Nilotinib Teva (Nilotinib Hydrochloride Dihydrate)

Nilotinib Hydrochloride Dihydrate, the active ingredient in Nilotinib Teva, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It treats Philadelphia chromosome‑positive chronic myeloid leukemia (CML) in the chronic phase and is used when disease control is needed after prior therapy.

GNH USA supplies Nilotinib Teva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

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 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.