DUODOPA

What it is

DUODOPA is an intestinal gel formulation containing levodopa and carbidopa monohydrate at concentrations of 20 mg/mL and 5 mg/mL respectively.

Approved indications

— Parkinson disease — Parkinson disease (advanced)

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. 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. Behavioural symptoms of impulse control disorders (such as pathological gambling, hypersexuality, increased libido, compulsive spending/buying, and binge eating, medication use and punding) have been reported in patients taking dopamine agonists for the treatment of Parkinson's disease, especially at high doses. In some patients, dopamine dysregulation syndrome (DDS), an addictive disorder which leads to excessive use of the medication, was observed during treatment with carbidopa/levodopa.

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. DUODOPA 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

DUODOPA is listed with Authority Required (STREAMLINED) restriction for Parkinson disease and advanced Parkinson disease. For advanced Parkinson disease, the maximum quantity is 8 packs for patients requiring more than 1 cassette per day.

Regulatory history

DUODOPA was first registered on the ARTG on 27 February 2008 (ARTG 133452). In November 2016, the PBAC recommended a change involving removal of specific wording from the Note section of the restriction for Parkinson disease. In November 2019, the PBAC recommended additional General Schedule and Section 100 (Highly Specialised Drugs Program) Authority Required (STREAMLINED) listings for both Parkinson disease and advanced Parkinson disease, with reduced maximum quantities and additional clinical criteria for patients requiring continuous administration.