ISTRADEFYLLINE TAB
Clinical Criteria Summary
Exclusion Criteria
- Patient is taking a strong CYP3A4 inducer
- Severe hepatic impairment (Child-Pugh Class C)
- End-stage renal disease (CrCl less than 15 mL/min) or hemodialysis
- Pregnancy
Inclusion Criteria
- Patient is under the care of a VA or VA Community Care neurologist or locally designated expert
- Diagnosis of Parkinson’s disease (PD) with at least 2 hours of OFF time per day
- Patient is receiving carbidopa/levodopa at least four times daily, with dose stable for at least 4 weeks prior to request
- Attempts to reduce dosing intervals of carbidopa/levodopa have not adequately resolved OFF periods
- Use of carbidopa/levodopa extended-release (ER) capsule formulation (RYTARY) or controlled-release (CR) tablet formulation throughout the day has 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
Additional Inclusion Criteria
- For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy