Frequently asked questions

Answers to some of the most common EPIDIOLEX questions. If you have a question not addressed below, you can request to be contacted by a Neurology Account Manager, or email medinfo@greenwichbiosciences.com

Epidiolex Fact Sheet

EPIDIOLEX®
(cannabidiol) Cannabidiol CV Symbol Blue
factsheet

This sheet provides a brief overview about EPIDIOLEX.

EPIDIOLEX and cannabinoids

  • 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 LGS and Dravet syndrome1
    • It was studied in the largest pivotal controlled clinical trial program to date for these rare epilepsies (N=516)2-4
    • EPIDIOLEX has a known and well-characterized safety profile2
  • 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 contaminants2
  • EPIDIOLEX is federally legal and eligible for insurance coverage for appropriate patients

References: 1. Food and Drug Administration website. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm611046.htm. Accessed June 29, 2018. 2. EPIDIOLEX [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc.; 2018. 3. Data on file. Greenwich Biosciences, Inc., Carlsbad, CA. 4. Ostendorf AP, Ng YT. Neuropsychiatr Dis Treat. 2017;13:1131-1140.

  • EPIDIOLEX oral solution contains highly purified, plant-derived cannabidiol1
    • EPIDIOLEX is manufactured in accordance with FDA standards, resulting in highly controlled and consistent cannabidiol concentrations of 100 mg/mL1,2
  • Synthetic cannabinoids are produced in laboratories through a chemical reaction to structurally or functionally mimic the effects of endocannabinoids or phytocannabinoids3
  • There are no synthetic cannabinoid products that have been evaluated in Phase 3 controlled trials for the treatment of seizures associated with LGS or Dravet syndrome

References: 1. Data on file. Greenwich Biosciences, Inc., Carlsbad, CA. 2. EPIDIOLEX [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc.; 2018. 3. Rosenberg EC, Tsien RW, Whalley BJ, Devinsky O. Neurotherapeutics. 2015;12(4):747-768.

  • Greenwich Biosciences, Inc. cannot provide advice on converting from a cannabidiol/cannabinoid product to EPIDIOLEX
  • Patients on other cannabinoid products were excluded from the EPIDIOLEX clinical trials1,2

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 cannabidiol1
  • 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 physician1
  • Please complete a Medical Information Request Form for additional information

Reference: 1. EPIDIOLEX [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc.; 2018.

EPIDIOLEX studies

  • In controlled and uncontrolled trials, an expanded access program, and other compassionate use programs, 850 patients with LGS and Dravet syndrome have been treated with EPIDIOLEX at the time of approval1
    • 482 patients treated for more than 1 year
    • 50 patients treated for more than 2 years
  • The long-term safety profile of EPIDIOLEX in the open-label extension trials up to 72 weeks was generally similar to that observed in the three 14-week trials for LGS and Dravet syndrome2,3
    • In the open-label extension trials, titration to doses over 20 mg/kg/day was permitted. At higher doses, an increase in adverse reactions is possible1-3
    • 5 deaths were reported in patients with LGS; none were deemed to be treatment-related by the investigator2
    • 2 deaths were reported in patients with Dravet syndrome, both of which were attributed to sudden unexplained death in epilepsy and deemed unrelated to treatment by the investigator3

References: 1. EPIDIOLEX [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc.; 2018. 2. Patel A, Gil-Nagel A, Chin R, et al. Poster presented at: American Epilepsy Society Annual Meeting; November 30-December 4, 2018; New Orleans, LA. 3. Scheffer IE, Halford J, Nabbout R, et al. Poster presented at: American Epilepsy Society Annual Meeting; November 30-December 4, 2018; New Orleans, LA.

Dosing and administration

  • The recommended dosing for EPIDIOLEX in the Prescribing Information is twice daily1
  • The clinical trials evaluated EPIDIOLEX delivered twice daily
  • Please complete a Medical Information Request Form for additional information
LEARN MORE ABOUT DOSING

Reference: 1. EPIDIOLEX [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc.; 2018.

  • EPIDIOLEX is approved for oral administration1
  • There are special considerations for patients with a feeding tube; please complete a Medical Information Request Form for additional information

Reference: 1. EPIDIOLEX [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc.; 2018.

  • Yes. It may be used, but there are recommended dose adjustments1
REVIEW DOSING CONSIDERATIONS FOR PATIENTS WITH HEPATIC IMPAIRMENT

Reference: 1. EPIDIOLEX [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc.; 2018.

  • As with most AEDs, EPIDIOLEX should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus1
  • Please complete a Medical Information Request Form for additional information

Reference: 1. EPIDIOLEX [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc.; 2018.

  • EPIDIOLEX is recognized by the Transportation Security Administration (TSA) as an FDA-approved cannabis-derived medicine, which means patients 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

Interactions, compatibility, allergies

  • 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, and the most commonly used concomitant AEDs across all studies were clobazam and valproate1
  • Concomitant use of valproate and elevated transaminase levels at baseline increase the risk of EPIDIOLEX dose-related transaminase elevations1
  • 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 EPIDIOLEX1
  • Dose adjustment of EPIDIOLEX or concomitant medications may be required1
REVIEW DOSING CONSIDERATIONS FOR PATIENTS WITH HEPATIC IMPAIRMENT REVIEW MONITORING CONSIDERATIONS FOR PATIENTS WITH HEPATIC IMPAIRMENT

Reference: 1. EPIDIOLEX [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc.; 2018.

  • 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 EPIDIOLEX1
  • Also note: EPIDIOLEX does not contain any artificial dyes or coloring

Reference: 1. EPIDIOLEX [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc.; 2018.

  • EPIDIOLEX is an oral solution of cannabidiol (100 mg/mL) in sesame seed oil1
    • 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 States2
    • Please complete a Medical Information Request Form for additional information

References: 1. EPIDIOLEX [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc.; 2018. 2. Sicherer SH, Munoz-Furlong A, Godbold JH, Sampson HA. J Allergy Clin Immunol. 2010;125:1322-1326.

Accessing EPIDIOLEX

  • EPIDIOLEX is dispensed by licensed pharmacists at the specialty pharmacies currently in the Epidiolex® EngageTM network
FIND SPECIALTY PHARMACIES
  • 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
  • As EPIDIOLEX is a Schedule V drug, the prescription should be either transmitted electronically or via fax to a Specialty Pharmacy within the Epidiolex Engage network
COMPLETE ENROLLMENT FORM
  • Copay assistance is available for commercially insured patients who reside in the United States
REVIEW ELIGIBILITY CRITERIA

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