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Bosulif

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Bosutinib )Instructions

Generic name: Bosutinib
Trade name: BOSULIF
All names: Bosutinib, Bosutinib, Inisul, Inisul, BMS-354825, BOSULIF, Bosutinib


Indications:
This product is used to treat adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase, accelerated phase and blast phase (blast myeloblastosis and blast phase) who are resistant to or intolerant to imatinib mesylate.


Usage and dosage:
(1) 500mg, once a day, take with food.
(2) If the patient does not achieve a complete hematological response by 8 weeks, or if a complete hematological response is achieved by 12 weeks without Grade 3 adverse reactions, the dose may be considered to be increased to 600 mg.
(3) If hematological and non-hematological toxic reactions occur, dose adjustment should be considered.


Adverse reactions:
Diarrhea, nausea, low platelets, vomiting, abdominal pain, rash, low red blood cell count (anemia), fever, fatigue


Contraindications:
Contraindicated for those allergic to Bosulif.


Precautions:
Gastrointestinal toxicity: Monitor patient symptoms, treat if necessary, and consider dose adjustment or discontinuation.
Myelosuppression: Monitor complete blood count and treat symptomatically if necessary.
Hepatotoxicity: During the first three months of treatment, monitor liver enzyme levels at least once a month, and adjust the dose or discontinue the drug if necessary.
Fluid retention: Monitor patients and treat symptomatically, adjust dosage, or discontinue medication if necessary.
Nephrotoxicity: Monitor the patient's renal function level during medication.
Embryofetal toxicity: Harmful to the fetus, women of childbearing age should avoid becoming pregnant while taking the drug.


Storage:
Store below 25℃.


Mechanism of action:
Bosutinib is a potent dual protein kinase Src/Abl inhibitor. Most CML patients have a genetic mutation called the Philadelphia chromosome, which causes the bone marrow to produce tyrosine kinase. This enzyme triggers the bone marrow to produce too many malformed, unhealthy white blood cells called granulocytes. Granulocytes fight infection. Bosutinib works by blocking tyrosine kinase signals that stimulate the bone marrow to accelerate the production of malformed and unhealthy granulocytes.


Safety and efficacy:
The efficacy of BOSUTINIB in newly treated CML patients is better than that of Gleevec. Bosutinib is an anti-cancer targeted drug developed and produced by overseas medical companies for the treatment of patients with CML chronic myelogenous leukemia. It is often used to treat patients who are resistant to imatinib/Gleevec, and has been used as a second-line drug for CML patients for a long time. However, bosutinib has gradually proven its therapeutic effect in overseas medical trials and has become a first-line CML targeted drug.
The study included a total of 536 patients with first-episode chronic phase CML, who were randomly assigned in a 1:1 ratio to the Imatinib group and the Bosutinib group for treatment. The study's primary endpoints were major molecular response rate (MMR) and complete cytogenetic response rate at 12 months. Bosutinib performed better than imatinib in terms of both molecular response rate and survival rate. In this study, compared with imatinib treatment, treatment of first-episode CML patients with bosutinib can achieve better MMR and CcyR. It has better efficacy and shorter onset of action, and the expected survival rate seems to be better.