Last update Nov. 4, 2022

Nintedanib Esylate

Low Risk

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

It is a triple angiokinase inhibitor (tyrosine kinases) indicated for the treatment of idiopathic pulmonary fibrosis, interstitial lung disease associated with systemic sclerosis and, in combination with docetaxel, for non-small cell lung cancer in 21-day cycles (docetaxel el day 1 and nintedanib on days 2 and 21 of each cycle). Oral administration 2 times a day.

Since the last update we have not found published data on its excretion in breastmilk.

Its pharmacokinetic characteristics (very high plasma protein binding, very large volume of distribution and moderately elevated molecular weight) make it very unlikely its excretion into breast milk in significant amounts.

Its very low oral bioavailability (≈ 5%; 20% with foods) minimizes the passage into plasma of the infant from ingested breast milk, except in the premature and in the immediate neonatal period in which there may be greater intestinal permeability.

The most common side effects of the drug are gastroenteritis, increased transaminases, and liver failure, reversible when treatment is reduced or discontinued.

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, -15 hours in cancer and 9.5 hours in pulmonary fibrosis (DrugBank)-, these 5 T½ would correspond to 75 hours (3 days) and 47,5 hours (2 days), respectively. Meanwhile, express and discard milk from the breast regularly. This will allow breastfeeding between cycles of cancer treatment, but not in the daily treatment of pulmonary fibrosis.

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 liver 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

We do not have alternatives for Nintedanib Esylate.

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

Nintedanib Esylate is also known as


Nintedanib Esylate in other languages or writings:

Groups

Nintedanib Esylate belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Nintedanib Esylate in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 4.7 (3.6 - 6.1) %
Molecular weight 650 daltons
Protein Binding 97.8 %
VD 15 l/Kg
pKa 10.86 -
Tmax 2 - 4 hours
10 - 15 ( pulm.fibros: 9.5 ) hours

References

  1. DRUGBANK ONLINE. DrugBank.com 2006 - Consulted on Jan. 9, 2024 Full text (link to original source)
  2. EMA. Nintedanib. Ficha técnica. 2019 Full text (in our servers)
  3. Boehringer I. Nintedanib. Drug Summary. 2017 Full text (in our servers)
  4. Anderson PO. Cancer Chemotherapy. Breastfeed Med. 2016 May;11:164-5. Abstract Full text (link to original source) Full text (in our servers)
  5. 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)

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