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Brand Name :
Danziten
(United States) [Available] ,Tasigna
(United States) [Available]Synonyms :
Nilotinib, Nilotinibum
Class :
Antineoplastics and Tyrosine Kinase Inhibitor
Brand Name :
Danziten
(United States) [Available] ,Tasigna
(United States) [Available]Synonyms :
Nilotinib, Nilotinibum
Class :
Antineoplastics and Tyrosine Kinase Inhibitor
Dosage Forms & Strengths  Â
capsule  Â
150mg  Â
200mg  Â
Chronic Myelogenous Leukemia (CML)
It is used for the treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase Ph+ CML-CP:
300
mg
Orally
twice a day
Dosage Forms & Strengths  Â
capsule  Â
50mg  Â
150mg  Â
200mg  Â
Chronic Myelogenous Leukemia (CML)
For > 1year children
230 mg per m2 orally 2x a day
and round to the nearest 50 mg dose
the Maximum dose given is 400 mg per dose
Dosing based on body surface area (BSA):
if BSA 0.32 m2: 50 mg orally 2x a day
if BSA 0.33-0.54 m2: 100 mg orally 2x a day
if BSA 0.55-0.76 m2: 150 mg orally 2x a day
if BSA 0.77-0.97 m2: 200 mg orally 2x a day
if BSA 0.98-1.19 m2: 250 mg orally 2x a day
if BSA 1.2-1.41 m2: 300 mg orally 2x a day
if BSA 1.42-1.63 m2: 350 mg orally 2x a day
if BSA 1.64 m2: 400 mg orally 2x a day
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval and toxicity of nilotinib  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval and toxicity of nilotinib  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval serious 
when both drugs are combined, there may be an increased effect of nilotinib by affecting hepatic or intestinal enzyme cyp3a4 metabolism  
when both drugs are combined, there may be an increased level of afatinib by p-glycoprotein (mdr1) efflux transporter  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  Â
when both drugs are combined, there may be a decreased effect of nilotinib by affecting hepatic or intestinal enzyme cyp3a4 metabolism  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increased level of bosutinib by p-glycoprotein (mdr1) efflux transporter  
when both drugs are combined, there may be a decreased effect of nilotinib by affecting hepatic or intestinal enzyme cyp3a4 metabolism  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increased effect of nilotinib by affecting hepatic or intestinal enzyme cyp3a4 metabolism  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increased effect of nilotinib by affecting hepatic or intestinal enzyme cyp3a4 metabolism  
when both drugs are combined, there may be an increased effect of nilotinib by affecting hepatic or intestinal enzyme cyp3a4 metabolism  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increased risk or severity of adverse effects  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be increased toxicity of nilotinib by qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increased effect of nilotinib by affecting hepatic or intestinal enzyme cyp3a4 metabolism  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increased effect of nilotinib by affecting hepatic or intestinal enzyme cyp3a4 metabolism  
when both drugs are combined, there may be an increased effect of nilotinib by affecting hepatic or intestinal enzyme cyp3a4 metabolism  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increased effect of nilotinib by affecting hepatic or intestinal enzyme cyp3a4 metabolism  
nilotinib: they may diminish the serum concentration of antacids
nilotinib: they may diminish the serum concentration of antacids
nilotinib: they may diminish the serum concentration of antacids
nilotinib: they may diminish the serum concentration of antacids
nilotinib: they may diminish the serum concentration of antacids
nilotinib: they may diminish the serum concentration of antacids
may increase the immunosuppressive effects of corticosteroids
may increase the immunosuppressive effects of corticosteroids
may increase the immunosuppressive effects of corticosteroids
may increase the immunosuppressive effects of corticosteroids
may increase the immunosuppressive effects of corticosteroids
may enhance the QTc-prolonging effect of Nilotinib
may enhance the QTc-prolonging effect of Nilotinib
may enhance the QTc-prolonging effect of Nilotinib
may enhance the QTc-prolonging effect of Nilotinib
may enhance the QTc-prolonging effect of Nilotinib
may have an increased QTc-prolonging effect when combined with nilotinib
may have an increased QTc-prolonging effect when combined with nilotinib
may have an increased QTc-prolonging effect when combined with nilotinib
may have an increased QTc-prolonging effect when combined with nilotinib
may have an increased QTc-prolonging effect when combined with nilotinib
nilotinib: they may increase the QTc-prolonging effect of QTc-prolonging Agents
nilotinib: they may increase the QTc-prolonging effect of QTc-prolonging Agents
nilotinib: they may increase the QTc-prolonging effect of QTc-prolonging Agents
nilotinib: they may increase the QTc-prolonging effect of QTc-prolonging Agents
QTc interval is increased both by lenvatinib and nilotinib
CYP3A strong enhancers of the small intestine may reduce the bioavailability of nilotinib
nilotinib and gilteritinib, when used in combination, increase the QTc interval
may increase the QTc interval when combined
when both drugs are combined, there may be an increased risk or severity of adverse effects  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increased risk or severity of adverse effects  
when both drugs are combined, there may be an increased effect of alprazolam by affecting hepatic or intestinal enzyme cyp3a4 metabolism  
when both drugs are combined, there may be a decreased level of nilotinib by increasing gastric ph  
when both drugs are combined, there may be an increased effect of oxycodone by affecting hepatic enzyme cyp2d6 metabolism  
when both drugs are combined, there may be an increase in qtc interval  
when both drugs are combined, there may be an increased effect of paclitaxel by p-glycoprotein (mdr1) efflux transporter  
It may diminish the effect when combined with griseofulvin by CYP3A4 metabolism
It may diminish the effects when combined with metformin by pharmacodynamic antagonism
nilotinib: they may enhance the serum concentration of CYP3A4 Inhibitors
nilotinib: they may enhance the serum concentration of CYP3A4 Inhibitors
nilotinib: they may enhance the serum concentration of CYP3A4 Inhibitors
nilotinib: they may enhance the serum concentration of CYP3A4 Inhibitors
nilotinib: they may enhance the serum concentration of CYP3A4 Inhibitors
when both drugs are combined, there may be a reduced metabolism of paclitaxel 
increase the therapeutic effect of daunorubicin by P-glycoprotein efflux transporter
the effect of nilotinib is decreased by lorlatinib, by altering intestinal or hepatic CYP3A4 enzyme metabolism
when both drugs are combined, there may be an increased effect of ivosidenib by affecting hepatic or intestinal enzyme cyp3a4 metabolism 
osimertinib and nilotinib, when used simultaneously, increase the QTc interval
increase the therapeutic effect of idarubicin by P-glycoprotein efflux transporter
may increase the QTc prolonging effect of QT-prolonging agents
when both drugs are combined, there may be an increased effect of alfentanil by affecting hepatic or intestinal enzyme cyp3a4 metabolism  
when both drugs are combined, there may be an increased effect of aliskiren by p-glycoprotein (mdr1) efflux transporter 
it increases the effect or level of finasteride by altering the intestinal/hepatic enzyme CYP3A4 metabolism
it increases the effect or level of dutasteride by altering the intestinal/hepatic enzyme CYP3A4 metabolism
Nilotinib works by blocking the activity of the Bcr-Abl tyrosine kinase, a key enzyme that promotes the growth and survival of leukemia cells in chronic myeloid leukemia (CML). It specifically binds to the ATP-binding site of Bcr-Abl, preventing activation of downstream signaling pathways. This inhibition disrupts cancer cell proliferation and survival. It also has a stronger binding affinity than imatinib, allowing it to overcome certain mutations that cause resistance to earlier treatments.Â
Adverse drug reactions:  Â
Frequency defined Â
>10% Â
Arthralgia  Â
Cough  Â
Extremity pain  Â
Asthenia  Â
Rash  Â
Headache  Â
Nausea  Â
Pruritus  Â
Fatigue  Â
Pyrexia  Â
Diarrhea  Â
Constipation  Â
Vomiting  Â
Muscle spasms  Â
Myalgia  Â
Abdominal pain  Â
Bone pain  Â
Back pain  Â
Dyspnea  Â
Nasopharyngitis  Â
Peripheral edema Â
<10%  Â
Dizziness Â
Insomnia Â
Hyperglycemia Â
Hyperkalemia Â
Hypomagnesemia Â
Neutropenia Â
Pancytopenia Â
Paresthesia Â
QT interval prolongation Â
HTN Â
Palpitations Â
QT interval prolongation Â
<1% Â
Aortic valve sclerosis Â
Abscess Â
Amnesia Â
Dehydration  Â
Peripheral arterial occlusive disease Â
Tumor lysis syndrome Â
Nilotinib may cause QT interval prolongation, which can lead to life-threatening arrhythmias, including sudden death. ECG monitoring is recommended at baseline, 7 days after starting treatment, after dose changes, and regularly during therapy. Electrolyte imbalances like low potassium or magnesium should be corrected before and during treatment. Nilotinib is contraindicated in patients with existing hypokalemia, hypomagnesemia, or long QT syndrome. Avoid combining it with drugs that also prolong the QT interval or with strong CYP3A4 inhibitors. For capsules, it should be taken on an empty stomach—at least 2 hours before and 1 hour after eating.
ContraindicationsÂ
Presence of long QT syndromeÂ
Untreated low levels of potassium (hypokalemia) or magnesium (hypomagnesemia)Â
CautionsÂ
Product Substitution: Avoid switching between Tasigna and Danziten without proper dose adjustment—may cause over- or underexposure, leading to adverse effects or reduced efficacy.Â
QT Prolongation: Risk of life-threatening arrhythmias like torsades de pointes. Monitor ECG at baseline, day 7, with dose changes, and as needed.Â
Electrolyte Imbalance: Correct potassium, magnesium, calcium, and sodium levels before and during treatment.Â
Cardiovascular Risk: Arterial occlusive events (e.g., stroke, heart attack) have been reported. Assess and manage cardiac risk factors; urgent attention needed for acute symptoms.Â
Myelosuppression: May cause anemia, neutropenia, or thrombocytopenia. Monitor CBC frequently and adjust dose if needed.Â
Pancreatitis: Elevated lipase and pancreatitis may occur. Monitor lipase monthly and assess if abdominal symptoms arise.Â
Hepatotoxicity: Monitor liver function (AST, ALT, bilirubin) regularly. Pediatric patients may be more susceptible.Â
Pregnancy warnings:   Â
Breastfeeding warnings:Â
Pregnancy Categories:     Â
Â
Nilotinib is a tyrosine kinase inhibitor primarily used to treat chronic myeloid leukemia (CML). It targets the BCR-ABL enzyme, a key driver of CML, and also blocks other kinases like c-Kit and PDGF receptors, which play roles in conditions such as gastrointestinal stromal tumors (GIST).Â
PharmacokineticsÂ
AbsorptionÂ
Nilotinib is well absorbed, reaching a peak plasma concentration of approximately 1,540 ng/mL after a dose of 300 mg twice daily, with the peak concentration occurring around 3 hours post-dose. The area under the concentration-time curve (AUC) for this dosing regimen is about 13,337 ng·hr/mL.Â
DistributionÂ
It is highly protein-bound (about 98%), and the blood-to-serum ratio is 0.68, indicating limited distribution into blood cells.Â
MetabolismÂ
Nilotinib undergoes hepatic metabolism, primarily through CYP3A4-mediated oxidation and hydroxylation. It acts as an inhibitor of CYP3A4, CYP2C8, CYP2C9, CYP2D6, and UGT1A1, and as an inducer of CYP2B6, CYP2C8, and CYP2C9 enzymes.Â
Elimination/ExcretionÂ
The drug has an elimination half-life of approximately 17 hours, with a clearance rate of about 29 L/hour. Excretion occurs predominantly through feces, accounting for around 93% of the eliminated dose.Â
PharmacodynamicsÂ
Nilotinib is a signal transduction inhibitor that targets BCR-ABL, c-Kit, and PDGF receptors, and is primarily used in the treatment of chronic myeloid leukemia (CML) and other types of leukemia.Â
Nilotinib should be taken orally every 12 hours, avoiding grapefruit or CYP3A4-inhibiting foods.Â
Capsules: Take on an empty stomach, swallow whole; do not open Cipla capsules. Tasigna capsules may be opened and mixed with applesauce if swallowing is difficult.Â
Tablets: Can be taken with or without food, swallow whole—do not crush or chew.Â
Generic name: nilotinibÂ
Pronunciation: nih-LOH-tih-nibÂ
Nilotinib is an anti-cancer drug helpful in treating certain blood cancer (CML-chronic myelogenous leukemia). It works by retarding or cessing the growth of cancerous cells.
The medicine is taken orally twice daily in the form of capsules.
Take plenty of water and fluids during nilotinib treatment.
Side effects of nilotinib are vomiting, nausea, headache, constipation, diarrhea, tiredness, irregular heartbeat. This drug also decreases bone marrow function.
Tell your physician if you develop any serious side effects.
Do not share your chemotherapeutic medications with others.
If you miss a dose, utilize it as soon as you think about it. And if it is near to the next dose, do not double the dose.
Nilotinib is not at all suitable for pregnant females as it harms the ingrowing foetus and causes birth defects.
Passage of chlorambucil in breast milk is still not known but is contraindicated during breast feeding.
Store the medication at room temperature in a moisture free space away from sunlight. It should not be held by children and pets.
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