Nilotinib

Nilotinib, sold under the brand name Tasigna among others, is an anti-cancer medication used to treat chronic myelogenous leukemia (CML) which has the Philadelphia chromosome.[1][2] It may be used both in initial cases of chronic phase CML as well as in accelerated and chronic phase CML that has not responded to imatinib.[1][2][3] It is taken by mouth.[1][3]

Common side effects may include low platelets, low white blood cells, anemia, rashes, vomiting, diarrhea, and joint pains.[3] Other serious side effects may include QT prolongation, sudden death, pancreatitis, and liver problems.[3] It is not safe for use during pregnancy.[3] Nilotinib is a Bcr-Abl tyrosine kinase inhibitor and works by interfering with signalling within the cancer cell.[1][3]

Nilotinib was approved for medical use in the United States in 2007.[1][3] It is on the World Health Organization's List of Essential Medicines.[4] It is approved as a generic medication.[5]

## Contents

* 1 Medical uses
* 2 Adverse effects
* 3 Interactions
* 4 Pharmacology
* 5 History
* 6 Society and culture
* 6.1 Legal status
* 7 Research
* 7.1 Parkinson's disease
* 7.2 Other
* 8 References

## Medical uses

Nilotinib is used to treat Philadelphia chromosome (Ph+)-positive chronic myelogenous leukaemia.[1][6] It is indicated for the treatment of newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase;[1][7] adults with chronic phase and accelerated phase Philadelphia chromosome positive chronic myeloid leukemia resistant to or intolerant to prior therapy that included imatinib;[1][7] and children with chronic phase and accelerated phase Philadelphia chromosome positive chronic myeloid leukemia resistant or intolerant to prior tyrosine-kinase inhibitor therapy.[1][7]

## Adverse effects

Nilotinib has a number of adverse effects including headache, fatigue, gastrointestinal problems such as nausea, vomiting, diarrhea and constipation, muscle and joint pain, rash and other skin conditions, flu-like symptoms, and reduced blood cell count. Less typical side effects are those of the cardiovascular system, such as high blood pressure, various types of arrhythmia, and prolonged QT interval. Nilotinib can also affect the body's electrolyte and glucose balance.[8] Though lung-related adverse effects are rare when compared with imatinib and dasatinib, there is a case report of acute respiratory failure from diffuse alveolar hemorrhage in a people taking nilotinib.[9]

Nilotinib carries a black box warning in the United States for possible heart complications.[1][10] Contraindications include long QT syndrome, hypokalaemia, hypomagnesaemia, pregnancy, planned pregnancy, lactation and galactose/lactose intolerance.[6][11]

Cautions include:[6]

* Myelosuppression
* Tumour lysis syndrome
* Liver impairment
* History of pancreatitis
* Check serum lipase periodically in order to detect pancreatitis
* Total gastrectomy
* Avoid pregnancy or impregnating women

Dose reduction has been recommended in people with liver problems which involves recommendation of lower starting dose and monitoring of any hepatic function abnormalities.[12]

Hepatitis B virus reactivation may also occur.[13]

## Interactions

Nilotinib has been reported as a substrate for OATP1B1 and OATP1B3. Interaction of nilotinib with OATP1B1 and OATP1B3 may alter its hepatic disposition and can lead to transporter mediated drug-drug interactions.[12] Nilotinib is an inhibitor of OATP-1B1 transporter but not for OATP-1B3.[14]

It is a substrate for CYP3A4 and hence grapefruit juice and other CYP3A4 inhibitors[15] will increase its action and inducers like St. John's wort[16] will decrease it. Patients report that pomegranates and starfruit may also interfere.

## Pharmacology

Crystal structure of Abl kinase domain (blue) in complex with nilotinib (red)

Nilotinib inhibits the kinases BCR-ABL,[17] KIT, LCK, EPHA3, EPHA8, DDR1, DDR2, PDGFRB, MAPK11 and ZAK.[18]

Structurally related to imatinib,[19] it is 10–30 fold more potent than imatinib in inhibiting Bcr-Abl tyrosine kinase activity and proliferation of Bcr-Abl expressing cells.[19][20][21][22]

## History

Nilotinib was developed by Novartis.[3] It was developed based on the structure of the Abl-imatinib complex to address imatinib intolerance and resistance.[23][20][21]

## Society and culture

### Legal status

It was approved for medical use by the US Food and Drug Administration (FDA) in October 2007,[24][8] the European Union in November 2007,[7][25] the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2021,[26] and the Therapeutic Goods Administration (TGA) in January 2008.[11]

## Research

### Parkinson's disease

There is weak evidence that nilotinib may be beneficial with Parkinson's disease (PD), with a small clinical trial suggesting it might halt progression and improve symptoms.[27] However, there were significant side effects including infection, liver function tests abnormalities, hallucinations and heart attack, and the benefit in PD disappeared at follow up after drug discontinuation, raising question as to whether it was truly a disease modifying therapy. Nilotinib is currently undergoing phase II studies for treatment of Parkinson's.[28] Scientists and medical professionals have advised caution with over-optimistic interpretation of its effects in Parkinson's due to the significant media hype surrounding the small and early clinical trial.[29][30] Dystonia and cognitive impairment have also been reported as side effects.[31]

### Other

Novartis announced in April 2011, that it was discontinuing a phase III trial of nilotinib as the first-line treatment of gastrointestinal stromal tumor (GIST) based on the recommendation of an independent data monitoring committee. Interim results showed Tasigna is unlikely to demonstrate superiority compared to Novartis's Gleevec (imatinib)*, the current standard of care in this setting.[32]

Low dose nilotinib is also being investigated for use in Alzheimer's disease, as well as for ALS, dementia and Huntington's disease.[33]

Nioltinib can be prepared as an amorphous solid distribution with resonant acoustic mixing in an attempt to avoid the interaction issues Tasigna has with food. Some work was done with 26 healthy volunteers, but a larger study has not been attempted.[34]

## References

1. ↑ 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 Cite error: Invalid `<ref>` tag; no text was provided for refs named `Tasigna FDA label`
2. ↑ 2.0 2.1 "Nilotinib". February 1, 2008. https://www.cancer.gov/about-cancer/treatment/drugs/nilotinib.
3. ↑ 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 "Nilotinib Monograph for Professionals". https://www.drugs.com/monograph/nilotinib.html.
4. ↑ The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023). Geneva: World Health Organization. 2023. WHO/MHP/HPS/EML/2023.02.
5. ↑ "First-Time Generic Drug Approvals 2024". March 8, 2024. https://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/first-generic-drug-approvals.
6. ↑ 6.0 6.1 6.2 "Tasigna (nilotinib) dosing, indications, interactions, adverse effects, and more". Medscape Reference. WebMD. http://reference.medscape.com/drug/tasigna-nilotinib-342198#showall.
7. ↑ 7.0 7.1 7.2 7.3 Cite error: Invalid `<ref>` tag; no text was provided for refs named `Tasigna EPAR`
8. ↑ 8.0 8.1 "Complete Nilotinib information from Drugs.com". Drugs.com. https://www.drugs.com/ppa/nilotinib.html.
9. ↑ "Acute respiratory failure from nilotinib-associated diffuse alveolar hemorrhage". Leukemia & Lymphoma 55 (10): 2408–2409. October 2014. doi:10.3109/10428194.2014.887714. PMID 24467220.
10. ↑ "FDA Approves Tasigna for Treatment of Philadelphia Chromosome Positive Chronic Myeloid Leukemia". U.S. Food and Drug Administration. October 30, 2007. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109017.htm.
11. ↑ 11.0 11.1 "Tasigna nilotinib" (PDF). TGA eBusiness Services. October 21, 2013. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2009-PI-00292-3.
12. ↑ 12.0 12.1 "Role of OATP-1B1 and/or OATP-1B3 in hepatic disposition of tyrosine kinase inhibitors". Drug Metabolism and Drug Interactions 29 (3): 179–190. March 2014. doi:10.1515/dmdi-2013-0062. PMID 24643910.
13. ↑ British national formulary : BNF 76 (76 ed.). Pharmaceutical Press. 2018. pp. 960. ISBN 978-0-85711-338-2.
14. ↑ "Inhibition of OATP-1B1 and OATP-1B3 by tyrosine kinase inhibitors". Drug Metabolism and Drug Interactions 29 (4): 249–259. May 2014. doi:10.1515/dmdi-2014-0014. PMID 24807167.
15. ↑ "Grapefruit juice-drug interactions". British Journal of Clinical Pharmacology 46 (2): 101–110. August 1998. doi:10.1046/j.1365-2125.1998.00764.x. PMID 9723817.
16. ↑ "Induction and inhibition of cytochromes P450 by the St. John's wort constituent hyperforin in human hepatocyte cultures". Drug Metabolism and Disposition 32 (5): 512–518. May 2004. doi:10.1124/dmd.32.5.512. PMID 15100173.
17. ↑ "AMN107 (nilotinib): a novel and selective inhibitor of BCR-ABL". British Journal of Cancer 94 (12): 1765–1769. June 2006. doi:10.1038/sj.bjc.6603170. PMID 16721371.
18. ↑ "Extended kinase profile and properties of the protein kinase inhibitor nilotinib". Biochimica et Biophysica Acta (BBA) - Proteins and Proteomics 1804 (3): 445–453. March 2010. doi:10.1016/j.bbapap.2009.11.008. PMID 19922818.
19. ↑ 19.0 19.1 "Advances in the structural biology, design and clinical development of Bcr-Abl kinase inhibitors for the treatment of chronic myeloid leukaemia". Biochimica et Biophysica Acta (BBA) - Proteins and Proteomics 1754 (1–2): 3–13. December 2005. doi:10.1016/j.bbapap.2005.07.040. PMID 16172030.
20. ↑ 20.0 20.1 "Nilotinib for the treatment of chronic myeloid leukemia: An evidence-based review". Core Evidence 4: 207–213. June 2010. doi:10.2147/CE.S6003. PMID 20694077.
21. ↑ 21.0 21.1 "Dasatinib: a new step in molecular target therapy". Annals of Oncology 18 (Suppl 6): vi42–vi46. June 2007. doi:10.1093/annonc/mdm223. PMID 17591830.
22. ↑ "Nilotinib: a second-generation tyrosine kinase inhibitor for chronic myeloid leukemia". Leukemia Research 34 (2): 129–134. February 2010. doi:10.1016/j.leukres.2009.08.031. PMID 19783301.
23. ↑ "Structural resemblances and comparisons of the relative pharmacological properties of imatinib and nilotinib". Bioorganic & Medicinal Chemistry 18 (19): 6977–6986. October 2010. doi:10.1016/j.bmc.2010.08.026. PMID 20817538.
24. ↑ "Drug Approval Package: Tasigna (Nilotinib) NDA #022068". 14 March 2008. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022068TOC.cfm.
25. ↑ "Tasigna : EPAR - Product Information". European Medicines Agency. Novartis Europharm Ltd.. October 18, 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000798/WC500034394.pdf.
26. ↑ Cite error: Invalid `<ref>` tag; no text was provided for refs named `Tasigna SmPC`
27. ↑ "Nilotinib Effects in Parkinson's disease and Dementia with Lewy bodies". Journal of Parkinson's Disease 6 (3): 503–517. July 2016. doi:10.3233/JPD-160867. PMID 27434297.
28. ↑ "Anticancer Drugs for Parkinson's Disease: Is It a Ray of Hope or Only Hype?". Annals of Indian Academy of Neurology 22 (1): 13–16. 2019. doi:10.4103/aian.AIAN_177_18. PMID 30692753.
29. ↑ "Media hype: Patient and scientific perspectives on misleading medical news". Movement Disorders 32 (9): 1319–1323. September 2017. doi:10.1002/mds.26993. PMID 28370445.
30. ↑ "Nilotinib - Differentiating the Hope from the Hype". Journal of Parkinson's Disease 6 (3): 519–522. July 2016. doi:10.3233/JPD-160904. PMID 27434298.
31. ↑ "Anticancer Drugs for Parkinson's Disease: Is It a Ray of Hope or Only Hype?". Annals of Indian Academy of Neurology 22 (1): 13–16. 2019. doi:10.4103/aian.AIAN_177_18. PMID 30692753.
32. ↑ "Global Novartis News Archive". http://www.novartis.com/newsroom/media-releases/en/2011/1504991.shtml.
33. ↑ "Cancer drug prevents build-up of toxic brain protein". MedicalXpress.com. May 10, 2013. https://medicalxpress.com/news/2013-05-cancer-drug-build-up-toxic-brain.html.
34. ↑ , Christian F.; Tzehaw Chen & Joseph McTarsney"Amorphous nilotinib microparticles and uses thereof"  patent US20250032491A1, issued 2025-01-30

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Targeted cancer therapy / antineoplastic agents (L01)

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RET inhibitors: Vandetanib (also VEGFR and EGFR). Entrectinib (ALK, ROS1, NTRK). c-MET inhibitor: Cabozantinib (also VEGFR2).

|

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Growth factor receptor modulators

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CNTF|

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EGF (ErbB)|

| EGF
(ErbB1/HER1)|

* Agonists: Amphiregulin
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FGF|

| FGFR1|

* Agonists: Ersofermin
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* Repifermin
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|

FGFR2|

* Agonists: Ersofermin
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* Palifermin
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* Antibodies: Aprutumab
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FGFR3|

* Agonists: Ersofermin
* FGF (1, 2 (bFGF), 4, 8, 9, 18, 23)
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* Antibodies: Burosumab (against FGF23)

FGFR4|

* Agonists: Ersofermin
* FGF (1, 2 (bFGF), 4, 6, 8, 9, 19)
* Trafermin

Unsorted|

* Agonists: FGF15/19

HGF (c-Met)|

* Agonists: Hepatocyte growth factor

* Potentiators: Dihexa (PNB-0408)

* Kinase inhibitors: Altiratinib
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IGF|

| IGF-1|

* Agonists: des(1-3)IGF-1
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|

IGF-2|

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* Antibodies: Dusigitumab
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Others|

* Binding proteins: IGFBP (1, 2, 3, 4, 5, 6, 7)

* Cleavage products/derivatives with unknown target: Glypromate (GPE, (1-3)IGF-1)
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LNGF (p75NTR)|

* Agonists: BDNF
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* Aptamers: Against NGF: RBM-004

* Decoy receptors: LEVI-04 (p75NTR-Fc)

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* Antibodies: Olaratumab
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RET (GFL)|

| GFRα1|

* Agonists: Glial cell line-derived neurotrophic factor (GDNF)
* Liatermin

* Kinase inhibitors: Vandetanib

|

GFRα2|

* Agonists: Neurturin (NRTN)

* Kinase inhibitors: Vandetanib

GFRα3|

* Agonists: Artemin (ARTN)

* Kinase inhibitors: Vandetanib

GFRα4|

* Agonists: Persephin (PSPN)

* Kinase inhibitors: Vandetanib

Unsorted|

* Kinase inhibitors: Agerafenib

SCF (c-Kit)|

* Agonists: Ancestim
* Stem cell factor

* Kinase inhibitors: Agerafenib
* Axitinib
* Dasatinib
* Imatinib
* Masitinib
* Nilotinib
* Pazopanib
* Quizartinib
* Sorafenib
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* Toceranib

TGFβ|

* See here instead.

Trk|

| TrkA|

* Agonists: Amitriptyline
* BNN-20
* BNN-27
* Cenegermin
* DHEA
* DHEA-S
* Gambogic amide
* NGF
* Tavilermide

* Antagonists: ALE-0540
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* Negative allosteric modulators: VM-902A

* Kinase inhibitors: Altiratinib
* AZD-6918
* CE-245677
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* Larotrectinib
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* Milciclib
* ONO-4474
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* PLX-7486
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* SNA-120 (pegylated K252a))

* Antibodies: Against TrkA: GBR-900; Against NGF: ABT-110 (PG110)
* ASP-6294
* Fasinumab
* Frunevetmab
* Fulranumab
* MEDI-578
* Ranevetmab
* Tanezumab

* Aptamers: Against NGF: RBM-004

* Decoy receptors: ReN-1820 (TrkAd5)

|

TrkB|

* Agonists: 3,7-DHF
* 3,7,8,2'-THF
* 4'-DMA-7,8-DHF
* 7,3'-DHF
* 7,8-DHF
* 7,8,2'-THF
* 7,8,3'-THF
* Amitriptyline
* BDNF
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* Deoxygedunin
* Deprenyl
* Diosmetin
* DMAQ-B1
* HIOC
* LM22A-4
* N-Acetylserotonin
* NT-3
* NT-4
* Norwogonin (5,7,8-THF)
* R7
* R13
* TDP6

* Antagonists: ANA-12
* Cyclotraxin B
* Gossypetin (3,5,7,8,3',4'-HHF)

* Ligands: DHEA

* Kinase inhibitors: Altiratinib
* AZD-6918
* CE-245677
* CH-7057288
* DS-6051
* Entrectinib
* GZ-389988
* K252a
* Larotrectinib
* Lestaurtinib
* ONO-4474
* ONO-5390556
* PLX-7486

TrkC|

* Agonists: BNN-20
* DHEA
* NT-3

* Kinase inhibitors: Altiratinib
* AZD-6918
* CE-245677
* CH-7057288
* DS-6051
* Entrectinib
* GZ-389988
* K252a
* Larotrectinib
* Lestaurtinib
* ONO-4474
* ONO-5390556
* PLX-7486

VEGF|

* Agonists: Placental growth factor (PGF)
* Telbermin
* VEGF (A, B, C, D (FIGF))

* Allosteric modulators: Cyclotraxin B

* Kinase inhibitors: Agerafenib
* Altiratinib
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* WHI-P 154

* Antibodies: Alacizumab pegol
* Bevacizumab
* Icrucumab
* Ramucirumab
* Ranibizumab

* Decoy receptors: Aflibercept

Others|

* Additional growth factors: Adrenomedullin
* Colony-stimulating factors (see here instead)
* Connective tissue growth factor (CTGF)
* Ephrins (A1, A2, A3, A4, A5, B1, B2, B3)
* Erythropoietin (see here instead)
* Glucose-6-phosphate isomerase (GPI; PGI, PHI, AMF)
* Glia maturation factor (GMF)
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* Interleukins/T-cell growth factors (see here instead)
* Leukemia inhibitory factor (LIF)
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* Midkine (NEGF2)
* Migration-stimulating factor (MSF; PRG4)
* Oncomodulin
* Pituitary adenylate cyclase-activating peptide (PACAP)
* Pleiotrophin
* Renalase
* Thrombopoietin (see here instead)
* Wnt signaling proteins

* Additional growth factor receptor modulators: Cerebrolysin (neurotrophin mixture)

See also
Receptor/signaling modulators
Signaling peptide/protein receptor modulators
Cytokine receptor modulators

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