contraception while you are taking treatment.
It's not clear if mipomersen can be found in breast milk or if it can harm nursing babies. It is not recommended to breastfeed when taking this medication.
How to take Mipomersen?
Be sure to follow the directions provided on the prescription label. Don't use this medication in smaller or larger doses or for longer than prescribed.
Mipomersen is administered under the skin. It is possible to be taught how to inject at home. Don't inject yourself with this medication if you aren't sure how to administer the injection, and dispose of the old needles.
Mipomersen is usually given only every week. It is best to take this medication at the same time each week.
Choose a different spot in your stomach, thigh, or upper arm every time you inject. The doctor will guide you to the ideal locations on your body to inject the medicine. Make sure you don't inject in the same spot twice at a time.
Mipomersen is just one component of a program for treatment that could also comprise a specific diet or other medication. Be sure to follow your physician's recommendations precisely.
Mipomersen must be kept in the refrigerator when it is possible.
Mipomersen is required to be at room temperature at the moment of the injection. You can take a vial or an already-filled syringe out of the refrigerator and let the temperature rise prior to injecting. Make sure to not warm the drug prior to using it. You should not take the cover of the needle from the syringe you have pre filled until you are able to administer the injection.
Mipomersen can also be stored at room temperature for as long as 14 days. Store the medication in its original container, and keep it away from light or heat.
Make sure to prepare your dose when you're prepared to give an injection. If you take any other medication that can be injected, don't mix it in with mipomersen. You can also inject it simultaneously.
Avoid using the medicine in the event that it appears cloudy or has particles. Contact your pharmacist to inquire about a new medication.
Every single-use vial (bottle) or syringe that is prefilled can be used only once. Toss it away after just one use, regardless of whether there's remaining medicine inside after you have injected your dosage.
Utilize a needle that is disposable only once and dispose of it inside a container with a puncture-proof seal (ask your pharmacist for information on where they can find one and what you can do with the needle). The container should be kept far from pets and kids.
Mipomersen may cause your liver enzymes to become excessively high. Your blood needs to be regularly tested. Your weekly treatments could be shortened or removed based on the results of the tests.
Details on dosage
Usual Adult Dose for Hyperlipidemia:
200 mg subcutaneously, once a week on the same day every week.
Indication: An adjunct to lipid-lowering medications and diet to reduce low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), total cholesterol (TC), and non-high-density lipoprotein cholesterol (nonHDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).
What happens if I miss the dose?
Make sure to take the missed dose immediately after you recall. Do not take the dose you missed when your dosage is less than three days in the future. Don't take extra medication to replace the missed dose.
What happens if I overdose?
For medical emergencies, seek emergency treatment or dial for help at the Poison Help Line at 1-800-222-1222.
What should be avoided?
Do not inject mipomersen into parts of the skin that are swelling and irritated. Avoid sunburn if you are suffering from conditions like psoriasis or the appearance of a skin eruption. It is also advised to avoid injecting into a part of the skin that has a scar or tattoo.
Don't drink more than one alcohol-based drink every day. The chance of sustaining liver damage when you're taking mipomersen.
Beware of eating food items that are loaded with cholesterol or fat. Mipomersen won't be very effective in decreasing your cholesterol if it is not followed by a cholesterol-lowering diet regimen.
Interaction with other drug
Other medications can interfere with mipomersen. This includes medications that are prescribed and available over the counter, vitamins, and natural products. Inform your healthcare providers of any medications you take now, as well as any medications you begin or stop taking.
