APOMORPHINE INJ,SOLN

Clinical Criteria Summary

Adults ≥30 years old
Parkinson’s disease diagnosis >3 years prior to therapy initiation
Stable dose of oral medications for at least 4 weeks prior to enrollment
Mean of ≥3 hours of off time per day over 2 days at screening/baseline, with no single day recording <2 hours of off time
Patients experiencing persistent motor fluctuations despite optimized oral or transdermal medication/levodopa therapy
Considered when oral medications can no longer manage motor fluctuations and dyskinesias
May be appropriate for patients who are not candidates for deep brain stimulation (DBS) or other invasive devices (e.g., elderly, non-surgical candidates)

Administered as a continuous subcutaneous infusion via Onapgo pump using 98 mg/20 mL (4.9 mg/mL) single dose cartridges
Initial dose: 1 mg/hour
Titrate based on response and tolerability in 0.5 to 1 mg/hour increments at intervals ≥1 day
Maximum continuous dosage: 6 mg/hour
Maximum total daily dose (including continuous infusion and extra doses): 98 mg/day administered over the waking day (e.g., 16 hours)

Due to incidence of nausea and vomiting, recommend starting trimethobenzamide 300 mg three times a day 3 days prior to initial apomorphine dose
Alternative: Start without antiemetics and titrate slowly based on effectiveness and tolerance
Monitor for infusion site reactions (skin nodules, erythema/pruritus, bruising), which are frequent reasons for discontinuation; mitigation strategies for skin irritation may be considered

Concomitant use of 5HT3 antagonists (including antiemetics such as ondansetron and alosetron)
Hypersensitivity or allergic reaction to apomorphine or any excipients, including sulfite (sodium metabisulfite)

Device-assisted therapies considered when oral medications can no longer manage motor fluctuations and dyskinesias
Non-motor symptoms of advanced Parkinson’s disease (e.g., severe dementia, chronic hallucinations, or psychosis) may impact therapy selection
Indicated for use during waking hours; daytime-only pump wear may be preferred by some patients, with bolus function available for morning use to prevent morning akinesia
Higher incidence of somnolence compared to continuous levodopa-based therapies (subcutaneous or intestinal gel)

Concurrent use of apomorphine injections
Concurrent use of a 5-HT3 antagonist (e.g., ondansetron, granisetron, dolasetron, palonosetron and alosetron)
Concurrent use of continuous subcutaneous or intrajejunal infusion of carbidopa/levodopa
Baseline resting corrected QT interval (QTc) > 450 msec for males and > 470 msec for females on electrocardiogram (ECG) or other risk factors for a prolonged QT interval

Diagnosis of Idiopathic Parkinson’s Disease
Patient is under the care of a VA or VA Community Care neurologist or locally designated expert
Motor fluctuations (“wearing off”) that require dosing of dopaminergic medications at intervals every 4 hours or less
Either higher frequency (≥5 times daily) carbidopa/levodopa immediate-release (IR) tablet or carbidopa/levodopa extended-release (ER) capsules throughout the day have not adequately resolved OFF periods
Contraindication, intolerance, or inadequate therapeutic response to at least one agent from two of the following classes: dopamine agonist, catechol-O methyl transferase [COMT] inhibitor, monoamine oxidase type B [MAO B] inhibitor
Discussion with the patient/caregiver/family regarding realistic efficacy expectations, device management, and potential device-related complications documented in the patient’s medical record