Product image of Nilotinib Stada 200 Mg Cápsulas (Nilotinib) supplied by GNH India

Nilotinib Stada 200 Mg Cápsulas

Active Ingredient:
Nilotinib
Origin:
EU

Nilotinib Stada 200 Mg Cápsulas (Nilotinib)

Nilotinib, the active ingredient in Nilotinib Stada 200 Mg Cápsulas, is a tyrosine kinase inhibitor presented as a 200 mg capsule for oral use. It treats chronic myeloid leukemia and Philadelphia chromosome‑positive acute lymphoblastic leukemia in adult patients. It is indicated for patients with the BCR‑ABL fusion gene driving disease progression.

GNH India supplies Nilotinib Stada 200 Mg Cápsulas as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide. The product conforms to European Union quality standards and is manufactured under GMP conditions.

Manufacturer / TM Owner

Stada Lda.

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Indications & Clinical Uses

Nilotinib is a targeted therapy that inhibits the BCR‑ABL tyrosine kinase pathway in certain leukemias.

  • Chronic myeloid leukemia (CML): Reduces disease progression and improves survival in patients with Philadelphia chromosome‑positive CML.
  • Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL): Contributes to remission induction and disease control in adult patients with Ph+ ALL.
  • CML after prior therapy: Provides an alternative option for patients who are resistant or intolerant to first‑line tyrosine kinase inhibitors.

How It Works

  • Nilotinib selectively binds to the ATP‑binding site of the BCR‑ABL fusion protein, inhibiting its tyrosine kinase activity. By blocking downstream signaling, it prevents uncontrolled proliferation of malignant cells. The drug also inhibits related kinases such as KIT and PDGFR, contributing to its antineoplastic effect in BCR‑ABL‑positive leukemias.

Side Effects

Common Side Effects

  • Elevated liver enzymes
  • Nausea
  • Diarrhea
  • Fatigue

Serious or Rare Side Effects

  • QT interval prolongation
  • Pancreatitis
  • Severe hepatic toxicity

Precautions & Warnings

Nilotinib requires careful monitoring and specific precautions:

  • Cardiac monitoring: Perform baseline ECG and periodic assessments due to risk of QT prolongation.
  • Hepatic function: Monitor liver enzymes regularly throughout therapy.
  • Electrolyte balance: Correct hypokalemia and hypomagnesemia before initiating treatment.
  • Drug interactions: Avoid concomitant use with strong CYP3A4 inhibitors.
  • Pregnancy and lactation: Use only if potential benefits justify the risk; safety not established.
  • Store at ambient temperature: Keep below 25 °C, in the original container, and protect from moisture.

Avoid Interactions

Nilotinib has several notable drug interactions:

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): can markedly increase nilotinib exposure.
  • QT‑prolonging agents (e.g., amiodarone, sotalol): may exacerbate cardiac risk.
  • Antacids containing aluminum or magnesium: reduce absorption if taken simultaneously.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., fluconazole): may increase levels, requiring dose adjustment.
  • Moderate CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce efficacy.
  • Warfarin: may require closer INR monitoring.

Frequently Asked Questions

Nilotinib Stada 200 Mg Cápsulas is indicated for adult patients with chronic myeloid leukemia (CML) that is Philadelphia chromosome‑positive, for Philadelphia chromosome‑positive acute lymphoblastic leukemia (Ph+ ALL), and for CML after prior therapy when resistance or intolerance to first‑line tyrosine kinase inhibitors occurs.

Nilotinib blocks the ATP‑binding site of the BCR‑ABL fusion protein, halting its tyrosine kinase activity. This inhibition stops downstream signaling that drives uncontrolled cell growth, leading to reduced proliferation of malignant leukemic cells and promoting apoptosis.

The exact dose and schedule of nilotinib are determined by the prescribing physician based on the patient’s specific diagnosis, disease stage, prior therapies, renal and hepatic function, and potential drug interactions. Dosing is individualized and should follow the clinician’s written order.

Safety of nilotinib in pregnancy and lactation has not been established. It should only be used if the potential therapeutic benefit justifies the potential risk to the fetus or infant, and the decision must be made by the treating physician in consultation with the patient.

Enquiries are submitted via the product page on gnhindia.com, where you specify the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any required import documentation.

Nilotinib is a second‑generation BCR‑ABL inhibitor with higher potency and selectivity than first‑generation agents like imatinib. It is often used when patients are resistant or intolerant to imatinib, offering deeper molecular responses but requiring careful monitoring for cardiac and metabolic adverse effects.

Store Nilotinib Stada 200 Mg Cápsulas at ambient temperature, preferably below 25 °C. Keep the capsules in the original blister pack or container, protect them from moisture and direct sunlight, and ensure they are out of reach of children.

Nilotinib capsules are taken orally, usually with a low‑fat meal to improve absorption. Patients should swallow the capsule whole with water, avoid taking antacids or supplements containing aluminum or magnesium within two hours, and follow the dosing schedule prescribed by their clinician.

The most serious risks associated with nilotinib include QT interval prolongation, which can lead to serious cardiac arrhythmias, severe hepatic toxicity, and pancreatitis. Patients should be monitored regularly with ECGs, liver function tests, and pancreatic enzyme assessments.

Nilotinib should not be used in patients with known hypersensitivity to the drug, those with a history of prolonged QT interval, severe hepatic impairment, or uncontrolled electrolyte abnormalities. Caution is also advised for patients taking other QT‑prolonging medications.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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