VITRAKVI (larotrectinib)
SELF ADMINISTRATION - ORAL
Indications for Prior Authorization:
- Indicated for the treatment of adult and pediatric patients with solid tumors that:
- have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,
- are metastatic or where surgical resection is likely to result in severe morbidity, and
- have no satisfactory alternative treatments or that have progressed following treatment.
The following criteria must be met:
- Chart note documentation is provided, AND
- Prescribed by an oncologist, AND
- Patient's tumor has a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, AND
- Patient meets one of the following criteria:
- Patients tumor is metastatic, OR
- Surgical resection of tumor will likely result in severe morbidity, AND
- Patient meets one of the following criteria:
- There are no satisfactory alternative treatments, OR
- The patient has a disease progression following treatment.
Dosing:
- Adults and Pediatric Patients with body surface area of at least 1.0 m2:
- 100 mg orally twice daily
- Pediatric Patients with body surface area less than 1.0 m2:
- 100 mg/m2 orally twice daily
- Vitrakvi® is dose adjusted, withheld or discontinued for adverse reactions
Approval:
1 year
Last review date: December 4, 2019