DUOPA- levodopa and carbidopa suspension
1 INDICATIONS AND USAGE
DUOPA is indicated for the treatment of motor fluctuations in patients with advanced Parkinson's disease.
2 DOSAGE AND ADMINISTRATION
2.1 DUOPA Daily Dose
DUOPA is administered over a 16-hour infusion period. The daily dose is determined by individualized patient titration and composed of:
A Morning Dose
A Continuous Dose
The maximum recommended daily dose of DUOPA is 2000 mg of the levodopa component (i.e., one cassette per day) administered over 16 hours. At the end of the daily 16-hour infusion, patients will disconnect the pump from the PEG-J and take their night-time dose of oral immediate-release carbidopa-levodopa tablets.
Treatment with DUOPA is initiated in 3 steps [see Dosage and Administration (2.2)]:
Conversion of patients to oral immediate-release carbidopa-levodopa tablets in preparation for DUOPA treatment.
Calculation and administration of the DUOPA starting dose (Morning Dose and Continuous Dose) for Day 1.
Titration of the dose as needed based on individual clinical response and tolerability.
DUOPA has an extra dose function that can be used to manage acute "Off" symptoms that are not controlled by the Morning Dose and the Continuous Dose administered over 16 hours. The extra dose function should be set at 1 mL (20 mg of levodopa) when starting DUOPA. If the amount of the extra dose needs to be adjusted, it is typically done in 0.2 mL increments. The extra dose frequency should be limited to one extra dose every 2 hours. Administration of frequent extra doses may cause or worsen dyskinesias.
Once no further adjustments are required to the DUOPA Morning Dose, Continuous Dose, or Extra Dose, this dosing regimen should be administered daily. Over time, additional changes may be necessary based on the patient's clinical response and tolerability.
2.2 Initiation and Titration Instructions
Prepare for DUOPA Treatment
Prior to initiating DUOPA, convert patients from all other forms of levodopa to oral immediate-release carbidopa-levodopa tablets (1:4 ratio). Patients should remain on a stable dose of their concomitant medications taken for the treatment of
DOSAGE FORMS AND STRENGTHS
Enteral suspension: 4.63 mg carbidopa and 20 mg levodopa per mL in a single-use cassette. Each cassette contains approximately 100 mL of suspension.