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.
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.
How Supplied/Storage and Handling
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.
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].
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.
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 make up for any missed dose. Advise patients to take Bosulif with a meal. Patients should be advised: "Do not crush or cut tablet. Do not touch or handle crushed or broken tablets."
• Gastrointestinal Problems
Advise patients that they may experience diarrhea, nausea, vomiting, abdominal pain, or blood in their stools with Bosulif and to seek medical attention promptly for these symptoms.
• Low Blood Cell Counts
Advise patients of the possibility of developing low blood cell counts and to immediately report fever, any suggestion of infection, or signs or symptoms suggestive of bleeding or easy bruising.
• Liver Problems
Advise |
