Last update May 2, 2019

Clorhidrat de Gemcitabina

Very High Risk

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

An analogue of cytarabine, which is in turn a pyrimidine nucleoside analogue with antineoplastic properties, by inhibiting DNA synthesis and inducing apoptosis. It is metabolized into several metabolites, two of them active: diphosphate (CDP) and triphosphate (CTP). It is used in the treatment of pancreatic, lung, breast and bladder cancer, intravenously in various patterns depending on the location of the tumour, but spaced over at least 7 days.

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

Its pharmacokinetic data - low molecular weight, low protein-binding (Johnson 2000) - 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 (12 hours) as a reference, these 5 T½ would correspond to 2,5 days. Due to major side effects, it would be advisable to wait 7 T½, which would correspond to 3,5 days. 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 (Veltkamp 2008) 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 Clorhidrat de Gemcitabina.

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

Clorhidrat de Gemcitabina belongs to this group or family:

Tradenames

Main tradenames from several countries containing Clorhidrat de Gemcitabina in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 10 (5 - 17) %
Molecular weight 300 daltons
Protein Binding < 10 %
VD 0.9 - 9.1 l/Kg
pKa 3.6 -
Tmax 0.5 hours
5 - 12 (metab.CTP: 19.4) hours

References

  1. BC Cancer. Gencitabine. Drug Summary. 2018 Full text (in our servers)
  2. AEMPS. Gemcitabina. Ficha técnica. 2017 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. 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. 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. Veltkamp SA, Jansen RS, Callies S, Pluim D, Visseren-Grul CM, Rosing H, Kloeker-Rhoades S, Andre VA, Beijnen JH, Slapak CA, Schellens JH. Oral administration of gemcitabine in patients with refractory tumors: a clinical and pharmacologic study. Clin Cancer Res. 2008 Jun 1;14(11):3477-86. Abstract
  9. Johnson SA. Clinical pharmacokinetics of nucleoside analogues: focus on haematological malignancies. Clin Pharmacokinet. 2000 Abstract

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