GNH USA

Europe — EMA

Krufton

GNH USA supplies Krufton (Nilotinib), a tyrosine kinase inhibitor indicated for chronic myeloid leukemia in adult patients. Request a quote for global supply.

Nilotinib Hydrochloride Dihydrate

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What is Nilotinib Hydrochloride Dihydrate?

Nilotinib Hydrochloride Dihydrate, the active ingredient in Krufton, is a tyrosine kinase inhibitor presented as a tablet for oral use. It selectively inhibits BCR‑ABL kinase activity to treat chronic myeloid leukemia in adult patients.

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

What is Nilotinib Hydrochloride Dihydrate used for?

Krufton is a targeted therapy that acts on the BCR‑ABL tyrosine‑kinase pathway in chronic myeloid leukemia. - Chronic phase CML: improves hematologic and cytogenetic response in Philadelphia chromosome‑positive patients. - Accelerated phase CML: helps achieve remission when disease progresses. - Imatinib‑resistant CML: provides an alternative oral option for patients who have failed prior tyrosine‑kinase inhibitor therapy.

What are the side effects of Nilotinib Hydrochloride Dihydrate?

Common Side Effects: - Nausea: mild to moderate gastrointestinal upset. - Rash: skin erythema or pruritus. - Fatigue: decreased energy levels. - Diarrhea: loose stools, often transient.

Serious or Rare Side Effects: - QT interval prolongation: may predispose to cardiac arrhythmias. - Pancreatitis: abdominal pain with elevated enzymes. - Severe liver injury: marked transaminase elevation or hepatitis. - Neutropenia: significant reduction in white blood cells. - Stevens‑Johnson syndrome: severe skin and mucosal reaction.

What precautions apply to Nilotinib Hydrochloride Dihydrate?

Patients should be monitored for cardiac, hepatic, and hematologic safety. - Cardiac monitoring: obtain baseline ECG and repeat periodically to assess QT interval. - Hepatic function: check liver enzymes before initiation and during therapy. - Electrolyte balance: correct hypokalemia and hypomagnesemia to reduce QT risk. - Drug interactions: avoid strong CYP3A4 inhibitors and concomitant QT‑prolonging agents. - Pregnancy and lactation: contraindicated unless benefits outweigh potential risks. - Store at ambient temperature: keep below 25°C in the original container, protect from moisture and light.

What does Nilotinib Hydrochloride Dihydrate interact with?

Nilotinib may interact with several concomitant medicines. Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): increase nilotinib exposure. - QT‑prolonging drugs (e.g., amiodarone, sotalol): additive risk of arrhythmia. - Antacids containing aluminum or magnesium: reduce nilotinib absorption. Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin): may modestly raise levels. - CYP3A4 inducers (e.g., rifampin, carbamazepine): may lower nilotinib concentrations. - Warfarin: monitor INR as nilotinib can affect anticoagulant control.

Frequently asked questions

What is Krufton used for?+
Krufton contains nilotinib, a targeted oral therapy approved for the treatment of Philadelphia chromosome‑positive chronic myeloid leukemia in adult patients, including those in chronic, accelerated, or blast phases and those who have shown resistance to prior tyrosine‑kinase inhibitors.
How does nilotinib work in the body?+
Nilotinib selectively binds to the ATP‑binding pocket of the BCR‑ABL fusion protein, inhibiting its tyrosine‑kinase activity. This blocks downstream signaling pathways that drive uncontrolled proliferation of leukemic cells, thereby reducing disease activity and allowing normal blood cell production.
What is the usual dose of Krufton?+
The specific dose of Krufton is determined by the prescribing physician based on the patient’s clinical condition, disease phase, and individual tolerance. Dosage adjustments may be required according to response and safety monitoring.
Is Krufton safe to use during pregnancy or breastfeeding?+
Nilotinib is classified as contraindicated in pregnancy and breastfeeding unless the potential benefit justifies the risk. Women of childbearing potential should use effective contraception, and nursing mothers should discuss alternatives with their healthcare provider.
How do I order Krufton from GNH USA?+
To place an order, submit an enquiry on the product page at gnh-usa.com specifying the required quantity. GNH USA works with 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 Krufton compare with other CML treatments?+
Krufton (nilotinib) is a second‑generation tyrosine‑kinase inhibitor offering higher potency against BCR‑ABL than first‑generation agents like imatinib. It is often chosen for patients who need a deeper molecular response or who have developed resistance to earlier therapies, while maintaining an oral dosing schedule.
What are the recommended storage conditions for Krufton?+
Krufton tablets should be stored at ambient temperature, below 25 °C, in the original packaging. Protect the product from moisture, direct sunlight, and excessive heat to maintain stability and potency.
How is Krufton administered?+
Krufton is taken orally, usually with a low‑fat meal to improve absorption. The tablets should be swallowed whole with water and not crushed or chewed. Patients should follow the dosing schedule prescribed by their clinician.
What are the most serious risks associated with Krufton?+
The most serious risks include QT interval prolongation leading to potential cardiac arrhythmias, severe liver injury, pancreatitis, and significant reductions in blood cell counts such as neutropenia or thrombocytopenia. Regular monitoring of cardiac, hepatic, and hematologic parameters is essential.
Who should not use Krufton?+
Krufton should be avoided in patients with a known hypersensitivity to nilotinib or any component of the formulation, those with uncontrolled cardiac arrhythmias or prolonged QT interval, and individuals taking strong CYP3A4 inhibitors or other QT‑prolonging drugs without appropriate medical supervision.
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.

Product details

Drug
Nilotinib Hydrochloride Dihydrate
Route
Oral Use
Manufacturer
Egis Pharmaceuticals Plc
Origin
EU

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