RUZURGI (amifampridine)

RUZURGI (amifampridine) 

SELF-ADMINISTRATION

Indications for Prior Authorization:

• Indicated for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in patients 6 to 17 years of age. 

Patients must meet the following criteria for the indication(s) above:

• Patient is 6 to 17 years of age, AND
• Prescribed by or in consultation with a neurologist, AND
• Patient has a diagnosis of symptomatic LEMS that interferes with daily functions (e.g. difficulty climbing stairs, walking up steep hills) as confirmed by chart note documentation, AND
• Documentation of a baseline clinical muscle strength assessment [examples may include but are not limited to the Quantitative Myasthenia Gravis (QMG) score, triple-timed up-and-go test (3TUG), Timed 25-foot Walk test (T25FW)], AND
• Patient does not have a history of seizures

Reauthorization:

• Positive clinical response to therapy (e.g. improvement in dynamometry, timed 25-foot walk test, timed up and go test) as confirmed by chart note documentation

Dosing:

• < 45 kg:
  • Initial: 7.5 to 15 mg/day in 2 to 3 divided doses
  • Maximum single dose: 15 mg/dose; maximum total daily dose: 50 mg(5 tablets)/day
• ≥ 45 kg:
  • Initial: 15 to 30 mg/day in 2 to 3 divided doses
  • Maximum single dose: 30 mg/dose; maximum total daily dose: 100 mg (10 tablets)/day

Approval:

• Initial: 3 months
• Renewal: 1 year