If you have had a seizure, there are many medicines that can help lower your risk of having more seizures. The right choice for you depends on many factors, including the cause of your seizures or the type of seizure you have. Epidiolex is a medicine for seizures in people who have seizures related to Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex.
How Does Epidiolex Work for Seizures?
Seizures are caused by sudden electrical activity changes in the brain. These changes are temporary but result in changes in movement, behavior, sensation, or awareness.
The exact way that Epidiolex works to decrease the number of seizures you have is not known. Epidiolex may slow down signals in the brain, and it is believed that Epidiolex works in more than one way to treat seizures.
How Do I Take Epidiolex?
Epidiolex is an oral solution that is supplied in an amber colored glass bottle. When you are ready to use the Epidiolex bottle, you should remove the child-resistant cap and place the supplied bottle adapter on the bottle. The bottle adapter will help you measure the exact dose of Epidiolex and should stay on the bottle. The child-resistant cap can be placed on the bottle over the bottle adapter.
You will usually take Epidiolex twice daily. Your health care provider will tell you how much to take.
The medicine comes with two reusable syringes of different sizes, and you should select the size that best matches your dose.
- If your dose is 1 mL or less, use the 1 mL syringe.
- If your dose is more than 1 mL, use the 5 mL syringe.
- If your dose is greater than 5 mL, use the 5 mL more than one time to complete the dose.
To remove your dose of Epidiolex, you should insert the appropriate size syringe into the bottle adapter with the plunger all the way down. Flip the bottle upside down and slowly pull back the plunger of the syringe to withdraw the dose you need.
Epidiolex should be slowly administered from the syringe to the inside of the cheek. Do not forcefully push the plunger or administer to the back of the throat as this may cause choking.
The bottle of Epidiolex can be used for up to 12 weeks. After 12 weeks, you should discard any Epidiolex that has not been used.
Follow your health care provider’s directions and read the full Instructions for Use that comes with your medicine.
How Was Epidiolex Studied for Seizures?
Epidiolex was studied in separate clinical trials for people with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. These studies are described below.
How Was Epidiolex Studied for Lennox-Gastaut syndrome (LGS)?
Two studies known as GWPCARE3 and GWPCARE4 tested whether Epidiolex could reduce seizures in people with LGS. In both studies, people aged 2 to 55 years continued their usual seizure medicines and were given either Epidiolex or a placebo that did not contain medicine for 14 weeks.
Most people in the studies were taking one to five medicines for their seizures when they started the study. The median (middle) number of seizure medicines at the time of study entry was three. The most common seizure medicines taken were Clobazam, Valproate, Lamotrigine, Levetiracetam, and Rufinamide. Even though they were already taking other seizure medicines, all of the people in these studies had two or more seizures per week during the four weeks before the study started. The studies looked at whether adding Epidiolex to their treatment decreased the number of drop seizures compared to placebo. A drop seizure is a type of seizure where your muscles go limp and you might drop something or fall.
- In GWPCARE3, people taking Epidiolex had a median drop seizure reduction of about 37% to 42%, compared to 17% with placebo.
- In GWPCARE4, people taking Epidiolex had a 44% reduction in drop seizures, compared to 22% with placebo.
- Overall, three times more people with LGS saw at least a 75% reduction in drop seizures with an Epidiolex compared with placebo.
Another study, known as GWPCARE5, treated people with Epidiolex for up to 39 months (about three years) and found that seizure rates remained lower compared to before they started taking the medicine.
Your results may differ from what was seen in clinical studies.
How Was Epidiolex Studied for Dravet Syndrome?
One study tested whether Epidiolex could reduce seizures in 120 people with Dravet syndrome. In this study, children and young adults aged 2 to 18 years continued their usual seizure medicines and were given either Epidiolex or a placebo that did not contain medicine for 14 weeks.
People in the study were taking one to five medicines for their seizures when they started the study. The median (middle) number of seizure medicines at the time of study entry was three. The most common seizure medicines taken were Clobazam, Valproate, Stiripentol, Levetiracetam, and Topiramate. Even though they were already taking other seizure medicines, all of the people in this study had four or more seizures during the four weeks before the study started. The study looked at whether adding Epidiolex to their treatment decreased the number of convulsive seizures compared to placebo. A convulsive seizure is a type of seizure where your body shakes uncontrollably, or your muscles stiffen or jerk.
- People taking Epidiolex had a median convulsive seizure reduction of 39%, compared to 13% with placebo.
- Almost twice as many people treated with Epidiolex had at least a 75% reduction in convulsive seizures compared to placebo.
- Around 7% of people treated with Epidiolex had no convulsive seizures during the study.
Your results may differ from what was seen in clinical studies.
How Was Epidiolex Studied for Tuberous Sclerosis Complex (TSC)?
One study tested whether Epidiolex could reduce seizures in 224 people with TSC. In this study, people aged 1 to 65 years continued their usual seizure medicines and were given either Epidiolex or a placebo that did not contain medicine for 16 weeks. People in the study were taking up to five medicines for their seizures when they started the study. The median (middle) number of seizure medicines at the time of study entry was three. The most common seizure medicines taken were Valproate, Vigabatrin, Levetiracetam, and Clobazam. Even though they were already taking other seizure medicines, all of the people in this study had eight or more seizures during the four weeks before the study started, with seizures occurring in at least three of those four weeks. The study looked at whether adding Epidiolex to their treatment decreased the number of TSC-related seizures compared to placebo.
- People taking Epidiolex had a median seizure reduction of 48% to 49%, compared to 24% with placebo.
- Almost twice as many people treated with Epidiolex had at least a 75% reduction in TSC-related seizures compared to placebo.
- Around 6% of people treated with Epidiolex had no TSC-related seizures.
Your results may differ from what was seen in clinical studies.
How Long Does it Take for Epidiolex to Work?
Epidiolex usually starts working to reduce seizures within four weeks, based on what was seen in studies. But everyone responds to seizure medicines differently, and some people may notice improvement sooner. Your health care provider will monitor your response to Epidiolex and may adjust your dose to find the right dose for you. Do not stop taking Epidiolex without first talking with your health care provider. Serious problems can occur if you stop taking Epidiolex suddenly.
What Are Common Side Effects of Epidiolex and How Can I Manage Them?
Some of the common side effects of Epidiolex include sleepiness, decreased appetite, liver problems, and diarrhea. Some side effects get better over time.
Diarrhea. Taking Epidiolex with meals may improve diarrhea. If you start taking Epidiolex with food, you should always take your Epidiolex with food to maintain consistent levels of Epidiolex in your blood. Contact your health care provider if diarrhea continues to be bothersome.
Liver problems. Your health care provider will monitor for liver problems before you start Epidiolex and during your treatment. Contact your health care provider right away if you have any of these symptoms:
- Nausea or vomiting
- Stomach or belly pain
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Light-colored poop
- Dark-colored urine (pee)
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Sleepiness. You may feel sleepy or tired when you start taking Epidiolex, but this may get better over time. Other medicines or alcohol may make you more sleepy. Until you know how Epidiolex affects you, you should not drive, operate heavy machinery, or attempt other tasks requiring alertness.
What Are Other Unique Considerations to Be Aware Of?
- The active ingredient in Epidiolex is Cannabidiol, also known as CBD. Epidiolex is the only cannabidiol currently approved by the Food and Drug Administration (FDA) and is a plant-based, highly purified form of CBD. Other CBD products sold online or from a dispensary are not regulated by the FDA and have not been tested for safety and efficacy. You should not use these products in place of Epidiolex.
- You may test positive on urine cannabinoid screens while taking Epidiolex. You should inform the person conducting the drug test that you are taking Epidiolex, an FDA-approved Cannabidiol medicine prescribed by your physician.
- Epidiolex can be used with most epilepsy diets. Epidiolex is made without sugar and can be used in people who follow a ketogenic diet. There are no dairy products in Epidiolex, and it does not contain gluten. Epidiolex does contain sesame seed oil, and you should avoid Epidiolex if you have a sesame seed allergy. Talk with your health care provider if you have questions about Epidiolex and your dietary restrictions.
How Do I Get Epidiolex?
Epidiolex is available through specialty pharmacies, which are pharmacies that focus on prescriptions for rare, complex, or chronic diseases. Usually your Epidiolex will be shipped directly to your home.
Is There Any Cost Assistance Available?
You may be eligible for assistance with the cost of your medicine. Find out more by visiting jazzcares.com or calling 833-533-5299. A copay savings program is available from the drugmaker for eligible patients. Learn more at www.epidiolex.com/how-to-get-epidiolex or call 833-426-4243.
