STALEVO

What it is

STALEVO is a combination medicine containing levodopa, carbidopa monohydrate, and entacapone. It is available in six film-coated tablet strengths, each containing a 4:1 ratio of levodopa to carbidopa monohydrate combined with 200 mg of entacapone in a standard release formulation: 50/12.5/200 mg, 75/18.75/200 mg, 100/25/200 mg, 125/31.25/200 mg, 150/37.5/200 mg and 200/50/200 mg.

Approved indications

— Management of patients with Parkinson's disease who are experiencing motor fluctuations.

Dosing overview

The optimum daily dosage of STALEVO must be determined by careful titration in each patient. The daily dose should preferably be optimised using one of the six available tablet strengths. Patients should be instructed to take only one STALEVO tablet per dose administration. The maximum STALEVO dose must not exceed 10 tablets per day for the strengths of 50/12.5/200 mg, 75/18.75/200 mg, 100/25/200 mg, 125/31.25/200 mg, and 150/37.5/200 mg. Using a maximum recommended daily dose of 375 mg of carbidopa monohydrate, the maximum daily dose of STALEVO 200/50/200 mg is 7 tablets per day. The maximum total daily levodopa dose administered in the form of STALEVO should not exceed 1500 mg.

Key safety warnings

STALEVO may induce orthostatic hypotension and should be given cautiously to patients who are taking other medicinal products which may cause orthostatic hypotension. Entacapone in association with levodopa has been associated with somnolence and episodes of sudden sleep onset in patients with Parkinson's disease and caution should therefore be exercised when driving or operating machines. Neuroleptic Malignant Syndrome (NMS), including rhabdomyolysis and hyperthermia, is characterised by motor symptoms (rigidity, myoclonus, tremor), mental status changes (e.g., agitation, confusion, coma), hyperthermia, autonomic dysfunction (tachycardia, labile blood pressure) and elevated serum creatine phosphokinase. A syndrome resembling the neuroleptic malignant syndrome has been reported with the abrupt withdrawal of antiparkinsonian agents, and isolated cases of NMS have been reported, especially following abrupt reduction or discontinuation of entacapone. For patients experiencing diarrhoea, a follow-up of weight is recommended. Prolonged or persistent diarrhoea suspected to be related to STALEVO may be a sign of colitis, and in the event of prolonged or persistent diarrhoea, the drug should be discontinued and appropriate medical therapy and investigations considered. Patients should be regularly monitored for the development of impulse control disorders. Behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating, medication use and punding can occur in patients treated with STALEVO, and review of treatment is recommended if such symptoms develop.

Contraindications

STALEVO is contraindicated in patients with known hypersensitivity to the active substances or excipients; during pregnancy and breast feeding; severe liver impairment; narrow-angle glaucoma; phaeochromocytoma due to the increased risk of hypertensive crisis; in co-administration with non-selective monoamine oxidase inhibitors (e.g. phenelzine, tranylcypromine) or with concurrent use of a selective MAO-A inhibitor plus a selective MAO-B inhibitor; in patients with a previous history of neuroleptic malignant syndrome and/or non-traumatic rhabdomyolysis; and in patients with suspicious undiagnosed skin lesions or a history of malignant melanoma because levodopa may activate malignant melanoma.

PBS listing

Information regarding PBS listing for STALEVO is not provided in the available source documents.

Regulatory history

Three STALEVO tablet strengths (50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg) were first listed on the Australian Register of Therapeutic Goods on 5 October 2004. The 200/50/200 mg strength was listed on 28 July 2008, and the 75/18.75/200 mg and 125/31.25/200 mg strengths were listed on 16 December 2009.