About

Nilotinib is a potent and selective tyrosine kinase inhibitor (TKI) primarily used in the treatment of chronic myeloid leukemia (CML). It specifically targets the Bcr-Abl fusion protein, which is the hallmark of CML, by binding to its ATP-binding site and inhibiting its kinase activity. This action prevents the proliferation of Bcr-Abl positive cells and induces apoptosis, effectively controlling the disease progression.

Nilotinib is administered orally and is extensively metabolized in the liver, primarily by CYP3A4. It is highly effective in achieving deep molecular responses in CML patients, including those resistant or intolerant to prior imatinib therapy. Due to its potential for QT prolongation and other cardiovascular events, careful monitoring of cardiac function and electrolyte levels is crucial during treatment.

Uses

Treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
Treatment of Ph+ CML in chronic or accelerated phase in adults resistant or intolerant to prior therapy.
Management of CML patients who have failed other TKI treatments.
Used in specific cases of CML with certain genetic mutations.

Directions For Use

Take orally, usually twice daily, on an empty stomach (at least 2 hours after and 1 hour before food). Swallow capsules whole.

Benefits

Highly effective in treating CML.
Achieves deep molecular responses.
Option for imatinib-resistant or intolerant patients.
Improves progression-free and overall survival.
Targets the specific Bcr-Abl protein.
Available as an oral medication.

Side Effects

Myelosuppression (thrombocytopenia, neutropenia, anemia)
Rash
Nausea
Fatigue
Headache
Diarrhea
Elevated lipase and amylase
QT prolongation
Fluid retention
Liver enzyme elevations
Muscle pain
Cardiovascular events (arterial occlusive events)

Safety Measures

Alcohol - Avoid or limit alcohol, as it may increase the risk of liver toxicity and other side effects.
Pregnancy - Contraindicated in pregnancy due to potential for fetal harm. Use effective contraception.
Breastfeeding - Not recommended during breastfeeding due to potential excretion into breast milk and harm to the infant.
Liver - Use with caution in patients with hepatic impairment; dose adjustments are necessary due to extensive liver metabolism.
Kidney - Generally safe in renal impairment, but caution is advised. No specific dose adjustment usually required.
Lung - Monitor for pulmonary adverse events, including interstitial lung disease, though less common than with some other TKIs.

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