Last update Oct. 4, 2020

Trabectedin

Very High Risk

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

Trabectedin is an antineoplastic agent derived from marine tunicates. It is used in the treatment of soft tissue sarcomas and ovarian cancer.
It is administered as an intravenous infusion every 3 weeks.

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

Its pharmacokinetic data (large volume of distribution, moderately high molecular weight and high percentage of protein binding) make it unlikely that it will transfer into breastmilk in significant amounts.

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% is eliminated, 96.9% after 5 T½, 98.4% after 6 T½ and 99% after 7 T½. 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 as reference the longest reported T½ of all active metabolites, these 5 T½ would correspond to 38 days. Due to major adverse effects, it would be advisable to wait 7 T½, which would correspond to 53 days. Meanwhile, express and discard breastmilk regularly.

The time needed to suspend breastfeeding is the same as the frequency of treatment cycles (every 21 days), makes it practically impossible to continue breastfeeding.

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

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 regularly expressing breastmilk, and breastfeeding can occur in periods when there are no significant traces of the drug in breastmilk (Anderson 2016) or at the end of treatment (Pistilli 2013).

Some chemotherapeutic agents with antibiotic effects can alter the composition of the microbiota (group of bacteria or bacterial flora) in milk and the concentration of some of its components (Urbaniak 2014). This possibly occurs temporarily with subsequent recovery, without any harmful effects being recorded in breastfed infants.

Women in chemotherapy during pregnancy have lower breastfeeding rates due to difficulties with breastfeeding (Stopenski 2017), needing more support to achieve it.

Given the amount of evidence that exists on the benefits of breastfeeding for the development of babies and the health of mothers, it is advisable to assess 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 Trabectedin.

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

Trabectedin in other languages or writings:

  • ترابيكتيدين (Arabic)
  • Трабектедин (Cyrillic)
  • Trabectédine (French)
  • 曲贝替定 (Chinese)
  • トラベクテジン (Japanese)
  • (1′R,6R,6aR,7R,13S,14S,16R)-6′,8,14-Trihydroxy-7′,9-dimethoxy-4,10,23-trimethyl-19-oxo-3′,4′,6,7,12,13,14,16-octahydrospiro[6,16-(epithiopropanooxymethano)-7,13-imino-6aH-1,3-dioxolo[7,8]isoquino[3,2-b][3]benzazocine-20,1′(2′H)-isoquinolin]-5-yl acetate (Chemical name)
  • C39 H43 N3 O11 S (Molecular formula)
  • L01CX01 (ATC Code/s)

Group

Trabectedin belongs to this group or family:

Tradenames

Main tradenames from several countries containing Trabectedin in its composition:

Pharmacokinetics

Variable Value Unit
Molecular weight 762 daltons
Protein Binding 98 %
VD 71.4 l/Kg
180 hours

References

  1. FDA-Janssen. Trabectedin (Yondelis). Drug Summary. 2018 Full text (in our servers)
  2. AEMPS-Pharma Mar. Trabectedina (Yondelis). Ficha técnica. 2012 Full text (in our servers)

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