Nilotinib Stada 150 Mg Cápsulas (Nilotinib)

Nilotinib is a targeted therapy that inhibits the BCR‑ABL pathway in chronic myeloid leukemia.

• Chronic phase CML: reduces leukemic cell proliferation and helps achieve cytogenetic and molecular responses.
• Accelerated phase CML: provides disease control when resistance to first‑line therapy occurs.
• Blast phase CML: offers a therapeutic option for patients with advanced disease who have the Philadelphia chromosome.

• Nilotinib selectively binds to the ATP‑binding site of the BCR‑ABL tyrosine kinase, preventing its activation. This blocks downstream signaling cascades that drive uncontrolled proliferation and survival of leukemic cells, leading to apoptosis and reduced disease burden in Philadelphia chromosome‑positive chronic myeloid leukemia.

Common Side Effects

• Nausea: mild to moderate gastrointestinal upset.
• Diarrhea: loose stools often occurring early in treatment.
• Rash: skin erythema or pruritus.
• Headache: transient and usually low‑grade.
• Fatigue: general tiredness without specific cause.
• Myalgia: muscle aches or stiffness.

Serious or Rare Side Effects

• QT interval prolongation: may lead to cardiac arrhythmias.
• Pancreatitis: abdominal pain with elevated enzymes.
• Severe hepatic injury: jaundice, elevated transaminases.
• Grade 3‑4 neutropenia: increased infection risk.
• Thrombocytopenia: bleeding tendency.
• Cardiovascular events: myocardial ischemia or stroke.

Patients should be monitored for cardiac, hepatic and hematologic safety.

• Cardiac monitoring: obtain baseline ECG and periodically assess QT interval.
• Hepatic function: check liver enzymes before initiation and during therapy.
• Hematologic surveillance: perform regular complete blood counts.
• Avoid strong CYP3A4 inhibitors: dose may increase and raise toxicity risk.
• Adjust in hepatic impairment: consider dose reduction if moderate liver dysfunction is present.
• Store at ambient temperature: keep in original container, protect from moisture and direct sunlight.

Nilotinib has several clinically relevant drug interactions that require attention.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise nilotinib plasma concentrations.
• QT‑prolonging agents (e.g., amiodarone, sotalol): increase risk of cardiac arrhythmias.
• Antacids containing aluminum or magnesium: reduce nilotinib absorption if taken simultaneously.

Moderate Interactions (Monitor Closely)

• CYP3A4 inducers (e.g., rifampin, St. John’s wort): may lower nilotinib exposure and reduce efficacy.
• Proton pump inhibitors: modestly affect gastric pH and could alter absorption.
• Warfarin: may enhance anticoagulant effect; monitor INR closely.