FOSCARBIDOPA/ FOSLEVODOPA INJ,SOLN
Clinical Criteria Summary
Document 733
Exclusion Criteria
- Currently taking or taken within 14 days a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine and tranylcypromine)
- Patient has not demonstrated a response to prior levodopa use
Inclusion Criteria
- Diagnosis of Idiopathic Parkinson’s disease
- Patient is under the care of a VA or VA Community Care neurologist
- Motor fluctuations (“wearing off”) that require dosing of dopaminergic medications at intervals every 4 hours or less
- Either combination of carbidopa/levodopa controlled-release (CR) and immediate-release (IR) tablet formulations 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 should be documented in the patient’s medical record.
Document 734
Indication & Patient Population
- Treatment of motor fluctuations in adults with advanced Parkinson’s disease
- Considered when oral medications can no longer manage motor fluctuations and dyskinesias
Dosing & Administration Requirements
- 24-hour/day continuous subcutaneous infusion
- Infusion rate calculated based on the patient’s current levodopa dose
- Requires use of VYAFUSER pump (Phillips-Medisize portable infusion pump)
- Dosage form: 120mg foscarbidopa and 2,400mg foslevodopa per 10mL vial
Contraindications
- Concurrent or recent (within 2 weeks) administration of a nonselective monoamine oxidase inhibitor (MAOI)
Warnings & Precautions
- Somnolence and falling asleep during activities of daily living
- Hallucinations/psychosis
- Development or worsening of impulse control/compulsive behavior
- Infusion site reactions/infections (e.g., redness, nodules)
- Withdrawal-emergent hyperpyrexia and confusion
- Dyskinesia
- Ischemic cardiovascular events
- Glaucoma
Clinical Considerations & Monitoring
- Non-motor symptoms of advanced PD (e.g., severe dementia, chronic hallucinations, or psychosis) may impact therapy selection
- Requires specialized monitoring due to acceptable risk profile with device-assisted therapies
- Mitigation strategies for infusion site reactions include topical or subQ steroids, oral NSAIDs, and topical cooling