Frequently asked questions

• EPIDIOLEX is the first and only FDA-approved prescription cannabidiol and the only cannabidiol formulation demonstrated in well-controlled clinical trials to be effective in reducing seizures associated with TSC, LGS, and Dravet syndrome
  • EPIDIOLEX was studied in over 900 patients with LGS, Dravet syndrome, and TSC—making up the largest controlled clinical trial program for an AED in these conditions to date^1-3*
  • EPIDIOLEX has a known and well-characterized safety profile
• EPIDIOLEX manufacturing has been inspected by and is in accordance with FDA standards, resulting in highly controlled and consistent cannabidiol concentrations of 100 mg/mL, free from contaminants¹
• EPIDIOLEX is federally legal and eligible for insurance coverage for appropriate patients

*There was a second randomized controlled trial in 199 patients with Dravet syndrome that has been completed since its original approval³

References: 1. Data on file. Greenwich Biosciences, Inc., Carlsbad, CA. 2. Ostendorf AP, Ng YT. Neuropsychiatr Dis Treat. 2017;13:1131-1140. 3. Miller I, Scheffer IE, Gunning B, et al. JAMA Neurol. 2020;77(5):613-621.

• EPIDIOLEX oral solution contains highly purified, plant-derived cannabidiol
  • EPIDIOLEX is manufactured in accordance with FDA standards, resulting in highly controlled and consistent cannabidiol concentrations of 100 mg/mL
• Synthetic cannabinoids are produced in laboratories through a chemical reaction to structurally or functionally mimic the effects of endocannabinoids or phytocannabinoids¹
• There are no synthetic cannabinoid products that have been evaluated in Phase 3 controlled trials for the treatment of seizures associated with LGS, Dravet syndrome, or TSC

Reference: 1. Grotenhermen F. Cannabinoids. 2016;1(1):10-14.

• Patients on other cannabinoid products were excluded from the EPIDIOLEX clinical trials^1,2
• Jazz Pharmaceuticals, Inc. cannot provide advice on converting from a cannabidiol/cannabinoid product to EPIDIOLEX

References: 1. Thiele EA, Marsh ED, French JA, et al. Lancet. 2018;391(10125):1085-1096. 2. Devinsky O, Patel AD, Cross JH, et al. N Engl J Med. 2018;378(20):1888-1897.

• As stated in the Prescribing Information, patients taking EPIDIOLEX may test positive on urine cannabinoid screens. In general, these tests are not specific or selective for tetrahydrocannabinol (THC) and therefore, may detect other cannabinoids, including cannabidiol
• In order to determine specific exposure and concentrations of cannabinoids, a specific blood test is required
• Patients/caregivers should inform the person giving the drug test that the patient is taking EPIDIOLEX, an FDA-approved medicine prescribed by their physician
• Please complete a Medical Information Request Form for additional information

• In controlled and uncontrolled trials, an expanded access program, and other compassionate use programs, 1183 patients with LGS, Dravet syndrome, and TSC have been treated with EPIDIOLEX
  • 683 patients treated for more than 1 year
  • 155 patients treated for more than 2 years
• EPIDIOLEX was also studied in open-label extension trials up to 3 years in LGS and Dravet syndrome, and 48 weeks in patients with TSC. The safety profile in these trials was generally similar to that observed in the four phase 3 trials for LGS, Dravet syndrome, and TSC^1-3
  • In the open-label extension trials, titration to doses over the recommended maximum maintenance dose was permitted. At higher doses, an increase in adverse reactions is possible^1-3
  • Eleven deaths were reported in patients with LGS; none were deemed to be treatment-related by the investigator¹
  • Four deaths were reported in patients with Dravet syndrome, none of which were deemed related to treatment by the investigator²
  • There was 1 death reported during the TSC open-label extension, which was deemed unrelated to treatment by the investigator³

References: 1. Patel AD, Chin RF, Mitchell W, et al. Poster presented at: American Epilepsy Society Annual Meeting; December 6-10, 2019; Baltimore, MD. 2. Scheffer IE, Halford J, Nabbout R, et al. Poster presented at: American Epilepsy Society Annual Meeting; December 6-10, 2019; Baltimore, MD. 3. Thiele E, Bebin EM, Filloux F, et al. Presented at: 2020 American Academy of Neurology Annual Meeting; May 2020; Virtual Meeting.

• The recommended dosing for EPIDIOLEX in the Prescribing Information is twice daily
• The clinical trials evaluated EPIDIOLEX delivered twice daily
• Please complete a Medical Information Request Form for additional information

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.

• Yes. It may be used, but there are recommended dose adjustments

• As with most AEDs, EPIDIOLEX should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus
• Please complete a Medical Information Request Form for additional information

• 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 United States
• For information about traveling with EPIDIOLEX, including rules and regulations, tips for navigating airport security, and useful contact numbers, patients can download a travel card
• To help make sure EPIDIOLEX stays safe and secure when traveling, patients may order a free travel case
• Since each country's laws vary, Jazz Pharmaceuticals is unable to provide guidance regarding travel with EPIDIOLEX to countries outside of the United States. Patients should contact the American consulate in their destination country and research the country's cannabis/marijuana laws prior to travel. In general, it is a good idea for the patient to carry proof of a valid prescription and to keep their medicine in its original container with the original label attached while traveling

• Nearly half (49%) of the patients in the LGS clinical trials and 65% of patients in the Dravet syndrome clinical trial were taking concomitant clobazam
• Valproate was the most commonly used concomitant AED in the TSC phase 3 trial, with 45% of patients receiving concomitant valproate, and 27% of patients receiving concomitant clobazam
• Concomitant use of valproate and elevated transaminase levels at baseline increase the risk of EPIDIOLEX dose-related transaminase elevations
• EPIDIOLEX can cause somnolence and sedation that generally occur early in treatment and may diminish over time; these effects occur more commonly in patients using clobazam and may be potentiated by other CNS depressants. Monitor patients for somnolence and sedation and advise patients not to drive or operate machinery until they have gained sufficient experience on EPIDIOLEX
• Pneumonia was observed more frequently with concomitant use of EPIDIOLEX and clobazam
• Dose adjustment of EPIDIOLEX or concomitant medications may be required

• EPIDIOLEX is made without sugar or carbohydrates, so it can be used with most epilepsy diets, such as the ketogenic diet. If you or your loved one are on a dietary therapy, talk to your doctor before taking EPIDIOLEX
• Also note: EPIDIOLEX does not contain any artificial dyes or coloring

• EPIDIOLEX should be taken consistently with respect to meals to reduce variability in cannabidiol plasma exposure
• Caffeine: In vivo data showed EPIDIOLEX increases exposure to caffeine by 15% for C_max and 95% for AUC compared to when caffeine was administered alone
• Alcohol: Coadministration of EPIDIOLEX with alcohol increased exposure to cannabidiol, with 93% increased C_max and 63% greater AUC
  • Concomitant use of EPIDIOLEX with other CNS depressants (including alcohol) may increase the risk of sedation and somnolence

• 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, and an allergy to a nut does not necessarily generalize to seeds
  • EPIDIOLEX should be avoided in patients with a known or suspected sesame seed allergy
  • Sesame seed allergies may affect 0.1% of the general population in the United States¹
  • Please complete a Medical Information Request Form for additional information

Reference: 1. Sicherer SH, Munoz-Furlong A, Godbold JH, Sampson HA. J Allergy Clin Immunol. 2010;125:1322-1326.

• EPIDIOLEX is dispensed by licensed pharmacists at the specialty pharmacies currently in the Epidiolex Engage^TM network

• Due to the weight-based dosing and titration for EPIDIOLEX, most patients will require a partial bottle fill, which the specialty pharmacy partners are equipped to handle
• Trained staff at specialty pharmacies can assist with patient- and caregiver-specific questions throughout the patient journey on EPIDIOLEX

• Copay assistance is available for eligible commercially insured patients who reside in the United States