Cytochrome P450 2C8 InhibitorsPrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Epidiolex
CANNABIDIOL
1 INDICATIONS AND USAGE EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older. EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older ( 1 )
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Brand names:Epidiolex
Quick Reference
Medicine ClassCytochrome P450 2C8 Inhibitors
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- CANNABIDIOL
- Medicine class
- Cytochrome P450 2C8 Inhibitors
- Brand names
- Epidiolex
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life of cannabidiol in plasma was 56 to 61 hours after twice-daily dosing for 7 days in healthy
- FDA approved
- Yes
What Is Epidiolex?
1 INDICATIONS AND USAGE EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older. EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older ( 1 )
Epidiolex (CANNABIDIOL) belongs to the Cytochrome P450 2C8 Inhibitors class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Epidiolex. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Epidiolex with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Epidiolex is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older.
EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older ( 1 )
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION • Obtain serum transaminases (ALT and AST) and total bilirubin levels in all patients prior to starting treatment. ( 2.1 , 5.1 ) • See Full Prescribing Information for titration. ( 2.2 , 2.3 ) Seizures Associated with Lennox-Gastaut Syndrome or Dravet Syndrome • The recommended starting dosage is 2.5 mg/kg by mouth 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). Seizures Associated with Tuberous Sclerosis Complex • The recommended starting dosage is 2.5 mg/kg by mouth twice daily (5 mg/kg/day). Increase the dose weekly by 2.5 mg/kg twice daily (5 mg/kg/day), as tolerated, to a recommended maintenance dosage of 12.5 mg/kg twice daily (25 mg/kg/day). ( 2.3 ) Patients with Impaired Hepatic Function •
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in labeling: • Hepatic Injury [see Warnings and Precautions ( 5.1 )] • Somnolence and Sedation [see Warnings and Precautions ( 5.2 )] • Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.3 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] • Withdrawal of Antiepileptic Drugs [see Warnings and Precautions ( 5.5 )] The most common adverse reactions (10% or more for EPIDIOLEX and greater than placebo) in patients with Lennox-Gastaut syndrome or Dravet syndrome are: somnolence;
- decreased appetite;
- transaminase elevations;
- fatigue, malaise, and asthenia;
- insomnia, sleep disorder, and poor quality sleep;
- and infections.
- ( 6.1 ) The most common adverse reactions (10% or more for EPIDIOLEX and greater than placebo) in patients with tuberous sclerosis complex are: diarrhea;
Serious
- 5 WARNINGS AND PRECAUTIONS • Hepatic 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.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS • Hepatic 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
How Epidiolex Works
12.1 Mechanism of Action The precise mechanisms by which EPIDIOLEX exerts its anticonvulsant effect in humans are unknown. Cannabidiol does not appear to exert its anticonvulsant effects through interaction with cannabinoid receptors.
Pharmacokinetics
Absorption
Absorption Cannabidiol has a time to maximum plasma concentration (T max ) of 2
Half-Life
half-life of cannabidiol in plasma was 56 to 61 hours after twice-daily dosing for 7 days in healthy
Metabolism
metabolites was > 94% in vitro
Excretion
Excretion EPIDIOLEX is excreted in feces, with minor renal clearance
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Epidiolexwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
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 disc
Frequently Asked Questions
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Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Epidiolex
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.