Last update March 24, 2019

Doxorubicin

Very High Risk

Very unsafe. Contraindicated. Use of an alternative or cessation of breastfeeding. Read the Comment.

Doxorubicin is a cytotoxic anthracycline antibiotic isolated from cultures of the caesium variety of Streptomyces peucetius.

Doxorubicin and its active metabolite doxorubicinol are excreted in breast milk in significant amounts and with a very high milk/plasma ratio (Pistilli 2013, Egan 1985).

There are two distinct pharmaceutical forms of doxorubicin, in the form of hydrochloride and in liposomal form, with very different pharmacokinetic profiles (Gabizon 2003).

Given the variability in interindividual pharmacokinetics, potential pharmacokinetic changes with co-administration with other medication (EMA 2017, Swenson 2003) and their serious side effects (cardiotoxicity, myelotoxicity and liver toxicity) (Tacar 2013, Danesi 2002), it is prudent not to breastfeed during treatment.

When possible, detection in the milk of each patient to determine the total elimination of the drug would be the best indicator for resuming breastfeeding between two rounds of chemotherapy.

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

For doxorubicin in hydrochloride form, with a mean elimination half-life (T½) of 30 hours, authors recommend waiting 7 to 10 days (between 5, 6 and 8 T½) after the last dose to restart breastfeeding. Meanwhile, express and discard breast milk regularly (Hale 2017 p.210).
For the liposomal form with a mean T ½ of 74 hours and a wide range, this is not applicable.

Some chemotherapeutics with antibiotic effects may alter the composition of the microbiota (combination of bacteria or bacterial flora) of the milk and the concentration of some of its components (Urbaniak 2014). This possibly occurs briefly with later recovery, with no harmful effects being reported in breastfed infants.

Given the strong evidence that exists on 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 that wishes to continue with breastfeeding (Koren 2013).

Alternatives

We do not have alternatives for Doxorubicin.

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

Doxorubicin is also known as


Doxorubicin in other languages or writings:

Group

Doxorubicin belongs to this group or family:

Tradenames

Main tradenames from several countries containing Doxorubicin in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. Baja - Low %
Molecular weight 544 daltons
Protein Binding 85 %
VD (809-1.214 l/m2). 25 l/Kg
Tmax 24 hours
HCl: 30. Lipos: 70 (24 - 231) hours
M/P ratio 4.4 -
Theoretical Dose 0.036 mg/Kg/d
Relative Dose 1.8 %

References

  1. BC Cancer Agency. Doxorubicin Hydrochloride. Drug Summary. 2017 Full text (in our servers)
  2. EMA. Doxorubicin liposomal. Drug Summary. 2017 Full text (in our servers)
  3. Hale TW, Rowe HE. Medications & Mothers' Milk. A Manual of Lactation Pharmacology. Springer Publishing Company. 2017
  4. EMA. Doxorubicina liposomal. Ficha técnica. 2017 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. AEMPS. Doxorubicina hidrocloruro. Ficha técnica. 2016 Full text (in our servers)
  7. 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)
  8. Tacar O, Sriamornsak P, Dass CR. Doxorubicin: an update on anticancer molecular action, toxicity and novel drug delivery systems. J Pharm Pharmacol. 2013 Abstract
  9. 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)
  10. 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
  11. Swenson CE, Bolcsak LE, Batist G, Guthrie TH Jr, Tkaczuk KH, Boxenbaum H, Welles L, Chow SC, Bhamra R, Chaikin P. Pharmacokinetics of doxorubicin administered i.v. as Myocet (TLC D-99; liposome-encapsulated doxorubicin citrate) compared with conventional doxorubicin when given in combination with cyclophosphamide in patients with metastatic breast cancer. Anticancer Drugs. 2003 Abstract
  12. Gabizon A, Shmeeda H, Barenholz Y. Pharmacokinetics of pegylated liposomal Doxorubicin: review of animal and human studies. Clin Pharmacokinet. 2003 Abstract
  13. Danesi R, Fogli S, Gennari A, Conte P, Del Tacca M. Pharmacokinetic-pharmacodynamic relationships of the anthracycline anticancer drugs. Clin Pharmacokinet. 2002 Abstract
  14. WHO / UNICEF. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development (WHO/UNICEF) 2002 Full text (link to original source) Full text (in our servers)
  15. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  16. Egan PC, Costanza ME, Dodion P, Egorin MJ, Bachur NR. Doxorubicin and cisplatin excretion into human milk. Cancer Treat Rep. 1985 Abstract

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