Bosutinib
BCR-ABL Positive Chronic Myelogenous Leukemia
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Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
Definite
Pharmaceutical Class
Kinase Inhibitor
Controlled Drug Substance
No
Bosutinib
Summary
Bosutinib is used to treat a type of cancer called chronic myeloid leukemia (CML) in adults and children. It is particularly useful for patients who are newly diagnosed or have not responded well to other treatments.
Bosutinib works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps to slow down or stop the spread of cancer cells in the body.
For adults with newly-diagnosed CML, the recommended dose is 400 mg once daily with food. For adults resistant or intolerant to prior therapy, the dose is 500 mg once daily with food. For children, the dose is based on body surface area, typically 300 mg/m to 400 mg/m once daily with food.
Common side effects of Bosutinib include diarrhea, nausea, abdominal pain, vomiting, and fatigue. More serious side effects can include liver toxicity, myelosuppression (a decrease in the production of blood cells), and fluid retention.
Bosutinib should not be used during pregnancy or breastfeeding. It is also contraindicated in patients with hypersensitivity to Bosutinib or its ingredients. Patients should be monitored for liver function, blood counts, and signs of fluid retention. Grapefruit products should be avoided as they can increase Bosutinib levels.
Indications and Purpose
How does Bosutinib work?
Bosutinib is a kinase inhibitor that blocks the action of an abnormal protein that signals cancer cells to multiply. By inhibiting this protein, Bosutinib helps to slow or stop the spread of cancer cells, making it effective in treating chronic myeloid leukemia.
Is Bosutinib effective?
Bosutinib is effective in treating chronic myeloid leukemia (CML), particularly in patients who are newly diagnosed or resistant to other treatments. Clinical trials have shown that Bosutinib can achieve major molecular responses and complete cytogenetic responses in a significant number of patients, demonstrating its efficacy in managing CML.
What is Bosutinib?
Bosutinib is used to treat chronic myeloid leukemia (CML) in adults and children. It works by inhibiting the activity of a protein that signals cancer cells to multiply, thereby slowing or stopping the spread of cancer cells. Bosutinib is particularly useful for patients who are newly diagnosed or have not responded to other treatments.
Directions for Use
For how long do I take Bosutinib?
Bosutinib is typically used until disease progression or intolerance to therapy. The duration can vary significantly depending on individual response and tolerance to the medication.
How do I take Bosutinib?
Take Bosutinib once daily with food, at the same time each day. Swallow the tablets whole without crushing or chewing. Avoid grapefruit and grapefruit juice, as they can increase the risk of side effects by raising Bosutinib levels in the body.
How long does it take for Bosutinib to start working?
Bosutinib may start to show effects within a few weeks, but the full benefit can take several months. The response time varies among individuals, and regular monitoring by a healthcare provider is essential to assess its effectiveness.
How should I store Bosutinib?
Store Bosutinib at room temperature, between 68°F to 77°F (20°C to 25°C). Keep it in its original container, tightly closed, and away from excess heat and moisture. Ensure it is out of reach of children and pets, and do not store it in the bathroom.
What is the usual dose of Bosutinib?
For adults with newly-diagnosed chronic phase CML, the recommended dose is 400 mg once daily with food. For adults with CML resistant or intolerant to prior therapy, the dose is 500 mg once daily with food. For pediatric patients, the dose is based on body surface area, typically 300 mg/m² to 400 mg/m² once daily with food.
Warnings and Precautions
Can Bosutinib be taken safely while breastfeeding?
Breastfeeding is not recommended during treatment with Bosutinib and for 2 weeks after the last dose, as it is unknown if the drug passes into breast milk and could harm a nursing infant.
Can Bosutinib be taken safely while pregnant?
Bosutinib can harm an unborn baby and should not be used during pregnancy. Women of childbearing potential should use effective contraception during treatment and for 2 weeks after the last dose. If you become pregnant while taking Bosutinib, inform your doctor immediately.
Can I take Bosutinib with other prescription drugs?
Bosutinib interacts with strong or moderate CYP3A inhibitors, which can increase its levels and risk of side effects. It also interacts with CYP3A inducers, which can decrease its effectiveness. Avoid using proton pump inhibitors, as they can reduce Bosutinib's absorption. Always inform your doctor of all medications you are taking.
Is Bosutinib safe for the elderly?
No specific dose adjustment is necessary for elderly patients, but caution is advised due to limited information. Elderly patients should be closely monitored for side effects, as they may be more sensitive to the effects of Bosutinib.
Who should avoid taking Bosutinib?
Important warnings for Bosutinib include the risk of liver toxicity, gastrointestinal issues, myelosuppression, and fluid retention. It is contraindicated in patients with hypersensitivity to Bosutinib or its ingredients. Patients should be monitored for liver function, blood counts, and signs of fluid retention. Avoid grapefruit products, as they can increase Bosutinib levels.
