Allergic or hypersensitivity reactions: Tell your provider if you develop any redness, itching, rash, or swelling after starting Epidiolex. These may need treatment or the drug may be stopped.
Some symptoms of liver problems may include:
Do not take Epidiolex if you are allergic or have a history of reactions to cannabidiol or any of the ingredients in this medicine (such as dehydrated alcohol, sesame seed oil, strawberry flavor, sucralose).
People who take Epidiolex may test positive for cannabis drug screens. Tell the person giving the drug test that you are taking Epidiolex for a medical reason.
Contraception: There is no information about the use of Epidiolex when a woman is taking a hormonal form of birth control. Some other seizure medicines can make certain forms of birth control less effective.
The majority of ALT elevations occurred in patients taking concomitant valproate [see DRUG INTERACTIONS]. Concomitant use of clobazam also increased the incidence of transaminase elevations, although to a lesser extent than valproate [see DRUG INTERACTIONS]. In EPIDIOLEX-treated patients with LGS or DS (10 and 20 mg/kg/day dosages), the incidence of ALT elevations greater than 3 times the ULN was 30% in patients taking both concomitant valproate and clobazam, 21% in patients taking concomitant valproate (without clobazam), 4% in patients taking concomitant clobazam (without valproate), and 3% in patients taking neither drug. In EPIDIOLEX-treated patients with TSC (25 mg/kg/day), the incidence of ALT elevations greater than 3 times the ULN was 20% in patients taking both concomitant valproate and clobazam, 25% in patients taking concomitant valproate (without clobazam), 0% in patients taking concomitant clobazam (without valproate), and 6% in patients taking neither drug. Consider discontinuation or dose adjustment of valproate or clobazam if liver enzyme elevations occur.
Be sure that you read, understand and follow these instructions carefully to ensure proper dosing of the oral solution.
Increases In Creatinine
Q: What should I do if the liquid in the bottle has turned cloudy?
If there are air bubbles in the oral syringe, keep the bottle upside down and push the plunger so that all of the liquid flows back into the bottle. Repeat Step 5 until the air bubbles are gone.
Cannabidiol may induce or inhibit CYP2B6 at clinically relevant concentrations. Cannabidiol inhibits uridine 5'-diphospho-glucuronosyltransferase (UGT) enzymes UGT1A9 and UGT2B7, but does not inhibit the UGT1A1, UGT1A3, UGT1A4, UGT1A6, or UGT2B17 isoforms.
AST increased, ALT increased, GGT increased
The recommended starting dose of cannabidiol is 2.5 mg/kg taken twice daily (5 mg/kg/day) for one week. After one week, the dose should be increased to a maintenance dose of 5 mg/kg twice daily (10 mg/kg/day). Based on individual clinical response and tolerability, each dose can be further increased in weekly increments of 2.5 mg/kg administered twice daily (5 mg/kg/day) up to a maximum recommended dose of 10 mg/kg twice daily (20 mg/kg/day).
– Two 1 ml syringes graduated in 0.05 ml increments (each 0.05 ml increment corresponds to 5 mg cannabidiol)
The primary endpoint was the percentage change from baseline in drop seizures per 28 days over the treatment period for the cannabidiol group compared to placebo. Drop seizures were defined as atonic, tonic, or tonic-clonic seizures that led or could have led to a fall or injury. Key secondary endpoints were the proportion of patients with at least a 50% reduction in drop seizure frequency, the percentage change from baseline in total seizure frequency, and Subject/Caregiver Global Impression of Change at the last visit.
With LGS and DS
In the clinical trials, the first onset of diarrhoea was typically in the first 6 weeks of treatment with cannabidiol. The median duration of diarrhoea was 8 days. The diarrhoea led to cannabidiol dose reduction in 10% of patients, temporary dose interruption in 1% of patients and permanent discontinuation in 2% of patients.
Suicidal behaviour and ideation have been reported in patients treated with AEDs in several indications. A meta-analysis of randomised placebo-controlled trials with AEDs has shown a small increased risk of suicidal behaviour and ideation. The mechanism of this risk is not known, and the available data do not exclude the possibility of an increased risk for cannabidiol.