Mipomersen

Generic name: Mipomersen
Brand names: Kynamro
Dosage form: subcutaneous solution (200 mg/mL)
Drug class: Miscellaneous antihyperlipidemic agents

Usage of Mipomersen

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 side effects

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.

Before taking Mipomersen

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.

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How to use Mipomersen

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).

Warnings

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.

What other drugs will affect Mipomersen

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.

Disclaimer

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