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This document outlines crucial safety information regarding the use of Bosulif (bosutinib). It is essential to understand these warnings to ensure safe usage. Please discuss any concerns with your healthcare provider.

• Low Blood Cell Counts: Bosulif may reduce your red and white blood cells and platelets, potentially causing fatigue, increased risk of infection, and bleeding or bruising. Regular blood tests will be conducted to monitor these levels. Notify your healthcare provider immediately if you experience fevers, chills, or persistent bleeding and bruising.

• Liver Damage: The medication can lead to liver injury, typically within the first three months of use but potentially at any time. Routine liver function tests will be performed. Be alert for symptoms such as fatigue, loss of appetite, nausea, vomiting, dark urine, right-side abdominal pain, or yellowing of the skin or eyes, and report these to your provider.

• Kidney Damage: Bosulif may impair kidney function, especially if pre-existing kidney issues are present. Lab tests will be used to monitor kidney health. Report any changes in urination frequency or blood in urine to your healthcare provider.

• Heart Problems: This medication can cause new or worsening heart conditions, including heart attacks or heart failure. Risk factors include older age, pre-existing heart conditions, diabetes, obesity, and high blood pressure. Symptoms may include chest pain or discomfort, and they require immediate medical attention.

• Fluid Retention: Bosulif can cause swelling in limbs or fluid accumulation around the heart or lungs, presenting as shortness of breath, weight gain, leg or ankle swelling, fatigue, and poor appetite. Notify your provider if these occur, as dosage adjustments or discontinuation might be necessary.

• Pregnancy Risks: Bosulif has shown potential harm to an unborn child and increased miscarriage risk. Women who can conceive should have a pregnancy test prior to treatment and use effective contraception during treatment and for at least two weeks following the last dose. Inform your provider immediately if pregnancy occurs during this timeframe.

There are no specific contraindications listed for Bosulif. Always follow your healthcare provider's guidance and report any adverse reactions or concerns promptly.

When taking this medication, you may experience common side effects such as nausea, diarrhea, stomach or abdominal pain, vomiting, headache, cough, joint pain, fatigue, and respiratory tract infections. While these effects are generally mild, it's important to consult your healthcare provider if they persist or worsen. Diarrhea is particularly common and can be managed by staying hydrated and, if necessary, using anti-diarrhea medication.

Be aware that this medication can also lead to low blood cell counts, which may result in symptoms like unusual tiredness, pale skin, or increased susceptibility to infections. Additionally, high creatinine levels, liver enzyme alterations, and mild rashes may occur. Although these side effects are often manageable, ongoing monitoring by your healthcare provider is advisable.

In some cases, more serious side effects may arise and necessitate prompt medical attention. These include severe stomach pain, yellowing of the skin or eyes, dark urine, significant swelling, sudden weight gain, or signs of kidney issues such as changes in urination. Allergic reactions, though rare, can be serious and may involve rash, itching or swelling, severe dizziness, and difficulty breathing. If you experience any of these symptoms, seek medical help immediately.

Lastly, there are serious side effects that are less common but critical to recognize, such as infections with high fevers or chills, serious bleeding or bruising, and potential liver damage. Heart-related issues like chest pain or shortness of breath also require urgent medical care. Always communicate with your healthcare provider about any concerning symptoms to ensure appropriate management and care.

Bosutinib, marketed as Bosulif, can interact with various medications and supplements. It is vital to inform your doctor and pharmacist about all the medicines and supplements you are taking, including prescription, over-the-counter medications, vitamins, and herbal products.

Certain medications that reduce stomach acid, such as antacids, H2 blockers (like Famotidine and ranitidine), and proton pump inhibitors (such as Omeprazole), may interact with bosutinib. Additionally, other drugs can influence how bosutinib is processed in the body, potentially altering its effectiveness. These include azole antifungals (e.g., Ketoconazole, Itraconazole), macrolide antibiotics (e.g., Clarithromycin), Nefazodone, HIV protease inhibitors (e.g., nelfinavir), rifamycins (e.g., Rifabutin), Ritonavir, St. John's wort, and medications used for seizures (e.g., Carbamazepine, Phenytoin), as well as telithromycin.

Furthermore, using bosutinib with live vaccines such as those for measles, mumps, rubella, rotavirus, varicella, and zoster is generally not recommended due to potential interactions. In some cases, the use of bosutinib alongside other medications, such as Aprepitant, Atazanavir, carbamazepine, clarithromycin, cobicistat, conivaptan, diltiazem, Erythromycin, Fluconazole, Imatinib, itraconazole, ketoconazole, nefazodone, phenytoin, Rifampin, ritonavir, St. John's wort, and several others, may necessitate dose adjustments or special monitoring by your healthcare provider. Always consult your healthcare professional before starting or stopping any medication.