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Bosutinib

    Brands

    DAE Class; Rx

    Common Brand Names; Bosulif

    • Antineoplastics, Tyrosine Kinase Inhibitors

    Multi-tyrosine kinase inhibitor
    Used for the treatment of adult patients with certain types of Philadelphia chromosome-positive chronic myelogenous leukemia
    Anaphylactic shock has been reported

    Newly-diagnosed chronic phase Philadelphia chromosome positive

    • Indicated for newly diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML)

    Chronic, accelerated, or blast phase Philadelphia chromosome positive

    • Indicated for chronic, accelerated, or blast phase Ph+ CML in patients resistant to or intolerant to other therapies, including imatinib
    Hypersensitivity
    • Creatinine increased (94%)
    • Hemoglobin decreased (89%)
    • Lymphocyte count decreased (84%)
    • Diarrhea (75%)
    • Platelet count decreased (68%)
    • Serum glutamic-pyruvic transaminase (SGPT)/ALT increased (68%)
    • Glucose increased (57%)
    • Serum glutamic-oxaloacetic transaminase (SGOT)/AST increased (56%)
    • Calcium decreased (55%)
    • Phosphorus decreased (54%)
    • Lipase increased (53%)
    • WBC decreased (50%)
    • Hepatic dysfunction (45%)
    • ANC decreased (42%)
    • Alkaline phosphatase increased (41%)
    • Rash (40%)
    • Abdominal pain (39%)
    • Nausea (37%)
    • Creatine kinase increased (36%)
    • Fatigue (33%)
    • Amylase increased (32%)
    • Respiratory tract infection (27%)
    • Headache (22%)
    • Vomiting (21%)
    • Arthralgia (18%)
    • Pyrexia (17%)
    • Edema (15%)
    • Constipation (13%)
    • Back pain (12%)
    • Pruritus (11%)
    • Cough (11%)
    • Dyspnea (11%)
    • Decreased appetite (11%)

    Diarrhea, nausea, vomiting, and abdominal pain may occur; monitor and manage patients using standards of care, including antidiarrheals, antiemetics, and fluid replacement

    Thrombocytopenia, anemia, and neutropenia occur with treatment; perform CBC weekly for first month and then monthly thereafter, or as clinically indicated

    Fluid retention may occur and manifest as pericardial effusion, pleural effusion, pulmonary edema, and/or peripheral edema

    Cardiac failure and left ventricular dysfunction have been reported in patients taking; monitor for signs and symptoms consistent with cardiac failure and treat as clinically indicated; interrupt, dose reduce, or discontinue as necessary

    Decline in glomerular filtration rate reported in patients receiving therapy, which in turn increases bosutinib exposure in patients; use caution in patients with moderate renal impairment; dosage adjustment recommended

    Fetal harm may occur when administered to pregnant females

    Monitor renal function at baseline and during therapy, especially in patients who have preexisting renal impairment or risk factors for renal dysfunction; consider dose adjustment in patients with baseline and treatment emergent renal impairment

    Pregnancy

    No data are available in pregnant women to inform the drug-associated risk; however, fetal harm may occur when administered to pregnant women based on mechanism of action and findings from animal studies

    Lactation

    Owing to the potential for serious adverse reactions in a nursing child, breastfeeding is not recommended during treatment and for at least 2 weeks after the last dose

    Adults

    600 mg/day PO.

    Geriatric

    600 mg/day PO.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Bosutinib

    tablet

    • 100mg
    • 400mg
    • 500mg

    capsule

    • 50 mg
    • 100 mg