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