Nilotinib, sold under the brand name Tasigna, is a tyrosine kinase inhibitor (TKI) used to treat Philadelphia chromosome-positive chronic myelogenous leukemia (CML). It is effective in both newly diagnosed cases and in patients whose CML has not responded to imatinib. Nilotinib works by selectively inhibiting BCR-ABL, the protein responsible for uncontrolled cell growth in CML.
Parent: Nilotinib
Parent: Nilotinib Hydrochloride Monohydrate / Nilotinib
Parent: Nilotinib
Parent: Nilotinib
Parent: Nilotinib
Parent: Nilotinib
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Parent: Nilotinib
Parent: Nilotinib
During the manufacturing and storage of nilotinib, various impurities can form, affecting the drug’s safety, potency, and stability.
Related Substances
These are structurally related compounds that may be present due to synthetic byproducts or degradation. Strict controls ensure they remain within acceptable limits.
Degradation Products
Nilotinib is susceptible to degradation when exposed to heat, light, and moisture, leading to the formation of unwanted byproducts that may reduce efficacy.
Residual Solvents
Trace amounts of solvents used in synthesis may remain in the final formulation. Regulatory agencies set strict guidelines to minimize potential toxicity risks.
Analytical Techniques for Impurity Detection
To ensure nilotinib meets high purity standards, analytical techniques such as High-Performance Liquid Chromatography (HPLC) and Mass Spectrometry (MS) are used for detection and quantification of impurities.
Avoid consuming grapefruit and grapefruit juice, as they can increase nilotinib levels in the blood, leading to a higher risk of side effects.
Nilotinib should be taken on an empty stomach, at least 2 hours before or 1 hour after a meal, as food can increase drug absorption and raise the risk of toxicity.
Common adverse events include QT prolongation (irregular heart rhythm), nausea, fatigue, headache, rash, and muscle cramps. Patients should undergo regular heart monitoring due to the risk of serious cardiac effects.
Yes, nilotinib can increase blood pressure, so regular blood pressure monitoring is recommended. Patients with pre-existing hypertension should be closely monitored while taking the medication.
