a luable)
n (%) BP CML
(N=60 eva luable)
n (%)
Abbreviations: CI = confidence interval, OHR = overall hematologic response, CHR = complete hematologic response
*
Overall hematologic response (OHR) = major hematologic response (complete hematologic response + no evidence of leukemia) or return to chronic phase (RCP). All responses were confirmed after 4 weeks. Complete hematologic response (CHR) for AP and BP CML: WBC less than or equal to institutional ULN, platelets greater than or equal to 100,000/mm3 and less than 450,000/mm3, absolute neutrophil count (ANC) greater than or equal to 1.0 × 109 /L, no blasts or promyelocytes in peripheral blood, less than 5% myelocytes + metamyelocytes in bone marrow, less than 20% basophils in peripheral blood, and no extramedullary involvement. No evidence of leukemia (NEL): Meets all other criteria for CHR except may have thrombocytopenia (platelets greater than or equal to 20,000/mm3 and less than 100,000/mm3) and/or neutropenia (ANC greater than or equal to 0.5 × 109 /L and less than 1.0 × 109 /L). Return to chronic phase (RCP) =disappearance of features defining accelerated or blast phases but still in chronic phase.
CHR* by Week 48
(95% CI)
21 (30.4)
(19.9, 42.7) 9 (15)
(7.1, 26.6)
OHR* by Week 48 38 (55.1) 17 (28.3)
(95% CI) (42.6, 67.1) (17.5, 41.4)
The CHR and OHR rates were based on a minimum follow-up of 12 months for patients with AP CML and 18 months for patients with BP CML. Of the 69 eva luable patients with AP CML, 4 patients had confirmed disease transformation to BP while on BOSULIF treatment.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
BOSULIF (bosutinib) tablets are supplied for oral administration in two strengths: a 100 mg yellow, oval, biconvex, film-coated tablet debossed with "Pfizer" on one side and "100" on the other; and a 500 mg red, oval, biconvex, film-coated tablet debossed with "Pfizer" on one side and "500" on the other. BOSULIF (bosutinib) tablets are available in the following packaging configurations (Table 8):
Table 8 Tablet Presentations
BOSULIF Tablets
Package Configuration Tablet Strength (mg) NDC Tablet Description
120 tablets per bottle 100 mg 0069-0135-01 Yellow, oval, biconvex, film-coated tablets, debossed "Pfizer" on one side and "100" on the other.
30 tablets per bottle 500 mg 0069-0136-01
Red, oval, biconvex, film-coated tablets, debossed "Pfizer" on one side and "500" on the other.
16.2 Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
16.3 Handling and Disposal
Procedures for proper disposal of anticancer drugs should be considered. Any unused product or waste material should be disposed of in accordance with local requirements, or drug take back programs.
17 PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling.
• Dosing and Administration
Instruct patients to take BOSULIF exactly as prescribed, not to change their dose or to stop taking BOSULIF unless they are told to do so by their doctor. If patients miss a dose beyond 12 hours, they should be advised to take the next scheduled dose at its regular time. A double dose should not be taken to m |
