GNH USA

Europe — EMA

Nilotinib Teva (Nilotinib Hydrochloride Dihydrate)

GNH USA supplies Nilotinib Teva (Nilotinib), a tyrosine kinase inhibitor for chronic myeloid leukemia treatment. Request a quote for reliable global supply.

Nilotinib Hydrochloride Dihydrate

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What is Nilotinib Hydrochloride Dihydrate?

Nilotinib, the active ingredient in Nilotinib Teva, 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 leukemic cell proliferation.

GNH USA supplies Nilotinib Teva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide. The product complies with EU marketing authorisation standards and is distributed under strict quality assurance protocols globally.

What is Nilotinib Hydrochloride Dihydrate used for?

Nilotinib is a tyrosine kinase inhibitor used in the management of Philadelphia chromosome‑positive chronic myeloid leukemia.

- Chronic myeloid leukemia (chronic phase): improves hematologic and cytogenetic response in adult patients. - Chronic myeloid leukemia (accelerated phase): achieves disease control and prolongs survival. - Chronic myeloid leukemia (blast phase): provides therapeutic benefit when combined with other agents.

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, often transient. - Rash: skin erythema or pruritus. - Fatigue: general tiredness. - Headache: mild cranial discomfort. - Myalgia: muscle aches.

Serious or Rare Side Effects: - QT interval prolongation: may lead to cardiac arrhythmias. - Pancreatitis: inflammation of the pancreas with abdominal pain. - Severe hepatic injury: marked elevation of liver enzymes or hepatitis. - Severe neutropenia: critically low neutrophil count increasing infection risk. - Cardiovascular events: ischemic heart disease or peripheral arterial disease.

What precautions apply to Nilotinib Hydrochloride Dihydrate?

Before initiating Nilotinib therapy, clinicians should consider several safety measures to minimise risk. - Cardiac monitoring: assess baseline ECG and correct electrolyte abnormalities. - Blood count surveillance: perform regular CBC to detect neutropenia or thrombocytopenia. - Liver function testing: monitor ALT, AST, and bilirubin levels periodically. - Drug interaction review: avoid concomitant strong CYP3A4 inhibitors and QT‑prolonging agents. - QT prolongation risk: use caution in patients with known prolonged QT interval or cardiac disease. - Store at room temperature: keep in original packaging, protect from moisture and direct sunlight.

What does Nilotinib Hydrochloride Dihydrate interact with?

Nilotinib interacts with several medicines, requiring careful management to avoid reduced efficacy or increased toxicity.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise nilotinib plasma levels. - QT‑prolonging drugs (e.g., amiodarone, sotalol): increase risk of cardiac arrhythmias. - Antacids containing aluminum or magnesium: reduce nilotinib absorption.

Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampin, St. John’s wort): may lower drug exposure. - Anticoagulants (e.g., warfarin): may require dose adjustment. - Statins metabolised by CYP3A4 (e.g., simvastatin): monitor for muscle toxicity.

Frequently asked questions

What is Nilotinib Teva used for?+
Nilotinib Teva is a prescription oral medication indicated for the treatment of adult patients with chronic myeloid leukemia (CML). It targets the BCR‑ABL fusion protein that drives the disease, helping to control disease progression and improve hematologic and cytogenetic outcomes.
How does nilotinib work?+
Nilotinib works by selectively binding to the ATP‑binding site of the BCR‑ABL tyrosine kinase, blocking its activity. This inhibition stops downstream signaling that promotes leukemic cell growth and survival, leading to reduced proliferation and increased apoptosis of malignant cells.
What determines the dose of Nilotinib Teva?+
The dose of Nilotinib Teva is set by the prescribing physician based on clinical guidelines, disease phase, patient weight, liver function, and potential drug interactions. Dosage adjustments may be required for specific patient characteristics, but the exact regimen is individualized and not standardized in public information.
Is Nilotinib safe during pregnancy or breastfeeding?+
Safety data for nilotinib in pregnancy and lactation are limited, and the drug is generally not recommended for use in pregnant or nursing women. Women of childbearing potential should use effective contraception, and any potential exposure should be discussed with a healthcare professional.
How do I order Nilotinib Teva from GNH USA?+
To order Nilotinib Teva, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements), and necessary import documentation.
How does Nilotinib compare with the main alternative drug?+
Nilotinib and imatinib are both BCR‑ABL tyrosine kinase inhibitors used for CML, but nilotinib is a second‑generation agent with higher potency and activity against many imatinib‑resistant mutations. Clinical studies suggest faster and deeper molecular responses with nilotinib, though safety profiles differ, requiring individualized selection by the treating physician.
How should Nilotinib be stored and handled?+
Nilotinib tablets should be stored at room temperature, below 25 °C, in their original blister pack to protect from moisture and light. Keep the medication out of reach of children and avoid storing in humid or excessively hot environments to maintain product stability.
How is Nilotinib administered?+
Nilotinib is taken orally as a whole tablet, usually with a low‑fat meal or as directed by the prescriber. The tablet should be swallowed with water and not chewed, crushed, or split unless specifically instructed. Consistent dosing times help maintain stable drug levels.
What are the most serious risks to watch for while taking Nilotinib?+
The most serious risks include QT interval prolongation, which can lead to life‑threatening arrhythmias, severe hepatic injury, pancreatitis, and marked reductions in blood cell counts such as neutropenia or thrombocytopenia. Patients should be monitored regularly for cardiac, liver, and hematologic parameters.
Who should not use Nilotinib?+
Nilotinib should not be used by individuals with known hypersensitivity to the drug or its excipients, patients with uncontrolled QT prolongation, or those taking concurrent medications that significantly increase the risk of cardiac arrhythmias. Caution is also advised for patients with severe hepatic impairment or active infections.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.
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Product details

Drug
Nilotinib Hydrochloride Dihydrate
Route
Oral Use
Manufacturer
Teva Nederland B.V.
Origin
EU

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