Last update Nov. 3, 2022

Erlotinib Hydrochloride

High Risk

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

Inhibitor of Epidermal Growth Factor receptor that acts by inhibition of tyrosine kinase phosphorylation and used to treat certain small cell lung cancers and advanced metastatic pancreatic cancers. Oral administration once daily.

At latest update, relevant published data on excretion into breast milk were not found.

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 long half-life could facilitate excretion in breast milk and due to its high bioavailability with food (≈ 100%) it would have systemic action in the infant.

The most common adverse effects of erlotinib are rash and diarrhoea. (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 (36 hours), these 5 T½ would correspond to 180 hours (8 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 hepatic 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.)


We do not have alternatives for Erlotinib Hydrochloride.

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

Erlotinib Hydrochloride in other languages or writings:


Erlotinib Hydrochloride belongs to these groups or families:


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


Variable Value Unit
Oral Bioavail. 59 - 100 %
Molecular weight 430 daltons
Protein Binding 93 %
VD 3.3 l/Kg
pKa 16.14 -
Tmax 4 hours
36.2 hours


  1. Royal Pharmaceutical Society. Martindale: The Complete Drug Reference Medicines Complete. available online from: 2022 Abstract
  2. Anderson PO. Cancer Chemotherapy. Breastfeed Med. 2016 May;11:164-5. Abstract Full text (link to original source) Full text (in our servers)
  3. Erlotinib. Drug Summary 2014 Full text (link to original source) Full text (in our servers)
  4. 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
  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)
  6. EMEA Erlotinib. Ficha técnica 2012 Full text (in our servers)
  7. Lu JF, Eppler SM, Wolf J, Hamilton M, Rakhit A, Bruno R, Lum BL. Clinical pharmacokinetics of erlotinib in patients with solid tumors and exposure-safety relationship in patients with non-small cell lung cancer. Clin Pharmacol Ther. 2006 Abstract

Total visits


Help us improve this entry

How to cite this entry

Do you need more information or did not found what you were looking for?

   Write us at

e-lactancia is a resource recommended by Academy of Breastfeeding Medicine - 2006 of United States of America

Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM