For: Lennox-Gastaut Syndrome, Dravet Syndrome
Epidiolex (cannabidiol) is a 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 is a strawberry flavored clear, colorless to yellow solution supplied in a 105 mL amber glass bottle with a child-resistant closure containing 100 mL of oral solution (NDC 70127-100-01). Each mL contains 100 mg of cannabidiol. EPIDIOLEX is packaged in a carton with two 5 mL calibrated oral dosing syringes and a bottle adapter (NDC 70127-100-10). The pharmacy will provide 1 mL calibrated oral dosing syringes when doses less than 1 mL are required.
16.2 Storage and Handling
Store EPIDIOLEX in an upright position at 20�C to 25�C (68�F to 77�F); excursions are permitted between 15�C to 30�C (59�F to 86�F). [See USP Controlled Room Temperature]. Do not freeze. Keep the cap tightly closed. Use within 12 weeks of first opening the bottle, then discard any remainder. These highlights do not include all the information needed to use EPIDIOLEX� safely and effectively. See full prescribing information for EPIDIOLEX.
EPIDIOLEX� (cannabidiol) oral solution, CV
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older (1)
DOSAGE AND ADMINISTRATION
Obtain serum transaminases (ALT and AST) and total bilirubin levels in all patients prior to starting treatment. (2.1, 5.1)
EPIDIOLEX is to be administered orally. (2.2)
The recommended starting dosage is 2.5 mg/kg taken twice daily (5 mg/kg/day). After one week, the dosage can be increased to a maintenance dosage of 5 mg/kg twice daily (10 mg/kg/day). (2.2)
Based on individual clinical response and tolerability, EPIDIOLEX can be increased up to a maximum recommended maintenance dosage of 10 mg/kg twice daily (20 mg/kg/day). See Full Prescribing Information for titration. (2.2)
Dosage adjustment is recommended for patients with moderate or severe hepatic impairment. (2.5, 8.6)
DOSAGE FORMS AND STRENGTHS
Oral solution: 100 mg/mL (3)
Hypersensitivity to cannabidiol or any of the ingredients in EPIDIOLEX (4)
WARNINGS AND PRECAUTIONS
Hepatocellular Injury: EPIDIOLEX can cause transaminase elevations. Concomitant use of valproate and higher doses of EPIDIOLEX increase the risk of transaminase elevations. See Full Prescribing Information for serum transaminase and bilirubin monitoring recommendations. (5.1)
Somnolence and Sedation: Monitor for somnolence and sedation and advise patients not to drive or operate machinery until they have gained sufficient experience on EPIDIOLEX. (5.2)
Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and thoughts. (5.3)
Hypersensitivity Reactions: Advise patients to seek immediate medical care. Discontinue and do not restart EPIDIOLEX if hypersensitivity occurs. (5.4)
Withdrawal of Antiepileptic Drugs: EPIDIOLEX should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus. (5.5)
The most common adverse reactions (10% or more for EPIDIOLEX and greater than placebo) are: somnolence; decreased appetite; diarrhea; transaminase elevations; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder, and poor quality sleep; and infections. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Greenwich Biosciences at 1-833-424-6724 (1-833-GBIOSCI) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Moderate or strong inhibitors of CYP3A4 or CYP2C19: Consider dose reduction of EPIDIOLEX. (7.1)
Strong inducer of CYP3A4 or CYP2C19: Consider dose increase of EPIDIOLEX. (7.1)
Consider a dose reduction of substrates of UGT1A9, UGT2B7, CYP2C8, CYP2C9, and CYP2C19 (e.g., clobazam). (7.2)
Substrates of CYP1A2 and CYP2B6 may also require dose adjustment. (7.2)
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm. (8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.