Resources for starting and taking EPIDIOLEX
Here are some helpful tools for considering, starting, and taking EPIDIOLEX, including step-by-step instructions, worksheets, and resources for school and travel.
Here are some helpful tools for considering, starting, and taking EPIDIOLEX, including step-by-step instructions, worksheets, and resources for school and travel.
This brochure contains all you need to know to start the conversation with your healthcare provider.
DOWNLOADEPIDIOLEX has now been cleared for takeoff everywhere in the US. Before you go, make sure you carry a copy of this travel document and click the link below to get your free travel case.
DOWNLOADA quick guide for caregivers that explains what happens after your doctor prescribes EPIDIOLEX and any steps you need to take.
DOWNLOADIf you're considering EPIDIOLEX as a treatment option, you may have some questions. Here you can find information about the medicine, the company that makes it, CBD, FDA approval, and a doctor discussion guide.
All about the first and only FDA-approved prescription CBD to treat seizures associated with LGS, Dravet syndrome, and TSC.
DOWNLOADAn in-depth exploration of cannabidiol, the active ingredient in EPIDIOLEX.
DOWNLOADQuestions to help you have a meaningful conversation with your doctor about treatment with EPIDIOLEX.
DOWNLOADEPIDIOLEX is an FDA-approved medicine containing purified cannabidiol made from plants. It is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older.
EPIDIOLEX is an oral solution that is taken twice daily. It should be administered consistently with respect to meals.
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.
You and your healthcare provider will decide if EPIDIOLEX is the right option.
This may depend on diagnosis and your response to current treatment.
Your healthcare provider may order blood tests and consider medicines and supplements you are currently taking, as well as other risk factors. See the Medication Guide for additional details.
If necessary, EPIDIOLEX can be administered with certain nasogastric tubes (NG-tube) or gastrostomy tubes (G-tube). For specific instructions, please see the EPIDIOLEX Prescribing Information and talk to your HCP for more information.
EPIDIOLEX has flexible dosing.
When starting EPIDIOLEX, your doctor may begin with a lower dose and slowly increase the amount of medicine to reach the dose he or she believes is right for you.
Once that dose is reached, your doctor will evaluate your response.
If needed, your doctor may adjust your dose based on your response to EPIDIOLEX and whether you are experiencing side effects.
Your doctor may also request blood work to evaluate liver function before you start and during treatment.
You should take EPIDIOLEX exactly as your doctor tells you. Do not stop taking EPIDIOLEX without first talking to your doctor. Stopping a seizure medicine suddenly can cause serious problems.
Be sure to tell your doctor if you are taking any other medicines so he or she can take that into account when creating your EPIDIOLEX dosing schedule.
EPIDIOLEX is made without sugar to be compatible with most epilepsy diets, such as the ketogenic diet. However, always talk to your doctor about your dietary therapy or any changes to dietary therapy before 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.
For a discussion guide with questions that can help you have a thoughtful and productive conversation with your doctor, download the Doctor Discussion Guide.
Your doctor will decide if EPIDIOLEX is right for you or your loved one and write a prescription to be filled at a specialty pharmacy that works with your insurance.
Specialty pharmacies offer expertise in the support and fulfillment of prescriptions for rare, complex, and/or chronic diseases and are like any other pharmacy where you fill FDA-approved prescription medicines. The specialty pharmacy will call you to discuss important information about your prescription, so keep an eye out for a call from a 1-800 number or a local number and be sure to check your voicemail.
The medicine is typically shipped directly to your home, and in some cases, you may be able to pick up your prescription from a local pharmacy. Most people receive their first bottle of EPIDIOLEX less than 10 days after their doctor prescribes it.
EPIDIOLEX is an FDA-approved medicine, which means you can only get it through a doctor's prescription.
While studies were not designed to prove how long it takes EPIDIOLEX to work, an exploratory analysis conducted after the studies were complete suggests that some patients with LGS had fewer drop seizures* after using EPIDIOLEX for 8 days, some patients with Dravet syndrome started having fewer convulsive seizures† as early as 10 days after starting EPIDIOLEX, and some patients with TSC had fewer TSC-associated seizures‡ after using EPIDIOLEX for 6 days. But everyone's symptoms can be different, so your experience with EPIDIOLEX may be different, too.
*Drop seizures included tonic, atonic, and tonic-clonic that led, or could have led, to a fall or injury.
†Convulsive seizures included tonic, tonic-clonic, atonic, and clonic.
‡TSC-associated seizures included different types of partial onset (focal) seizures and generalized seizures.
The ingredients that make up EPIDIOLEX include cannabidiol (CBD), sesame seed oil, sucralose (an artificial sweetener), alcohol, and strawberry flavor. Alcohol is added to dissolve the sucralose, which is added for flavor and to ensure that EPIDIOLEX ingredients are compatible with the ketogenic diet.
Dairy products are not used in the manufacturing of EPIDIOLEX.
EPIDIOLEX does not contain gluten (wheat, barley, or rye).
EPIDIOLEX is an oral solution of cannabidiol (100 mg/mL) in sesame seed oil. It is important to note that sesame is a seed, not a nut, so if you're allergic to one, you may not necessarily be allergic to the other. Sesame seed allergies have been estimated to affect 0.23% of the general population in the US. Nut allergies are more common and may affect 1.4% of the population. EPIDIOLEX should be avoided in patients with a known or suspected sesame seed allergy.
EPIDIOLEX will not make you feel "high," the common effect associated with THC. EPIDIOLEX and THC are entirely different from each other and have different effects on the body.
EPIDIOLEX is an FDA-approved prescription medicine and is therefore legal under federal and state laws. Keep your prescription inside your travel case so it’s always nearby should anyone need to see it.
EPIDIOLEX is recognized by the Transportation Security Administration (TSA) as an FDA-approved cannabis-derived medicine, which means you can legally carry it on airplanes anywhere in the US. For information about traveling with EPIDIOLEX, including rules and regulations, tips for navigating airport security, and useful contact numbers, download a travel card. Join the EPIDIOLEX support program and receive a free travel case to help make sure your EPIDIOLEX stays safe and secure wherever you go.
When your doctor prescribes EPIDIOLEX, he or she will submit the prescription to the specialty pharmacy that works with your insurance to determine coverage. You will probably receive a call from the pharmacy (look out for a 1-800 number or a local number) or your healthcare provider to get any information needed to finish filling your prescription. Once your coverage has been confirmed, the medicine will be shipped directly to your home for free. The aim is to get your prescription filled as quickly as possible, but this may take some time.
There is a robust support program for patients taking EPIDIOLEX. It includes the EPIDIOLEX® Copay Savings Program, help with taking EPIDIOLEX, and advice for living with LGS, Dravet syndrome, or TSC. For more information and to sign up, click here.
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 you start taking EPIDIOLEX and during 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 & 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 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:
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 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 healthcare provider tells you. Do not stop taking EPIDIOLEX without first talking to your healthcare provider. Stopping a seizure 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 healthcare provider. Tell healthcare providers 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. You and your healthcare provider will have to decide if you should take EPIDIOLEX while you are pregnant.
If you become pregnant while taking EPIDIOLEX, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry (by calling 1-888-233-2334). The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy.
Because many medicines like EPIDIOLEX are passed into breast milk, talk to your healthcare provider about the best way to feed your baby while taking EPIDIOLEX.
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 refer to 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 1-833-424-6724.
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 you start taking EPIDIOLEX and during 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 & 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 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:
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 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 healthcare provider tells you. Do not stop taking EPIDIOLEX without first talking to your healthcare provider. Stopping a seizure 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 healthcare provider. Tell healthcare providers 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. You and your healthcare provider will have to decide if you should take EPIDIOLEX while you are pregnant.
If you become pregnant while taking EPIDIOLEX, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry (by calling 1-888-233-2334). The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy.
Because many medicines like EPIDIOLEX are passed into breast milk, talk to your healthcare provider about the best way to feed your baby while taking EPIDIOLEX.
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 refer to 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 1-833-424-6724.