Stiripentol Powder for Suspension

What is this medication?

STIRIPENTOL (stir i PEN tol) prevents and controls seizures in people with Dravet syndrome who are also taking clobazam. It works by calming overactive nerves in your body.

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

COMMON BRAND NAME(S): DIACOMIT

What should I tell my care team before I take this medication?

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

• Depression
• Kidney disease
• Liver disease
• Phenylketonuria (PKU)
• Suicidal thoughts, plans, or attempt
• An unusual or allergic reaction to stiripentol, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth after mixing the powder in a glass of water. To be sure there is no medication left in the drinking cup, add a small amount of water to the cup and drink all the mixture. Take it as directed on the prescription label at the same time every day. Take it with food. Keep taking it unless your care team tells you to stop.

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 care team about the use of this medication in children. While it may be prescribed for children as young as 6 months for selected conditions, precautions do apply.

Overdosage: If you think you have 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, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Alcohol
• Benzodiazepines, such as alprazolam, diazepam, lorazepam
• Caffeine
• Certain antihistamines
• Certain medications for depression, such as amitriptyline, sertraline, trazodone
• Certain medications for seizures, such as carbamazepine, clobazam, phenytoin, phenobarbital, primidone
• Clopidogrel
• Glyburide
• Medications that cause drowsiness before a procedure, such as propofol
• Medications that help you fall asleep
• Medications that relax muscles
• Methotrexate
• Opioids for pain or cough
• Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine
• Prazosin
• Quinidine
• Rifampin
• Theophylline
• Thiotepa

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 medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This product may contain aspartame, which is a source of phenylalanine. If you have phenylketonuria (PKU), contact your care team for advice.

Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

You may need blood work done while you are taking this medication. Your weight will be checked often. Children who take this medication should have their weight and growth checked often.

Watch for new or worsening thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Infection—fever, chills, cough, or sore throat
• Thoughts of suicide or self-harm, worsening mood, or feelings of depression
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Agitation, feeling irritable or restless
• Drowsiness
• Loss of appetite with weight loss
• Loss of balance or coordination
• Low muscle tone, decrease in reflexes, mobility, or posture
• Nausea
• Tremors or shaking
• Trouble sleeping
• Trouble speaking

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 medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original packaging until you are ready to take it. Protect from light. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.