Bosulif

Bosulif is a prescription medicine used to treat adults and children 1 year of age and older who have a certain type of leukemia called chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) who are newly diagnosed or who no longer benefit from or did not tolerate other treatment. Adults with accelerated phase (AP) or blast phase (BP) Ph+ CML who can no longer benefit from or did not tolerate other treatment.

Benefits

• Specifically targets the BCR-ABL1 fusion gene, the hallmark of Ph+ CML.
• Effective in patients who are newly diagnosed or resistant/intolerant to prior TKI therapies (e.g., imatinib, dasatinib, nilotinib).
• Helps reduce the number of abnormal white blood cells and achieve hematologic and cytogenetic remission.
• Taken orally, allowing for at-home treatment without the need for injections.
• Offers an alternative for patients with limited options due to resistance mutations or side effect profiles of other TKIs.
• Available in multiple strengths, making dose adjustments easier based on patient tolerance.

Dosage

• Newly diagnosed Ph+ CML (chronic phase): 400 mg once daily with food.
• Previously treated Ph+ CML (chronic, accelerated, or blast phase): 500 mg once daily with food.
• Dosage may be adjusted based on side effects, liver function, or drug interactions.
• Tablets should be taken with food to enhance absorption and reduce gastrointestinal side effects.

Warnings and Precautions

• Liver toxicity can occur; liver function tests should be monitored regularly.
• May cause diarrhea, which can lead to dehydration and electrolyte imbalance if not managed properly.
• Myelosuppression (low white blood cells, red blood cells, or platelets) may occur; regular blood count monitoring is essential.
• Risk of cardiac side effects, such as QT prolongation and arrhythmias. Use with caution in patients with heart disease or on QT-prolonging drugs.
• May cause renal impairment or elevate creatinine levels; monitor kidney function.
• Use with caution in patients with gastrointestinal disorders due to increased risk of GI bleeding or perforation.
• Not recommended during pregnancy or breastfeeding; may harm the fetus. Effective contraception is required during treatment and for at least 2 weeks after stopping.
• Should not be used in combination with strong CYP3A inhibitors or inducers (e.g., ketoconazole, rifampin).
• Use with caution in elderly patients due to increased risk of toxicity.

Usage Instructions

• Take exactly as prescribed, once daily with food.
• Swallow tablets whole with water; do not crush or chew.
• If a dose is missed by less than 12 hours, take it as soon as remembered. If more than 12 hours have passed, skip the dose. Do not double the next dose.
• Regular follow-up and blood tests are necessary to monitor treatment response and detect side effects early.
• Continue treatment unless advised otherwise by your healthcare provider, even if symptoms improve.

Storage Information

• Store at 20°C to 25°C (68°F to 77°F).
• Keep the medication in its original packaging to protect from light and moisture.
• Do not store in the bathroom or near heat sources.
• Keep out of reach of children.

Common Side Effects

• Mild to moderate effects: Diarrhea (very common), nausea or vomiting, Fatigue, abdominal pain, headache, skin rash or increased liver enzymes (ALT, AST).
• Serious (seek medical attention): Signs of liver damage (jaundice, dark urine, abdominal pain), persistent diarrhea or severe dehydration, signs of bone marrow suppression (unusual bruising or infections), irregular heartbeat or chest pain, swelling, shortness of breath, or rapid weight gain or vision changes or neurological symptoms (rare but serious).