Mipomersen is a cholesterol-lowering medication. It reduces blood levels of "bad" cholesterol, such as low-density lipoprotein (LDL), apolipoprotein-B (apo-B), or non-high-density lipoprotein (non-HDL).

Mipomersen is used together with a low-fat diet and other treatments to lower total cholesterol in people with homozygous familial hypercholesterolemia (an inherited type of high cholesterol). Mipomersen is not for use in people with heterozygous familial hypercholesterolemia.

It is not known whether mipomersen will lower your risk of heart disease.

Mipomersen is available only from a certified pharmacy under a special program called Kynamro REMS. Your doctor must be registered in the program in order to prescribe mipomersen for you.

Mipomersen may also be used for purposes not listed in this medication guide.

Mipomersen is available only from a certified pharmacy.

You should not use mipomersen if you have active liver disease or abnormal liver function tests. Tell your doctor right away if you have liver symptoms, such as vomiting, fever, stomach pain, itching, tiredness, dark urine, or jaundice (yellowing of the skin or eyes).

Mipomersen can cause your liver enzymes to get too high. Your blood will need to be tested often. Your treatments may be stopped based on the results of these tests.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Mipomersen is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Mipomersen is usually given once per week. Use this medicine on the same day each week, at the same time of day.

Use a different place on your stomach, thigh, or upper arm each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Mipomersen is only part of a treatment program that may also include a special diet and other medications. Follow your doctor's instructions very closely.

Mipomersen should be stored in a refrigerator, if possible.

Mipomersen must be at room temperature at the time of injection. Take a vial or prefilled syringe out of the refrigerator and allow it to reach room temperature before giving an injection. Do not heat the medicine before using. Do not remove the needle cover from the prefilled syringe until you are ready to give the injection.

Mipomersen may also be stored at room temperature for up to 14 days. Keep the medicine in its original container and protect from heat or light.

Prepare your dose only when you are ready to give an injection. If you use any other injectable medication, do not mix it with mipomersen or inject it at the same time you inject mipomersen.

Do not use the medicine if it looks cloudy or has particles in it. Call your pharmacist for new medicine.

Each single-use vial (bottle) or prefilled syringe is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle only once, then throw away in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Mipomersen can cause your liver enzymes to get too high. Your blood will need to be tested often. Your weekly treatments may be delayed or permanently discontinued based on the results of these tests.

Usual Adult Dose for Hyperlipidemia:

200 mg subcutaneously once weekly on the same day each 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).

You should not use mipomersen if you are allergic to it, or if you have:

• active liver disease; or

• abnormal liver function tests.

To make sure mipomersen is safe for you, tell your doctor if you have:

• cirrhosis or other liver disease;

• kidney disease (or if you are on dialysis); or

• if you drink alcohol.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using mipomersen.

Using mipomersen during pregnancy could harm the unborn baby. Tell your doctor if you are pregnant or if you become pregnant while using mipomersen. Use effective birth control during treatment.

It is not known whether mipomersen passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Use the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 3 days away. Do not use extra medicine to make up the missed dose.

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

Avoid injecting mipomersen into skin areas that are swollen, irritated, sunburned, or affected by conditions such as psoriasis or a skin rash. Also avoid injecting into any skin area with a scar or tattoo.

Avoid drinking more than 1 alcoholic drink per day. It may increase your risk of liver damage while you are taking mipomersen.

Avoid eating foods that are high in fat or cholesterol. Mipomersen will not be as effective in lowering your cholesterol if you do not follow a cholesterol lowering diet plan.

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

Mipomersen may cause serious side effects. Stop using mipomersen and call your doctor at once if you have:

• flu symptoms within 2 days after an injection--fever, chills, body aches, tired feeling, joint or muscle pain;

• pain, swelling, redness, itching, bruising, or tenderness where an injection was given; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of mipomersen may include:

• nausea;

• headache; or

• flu symptoms.

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

Other drugs may interact with mipomersen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.