DOSTINEX

What it is

DOSTINEX contains the active ingredient cabergoline. Cabergoline is a dopaminergic ergoline derivative with potent and long-lasting dopamine D2 receptor agonist properties. DOSTINEX tablets are available in strengths of 1.0 mg or 2.0 mg.

Approved indications

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

Dosing overview

Dose optimisation 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/day for patients with signs and symptoms of Parkinson's disease. DOSTINEX should be given as a single daily dose. The safety and efficacy of doses higher than those recommended have not been established.

Key safety warnings

DOSTINEX 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 DOSTINEX. Postural hypotension can occur following administration of cabergoline, particularly during the first days of administration of DOSTINEX. Care should be exercised when administering DOSTINEX concomitantly with drugs known to lower blood pressure. 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. The prevalence of valvular regurgitation potentially attributable to cabergoline may be in the range of 20% or greater. 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 occur at least every 6 to 12 months. A past history of psychiatric illness is a predictor of depressive adverse events on DOSTINEX. Screening of such patients who may be more likely to develop depression is therefore recommended. Pathological (compulsive) behaviour such as gambling, increased libido, hypersexuality, shopping, eating, medication use and punding (repetitive purposeless activity) have been reported in patients treated with dopaminergic agents for the treatment of Parkinson's disease, including cabergoline and levodopa, especially at high doses.

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

DOSTINEX 500 micrograms tablet is listed on the PBS with a restricted restriction status. The ex-manufacturer price is A$36.40.

Regulatory history

DOSTINEX (cabergoline 0.5 mg tablet) was first registered on the Australian Register of Therapeutic Goods on 21 April 1995. The product received initial approval on 10 June 2004.