Taro-Dasatinib

Dasatinib

• Brand(s): Sprycel and generics (see formulary for list of funded generics)
• Dosage Form/Strength: 20 mg, 50 mg, 70 mg, 100 mg tablet

For the treatment of Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in the chronic phase.¹

Dosing recommendation: 100 mg per day.

Renewals will be considered for patients who have experienced hematologic and/or cytogenic response and are expected to continue to do so.

Duration of Approval: 1 Year

Exclusion criteria:
Combination treatment with any two or more of the oral tyrosine-kinase inhibitors (TKI) (i.e., imatinib, nilotinib or dasatinib) will not be funded.

¹Note: Funding is only considered for any two oral TKIs* per patient in a lifetime for chronic phase CML (*TKIs: imatinib, nilotinib, or dasatinib). If a patient develops grade 3 or grade 4 toxicity on one of the listed TKI’s within 3 months of initiating therapy, funding for a third oral TKI will be allowed.

For the treatment of patients with accelerated phase or blast phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) with documented resistance¹ or intolerance² (as defined below) to imatinib therapy

Dosing recommendation: 140 mg per day.

Definitions of resistance and intolerance:
¹Imatinib resistance is defined as primary or acquired resistance to imatinib at doses of at least 600 mg/day or through a mutational analysis report.
²Intolerance to imatinib (at any dose) is defined as persistent grade 3 or grade 4 toxicity requiring discontinuation of therapy.

Renewals will be considered for patients who have experienced hematologic and/or cytogenic response and are expected to continue to do so.

Duration of Approval: 1 Year

Exclusion criteria:

• Combination treatment with any 2 or more of the oral TKIs (i.e. imatinib, nilotinib or dasatinib) will not be funded.
• Dasatinib is not funded as a sequential third line therapy in patients who experience primary or acquired resistance (not including mutational resistance) to nilotinib.

For the treatment of Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in patients meeting the following criteria:

1. An adult patient with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph +ALL); AND

2. Patient’s disease is resistant¹ to imatinib-containing chemotherapy (patient must have tried 600 mg/day); OR

3. Patient has experienced intolerance² to imatinib therapy.

¹Imatinib resistance is defined as primary or acquired resistance to imatinib at doses of at least 600 mg/day or through a mutational analysis report.

²Intolerance to imatinib (at any dose) is defined as the patient has experienced persistent grade 3 or grade 4 toxicity requiring discontinuation of therapy.

Renewals will be considered after confirmation from the patient’s physician that the patient has benefited or continues to benefit from therapy with Sprycel and is expected to continue to do so.

Duration of Approval: 1 Year

Reimbursement of dasatinib for children with acute lymphoblastic leukemia will be considered on a case-by-case basis.

EAP Drug Request Form:

Standard Form for EAP Drug Requests