XOSPATA (gilteritinib)

XOSPATA (gilteritinib)

SELF ADMINISTRATION

Indication for Prior Authorization:

• Indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test

Patients must meet the following criteria for the indications above:

• Patient is 18 years of age or older, AND

• Diagnosis of relapsed or refractory AML confirmed by chart note documentation, AND

• The patient has an FLT3 mutation as confirmed by an FDA approved test, AND

• Prescribed by or in consultation with an oncologist

Dosing:

• Oral: 120 mg once daily for a minimum of 6 months (to allow time for a clinical response) or until disease progression or unacceptable toxicity

• Avoid concomitant use with P-gp and strong CYP3A inducers and CYP3A inhibitors

Approval:

• Initial: 6 months

• Renewal: 1 year