cannabidiol + delta-9-tetrahydrocannabinol: clinical use

Prescribing considerations

• Initiation and supervision require a physician experienced in treating MS-related spasticity.
• Confirm inadequate response to other anti-spasticity treatment and continue only if the initial trial produces clinically significant improvement.
• Assess psychiatric and substance-misuse history, seizures, cardiovascular disease, fall risk and ability to use the spray safely.
• Use is not recommended in people under 18 because efficacy was not demonstrated.
• Moderate or severe hepatic impairment is not advised; use additional caution and frequent assessment in renal impairment.
• Counsel about cognitive impairment, driving law, controlled-drug travel restrictions and contraception.

Contraindications and cautions

• Hypersensitivity to cannabinoids or any excipient.
• Known or suspected personal or family history of schizophrenia or another psychotic illness.
• History of severe personality disorder or another significant psychiatric disorder, except depression associated with the underlying condition.
• Breastfeeding.

Monitoring

• Patient-reported change in spasticity and continued clinical value.
• Dizziness, somnolence, cognition, mood, psychotic symptoms and suicidal ideation.
• Blood pressure, pulse, syncope and falls where clinically relevant.
• Oral mucosa for persistent soreness, ulceration, peeling or discolouration.
• Clinical status in hepatic or renal impairment and after important interacting medicines are started or stopped.
• Adherence to contraception and driving-safety advice.

Clinical pharmacology

THC is a partial agonist at CB1 and CB2 receptors and modifies synaptic neurotransmitter release. THC and CBD are lipophilic, undergo cytochrome P450 metabolism and are absorbed through the oromucosal surface; food can substantially increase exposure.

Formulation and product differences

• The product is a metered yellow-brown oromucosal solution containing standardised Cannabis sativa extracts.
• Excipients include ethanol, propylene glycol and peppermint oil.
• Unopened containers require upright refrigerated storage; after opening, store upright below 25°C and discard after the labelled in-use period.
• This authorised product is not interchangeable with consumer CBD oils, herbal cannabis or other cannabis-based products.