Mipomersen

Mipomersen is a medication that helps lower cholesterol. It lowers blood levels of "bad" cholesterol, including low-density lipoprotein (LDL), apolipoprotein-B (apo-B), and non-high-density lipoprotein (non-HDL).

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

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

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

Mipomersen may also be used for other reasons not mentioned in this medication guide.

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

Mipomersen is injected under the skin. You may be taught how to give injections at home. Do not self-inject this medicine if you do not understand how to perform 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 spot on your stomach, thigh, or upper arm each time you give the injection. Your healthcare provider will show you the best areas on your body to inject the medication. Do not inject in the same spot two times in a row.

Mipomersen is only one part of a treatment plan 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 when you inject it. Take a vial or prefilled syringe out of the refrigerator and let it reach room temperature before giving an injection. Do not heat the medicine before using it. Do not remove the needle cover from the prefilled syringe until you are ready to inject.

Mipomersen can also be stored at room temperature for up to 14 days. Keep the medicine in its original container and protect it from heat and 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 as 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 it away after one use, even if there is still some medicine left after your dose.

Use a disposable needle only once, then throw it away in a puncture-proof container (ask your pharmacist where to 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 become too high. Your blood will need to be tested often. Your weekly treatments may be delayed or stopped permanently based on the results of these tests.

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 become too high. Your blood will need to be tested often. Your treatments may be stopped based on the results of these tests.

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

• active liver disease; or
• abnormal liver function tests.

To ensure 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 do blood tests to ensure you do not have conditions that would make it unsafe for you to use 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 if mipomersen passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

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 right away if you have:

• flu symptoms within 2 days after an injection--fever, chills, body aches, feeling tired, 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.

Usual Adult Dose for Hyperlipidemia:

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

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.

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