XADAGO (safinamide)
SELF ADMINISTRATION - ORAL
Indications for Prior Authorization:
- Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes (Xadago has not been shown to be effective as monotherapy for the treatment of PD)
Patients must meet the following criteria for the indication(s) above:
- Patient is 18 years of age or older, AND
- Diagnosis of Parkinson's disease and member is experiencing "off" time on levodopa/carbidopa therapy, AND
- Will be used concomitantly with levodopa/carbidopa and will not be used as monotherapy, AND
- Patient does not have severe hepatic impairment (Child-Pugh C), AND
- Patient has tried and failed rasagiline and entacapone, AND
- Patient will not be using Xadago concomitnantly with other MAO-Is or potent inhibitors of monoamine oxidase, opioids, SNRIs, TCAs (or tetracycline or triazolpyridine antidepressants), cyclobenzaprine, methylphenidate, amphetamine and their derivatives, St. John's wort, or dextromethorphan
Dosing:
- Initial: 50 mg once daily
- Maintenance: after two weeks the dose may be increased to 100 mg once daily
- Moderate hepatic impairment: max is 50 mg once daily
- Severe hepatic impairment: contraindicated
Approval:
- 1 year