CABASER

What it is

Cabaser contains the active ingredient cabergoline. Cabaser tablets for oral administration contain 1.0 mg or 2.0 mg cabergoline. Cabaser is a dopaminergic ergoline derivative with potent and long-lasting dopamine D2 receptor agonist properties.

Approved indications

— Management of the signs and symptoms of Parkinson's disease.

Dosing overview

Optimisation of dose should be obtained through slow initial dose titration from starting doses of 0.5 mg (monotherapy patients) to 1 mg (patients on levodopa). Increments of the daily dose of 0.5–1 mg should be done at weekly (initial weeks) or bi-weekly intervals, up to optimal doses. The recommended therapeutic dosage is 2 to 3 mg per day for patients with signs and symptoms of Parkinson's disease. Cabaser should be given as a single daily dose. Cabaser is to be administered by the oral route and it is recommended that Cabaser be taken with meals.

Key safety warnings

Cabaser has been associated with somnolence and episodes of sudden sleep onset in patients with Parkinson's disease. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Cabaser. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Cabergoline can cause fibrotic reactions and cardiac valvulopathy. Ongoing treatment with cabergoline will require continued monitoring for these adverse events. Fibrotic and serosal inflammatory disorders such as pleuritis, pleural effusion, pleural fibrosis, pulmonary fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves (aortic, mitral and tricuspid) or retroperitoneal fibrosis have occurred after prolonged usage of ergot derivatives such as cabergoline. Valvulopathy has been associated with cumulative doses and has been observed at recommended doses. All patients should undergo a cardiovascular evaluation, including an echocardiogram, to assess potential presence of asymptomatic valvular disease. Following treatment initiation, the first echocardiogram should occur within 3–6 months; thereafter, the frequency of echocardiographic monitoring should be determined by appropriate individual clinical assessment with particular emphasis on signs and symptoms, but should occur at least every 6 to 12 months. Postural hypotension can occur following administration of cabergoline, particularly during the first days of administration of Cabaser. Studies have shown that a past history of psychiatric illness is a predictor of depressive adverse events on Cabaser. Screening of such patients who may be more likely to develop depression is therefore recommended.

Contraindications

Hypersensitivity to cabergoline, other ergot alkaloids or to any of the excipients. History of pulmonary, pericardial or retroperitoneal fibrotic disorders. Anatomical evidence of cardiac valvulopathy of any valve (for example, echocardiogram showing valve leaflet thickening, valve restriction, valve mixed restriction–stenosis).

PBS listing

Cabaser 1 mg tablets and 2 mg tablets are listed on the PBS with restriction, with ex-manufacturer prices of A$24.82 and A$33.27 respectively as of the schedule dated 2026-05-01.

Regulatory history

Cabaser was first listed on the ARTG on 24 October 1996 as a 1 mg tablet (ARTG 57360) and a 2 mg tablet (ARTG 57367). The date of first approval was 10 June 2004.