Last update March 24, 2019

L01AA09

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 alkylating agent indicated in the treatment of chronic lymphocytic leukemia, indolent non-Hodgkin’s lymphomas and multiple myeloma.
Intravenous administration on days 1 and 2 every 3 to 4 weeks, 3 to 6 cycles.

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

Its high percentage of protein binding and short half-life (AEMPS 2018, Lundbeck 2017, Darwish 2015, Dubbelman 2013, Preiss 1985) make it unlikely it will transfer into breastmilk in significant quantities.

Its practically zero oral bioavailability (Preiss 1985) would make its transfer to infant plasma from ingested breast milk difficult, except in premature infants and the immediate neonatal period when there may be greater intestinal permeability.

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 five half-lives can be considered a safe waiting period before resuming breastfeeding (Anderson 2016).

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

Expert authors recommend waiting 24 hours (12 T½ of the parent compound and 8 T½ of the metabolite M3) after the last dose before restarting breastfeeding. Meanwhile, express and discard breastmilk regularly (Briggs 2015).

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 L01AA09.

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.

Group

L01AA09 belongs to this group or family:

Tradenames

Main tradenames from several countries containing L01AA09 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. < 1 %
Molecular weight 395 daltons
Protein Binding 95 %
VD 0.28 l/Kg
pKa 6.65 -
0.47 - 0.67 (M3: 3 h) hours

References

  1. AEMPS. Bendamustina. Ficha técnica. 2018 Full text (in our servers)
  2. Lundbeck. Bendamustine. Drug Summary. 2017 Full text (in our servers)
  3. Anderson PO. Cancer Chemotherapy. Breastfeed Med. 2016 May;11:164-5. Abstract Full text (link to original source) Full text (in our servers)
  4. Darwish M, Bond M, Hellriegel E, Robertson P Jr, Chovan JP. Pharmacokinetic and pharmacodynamic profile of bendamustine and its metabolites. Cancer Chemother Pharmacol. 2015 Abstract
  5. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  6. Dubbelman AC, Rosing H, Darwish M, D'Andrea D, Bond M, Hellriegel E, Robertson P Jr, Beijnen JH, Schellens JH. Pharmacokinetics and excretion of 14C-bendamustine in patients with relapsed or refractory malignancy. Drugs R D. 2013 Abstract
  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. Preiss R, Sohr R, Matthias M, Brockmann B, Hüller H. [The pharmacokinetics of bendamustine (Cytostasane) in humans]. Pharmazie. 1985 Abstract

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