Tasimelteon Suspension

What is this medication?

TASIMELTEON (ta si MEL tee on) treats sleep disorders in people with Smith-Magenis syndrome. It helps regulate your sleep cycle.

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

COMMON BRAND NAME(S): HETLIOZ LQ

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

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

• Liver disease
• Smoke tobacco cigarettes
• An unusual or allergic reaction to tasimelteon, 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. Take it as directed on the prescription label at the same time every night. Shake well before using. Use a specially marked oral syringe, spoon, or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take it on an empty stomach, at least 30 minutes before and 2 hours after food. Keep taking it unless your care team tells you to stop.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 3 years 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, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medication with any of the following:

• Ramelteon
• Viloxazine

This medication may also interact with the following:

• Alcohol
• Certain medications for blood pressure, heart disease, irregular heart beat like acebutolol, metoprolol, or propranolol
• Certain medications for fungal infections like ketoconazole
• Fluvoxamine
• Melatonin
• Rifampin

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. It may be some time before you see the benefit from this medication.

Limit your activities to preparing for bed after taking this medication. You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Alcohol may interfere with the effects of this medication. Avoid alcoholic drinks.

If you smoke, tell your care team if you notice this medication is not working well for you. Talk to your care team if you decide to stop smoking.

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

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

• Headache
• Vivid dreams or nightmares

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 in the refrigerator. Do not freeze. Get rid of any unused medication after it expires or 5 weeks after opening for the 48 mL bottle and 8 weeks after opening for the 158 mL bottle.

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, pour 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.