TUKYSA (tucatinib)
SELF ADMINISTRATION
Indications for Prior Authorization:
- Indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting
Patients must meet the following criteria for the indication(s) above:
- Patient has a diagnosis of advanced, unresectable, or metastatic HER2-positive breast cancer as confirmed by chart note documentation, AND
- Prescribed by or in consultation with an oncologist, AND
- Patient has received one or more prior anti-HER2-based regimens in the metastatic setting, AND
- Tukysa™ will be used in combination with trastuzumab and capecitabine
Reauthorization Criteria:
- Patient had a positive response to therapy as confirmed by specialist chart note documentation
Dosing:
- 300 mg taken orally twice daily
- Severe Hepatic Impairment: 200 mg orally twice daily
- Tukysa™ should not be used in combination with strong CYP3A inducers or moderate CYP2C8 inducers
- If concomitant use with strong CYP2C8 inhibitors cannot be avoided, reduce Tukysa™ dose
- Avoid concomitant use with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities
- Consider reducing the dose of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities
Approval:
1 year
Last review date: August 18, 2020