KOSELUGO (selumetinib)

SELF ADMINISTRATION - Oral

Indications for Prior Authorization:
  • The treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
Patients must meet the following criteria for the indication(s) above:
  • Chart note documentation must confirm diagnosis of neurofibromatosis type 1, AND
  • Prescribed by or in consultation with an oncologist or neurologist, AND
  • Patient has plexiform neurofibromas that are BOTH of the following:
    • Inoperable
    • Causing significant morbidity (e.g., disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment), AND
  • Patient is able to swallow a capsule whole, AND
  • Body surface area (BSA) is provided (dosing is based on BSA). (Patient must have a BSA of at least 0.55 m2), AND
  • ONE of the following:
    • Patient is 2 years old to 17 years old, OR
    • Both of the following:
      • Patient is 18 years of age or older, and
      • Patient is continuing therapy
Reauthorization criteria:
  • Specialist chart note documentation provided shows a clinical response to therapy
Dosing:
  • Recommended dosage: 25 mg/m2 orally twice daily (approximately every 12 hours) without food on empty stomach until disease progression or unacceptable toxicity
  • Do not consume food 2 hours before each dose or 1 hour after each dose
  • Dosing reductions are recommended for toxicities, hepatic impairment, and drug interactions.
Approval:
  • Initial: 6 months
  • Renewal: 1 year

 

Last review date: August 18, 2020