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Systemic Anti-Cancer Therapy Regimen Library

Home > LEU CML - nilotinib > LEU - nilotinib 400
This regimen is a component of LEU CML - nilotinib

nilotinib 400 (LEU CML - nilotinib)

Treatment Overview

Accelerated, blast or chronic phase CML resistant or intolerant to previous therapy, including imatinib - give continuously until disease progression or unacceptable toxicity.


Cardiovascular risk factor and baseline QTc interval assessment are recommended, consult prescribing information for details.

Cycle 1 (and all further cycles) - 30 days

Cycle length:
30

Cycle details

Cycle 1 (and all further cycles) - 30 days

Medication Dose Route Days Max Duration
nilotinib 400 mg Twice daily oral administration 1 to 30

Full details

Cycle 1 (and all further cycles) - 30 days

Day: 1

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 2

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 3

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 4

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 5

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 6

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 7

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 8

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 9

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 10

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 11

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 12

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 13

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 14

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 15

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 16

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 17

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 18

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 19

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 20

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 21

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 22

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 23

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 24

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 25

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 26

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 27

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 28

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 29

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Day: 30

Medication Dose Route Max duration Details
nilotinib 400 mg Twice daily oral administration
Instructions:

Take each dose on an empty stomach—at least one hour before or two hours after food. Swallow whole with a glass of water. Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.

Supportive Care Factors

Factor Value
Emetogenicity: Minimal to low
Tumour lysis syndrome prophylaxis: Tumour lysis syndrome prophylaxis may be considered

Antiviral prophylaxis for hepatitis B virus: Guidance is limited to high-risk anti-cancer medicines. Clinicians will need to assess individual patient risk for other anti-cancer medicines.

References

Ng, T. and A. Chan. 2012. "Dosing modifications of targeted cancer therapies in patients with special needs: evidence and controversies." Crit Rev Oncol Hematol 81(1):58-74., PMID: 21429761

Saglio G, Kim DW, Issaragrisil S et al. 2010 " Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia". N Engl J Med. Jun 17;362(24):2251-2259., PMID: 20525993

Hochhaus, A., G. Saglio, T. P. Hughes, et al. 2016. "Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial." Leukemia 30(5):1044-1054., PMID: 26837842

Giles, F. J., D. Rea, G. Rosti, et al. 2017. "Impact of age on efficacy and toxicity of nilotinib in patients with chronic myeloid leukemia in chronic phase: ENEST1st subanalysis." J Cancer Res Clin Oncol 143(8):1585-1596., PMID: 28364360

Hochhaus, A., T. Masszi, F. J. Giles, et al. 2017. "Treatment-free remission following frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the ENESTfreedom study." Leukemia 31(7):1525-1531., PMID: 28218239

Le Coutre P et al. "Nilotinib in accelerated phase chronic myelogenous leukemia patients with imatinib-resistance or –intolerance: update of a phase II study." J Clin Oncol 26:2008 (May 20 suppl; abstract 7050).

le Coutre, P., O. G. Ottmann, F. Giles, et al. 2008. "Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is active in patients with imatinib-resistant or - intolerant accelerated-phase chronic myelogenous leukemia." Blood 111(4):1834-1839., PMID: 18048643

le Coutre PD, Giles FJ, Hochhaus A et al. 2012. " Nilotinib in patients with Ph+ chronic myeloid leukemia in accelerated phase following imatinib resistance or intolerance: 24-month follow-up results." Leukemia. Jun;26(6):1189-94., PMID: 22076466

Baccarani, M., M. W. Deininger, G. Rosti, et al. 2013. "European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013." Blood 122(6):872-884., PMID: 23803709

Novartis New Zealand Limited Tasigna New Zealand Datasheet 30 June 2020 https://www.medsafe.govt.nz/profs/datasheet/t/Tasignacap.pdf (Accessed 29 March 2022).

* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.

s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.