Mipomersen, Injection

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KEY POINTS

• This medicine is given by injection to lower cholesterol in people who have homozygous familial hypercholesterolemia. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause serious liver problems or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: apolipoprotein B-100 inhibitor; cholesterol-lowering medicine

Generic and brand names: mipomersen, injection; Kynamro

What is this medicine used for?

This medicine is given by injection to lower cholesterol in people who have inherited a gene that causes high levels of LDL (homozygous familial hypercholesterolemia). It is not used to lower cholesterol in people who do not have this condition.

You must be enrolled in a special program before you can receive this medicine. Only a few pharmacies are allowed to sell it. For more information call 1-877-KYNAMRO.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Kidney problems
• Liver disease
• Problems with alcohol abuse

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Talk with your healthcare provider about effective birth control. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Use this medicine exactly as your healthcare provider prescribes. Do not stop using this medicine without your healthcare provider’s approval. Do not use more of it or use it longer than prescribed.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine comes in single-use prefilled syringes. You may be able to give yourself these shots or have someone at home give them to you. Your healthcare provider will teach you how to use this medicine at home. Be sure you know how and when to have them and how much medicine to use. Your healthcare provider will determine the exact dosage of the medicine. This medicine is usually given once a week as an injection just under the skin. Give the injection on the same day of the week at the same time of day.

Warm the prefilled syringe at room temperature for 30 to 40 minutes after you take it out of the refrigerator before you use it. Use a different area for the shot each time, as directed by your healthcare provider. Do not give shots into skin that is tender, bruised, or red, or where you have scars or stretch marks. If you are not sure of how to give yourself the shots, ask your healthcare provider or pharmacist for help.

What if I miss a dose?

If you miss a dose, use it as soon as 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 use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine may cause serious liver problems. You need liver tests before you start this medicine and regularly while you are receiving this medicine. Keep all appointments. If you develop nausea, vomiting, a fever, stomach pain, unexplained loss of appetite, itching, yellowing of your eyes or skin, light-colored bowel movements, dark urine, or severe tiredness or weakness, contact your healthcare provider right away. These may be signs of a liver problem.

Alcohol may increase the risk of liver problems. Do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Yellowing of your skin or eyes; dark urine; light-colored bowel movements; unexplained loss of appetite; severe nausea, vomiting, or stomach pain; severe or ongoing itching; unexplained fever; severe tiredness or weakness; chest pain; irregular heartbeat; unexplained swelling in hands or feet; severe injection site pain, redness, swelling, or itching.

Other: Mild nausea, mild stomach pain, headache, mild muscle or joint pain, mild tiredness, trouble sleeping; mild injection site pain, redness, swelling, or itching; mild fever and chills.

What products might interact with this medicine?

When you take this medicine with other medicines; it can change the way this or any of the other medicines work. Nonprescription medicines; vitamins; natural remedies; and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Acetaminophen and medicines that contain acetaminophen
• Amiodarone (Cordarone, Pacerone)
• Antibiotics such as demeclocycline, doxycycline (Doryx, Monodox, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), and tetracycline
• Isotretinoin (Absorica, Amnesteem, Claravis, Myorisan, Zenatane)
• Lomitapide (Juxtapid)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Tamoxifen

Do not drink alcohol while taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the refrigerator in the original carton. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. Warm the medicine to room temperature for 30 minutes before you give an injection. This medicine may be stored at room temperature for up to 14 days if it is kept away from heat.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.