Mipomersen (mi-poe-MER-sen)

Treats high cholesterol levels in people with homozygous familial hypercholesterolemia.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. This medicine is usually given once a week, on the same day of the week.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. It is usually given in the stomach, thighs, or upper arms.
• Use a new needle and syringe each time you inject your medicine.
• Allow the medicine to warm to room temperature for at least 30 minutes before you use it.
• Do not remove the needle cover of the prefilled syringe until you are ready to give the shot.
• Use each syringe only once. Do not save leftover medicine.
• Do not inject the medicine on skin areas that have cuts, scrapes, scars, rashes, sunburns, or tattoos.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
• Missed dose: If you miss a dose of this medicine, use it as soon as you remember. If it is less than 3 days until your next regular dose, skip the missed dose and use your next dose at the regular time. Do not use extra medicine to make up for the missed dose. Always allow at least 3 days between doses.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. You may also store the medicine at room temperature, away from heat and light, for up to 14 days. Keep your medicine in the original package until you are ready to use it.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how mipomersen works. Tell your doctor if you are using any of the following:
  • Acetaminophen, amiodarone, isotretinoin, methotrexate, tamoxifen
  • Tetracycline antibiotic
• Do not drink more than one alcoholic drink per day while you are using this medicine. Alcohol can increase your risk for liver problems.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, if you have liver disease or kidney problems, or if you are receiving dialysis.
• This medicine may cause serious liver problems.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes

If you notice these less serious side effects, talk with your doctor:

• Mild flu-like symptoms, fever, chills, body aches, tiredness
• Mild nausea
• Pain, itching, burning, swelling, or a lump under your skin where the shot is given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088