Generic Name: cannabidiol
Dosage Form: Oral Solution
Date of Approval: June 25, 2018
Company: GW Pharmaceuticals plc
Treatment for: Lennox-Gastaut Syndrome; Dravet Syndrome
Medically reviewed on Oct 1, 2018
FDA Approves Epidiolex
The U.S. Food and Drug Administration (FDA) has approved Epidiolex (cannabidiol) oral solution, the first prescription pharmaceutical formulation of highly-purified, marijuana plant-derived cannabidiol (CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age or older.
Epidiolex was added to schedule V of the Controlled Substances Act in September 2018.
Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
Epidiolex can cause serious side effects, including:
- Epidiolex may cause liver problems. Your healthcare provider may order blood tests to check your liver before you start, and during treatment. In some cases, treatment may need to be stopped.
Call your healthcare provider right away if you develop any of these signs and symptoms of liver problems during treatment:
- loss of appetite, nausea, vomiting
- fever, feeling unwell, unusual tiredness
- yellowing of the skin or the whites of the eyes (jaundice)
- unusual darkening of the urine
- right upper stomach area pain or discomfort
- 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:
- thoughts about suicide or dying
- attempt to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
- Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled.
- 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.
What is Epidiolex?
- Epidiolex is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in people 2 years of age and older.
- [There is a pending DEA decision for control of Epidiolex (cannabidiol) under the Controlled Substances Act. A statement for patients about abuse and dependence risks cannot be completed at this time.]
- It is not known if Epidiolex is safe and effective in children under 2 years of age.
Who should not take Epidiolex?
Do not take Epidiolex if you are allergic to cannabidiol or any of the ingredients. See the end of this Medication Guide for a complete list of ingredients.
Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:
- have or have had depression, mood problems or suicidal thoughts or behavior.
- have liver problems.
- have abused or been dependent on prescription medicines, street drugs or alcohol.
- are pregnant or plan to become pregnant. Tell your healthcare provider right away if you become pregnant while taking Epidiolex. You and your healthcare provider will 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. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy.
- are breastfeeding or plan to breastfeed. It is not known if Epidiolex passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Epidiolex.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and any cannabis-based products.
Epidiolex may affect the way other medicines work, and other medicines may affect how Epidiolex works. Do not start or stop taking other medicines without talking to your healthcare provider. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Tell your healthcare provider if you are planning to have a cannabis drug screen because Epidiolex may affect your test results. Tell the person giving the drug test that you are taking Epidiolex.
How should I take Epidiolex?
- Read the Instructions for Use provided with your prescription for information on the right way to use Epidiolex.
- Take this medicine exactly as your healthcare provider tells you.
- Your healthcare provider will tell you how much to take and when to take it.
- Take Epidiolex about the same time each day consistently either with or without food.
- Measure each dose using the bottle adapter and 5 mL dosing syringes that come with Epidiolex. If your dose is less than 1 mL, your pharmacist will provide you with 1 mL syringes to take your medicine.
- Use a dry syringe each time you take your dose. If water is inside the syringe, it could cause the oil based medicine to look cloudy.
What should I avoid while taking Epidiolex?
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how Epidiolex affects you. Epidiolex may cause you to feel sleepy.
Epidiolex side effects
Epidiolex can cause serious side effects, including:
- See Important information.
The most common side effects include:
- decreased appetite
- increase in liver enzymes
- feeling very tired and weak
- sleep problems
These are not all of the possible side effects. For more information ask your healthcare provider or pharmacist.
Tell your healthcare provider about any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also contact Greenwich Biosciences at 1-833-424-6724 (1-833-GBIOSCI).
How should I store Epidiolex?
- Store Epidiolex at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
- Always store the medicine in its original bottle in an upright position.
- Do not refrigerate or freeze.
- Keep the child-resistant cap tightly closed.
- Use Epidiolex within 12 weeks of first opening the bottle. Throw away (dispose of) any unused medicine after 12 weeks.
Keep all medicines out of the reach of children and pets.
General Information about the safe and effective use of Epidiolex.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information that is written for health professionals.
What are the ingredients in Epidiolex?
Active ingredient: cannabidiol
Inactive ingredients: dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose Epidiolex does not contain gluten (wheat, barley or rye).
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.