Last update March 24, 2019

Busulfan

High Risk

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

An antineoplastic with non-specific alkylating action.
Indicated in the palliative treatment of chronic myeloid leukemia, in Polycythemia Vera, myelofibrosis, thrombocythemia and in transplants.
It is administered orally or intravenously every 6 or 24 hours in cycles or on an ongoing basis.

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

Its pharmacokinetic data (low molecular weight, low protein binding and high lipophilicity) means it is likely to transfer into milk in potentially significant quantities.

A baby whose mother took busulfan (4 mg/day) for 5 weeks did not have any haematological disorder (Bounameaux 1964).

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 as a reference, these 5 T½ would correspond to 15 hours. Due to major side effects, it would be advisable to wait 7 T½, which would correspond to 21 hours. Meanwhile, express and discard milk from the breast regularly to maintain production.
Some authors recommend waiting 24 hours after the last dose to restart breastfeeding. (Hale 2017 p 134).

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.

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, 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).

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).

Alternatives

We do not have alternatives for Busulfan.

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

Busulfan in other languages or writings:

Group

Busulfan belongs to this group or family:

Tradenames

Main tradenames from several countries containing Busulfan in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 80 - 100 %
Molecular weight 246 daltons
Protein Binding 32 %
VD 0.94 l/Kg
Tmax 0.5 - 2 hours
2 - 3 hours

References

  1. BC Cancer DM. Busulfan. Drug Summary. 2018 Full text (in our servers)
  2. 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
  3. AEMPS-Aspen. Busulfano. Ficha técnica. 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. 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)
  6. 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
  7. Bounameaux Y, Durenne JM. Un cas de leucémie chez une femme allaitante: effets du traitement par le Busulfan sur le nourrisson. [A case of leukemia in a lactating female: effect of treatment with Busulfan on the infant]. Ann Soc Belges Med Trop Parasitol Mycol. 1964 Abstract

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