What is EPIDIOLEX?
EPIDIOLEX is an FDA-approved, plant-derived, purified cannabidiol oral solution that is used to treat seizures associated with Dravet or LGS in patients 2 years of age or older.
How is EPIDIOLEX taken?
EPIDIOLEX is an oral solution that is taken twice daily. It should be administered consistently with respect to meals.
Does EPIDIOLEX interact with my other medications?
EPIDIOLEX may interact with other seizure medicines or medications you are taking. Therefore, talk to your doctors or pharmacist if you have any questions about the other medications you are taking and whether any dose adjustments may be necessary.
How do I know if EPIDIOLEX is right for me or my loved one?
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.
Can EPIDIOLEX be taken with a gastrostomy tube (g-tube)?
If you or your loved one has a gastrostomy tube (g-tube), there are special considerations. To learn more, please contact Greenwich Biosciences at 1‐833-424-6724 (1-833-GBIOSCI) and talk to your doctor about your specific needs.
How is EPIDIOLEX dosed?
EPIDIOLEX has flexible dosing.
Your doctor may also request blood work to evaluate liver function before you start and during treatment.
In clinical studies, a therapeutic dose
(10 mg/kg/day) was achieved as early as the 8th day of 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.
When the dose of EPIDIOLEX was increased to 20 mg/kg/day from the maintenance dose of 10 mg/kg/day, there was a somewhat greater reduction in seizure rates; however, there was also an increase in side effects.
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 dosing schedule.
Is EPIDIOLEX compatible with the ketogenic diet?
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.
What are the most common side effects of EPIDIOLEX?
The most common side effects are sleepiness, decreased appetite, diarrhea, increase in liver enzymes, feeling very tired and weak, rash, sleep problems, and infections.
How do I receive my EPIDIOLEX prescription?
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. You will be contacted by the specialty pharmacy or your healthcare provider. Keep an eye out for a call that may be from a 1-800 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. This process is typically 10 to 14 days; however, it may take longer in some cases.
What is in EPIDIOLEX?
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 is compatible with the ketogenic diet.
Does EPIDIOLEX contain dairy, gluten, or nuts?
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 allergic reactions to one may not necessarily cross-generalize to the other. Sesame seed allergies have been estimated to affect 0.1% of the general population in the US. Nut allergies have a higher prevalence and may affect 1.4% of the population. EPIDIOLEX should be avoided in patients with a known or suspected sesame seed allergy.
Will EPIDIOLEX get me/my loved one high?
EPIDIOLEX does not create euphoric effects associated with THC, the ingredient in the cannabis plant that can make you feel “high.” EPIDIOLEX and THC are entirely distinct cannabinoids that have different properties and effects.
Is EPIDIOLEX legal?
EPIDIOLEX is an FDA-approved prescription medicine and is therefore legal under federal law. Keep your prescription inside your travel case so it’s always nearby should anyone need to see it.
Can I travel with EPIDIOLEX?
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 U.S. For information about traveling with EPIDIOLEX, including rules and regulations, tips for navigating airport security, and useful contact numbers, download a travel card. And, to help make sure EPIDIOLEX stays safe and secure wherever you go, order a free travel case.
How do I find out about financial or patient support for EPIDIOLEX?
EPIDIOLEX ENGAGE™ 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 Dravet and LGS. For more information and to sign up, go to EPIDIOLEX ENGAGE™.
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