Indications & Important Safety Information
What is EPIDIOLEX?
EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.
It is not known if EPIDIOLEX is safe and effective in children under 2 years of age.
What is the Most Important Information I Should Know About EPIDIOLEX?
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:
- loss of appetite, nausea, vomiting
- fever, feeling unwell, unusual tiredness
- yellowing of the skin or the whites of the eyes (jaundice)
- itching
- 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 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 sleepiness, decreased appetite, diarrhea, increase in liver enzymes, 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.
EPIDIOLEX is a federally controlled substance (CV) because it has a low potential for abuse. Keep EPIDIOLEX in a safe place to prevent theft, misuse, or abuse.
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.
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 Greenwich Biosciences at 1-833-424-6724 (1-833-GBIOSCI).
