Epidiolex is a prescription medicine used to treat seizures in people with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex.

Epidiolex is for use in adults and children who are at least 1 year old.

In April 2020, the U.S. Drug Enforcement Administration (DEA) announced the removal of cannabidiol from Schedule V of the Controlled Substances Act. Epidiolex is no longer considered a controlled substance.

You should not use Epidiolex if you are allergic to cannabidiol or sesame seed oil.

Cannabidiol can harm your liver. Your liver function may need to be checked before and during treatment.

Call your doctor at once if you have symptoms such as: nausea, vomiting, loss of appetite, right-sided upper stomach pain, tiredness, itching, dark urine, or yellowing of the skin or eyes.

Avoid driving or hazardous activity until you know how Epidiolex will affect you.

Some people have thoughts about suicide while taking Epidiolex. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Take Epidiolex exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Epidiolex is usually taken 2 times per day. Take the medicine at the same times each day.

You may take Epidiolex with or without food, but take it the same way each time.

Measure this medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). Make sure the dosing syringe is completely dry before measuring your dose.

Epidiolex liquid may be given through a feeding tube that is not made of polyvinyl chloride (PVC).

Cannabidiol can harm your liver. Your liver function may need to be checked before and during treatment. You may need to stop taking Epidiolex based on the results.

Store at room temperature, away from moisture and heat. Do not refrigerate or freeze. Keep the bottle tightly closed and in an upright position when not in use.

Throw away any unused liquid 12 weeks after you first opened the bottle.

Epidiolex can affect a drug-screening test and you may test positive for cannabis (marijuana). Tell the laboratory staff that you use cannabidiol.

Do not stop using Epidiolex suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

Usual Adult Dose for Lennox-Gastaut Syndrome:

Initial dose: 2.5 mg/kg orally twice a day
-After 1 week, may increase dose to 5 mg/kg orally twice a day
-For patients tolerating therapy and requiring further seizure reduction, may increase in 2.5 mg/kg twice a day increments as tolerated but no more frequently than every other day
Maintenance dose: 10 to 20 mg/kg/day
Maximum dose: 20 mg/kg/day

Comments:
-A dose of 20 mg/kg/day has demonstrated a greater reduction in seizure rates, but is associated with an increase in adverse reactions.
-Consistent dosing with respect to meals is recommended to reduce variability in cannabidiol plasma exposure.

Use: For the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome.

Usual Adult Dose for Dravet Syndrome:

Initial dose: 2.5 mg/kg orally twice a day
-After 1 week, may increase dose to 5 mg/kg orally twice a day
-For patients tolerating therapy and requiring further seizure reduction, may increase in 2.5 mg/kg twice a day increments as tolerated but no more frequently than every other day
Maintenance dose: 10 to 20 mg/kg/day
Maximum dose: 20 mg/kg/day

Comments:
-A dose of 20 mg/kg/day has demonstrated a greater reduction in seizure rates, but is associated with an increase in adverse reactions.
-Consistent dosing with respect to meals is recommended to reduce variability in cannabidiol plasma exposure.

Use: For the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome.

Usual Adult Dose for Tuberous Sclerosis Complex:

Initial dose: 2.5 mg/kg orally twice a day
-Increase dose in weekly increments of 2.5 mg twice a day (5 mg/kg/day) as tolerated to 12.5 mg/kg twice a day
-For patients requiring a more rapid titration, the dose may be increased no more frequently than every other day
Maintenance dose: 25 mg/kg/day
Maximum dose: 25 mg/kg/day

Comments:
-The effectiveness of doses lower than 25 mg/kg/day has not been studied.
-Consistent dosing with respect to meals is recommended to reduce variability in cannabidiol plasma exposure.

Use: For the treatment of seizures associated with tuberous sclerosis complex.

Usual Pediatric Dose for Lennox-Gastaut Syndrome:

1 year or older:
Initial dose: 2.5 mg/kg orally twice a day
-After 1 week, may increase dose to 5 mg/kg orally twice a day
-For patients tolerating therapy and requiring further seizure reduction, may increase in 2.5 mg/kg twice a day increments as tolerated but no more frequently than every other day
Maintenance dose: 10 to 20 mg/kg/day
Maximum dose: 20 mg/kg/day

Comments:
-A dose of 20 mg/kg/day has demonstrated a greater reduction in seizure rates, but is associated with an increase in adverse reactions.
-Consistent dosing with respect to meals is recommended to reduce variability in cannabidiol plasma exposure.

Use: For the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 1 year and older.

Usual Pediatric Dose for Dravet Syndrome:

1 year or older:
Initial dose: 2.5 mg/kg orally twice a day
-After 1 week, may increase dose to 5 mg/kg orally twice a day
-For patients tolerating therapy and requiring further seizure reduction, may increase in 2.5 mg/kg twice a day increments as tolerated but no more frequently than every other day
Maintenance dose: 10 to 20 mg/kg/day
Maximum dose: 20 mg/kg/day

Comments:
-A dose of 20 mg/kg/day has demonstrated a greater reduction in seizure rates, but is associated with an increase in adverse reactions.
-Consistent dosing with respect to meals is recommended to reduce variability in cannabidiol plasma exposure.

Use: For the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 1 year and older.

Usual Pediatric Dose for Tuberous Sclerosis Complex:

1 year or older:
Initial dose: 2.5 mg/kg orally twice a day
-Increase dose in weekly increments of 2.5 mg twice a day (5 mg/kg/day) as tolerata to 12.5 mg/kg twice a day
-For patients requiring a more rapid titration, the dose may be increased no more frequently than every other day
Maintenance dose: 25 mg/kg/day
Maximum dose: 25 mg/kg/day

Comments:
-The effectiveness of doses lower than 25 mg/kg/day has not been studied.
-Consistent dosing with respect to meals is recommended to reduce variability in cannabidiol plasma exposure.

Use: For the treatment of seizures associated with tuberous sclerosis complex in patients 1 year and older.

Epidiolex is not approved for use by anyone younger than 1 year old.

To make sure Epidiolex is safe for you, tell your doctor if you have ever had:

• liver disease;

• drug or alcohol addiction;

• depression, a mood disorder; or

• suicidal thoughts or actions.

Some people have thoughts about suicide while taking Epidiolex. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

It is not known whether cannabidiol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of cannabidiol on the baby.

It may not be safe to breast-feed while using Epidiolex. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Drinking alcohol with Epidiolex can increase drowsiness.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction to Epidiolex: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have symptoms of liver problems, such as:

• nausea, vomiting, loss of appetite;

• tiredness, not feeling well;

• right-sided upper stomach pain;

• itching;

• dark urine; or

• jaundice (yellowing of the skin or eyes).

Common Epidiolex side effects may include:

• drowsiness;

• changes in appetite or weight;

• feeling weak or tired;

• infections (fever, flu symptoms, cough, swelling, redness, itching);

• diarrhea;

• sleep problems (insomnia);

• rash; or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using Epidiolex with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• other seizure medications (especially clobazam or valproate); or

• cannabis-based products.

This list is not complete. Many other drugs can interact with cannabidiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.