NABILONE

Nabilone is for administration to adults only. It is not recommended for use in children younger than 18 years of age as safety and efficacy have not been established. The usual adult dosage is 1 mg or 2 mg twice a day. To minimise side-effects, it is recommended that the lower starting dose is used and that the dose is increased as necessary.

The first dose should be administered the night before initiation of chemotherapy, and the second dose should be given one to three hours before the first dose of the oncolytic agent is administered. The maximum daily dose should not exceed 6 mg, given in three divided doses.

Nabilone may be administered throughout each cycle of chemotherapy and, if necessary, for 48 hours after the last dose of each cycle. Data on the chronic use of nabilone are not available. The elderly as for adults (see ‘precautions’).

During controlled clinical trials of nabilone, virtually all patients experienced at least one adverse reaction. These included pyschotomimetic reactions. In these trials, the commonest statistically significant adverse events (in decreasing order of incidence) were: drowsiness, vertigo/dizziness, euphoria (high), dry mouth, ataxia, visual disturbance, concentration difficulties, sleep disturbance, dysphoria, hypotension, headache and nausea.

Other reported events include confusion, disorientation, hallucinations, psychosis, depression, decreased co-ordination, tremors, tachycardia, decreased appetite and abdominal pain. Tolerance to such CNS effects as relaxation, drowsiness and euphoria develops rapidly and is readily reversible.

Drug abuse and dependence:

Nabilone is an abusable substance, capable of producing subjective side-effects, such as euphoria or "high", at therapeutic doses. , a few days). The physical dependence capability of Nabilone is unknown. Patients who participated in clinical trials, up to 5 days duration, showed no withdrawal symptoms on cessation of dosing.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

As nabilone is excreted primarily by the biliary route, the drug is not recommended for use in patients with severe liver dysfunction. Patients receiving nabilone should be closely observed, if possible, within an inpatient setting.

This is especially important during the treatment of naive patients. However, even patients experienced with cannabinoid agents may have serious untoward responses not predicted by prior uneventful exposures. Patients should be made aware of possible changes of mood and other adverse behavioural effects of the drug.

Since nabilone can elevate supine and standing heart rates and cause postural hypotension, it should be used with caution in the elderly and in patients with hypertension and heart disease.

Nabilone is contra-indicated in patients with a known allergy to cannabinoid agents and when the nausea and vomiting arises from any cause other than cancer chemotherapy.