Nilotinib Teva (Nilotinib Hydrochloride Dihydrate)

Nilotinib is a targeted therapy that acts on the BCR‑ABL tyrosine‑kinase pathway in chronic myeloid leukemia.

• Chronic myeloid leukemia (CML) in chronic phase: provides disease control and prolongs survival.
• CML in accelerated phase: helps achieve hematologic and cytogenetic responses when disease progresses.
• CML after imatinib resistance or intolerance: offers an alternative mechanism of action to overcome treatment failure.

• Nilotinib selectively inhibits the BCR‑ABL tyrosine kinase, a fusion protein that drives uncontrolled proliferation of leukemic cells. By binding to the ATP‑binding site of BCR‑ABL, it blocks downstream signaling pathways such as RAS/RAF/MEK/ERK and PI3K/AKT, leading to reduced cell growth and induction of apoptosis in malignant clones.

Nilotinib may cause a range of adverse reactions, some of which are common and others that are serious but less frequent.

Common Side Effects

• Nausea: mild to moderate upset stomach.
• Diarrhea: loose stools that may require fluid replacement.
• Rash: skin irritation or erythema.
• Elevated liver enzymes: mild increases in ALT/AST.
• Fatigue: generalized tiredness.
• Myalgia: muscle aches.

Serious or Rare Side Effects

• Cardiovascular events: myocardial infarction, angina, or arterial occlusion.
• QT interval prolongation: risk of serious arrhythmias.
• Severe hepatotoxicity: marked elevation of liver enzymes or hepatitis.
• Pancreatitis: inflammation of the pancreas.
• Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.
• Hyperglycemia: significant rise in blood glucose levels.

Patients should be monitored for specific safety concerns before and during therapy.

• Cardiac assessment: evaluate history of cardiovascular disease before initiating treatment.
• Electrolyte monitoring: correct hypokalemia, hypomagnesemia, and hypocalcemia to reduce QT risk.
• Liver function tests: perform baseline and periodic ALT/AST measurements.
• Blood glucose: monitor fasting glucose in patients with diabetes or risk factors.
• Pregnancy and lactation: avoid use; discuss contraception with prescriber.
• Store at ambient temperature: keep below 25 °C, retain in original container, protect from moisture and light.

Nilotinib interacts with several drug classes that can alter its exposure or increase toxicity.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise nilotinib plasma levels and heighten adverse events.
• Proton pump inhibitors (e.g., omeprazole): reduce nilotinib absorption, compromising efficacy.
• St. John’s wort: induces CYP3A4, lowering drug concentrations.

Moderate Interactions (Monitor Closely)

• Antacids containing aluminum or magnesium: may affect absorption; separate dosing by at least 2 hours.
• Anticoagulants (e.g., warfarin): monitor INR as nilotinib can affect clotting parameters.
• Statins metabolized by CYP3A4 (e.g., simvastatin): consider dose adjustment or alternative lipid‑lowering agents.