Last update Sept. 12, 2022

Mitoxantrone Hydrochloride

Very High Risk

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

Mitoxantrone, an analog of daunorubicin, is an anthracycline antibiotic with antineoplastic actions similar to those of doxorubicin. It is indicated in the treatment of various types of cancer and multiple sclerosis (Almas 2016, Alroughani 2016, Cree 2013). It is administered intravenously alone or in combination in once-daily regimens for 1 to 7 days and repeated at 21 days or 1-3 months.

It is excreted in breast milk in amount that may be significant. (Azuno 1995)

During 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, the production of milk can be maintained by regularly expressing milk from the breast, being able to return to breastfeeding 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)

Pharmacokinetics show 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 plasmatic concentrations of 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 published T½ of all the active metabolites (432 hours, 18 days) as a reference, these 5 T½ would correspond to 90 days. Due to major side effects, it would be advisable to wait 7 T½, which would correspond to 126 days (4 months). Meanwhile, breast milk should be expressed and discarded regularly. These waiting times make continuation of breastfeeding impossible.

When it is possible to do so, milk detections of each patient to determine the total elimination of the drug would be the best indicator to resume breastfeeding between two cycles of chemotherapy.

Some chemotherapeutic agents with an antibiotic effect can alter the composition of the microbiota (bacterial set or bacterial flora) of the milk 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 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 these related products:

  • Maternal Cancer ( Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.)
  • Maternal Multiple Sclerosis (Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)

Alternatives

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

Mitoxantrone Hydrochloride in other languages or writings:

Groups

Mitoxantrone Hydrochloride belongs to these groups or families:

Tradenames

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

Pharmacokinetics

Variable Value Unit
Oral Bioavail. Baja / Poor %
Molecular weight 445 daltons
Protein Binding 78 %
VD 8 - 14 l/Kg
pKa 8.27 -
75 (23 - 215) / Metab: 432 hours
Theoretical Dose 0.02 mg/Kg/d
Relative Dose 10.9 %

References

  1. AEMPS. Mitoxantrona. Ficha técnica. 2019 Full text (in our servers)
  2. Pfizer. Mitoxantrone. Drug Summary. 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. Anderson PO. Cancer Chemotherapy. Breastfeed Med. 2016 May;11:164-5. Abstract Full text (link to original source) Full text (in our servers)
  5. Almas S, Vance J, Baker T, Hale T. Management of Multiple Sclerosis in the Breastfeeding Mother. Mult Scler Int. 2016;2016:6527458. Abstract Full text (link to original source) Full text (in our servers)
  6. Alroughani R, Altintas A, Al Jumah M, Sahraian M, Alsharoqi I, AlTahan A, Daif A, Dahdaleh M, Deleu D, Fernandez O, Grigoriadis N, Inshasi J, Karabudak R, Taha K, Totolyan N, Yamout BI, Zakaria M, Bohlega S. Pregnancy and the Use of Disease-Modifying Therapies in Patients with Multiple Sclerosis: Benefits versus Risks. Mult Scler Int. 2016 Abstract Full text (link to original source) 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. 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)
  9. 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
  10. Cree BA. Update on reproductive safety of current and emerging disease-modifying therapies for multiple sclerosis. Mult Scler. 2013 Jun;19(7):835-43. Abstract Full text (link to original source) Full text (in our servers)
  11. Azuno Y, Kaku K, Fujita N, Okubo M, Kaneko T, Matsumoto N. Mitoxantrone and etoposide in breast milk. Am J Hematol. 1995 Abstract

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