Last update Aug. 23, 2021

L01XX14

High Risk

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

Retinoic acid form of vitamin A, with cytostatic effects.
Indicated, together with arsenic trioxide, in the treatment of acute promyelocytic leukemia.
Oral administration in two daily doses until complete remission or a maximum of 3 months.

At the date of the last update, there was no available published data on its excretion in breast milk.

Its pharmacokinetic data (very high percentage of protein binding, wide volume of distribution, low pKa and short half-life) make it unlikely that it will pass into breast milk in a clinically significant quantity.

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 94%, after 5 T½ 96.9%, after 6 T½ 98.4% and after 7 T½ 99%. Above 7 T½, plasma drug concentrations in the body are negligible. In general, a period of five half-lives can be considered a safe waiting period to return to breastfeeding (Anderson 2016).

Taking as reference the longest published T½ of all active metabolites (2 hours), these 5 T½ would correspond to 10 hours. Due to the significant adverse effects, it may be advisable to wait 7 T½, which would correspond to 14 hours. Meanwhile, express and discard breast milk regularly.

Breastfeeding must be discontinued during cancer treatment 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 mother and infant (Pistilli 2013). If the mother wishes, milk production can be maintained by regular expression of the breast, and lactation can be restored in periods when no significant traces of the drug remain in the milk (Anderson 2016) or at the end of treatment (Pistilli 2013).

Dosing every 12 hours and simultaneous treatment with other chemotherapeutic drugs make it very difficult to continue breastfeeding.

Breastfeeding has abundant sufficiently proven benefits for the health of the mother and the health and development of the infant. The risk-benefit assessment of breastfeeding during any maternal treatment, including chemotherapy, must be considered on an individual basis (Koren 2013).

Given the strong evidence that exists on the benefits of breastfeeding for the development of babies and the health of mothers, it is convenient 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:

  • Arsenic Trioxide (Very unsafe. Contraindicated. Use of an alternative or cessation of breastfeeding. Read the Comment.)
  • Tretinoin (topical use) ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

Alternatives

We do not have alternatives for L01XX14.

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

L01XX14 belongs to this group or family:

Tradenames

Main tradenames from several countries containing L01XX14 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 50 %
Molecular weight 300 daltons
Protein Binding > 95 %
VD 0.4 l/Kg
pKa 4.76 -
Tmax 1 - 2 hours
0.7 (0.5 - 2) hours

References

  1. AEMPS. Tretinoina (Vesanoid). Ficha técnica. 2020 Full text (in our servers)
  2. Anderson PO. Cancer Chemotherapy. Breastfeed Med. 2016 May;11:164-5. Abstract Full text (link to original source) Full text (in our servers)
  3. BC Cancer. Tretinoin (Vesanoid). Drug Summary. 2014 Full text (in our servers)
  4. 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
  5. 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)

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