Bonitar Tablet

Bosutinib tablets are indicated for the treatment of: - Adult patients with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), resistant or intolerant to prior therapy. - Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy. Pediatric use information is approved for PF PRISM CV’s BOSULIF® (Bosutinib) tablets. However, due to PF PRISM CV’s marketing exclusivity rights, this drug product is not labeled with that information. Bosutinib is a kinase inhibitor indicated for the treatment of: - adult patients with chronic phase Ph+ chronic myelogenous leukemia (CML), resistant or intolerant to prior therapy. - adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

• Gastrointestinal Toxicity: Monitor and manage as necessary. Withhold, dose reduce, or discontinue Bosutinib tablets. - Myelosuppression: Monitor blood counts and manage as necessary. Withhold, dose reduce or discontinue Bosutinib tablets - Hepatic Toxicity: Monitor liver enzymes at least monthly for the first 3 months and as needed. - Cardiovascular Toxicity: Monitor and manage as necessary. Interrupt, dose reduce, or discontinue Bosutinib tablets. - Fluid Retention: Monitor patients and manage using standard of care treatment. - Renal Toxicity: Monitor patients for renal function at baseline and during therapy with Bosutinib tablets. - Embryo-Fetal Toxicity: Bosutinib tablets can cause fetal harm. Advise female patients of reproductive potential of potential risk to a fetus and to use effective contraception. Gastrointestinal Toxicity Diarrhea, nausea, vomiting, and abdominal pain occur with Bosutinib tablets treatment. Monitor and manage patients using standards of care, including antidiarrheals, antiemetics, and fluid replacement. Among 546 adult patients in a single-arm study in patients with CML who were resistant or intolerant to prior therapy, the median time to onset for diarrhea (all grades) was 2 days and the median duration per event was 2 days. Among the patients who experienced diarrhea, the median number of episodes of diarrhea per patient during treatment with Bosutinib tablets was 3 (range 1 to 268). To manage gastrointestinal toxicity, withhold, dose reduce, or discontinue Bosutinib tablets as necessary. Pediatric use information is approved for PF PRISM CV’s BOSULIF® (Bosutinib) tablets. However, due to PF PRISM CV’s marketing exclusivity rights, this drug product is not labeled with that information. Myelosuppression Thrombocytopenia, anemia and neutropenia occur with Bosutinib tablets treatment. Perform complete blood counts weekly for the first month of therapy and then monthly thereafter, or as clinically indicated. To manage myelosuppression, withhold, dose reduce, or discontinue Bosutinib tablets as necessary. Hepatic Toxicity Bosutinib may cause elevations in serum transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]). Two cases consistent with drug induced liver injury (defined as concurrent elevations in ALT or AST greater than or equal to 3×ULN with total bilirubin greater than 2×ULN and alkaline phosphatase less than 2×ULN) have occurred without alternative causes. This represented 2 out of 1711 patients in Bosutinib tablets clinical trials. Among the 546 adult patients in a single-arm study in patients with CML who were resistant or intolerant to prior therapy, the incidence of increased ALT was 53.3% and AST elevation was 46.7%. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Gastrointestinal toxicity. Myelosuppression. Hepatic toxicity. Cardiovascular toxicity. Fluid retention. Renal toxicity. - Most common adverse reactions (≥20%), in adult patients with CML are diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, and respiratory tract infection. The most common laboratory abnormalities (≥20%) in adult patients are creatinine increased, hemoglobin decreased, lymphocyte count decreased, platelets decreased, ALT increased, calcium decreased, white blood cell count decreased, AST increased, absolute neutrophil count decreased, glucose increased, phosphorus decreased, urate increased, alkaline phosphatase increased, lipase increased, creatine kinase increased, and amylase increased. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions, in ≥20% of adults with resistance or intolerance to prior therapy (N=814) were diarrhea (80%), rash (44%), nausea (44%), abdominal pain (43%), vomiting (33%), fatigue (33%), hepatic dysfunction (33%), respiratory tract infection (25%), pyrexia (24%), and headache (21%). The most common laboratory abnormalities that worsened from baseline in ≥20% of adults were creatinine increased (93%), hemoglobin decreased (90%), lymphocyte count decreased (72%), platelets decreased (69%), ALT increased (58%), calcium decreased (53%), white blood cell count decreased (52%), absolute neutrophils count decreased (50%), AST increased (50%), glucose increased (46%), phosphorus decreased (44%), urate increased (41%), alkaline phosphatase increased (40%), lipase increased (36%), creatine kinase increased (29%), and amylase increased (24%). Adverse Reactions in Adult Patients With Imatinib-Resistant or-Intolerant Ph+ CP, AP, and BP CML The single-arm clinical trial enrolled patients with Ph+ CP, AP and BP CML and with resistance or intolerance to prior therapy. The safety population (received at least 1 dose of Bosutinib tablets) included 546 CML patients: - two hundred eighty-four patients with CP CML previously treated with imatinib only who had a median duration of Bosutinib tablets treatment of 26 months (range: 0.2 to 155 months), and a median dose intensity of 437 mg/day. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.