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EPIDIOLEX is the first and only FDA-approved prescription CBD used to treat seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients 1 year of age and older.
EPIDIOLEX significantly reduced drop seizures in people living with LGS
Monthly drop-seizure* reduction over the 14-week treatment period.
REDUCTION
EPIDIOLEX
10 mg/kg/day dose
REDUCTION
EPIDIOLEX
20 mg/kg/day dose
REDUCTION
In the placebo group
In another study, there was a 44% monthly reduction in drop seizures among patients taking EPIDIOLEX in the 20 mg/kg/day group, compared with a 22% reduction taking placebo.
4% of people taking EPIDIOLEX 20 mg/kg/day (compared with 0% of people taking placebo) reported no drop seizures. In another study, 4% of people taking EPIDIOLEX 10 mg/kg/day and 7% who took EPIDIOLEX 20 mg/kg/day (compared with 1% of people taking placebo) reported no drop seizures.†
3x more people living with LGS saw a substantial reduction of 75% or greater in their drop seizures with EPIDIOLEX 10 mg/kg/day (11%), compared with placebo (3%).
More than 500 people with LGS and Dravet syndrome took part in 3 clinical studies—the largest placebo-controlled, clinical study program of these conditions to date. Even after these trials were completed, the majority of people continued taking EPIDIOLEX for more than a year.
EPIDIOLEX clinical trials included people who had typically failed on 4-6 prior antiseizure medicines. These people were typically also taking 3 antiseizure medicines at the time, but their seizures were still uncontrolled.
The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections.
Clobazam, valproate, lamotrigine, and levetiracetam.
At 20 mg/kg/day doses, there was a somewhat greater reduction in seizure rates than with 10 mg/kg/day doses; however, there was also an increase in EPIDIOLEX side effects.
of caregivers reported an improvement in their loved one’s overall condition on the Subject/Caregiver Impression of change (S/CGIC) scale.*
of caregivers reported an improvement in their loved one’s overall condition on the scale.*
*The S/CGIC is a 7-point scale that ranges from “Very Much Improved” to “Very Much Worse,” evaluating patient or caregiver assessment of the patient’s overall condition from the beginning of the study to the end of the study.
Patients who stayed on EPIDIOLEX after the initial trial maintained seizure reduction in a 3-year open-label phase.
*Drop seizures included tonic, atonic, and tonic-clonic that led, or could have led, to a fall or injury.
†During the 12-week maintenance period.
EPIDIOLEX reduced convulsive seizures in people living with Dravet syndrome
Monthly convulsive-seizure* reduction over the 14-week treatment period.
REDUCTION
EPIDIOLEX
20 mg/kg/day dose
REDUCTION
In the placebo group
7% of people taking EPIDIOLEX 20 mg/kg/day (compared with 0% of people taking placebo) reported no convulsive seizures.†
in their convulsive seizures with EPIDIOLEX 20 mg/kg/day (23%), compared with placebo (12%).
More than 500 people with LGS and Dravet syndrome took part in 3 clinical studies—the largest placebo-controlled, clinical study program of these conditions to date. Even after these trials were completed, the majority of people continued taking EPIDIOLEX for more than a year.
EPIDIOLEX clinical trials included people who had typically failed on 4-6 prior antiseizure medicines. These people were typically also taking 3 antiseizure medicines at the time, but their seizures were still uncontrolled.
The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections.
Clobazam, valproate, and stiripentol.
10 mg/kg/day as a maintenance dose.
20 mg/kg/day as a maximum dose.
Patients who stayed on EPIDIOLEX after the initial trial maintained seizure reduction in a 3-year open-label phase.
*Convulsive seizures include several seizure types: tonic, tonic-clonic, atonic, and clonic.
†During the 12-week maintenance period.
Reduction in TSC-associated seizures* over the 16-week treatment period.
REDUCTION
EPIDIOLEX
25 mg/kg/day dose
REDUCTION
In the placebo group
6% of people taking EPIDIOLEX achieved freedom from TSC-associated seizures (compared with 0% of people taking placebo).
More people reduced their TSC seizures by 75% or more with EPIDIOLEX 25 mg/kg/day (19%), compared with 0% of people taking placebo.
More than 200 people with TSC took part in a clinical trial to determine if EPIDIOLEX reduced the rate of seizures associated with TSC. After this trial was completed, almost all patients continued taking EPIDIOLEX as part of an extension of the study.
People with TSC in the EPIDIOLEX clinical trial had typically failed on 4 prior antiseizure medicines. They were also taking an average of 3 antiseizure medicines at the time of the study, but their seizures were still uncontrolled.
The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections.
EPIDIOLEX can be used in combination with many commonly prescribed antiseizure medicines. In this study, the most common antiseizure medicines patients had taken, while also taking EPIDIOLEX, were valproate, vigabatrin, levetiracetam, and clobazam.
Patients who stayed on EPIDIOLEX after the initial trial maintained seizure reduction in a 3-year open-label phase.
*TSC-associated seizures included different types of partial onset (focal) seizures and generalized seizures.
EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before you start taking EPIDIOLEX and during treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if you start to have any of these signs and symptoms of liver problems during treatment with EPIDIOLEX:
Your doctor may order blood tests to monitor for other EPIDIOLEX side effects.
EPIDIOLEX may cause you to feel sleepy, which may get better over time. Other medicines (e.g., clobazam) or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how EPIDIOLEX affects you.
Like other antiepileptic drugs, EPIDIOLEX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
How can I watch for early symptoms of suicidal thoughts and actions?
Do not stop taking EPIDIOLEX without first talking to your healthcare provider. Stopping a seizure medicine such as EPIDIOLEX suddenly can cause you to have seizures more often or seizures that do not stop (status epilepticus).
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Do not take EPIDIOLEX if you are allergic to cannabidiol or any other ingredients in EPIDIOLEX.
EPIDIOLEX may interact with some antiseizure medicines or other medicines you are taking. Do not start or stop other medicines without talking to your doctor. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and cannabis-based products.
This brochure is all about the first and only FDA-approved prescription CBD to treat seizures associated with LGS, Dravet syndrome, and TSC.
Important Safety Information
What is the Most Important Information I Should Know About EPIDIOLEX (cannabidiol)?
Do not take if you are allergic to cannabidiol or any of the ingredients in EPIDIOLEX. EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before and during EPIDIOLEX treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if…
Indications
What is EPIDIOLEX (cannabidiol)?
EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex… in patients 1 year of age and older. It is not known if EPIDIOLEX is safe and effective in children under 1 year of age.
Important Safety Information & Indications Important Safety Information & Indications
What is the Most Important Information I Should Know About EPIDIOLEX (cannabidiol)?
Do not take if you are allergic to cannabidiol or any of the ingredients in EPIDIOLEX.
EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before and during EPIDIOLEX treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if you start to have any of these signs and symptoms of liver problems during treatment with EPIDIOLEX:
EPIDIOLEX may cause you to feel sleepy, which may get better over time. Other medicines (e.g., clobazam) or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how EPIDIOLEX affects you.
Like other antiseizure medicines, EPIDIOLEX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your doctor right away if you have any signs of depression or anxiety, thoughts about suicide or self-harm, feelings of agitation or restlessness, aggression, irritability, or other unusual changes in behavior or mood, especially if they are new, worse, or worry you.
Take EPIDIOLEX exactly as your doctor tells you. Do not stop taking EPIDIOLEX without first talking to your doctor. Stopping an antiseizure medicine suddenly can cause serious problems.
What Else Should I Know When Taking EPIDIOLEX?
The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections.
EPIDIOLEX may affect the way other medicines work, and other medicines may affect how EPIDIOLEX works. Do not start or stop other medicines without talking to your doctor. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and cannabis-based products.
What Additional Information Applies to Women?
If you are pregnant or plan to become pregnant, EPIDIOLEX may harm your unborn baby, and medicines like EPIDIOLEX may be passed into breast milk. You and your doctor will decide if you should take EPIDIOLEX and about the best way to feed your baby while taking EPIDIOLEX. If you become pregnant while taking EPIDIOLEX, discuss registering with the EPIDIOLEX Pregnancy Surveillance Program (855-272-7158 or epidiolexpregnancystudy.com) and the North American Antiepileptic Drug Pregnancy Registry (888-233-2334 or aedpregnancyregistry.org). The purpose of these registries is to collect information about the safety of antiseizure medicines during pregnancy.
What is EPIDIOLEX (cannabidiol)?
EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older. It is not known if EPIDIOLEX is safe and effective in children under 1 year of age.
Please read the EPIDIOLEX Medication Guide and Instructions for Use for additional important information.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also contact Jazz Pharmaceuticals at 1-800-520-5568.
Important Safety Information
What is the Most Important Information I Should Know About EPIDIOLEX (cannabidiol)?
Do not take if you are allergic to cannabidiol or any of the ingredients in EPIDIOLEX. EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before and during EPIDIOLEX treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if…
Indications
What is EPIDIOLEX (cannabidiol)?
EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex… in patients 1 year of age and older. It is not known if EPIDIOLEX is safe and effective in children under 1 year of age.
Important Safety Information & Indications Important Safety Information & Indications
What is the Most Important Information I Should Know About EPIDIOLEX (cannabidiol)?
Do not take if you are allergic to cannabidiol or any of the ingredients in EPIDIOLEX.
EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before and during EPIDIOLEX treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if you start to have any of these signs and symptoms of liver problems during treatment with EPIDIOLEX:
EPIDIOLEX may cause you to feel sleepy, which may get better over time. Other medicines (e.g., clobazam) or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how EPIDIOLEX affects you.
Like other antiseizure medicines, EPIDIOLEX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your doctor right away if you have any signs of depression or anxiety, thoughts about suicide or self-harm, feelings of agitation or restlessness, aggression, irritability, or other unusual changes in behavior or mood, especially if they are new, worse, or worry you.
Take EPIDIOLEX exactly as your doctor tells you. Do not stop taking EPIDIOLEX without first talking to your doctor. Stopping an antiseizure medicine suddenly can cause serious problems.
What Else Should I Know When Taking EPIDIOLEX?
The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections.
EPIDIOLEX may affect the way other medicines work, and other medicines may affect how EPIDIOLEX works. Do not start or stop other medicines without talking to your doctor. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and cannabis-based products.
What Additional Information Applies to Women?
If you are pregnant or plan to become pregnant, EPIDIOLEX may harm your unborn baby, and medicines like EPIDIOLEX may be passed into breast milk. You and your doctor will decide if you should take EPIDIOLEX and about the best way to feed your baby while taking EPIDIOLEX. If you become pregnant while taking EPIDIOLEX, discuss registering with the EPIDIOLEX Pregnancy Surveillance Program (855-272-7158 or epidiolexpregnancystudy.com) and the North American Antiepileptic Drug Pregnancy Registry (888-233-2334 or aedpregnancyregistry.org). The purpose of these registries is to collect information about the safety of antiseizure medicines during pregnancy.
What is EPIDIOLEX (cannabidiol)?
EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older. It is not known if EPIDIOLEX is safe and effective in children under 1 year of age.
Please read the EPIDIOLEX Medication Guide and Instructions for Use for additional important information.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also contact Jazz Pharmaceuticals at 1-800-520-5568.
EPIDIOLEX was recently approved by the FDA to treat seizures associated with tuberous sclerosis complex (TSC) in people 1 year of age and older. You can find results of the EPIDIOLEX TSC study here and see the stories on people living with TSC who take EPIDIOLEX here.
See our updated Prescribing Info, featuring TSC information, here.
