Monograph
L01CX01 - Trabectedin |
Propably not porphyrinogenic |
PNP |
Rationale
Probably insignificant hepatic exposure. No capacity for CYP-induction or irreversible CYP-inhibition. Side effects such as nausea, anorexia and vomiting may be potentially porphyrinogenic through reduction in caloric intake.
Chemical description
A tetrahydro-isoquinoline originally extracted from the marine tunicate Ectinascidia turbinata, now manufactured synthetically.
Therapeutic characteristics
Trabectedin is a DNA-binding agent used for the treatment of advanced soft-tissue sarcomas. Administered as an intravenous infusion. Common adverse reactions of trabectedin that can be confused with an acute porphyric attack are vomiting, nausea, obstipation, abdominal pain, peripheral neuropathy, paraesthesia and insomnia. Side effects such as nausea, anorexia and vomiting may be potentially porphyrinogenic through reduction in caloric intake.
Hepatic exposure
Therapeutic plasma levels are typically less than 10 nM (EMEA, 2007), therefore hepatic exposure is insignificant.
Metabolism and pharmacokinetics
Trabectedin is oxidatively metabolized primarily by CYP 3A4. Other P450 enzymes may contribute to metabolism. Trabectedin does not induce or inhibit major cytochrome P450 enzymes.
References
# | Citation details | PMID |
---|---|---|
* | Drug reference publications | |
1. | Sweetman SC, editor. Martindale: The complete drug reference. Trabectedin. Pharmaceutical Press 2009.
|
|
* | Government bodies | |
2. | EMEA. Trabectedin:
scientific discussion. 2007. http://www.ema.europa.eu/humandocs/PDFs/EPAR/yondelis/H-773-en6.pdf. |
|
* | Summary of Product Characteristics | |
3. | Norwegian medicines agency. Summary of Product Characteristics (SPC). Yondelis.
|
Similar drugs
Tradenames and packages
From some sources, we get a list of packages (United Kingdom, Ireland, Estonia).
Other sources contain more or less "clean" versions of the trade name (Denmark, Finland, Iceland, Lithuania, Norway).
What you see here is the raw data we get from each country, so there will appear to be duplicates. The bold names
are the searchable terms. The gray names that follow are all mapped to the bolded term.
Note: The cleaning is done automatically by a proprietary algorithm, and it may produce errors.
We strive to improve it continuously.
Netherlands
Trabectedine · Trabectedine EVER Pharma 0,25 mg, poeder voor concentraat voor oplossing voor infusie · Trabectedine EVER Pharma 1 mg, poeder voor concentraat voor oplossing voor infusie · Trabectedine Teva 0,25 mg, poeder voor concentraat voor oplossing voor infusie · Trabectedine Teva 1 mg, poeder voor concentraat voor oplossing voor infusie · Yondelis · Yondelis 0.25 mg, poeder voor concentraat voor oplossing voor infusie · Yondelis 1 mg, poeder voor concentraat voor oplossing voor infusieBelgium
Trabectedin · Trabectedin EG 0.25 mg sol. perf. (pdr., à diluer) i.v. flac. · Trabectedin EG 1 mg sol. perf. (pdr., à diluer) i.v. flac. · Trabectedin Ever Pharma 0.25 mg sol. perf. (pdr., à diluer) i.v. flac. · Trabectedin Ever Pharma 1 mg sol. perf. (pdr., à diluer) i.v. flac. · Trabectedine · Trabectedine Sun 0.25 mg sol. perf. (pdr., à diluer) i.v. flac. · Trabectedine Sun 1 mg sol. perf. (pdr., à diluer) i.v. flac. · Trabectedine Teva 0.25 mg sol. perf. (pdr., à diluer) i.v. flac. · Trabectedine Teva 1 mg sol. perf. (pdr., à diluer) i.v. flac. · Yondelis · Yondelis 0.25 mg sol. perf. (pdr., à diluer) i.v. flac. · Yondelis 1 mg sol. perf. (pdr., à diluer) i.v. flac.United Kingdom
Trabectedin · Trabectedin 1mg powder for solution for infusion vials · Trabectedin 250microgram powder for solution for infusion vials · Yondelis · Yondelis 0.25mg powder for concentrate for solution for infusion vials · Yondelis 1mg powder for concentrate for solution for infusion vialsDenmark
Trabectedin · Trabectedin "Teva" · Trabektedin · Trabektedin "Sun" · YondelisNorway
Trabectedin EVER Pharma · YondelisPoland
Trabectedin EVER PHARMA · YondelisLuxembourg
Trabectedin · Trabectedin EG · Trabectedine · Trabectedine Teva · YONDELISIceland
YondelisFinland
Trabectedin EVER Pharma · Trabectedin STADA · YondelisLatvia
Yondelis
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