One thing patients must know when taking the drug: What are the precautions for bosutinib?

In clinical studies of Bosutinib (Bosutinib), warnings and precautions such as gastrointestinal toxicity, bone marrow suppression, hepatotoxicity, cardiovascular toxicity, fluid retention, nephrotoxicity , embryo-fetal toxicity have emerged. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity.

1. Gastrointestinal toxicity: Diarrhea, nausea, vomiting and abdominal pain may occur during treatment with bosutinib. Monitor and manage patients using standards of care, including antidiarrheal medications, antiemetics, and fluid replacement.

2. Myelosuppression: Thrombocytopenia, anemia and neutropenia may occur during treatment with bosutinib. Complete blood counts should be performed weekly during the first month of treatment and monthly thereafter, or as clinically indicated.

3. Hepatotoxicity: may lead to an increase in serum aminotransferases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]). During the first 3 months of bosutinib treatment, perform liver enzyme testing monthly as clinically indicated. Liver enzymes should be monitored more frequently in patients with elevated transaminases.

4. Cardiovascular toxicity: Can lead to cardiovascular toxicity, including heart failure, left ventricular dysfunction and cardiac ischemic events;more common in patients with risk factors for coronary artery disease, including a history of diabetes, body mass index greater than30, hypertension and vascular disease. Monitor patients for signs and symptoms consistent with heart failure and cardiac ischemia and treat as clinically indicated.

5. Fluid retention: Fluid retention may occur, which may manifest as pericardial effusion, pleural effusion, pulmonary edema and/or peripheral edema. Monitor and manage patients using standards of care.

6. Nephrotoxicity: In patients treated with bosutinib, the estimated glomerular filtration rate (eGFR) decreased during treatment. In these studies, patients received treatment for a median duration of approximately 24 months. Monitor renal function at baseline and during treatment with bosutinib, with special attention in patients with preexisting renal impairment or risk factors for renal dysfunction. Consider dose adjustments in patients who develop renal impairment at baseline and on treatment.

7. Embryo-Fetal Toxicity: According to the results of animal studies and its mechanism of action, bosutinib taken by pregnant women can cause harm to the fetus. There are no data available in pregnant women to inform drug-related risks. In animal reproduction studies in rats and rabbits, oral administration of bosutinib during organogenesis resulted in adverse developmental outcomes, including structural abnormalities, embryo-fetal mortality, and growth changes at maternal exposures (AUC) as low as 1.2 times the human exposure of 500 mg/day. Inform pregnant women of potential risks to the fetus. Advise females of childbearing potential to use effective contraception during treatment and for at least 2 weeks after the last dose.

The original drug of bosutinib is not marketed in the country. Currently, bosutinib is sold overseas in both original and generic versions. The Turkish version of the original drug costs about 2,000 to 3,000 yuan, and the European version of the original drug costs about 30,000 yuan. In addition, there are cheaper generic drugs, which cost more than one thousand yuan, and the ingredients of the original drugs and generic drugs are basically the same.