Stiripentol

WHY is this medicine prescribed?

Stiripentol is used along with clobazam (Onfi^®, Sympazan^®) to control seizures in adults and children 6 months of age and older who weigh at least 7 kg (15 pounds) who have Dravet syndrome (a disorder that begins in early childhood and causes seizures and later may lead to developmental delays and changes in eating, balance, and walking). Stiripentol is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement activity in the brain.

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?

Stiripentol comes as a capsule and a powder to be mixed with water to take by mouth. It is usually taken two or three times a day during a meal. Take stiripentol at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take stiripentol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole with a glass of water; do not break or open them.

If you are taking the powder for oral suspension, you must mix it with water immediately before taking it. The doctor will tell you how many packets of stiripentol powder to use and how much water to mix it with. Carefully read the manufacturer's instructions that describe how to mix and take a dose of stiripentol. Be sure to ask your pharmacist or doctor if you have any questions about how to mix or take this medication.

Stiripentol controls your condition but does not cure it. Continue to take stiripentol even if you feel well. Do not stop taking stiripentol without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking stiripentol, your seizures may become worse. Your doctor will probably decrease your dose gradually.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with stiripentol 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 (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before taking stiripentol,

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

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with stiripentol, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• also tell your doctor if you have or have ever had depression, mood problems, or suicidal thoughts or behavior or kidney or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking stiripentol, call your doctor.

• ask your doctor about the safe use of alcoholic beverages while you are taking stiripentol. Alcohol can make the side effects from stiripentol worse.

• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent damage to your brain that can cause severe intellectual disability), you should know that stiripentol oral powder is sweetened with aspartame that forms phenylalanine.

• you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking stiripentol. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants, such as stiripentol, to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as one week after they started taking the medication. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); thinking about harming or killing yourself, or planning or trying to do so; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about drinking or eating a lot of caffeine-containing products such as coffee, tea, energy drinks, cola, or chocolate.

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

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

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

• sleepiness
• tiredness
• problems with coordination
• uncontrollable shaking of a part of the body
• loss of muscle tone
• difficulty speaking
• drooling
• nausea
• vomiting
• changes in weight

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• cough, sore throat, fever, chills, or other signs of infection
• unusual bruising or bleeding
• blood in urine or stools

Stiripentol can cause loss of appetite and weight loss. If you notice your child is losing weight, call your doctor. Your doctor will watch your child's growth carefully. Talk to your doctor if you have concerns about your child's growth or weight while he or she is taking this medication.

Stiripentol may cause other side effects. Call your doctor if you have any unusual problems while taking 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 at room temperature and away from light, excess heat, and moisture (not in the bathroom).

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

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.

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?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to stiripentol.

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.