Mipomersen Solution for injection

What is this medicine?

MIPOMERSEN (mi" poe mer' sen) is used in combination with diet and other medicines to lower blood cholesterol levels in patients with a genetic disorder that results in high blood cholesterol levels.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• if you often drink alcohol

• kidney disease

• liver disease

• an unusual or allergic reaction to mipomersen, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose or forget to take your dose at your usual weekly time, you can take it when you remember, unless it is less than 3 days until your next weekly dose. If it is less than 3 days until your next weekly dose, wait and take your next weekly dose at your regularly scheduled time. Do not take double or extra doses.

What may interact with this medicine?

• acetaminophen

• amiodarone

• isotretinoin

• lomitapide

• methotrexate

• tamoxifen

• tetracycline

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This medicine can cause liver injury. The risk of liver injury is increased in patients who drink alcohol while taking this medicine. Do not drink more than one alcoholic drink per day while taking this medicine.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• dark urine

• general ill feeling or flu-like symptoms

• light-colored stools

• loss of appetite, nausea

• right upper belly pain

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• headache

• nausea

• pain, redness, or irritation at site where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 2 and 8 degrees C (36 and 46 degrees F). If a refrigerator is not available, this medicine may be stored at or below 30 degrees C (86 degrees F) for up to 14 days if it is kept away from heat.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.