Last update May 2, 2019

Azacitidine

Very High Risk

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

An analogue of pyrimidine nucleoside with antineoplastic, antiviral and immunosuppressive properties.
It is used in the treatment of myelodysplastic syndromes and acute myeloid leukemia and chronic myelomonocytic leukemia, intravenously or subcutaneously for 7 days in cycles every 4 weeks.

Since the last update we have not found any published data on its excretion in breast milk.

Its pharmacokinetic data (low molecular weight and high pKa) makes transfer to milk possible in amounts that could be significant.

It is known from pharmacokinetics that after 3 elimination half-lives (T½), 87.5% of the drug is eliminated from the organism; 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 the longest published T½ of all the active metabolites as a reference (6,2 hours: Marcucci 2005), these 5 T½ would correspond to 31 hours. Due to major side effects, it would be advisable to wait 7 T½, which would correspond to 43 hours. Meanwhile, express and discard milk from the breast regularly to maintain production.

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.

Its very low oral bioavailability (Cogle 2015, Laille 2014) hinders transfer to infant plasma from breastmilk, except in premature babies and the immediate neonatal period when there may be increased intestinal permeability.

During the treatment of cancer, breastfeeding should be interrupted temporarily 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 regularly expressing breastmilk, being able to resume 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 because they experience 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 Azacitidine.

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

Azacitidine is also known as


Azacitidine in other languages or writings:

Group

Azacitidine belongs to this group or family:

Tradenames

Main tradenames from several countries containing Azacitidine in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 2.8 - 17 %
Molecular weight 244 daltons
VD 1.1 l/Kg
pKa 12.55 -
Tmax 0.5 hours
6.2 hours

References

  1. Celgene. Azacitidine (Vidaza). 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. Chou WC, Yeh SP, Hsiao LT, Lin SF, Chen YC, Chen TY, Laille E, Galettis A, Dong Q, Songer S, Beach CL. Efficacy, safety, and pharmacokinetics of subcutaneous azacitidine in Taiwanese patients with higher-risk myelodysplastic syndromes. Asia Pac J Clin Oncol. 2017 Oct;13(5):e430-e439. 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. Cogle CR, Scott BL, Boyd T, Garcia-Manero G. Oral Azacitidine (CC-486) for the Treatment of Myelodysplastic Syndromes and Acute Myeloid Leukemia. Oncologist. 2015 Dec;20(12):1404-12. Abstract
  6. Laille E, Savona MR, Scott BL, Boyd TE, Dong Q, Skikne B. Pharmacokinetics of different formulations of oral azacitidine (CC-486) and the effect of food and modified gastric pH on pharmacokinetics in subjects with hematologic malignancies. J Clin Pharmacol. 2014 Jun;54(6):630-9. Abstract
  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. 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. EMA - Celgene. Azacitidina (Vidaza). Ficha técnica. 2013 Full text (in our servers)
  10. 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)
  11. Marcucci G, Silverman L, Eller M, Lintz L, Beach CL. Bioavailability of azacitidine subcutaneous versus intravenous in patients with the myelodysplastic syndromes. J Clin Pharmacol. 2005 May;45(5):597-602. Abstract

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