Last update Nov. 6, 2022

Nilotinib Hydrochloride

Low Risk

Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.

Inhibitor of BCR-ABL and SRC tyrosine kinase that is used for treatment of Chronic Myeloid Leukemia with positive Philadelphia chromosome. Oral administration twice daily.

Its pharmacokinetic data (high percentage of protein binding and moderately high molecular weight) explain the negligible passage into breast milk observed. (Chelysheva 2018)

No problems were seen in one infant during 9 months of breastfeeding. (Alizadeh 2015)

Oral bioavailability (30%) is increased twofold when given with food. (Martindale, PDR)

The drug is usually well tolerated; the most frequent side effects of the drug are gastroenteritis, pain, rash and, rarely, reversible lymphopenia when the dose is reduced. (Martindale)

It is known from pharmacokinetics that after 3 elimination half-lives (T½) 87.5% of the drug is eliminated from the body; after 4 T½ it is 94%, after 5 T½, 96.9%, after 6 T½, 98.4% and after 7 T½ it is 99%. From 7 T½ the plasma concentrations of the drug in the body are negligible. In general, a period of at least five half-lives can be considered a safe waiting period before breastfeeding again.(Anderson 2016).

Taking the longest T½ published as a reference (17 hours), these 5 T½ would correspond to 85 hours (3.5 days). Meanwhile, express and discard milk from the breast regularly. This does not allow breastfeeding during treatment.

Abrupt weaning can be psychologically traumatic for both the mother and the infant. (Pistilli 2013). 

Until more published data is known about this drug in relation to breastfeeding, better known alternatives may be preferable, especially during the neonatal period and in the event of prematurity.

If used during lactation, it is advisable to monitor growth and appetite and the possible appearance of diarrhea in the infant, as well as monitor hematological function periodically.

Given the strong evidence that exists regarding the benefits of breastfeeding for the development of babies and the health of mothers, it is advisable to evaluate the risk-benefit of any maternal treatment, including chemotherapy, individually advising each mother who wishes to continue with breastfeeding. (Koren 2013)


See below the information of this related product:

  • Maternal Cancer ( Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.)

Alternatives

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Nilotinib Hydrochloride in other languages or writings:

Groups

Nilotinib Hydrochloride belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Nilotinib Hydrochloride in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 30 %
Molecular weight 584 daltons
Protein Binding 98 %
pKa 12.38 -
Tmax 3 hours
15 - 17 hours
Theoretical Dose ≈ 0.02 mg/Kg/d
Relative Dose ≈ 0.3 %

References

  1. Royal Pharmaceutical Society. Martindale: The Complete Drug Reference Medicines Complete. available online from: https://www.medicinescomplete.com 2022 Abstract
  2. Chelysheva E, Aleshin S, Polushkina E, Shmakov R, Shokhin I, Chilov G, Turkina A. Breastfeeding in Patients with Chronic Myeloid Leukaemia: Case Series with Measurements of Drug Concentrations in Maternal Milk and Literature Review. Mediterr J Hematol Infect Dis. 2018 May 1;10(1):e2018027. Abstract Full text (link to original source)
  3. Anderson PO. Cancer Chemotherapy. Breastfeed Med. 2016 May;11:164-5. Abstract Full text (link to original source) Full text (in our servers)
  4. Alizadeh H, Jaafar H, Kajtár B. Outcome of 3 pregnancies in a patient with chronic myeloid leukemia who received 3 types of tyrosine kinase inhibitors each in different pregnancy: follow-up of the case with a review of published reports. Ann Saudi Med. 2015 Nov-Dec;35(6):468-71. Abstract Full text (link to original source)
  5. PDR.net. Nilotinib. Drug Summary 2014 Full text (link to original source) Full text (in our servers)
  6. Koren G, Carey N, Gagnon R, Maxwell C, Nulman I, Senikas V; Society of Obstetricians and Gynaecologists of Canada. Cancer chemotherapy and pregnancy. J Obstet Gynaecol Can. 2013 Mar;35(3):263-278. Abstract Full text (link to original source) Full text (in our servers)
  7. Pistilli B, Bellettini G, Giovannetti E, Codacci-Pisanelli G, Azim HA Jr, Benedetti G, Sarno MA, Peccatori FA. Chemotherapy, targeted agents, antiemetics and growth-factors in human milk: how should we counsel cancer patients about breastfeeding? Cancer Treat Rev. 2013 May;39(3):207-11. Abstract
  8. EMEA Nilotinib Ficha técnica 2012 Full text (in our servers)
  9. Di Gion P, Kanefendt F, Lindauer A, Scheffler M, Doroshyenko O, Fuhr U, Wolf J, Jaehde U. Clinical pharmacokinetics of tyrosine kinase inhibitors: focus on pyrimidines, pyridines and pyrroles. Clin Pharmacokinet. 2011 Abstract
  10. Tanaka C, Yin OQ, Sethuraman V, Smith T, Wang X, Grouss K, Kantarjian H, Giles F, Ottmann OG, Galitz L, Schran H. Clinical pharmacokinetics of the BCR-ABL tyrosine kinase inhibitor nilotinib. Clin Pharmacol Ther. 2010 Abstract

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