Europe — EMA
Nilotinib Teva Uk Limited (Nilotinib Hydrochloride Dihydrate)
GNH USA supplies Nilotinib Teva Uk Limited (Nilotinib), a tyrosine kinase inhibitor for chronic myeloid leukemia. Request a quote for global supply.
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What is Nilotinib Hydrochloride Dihydrate?
Nilotinib, the active ingredient in Nilotinib Teva Uk Limited, is a tyrosine kinase inhibitor presented as an oral tablet for oral use. It is indicated for the treatment of chronic myeloid leukemia in adult patients, targeting the BCR‑ABL fusion protein that drives malignant cell proliferation.
GNH USA supplies Nilotinib Teva Uk Limited as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide. The company adheres to stringent quality standards and provides regulatory documentation to support import and distribution across multiple regions.
What is Nilotinib Hydrochloride Dihydrate used for?
Nilotinib is used to target BCR‑ABL–positive leukemias, primarily chronic myeloid leukemia.
- Chronic phase CML: reduces disease burden and prolongs survival in adult patients. - Accelerated phase CML: helps achieve hematologic and cytogenetic responses. - Blast phase CML: provides disease control when combined with other therapies.
What are the side effects of Nilotinib Hydrochloride Dihydrate?
Nilotinib may cause a range of adverse reactions, which are categorized by frequency and severity.
Common Side Effects: - Nausea: mild to moderate upset stomach. - Diarrhea: loose stools. - Fatigue: general tiredness. - Rash: skin irritation.
Serious or Rare Side Effects: - Cardiovascular events: including arterial occlusion, myocardial infarction. - Hepatotoxicity: elevated liver enzymes or hepatitis. - Pancreatitis: inflammation of the pancreas.
What precautions apply to Nilotinib Hydrochloride Dihydrate?
When prescribing nilotinib, clinicians should consider several precautionary measures to minimize risk.
- Cardiac assessment: evaluate history of arterial disease before initiating therapy. - Liver function monitoring: check hepatic enzymes regularly during treatment. - Electrolyte balance: monitor serum potassium and magnesium levels. - Drug interactions: avoid concomitant use with strong CYP3A4 inhibitors. - Pregnancy and lactation: contraindicated in pregnancy; advise effective contraception and avoid breastfeeding. - Store at ambient temperature: keep tablets below 25 °C in original packaging, protected from moisture and light.
What does Nilotinib Hydrochloride Dihydrate interact with?
Nilotinib interacts with several medicines that can alter its plasma concentration or increase toxicity.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise nilotinib levels, risking severe adverse events. - Proton pump inhibitors (e.g., omeprazole) taken concomitantly: reduce absorption and efficacy. - Antacids containing aluminum or magnesium: decrease oral bioavailability.
Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampin, carbamazepine): may lower nilotinib exposure, reducing effectiveness. - Anticoagulants (e.g., warfarin): may require dose adjustment and INR monitoring. - Statins metabolized by CYP3A4 (e.g., simvastatin): increased risk of myopathy, consider alternative lipid‑lowering agents.



