Mipomersen Injection

IMPORTANT WARNING:

Mipomersen is no longer commercially available in the U.S. See the FDA website (https://www.accessdata.fda.gov/scripts/cder/daf/) for information on drugs that have been discontinued.

Because this drug is no longer available in the U.S. market, this document is no longer updated by AHFS DI. If this drug is used in countries other than the U.S., it is essential that the manufacturers' labeling be consulted for more recently available information.

Mipomersen injection may cause liver damage. Tell your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had liver disease, including liver damage that developed while you were taking another medication. Your doctor will probably tell you not to use mipomersen injection if you have liver disease. Tell your doctor and pharmacist if you regularly take acetaminophen (Tylenol, in other medications for pain) and if you are taking amiodarone (Cordarone, Pacerone); other medications for high cholesterol; methotrexate (Rheumatrex, Trexall); tamoxifen (Soltamox); or tetracycline antibiotics such as doxycycline (Doryx, Vibra-Tabs, Vibramycin), minocycline (Dynacin, Minocin), and tetracycline (Sumycin). If you experience any of the following symptoms, call your doctor immediately: nausea, vomiting, loss of appetite, stomach pain, excessive tiredness, yellowing of the skin or eyes, dark urine, or itching.

Drinking alcohol increases the risk that you will develop liver damage during your treatment with mipomersen injection. Do not drink more than one alcoholic beverage per day while you are using this medication.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before and during your treatment to check your body's response to mipomersen injection.

Because of the risk of liver damage, a program has been set up to monitor patients using mipomersen injection. Your doctor will need to complete training and register with the program before prescribing this medication. You will only be able to receive your medication from a pharmacy that has been certified to dispense mipomersen injection. Ask your doctor for more information about how to get your medication.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with mipomersen injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of using mipomersen injection.

WHY is this medicine prescribed?

Mipomersen injection is used to decrease levels of cholesterol and other fatty substances in the blood in people who have homozygous familial hypercholesterolemia (HoFH; a rare inherited condition that causes very high levels of cholesterol in the blood, increasing the risk of serious heart disease). Some people with HoFH may be treated with LDL apheresis (a procedure that removes LDL from the blood), but mipomersen injection should not be used along with this treatment. Mipomersen injection should not be used to decrease cholesterol levels in people who do not have HoFH. Mipomersen injection is in a class of medications called antisense oligonucleotide (ASO) inhibitors. It works by preventing certain fatty substances from forming in the body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Mipomersen injection comes as a solution to inject under the skin. It is usually injected once a week. Inject mipomersen injection on the same day of the week and at around the same time of day every time you inject it. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use mipomersen injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

Mipomersen injection may help control your cholesterol but will not cure your condition. It may take 6 months or longer for your cholesterol level to decrease significantly. Continue to use mipomersen injection even if you feel well. Do not stop using mipomersen injection without talking to your doctor.

You can inject mipomersen yourself or have a friend or relative inject the medication for you. Your doctor will show you or the person who will be injecting the medication how to give the injection. You and the person who will be injecting the medication should read the manufacturer's instructions for use that come with the medication. Ask your doctor if you have any question or do not understand how to inject mipomersen.

Mipomersen injection comes in pre-filled syringes and in vials. If you are using vials of mipomersen injection, your doctor will tell you what type of syringe you should use and how you should draw the medication into the syringe. Do not mix any other medications in the syringe with mipomersen injection.

Take mipomersen injection out of the refrigerator at least 30 minutes before you plan to inject it to allow the medication to come to room temperature. Keep the syringe in its packaging to protect it from light during this time. Do not try to warm the syringe by heating it in any way.

Always look at mipomersen injection before injecting it. Be sure that the packaging is sealed, undamaged and labeled with the correct name of the medication and an expiration date that has not passed. Check that the solution in the vial or syringe is clear and colorless or slightly yellow. Do not use a vial or syringe if it is damaged, expired, discolored, or cloudy or if it contains particles.

You can inject mipomersen anywhere on the outer part of your upper arms, your thighs, or your stomach, except your navel (belly button) and the area 2 inches around it. Choose a different spot each time you inject the medication. Do not inject into skin that is red, swollen, infected, scarred, tattooed, sunburned or that is affected by a rash or a skin disease such as psoriasis.

Each pre-filled syringe or vial only contains enough mipomersen injection for one dose. Do not try to use vials or syringes more than once. Dispose of used syringes in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture-resistant container.

What SPECIAL PRECAUTIONS should I follow?

Before injecting mipomersen injection,

• tell your doctor and pharmacist if you are allergic to mipomersen, any other medications, or any of the ingredients in mipomersen injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• do not inject any other medications at the same time that you inject mipomersen. Ask your doctor or pharmacist when to inject your medications.

• tell your doctor if you have or have ever had kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should use birth control to prevent pregnancy during your treatment. Talk to your doctor about methods of birth control that will work for you. If you become pregnant during your treatment, stop using mipomersen injection and call your doctor immediately.

What SPECIAL DIETARY instructions should I follow?

Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. You can also visit the National Cholesterol Education Program (NCEP) website at http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf for additional dietary information.

What should I do IF I FORGET to take a dose?

If you remember at least 3 days before your next scheduled dose, take the missed dose right away. However, if you remember less than 3 days before your next scheduled dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Mipomersen injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, pain, tenderness, swelling, discoloration, itching, or bruising of the skin where you injected mipomersen
• flu-like symptoms such as fever, chills, muscle pain, joint pain, weakness, and tiredness that are most likely to occur during the first 2 days after you inject mipomersen
• headache
• difficulty falling asleep or staying asleep
• pain in the arms or legs

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• chest pain
• pounding heartbeat
• swelling of the arms, hands, feet, ankles, or lower legs
• rash
• hives
• swelling of the face, throat, tongue, lips, or eyes
• hoarseness
• difficulty swallowing or breathing

Mipomersen injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in a refrigerator and protect it from light. If no refrigerator is available, you can store the medication at room temperature for up to 14 days.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.