LECIGON

What it is

LECIGON is an intestinal gel cartridge containing levodopa 20 mg/mL, carbidopa monohydrate 5 mg/mL, and entacapone 20 mg/mL.

Approved indications

— Advanced idiopathic Parkinson disease with severe motor fluctuations despite optimised alternative pharmacological treatment.

Key safety warnings

Levodopa has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with levodopa. All patients should be monitored carefully for the development of mental changes, depression with suicidal tendencies, or other serious antisocial behaviour. Patients with Parkinson's disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. Whether the increased risk observed was due to Parkinson's disease or other factors, such as drugs used to treat Parkinson's disease, is unclear. Patients and providers are advised to monitor for melanomas frequently and on a regular basis when using combination levodopa/carbidopa monohydrate tablet for any indication. Patients should be regularly monitored for the development of impulse control disorders. Patients and caregivers should be made aware that behavioural symptoms of impulse control disorders (such as pathological gambling, hypersexuality, increased libido, compulsive spending/buying, and binge eating, medication use and punding) has been reported in patients taking dopamine agonists for the treatment of Parkinson's disease, especially at high doses.

Contraindications

Monoamine oxidase inhibitors (MAOIs) and combination levodopa/carbidopa monohydrate tablet should not be given concomitantly. MAOIs must be discontinued at least 2 weeks prior to initiating therapy with combination levodopa/carbidopa monohydrate. KINSON is contraindicated in patients with known hypersensitivity to this drug or any component of this medication, and in patients with narrow-angle glaucoma. Because levodopa may activate a malignant melanoma, it should not be used in patients with suspicious undiagnosed skin lesions or history of melanoma.

PBS listing

The document sources do not contain information on PBS listing details including strengths listed, item count, restriction type, or ex-manufacturer price for LECIGON.

Regulatory history

LECIGON levodopa 20 mg/mL / carbidopa monohydrate 5 mg/mL / entacapone 20 mg/mL intestinal gel cartridge was first listed on the ARTG on 1 September 2023. In March 2024, the PBAC did not recommend LECIGON for advanced idiopathic Parkinson disease with severe motor fluctuations. In July 2024, the PBAC recommended LECIGON for advanced idiopathic Parkinson disease with severe motor fluctuations despite optimised alternative pharmacological treatment. In November 2024, the PBAC provided advice on revised equi-effective doses for cost-minimisation purposes.