Nilotinib Hydrochloride

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; Maternal Neoplasia (Unsafe. Moderate/severe adverse effects. Compatible under certain circumstances. Follow-up recommended. Use safer alternative or discontinue breastfeeding from 5 to 7 T ½ . Read Commentary.)