cannabidiol: clinical use

Prescribing considerations

• Initiation and supervision should be by a clinician experienced in epilepsy treatment.
• Confirm that the indication and required concomitant treatment match the product licence.
• Review antiseizure polypharmacy, hepatic function, food pattern and potential interactions.
• Use caution with hepatic impairment, baseline liver-test abnormalities, valproate, clobazam and other potentially hepatotoxic medicines.
• Avoid abrupt withdrawal because seizure frequency may increase.

Contraindications and cautions

• Hypersensitivity to cannabidiol or any excipient, including refined sesame oil.
• Transaminases above three times the upper limit of normal together with bilirubin above twice the upper limit of normal.

Monitoring

• Check ALT, AST and total bilirubin before and during treatment; intensify monitoring with valproate or abnormal baseline results.
• Monitor sedation, particularly with clobazam or other central nervous system depressants.
• Monitor seizure frequency, mood or suicidal thinking, appetite, weight and growth.
• Consider relevant antiseizure or immunosuppressant plasma concentrations where interactions are possible.

Clinical pharmacology

Cannabidiol is extensively metabolised through hepatic CYP and UGT pathways, particularly CYP2C19, CYP3A4, UGT1A9 and UGT2B7. It is highly protein-bound, has an active 7-hydroxy metabolite and is mainly eliminated through metabolism and faecal excretion.

Formulation and product differences

• The oral solution contains refined sesame oil, ethanol, sucralose and strawberry flavour containing benzyl alcohol.
• It is supplied with calibrated oral syringes and bottle adaptors.
• Compatible feeding-tube materials and flushing requirements are product-specific.
• Discard remaining solution 12 weeks after first opening.

Oral solution

Route: Oral

Strengths: 100 mg/mL