Last update March 24, 2019

Capecitabine

High Risk

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

Capecitabine is a prodrug which is converted into fluorouracil and other active metabolites in body tissues (EMA 2018, Derissen 2016, Calzas 2003). It is used as a treatment for colon, colorectal, breast and gastric cancers.
It is administered orally twice a day in 14-day cycles followed by a 7-day rest for 6 months (EMA 2018).

Since the last update we have not found published data on the excretion of capecitabine in breastmilk, but its active metabolite, fluorouracil, is excreted in breastmilk in undetectable, clinically insignificant amounts (Peccatori 2012) which can be explained by its pharmacokinetics: fast degradation to non-active metabolites and very low liposolubility (Pistilli 2013).

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, 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 as reference the longest published T½ of all the active metabolites (EMA 2018), these 5 T½ would correspond to 5.5 hours. Due to major side effects, it would be advisable to wait 7 T½, which would correspond to 8 hours. Meanwhile, express and discard milk from the breast regularly.
Some authors recommend waiting 24 hours (21 T½) after the last dose to resume breastfeeding. (Hale 2017 p.148).

During breast cancer treatment, breastfeeding must be interrupted due to potentially serious side effects for the infant. Chemotherapy does not affect milk production during or after treatment. Abrupt weaning can be psychologically traumatic for both the mother and the infant (Pistilli 2013). If the mother wishes, production of milk can be maintained by regular expressing of the breast, resumption of breastfeeding being possible in the periods in which no significant traces of the drug remain in the milk (Anderson 2016) or at the end of the treatment (Pistilli 2013).

Some chemotherapeutic agents with an antibiotic effect can alter the composition of the microbiota (bacterial set or bacterial flora) of breastmilk and the concentration of some of its components (Urbaniak 2014). This possibly occurs temporarily with subsequent recovery, although no harmful effects are assumed or have been reported in breastfed infants.

Women undergoing chemotherapy during pregnancy have lower rates of breastfeeding due to difficulties in breastfeeding (Stopenski 2017), needing more support to achieve it.

Given the strength of the existing evidence on the benefits of breastfeeding for the development of babies and the health of mothers, the risk-benefit of any maternal treatment should be evaluated, including chemotherapy, individually advising each mother who wishes to continue with breastfeeding (Koren 2013).


See below the information of these related products:

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

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

Capecitabine in other languages or writings:

Group

Capecitabine belongs to this group or family:

Tradenames

Main tradenames from several countries containing Capecitabine in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. > 90 %
Molecular weight 359 daltons
Protein Binding 10 - 62 %
pKa 8.23 -
Tmax 1.5 hours
0.8 - 1.1 hours

References

  1. EMA - Roche. Capecitabine (Xeloda). Drug Summary. 2018 Full text (in our servers)
  2. EMA - Roche. Capecitabina (Xeloda). Ficha técnica. 2018 Full text (in our servers)
  3. Stopenski S, Aslam A, Zhang X, Cardonick E. After Chemotherapy Treatment for Maternal Cancer During Pregnancy, Is Breastfeeding Possible? Breastfeed Med. 2017 Mar;12:91-97. Abstract
  4. Derissen EJ, Jacobs BA, Huitema AD, Rosing H, Schellens JH, Beijnen JH. Exploring the intracellular pharmacokinetics of the 5-fluorouracil nucleotides during capecitabine treatment. Br J Clin Pharmacol. 2016 Abstract Full text (link to original source) Full text (in our servers)
  5. Anderson PO. Cancer Chemotherapy. Breastfeed Med. 2016 May;11:164-5. Abstract Full text (link to original source) Full text (in our servers)
  6. Urbaniak C, McMillan A, Angelini M, Gloor GB, Sumarah M, Burton JP, Reid G. Effect of chemotherapy on the microbiota and metabolome of human milk, a case report. Microbiome. 2014 Jul 11;2:24. Abstract Full text (link to original source) Full text (in our servers)
  7. 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)
  8. 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
  9. Peccatori FA, Giovannetti E, Pistilli B, Bellettini G, Codacci-Pisanelli G, Losekoot N, Curigliano G, Azim HA Jr, Goldhirsch A, Peters GJ. "The only thing I know is that I know nothing": 5-fluorouracil in human milk. Ann Oncol. 2012 Abstract Full text (link to original source) Full text (in our servers)
  10. Calzas Rodríguez J, de la Nogal Fernández B, Arrieta Garmendia JM, Lastra Aras E, García Castaño A, Barrio Gil-Fournier A, García Girón C. [Capecitabine: an oral chemotherapeutic agent against metastatic breast and colorectal cancer]. Farm Hosp. 2003 Abstract Full text (link to original source) Full text (in our servers)

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