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Does Ketoconazole Interact with Trabectedin?

Ketoconazole and Trabectedin have a major drug interaction according to U.S. FDA drug labeling data. 7 DRUG INTERACTIONS CYP3A inhibitors: Avoid concomitant strong CYP3A inhibitors ( 7.1 ) CYP3A inducers: Avoid concomitant strong CYP3A inducers ( 7.2 ) 7.1 Effect of Cytochrome CYP3A Inhibitors Coadministration of YONDELIS with ketoconazole, a strong CYP3A inhibitor, increased systemic exposure of trabectedin by 66%. Avoid using strong CYP3A inhibitors (e.g., oral ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, indinavir, lopinavir, ritonavir, boceprevir, nelfinavir, saquinavir, telaprevir, nefazodone, conivaptan) in patients taking YONDELIS. Drug Interactions Effect of Strong CYP3A Inhibitors on Trabectedin Coadministration of multiple doses of ketoconazole (200 mg twice daily for 7.5 days) with a single dose of YONDELIS (0.58 mg/m 2 ) on day 1 increased trabectedin dose-normalized AUC by 66% and C max by 22% compared to a single YONDELIS dose (1.3 mg/m 2 ) given alone. Patients taking both medications should consult their healthcare provider before starting, stopping, or changing the dosage of either drug. This information is based on official FDA drug labeling sourced from OpenFDA and the NIH National Library of Medicine.

Severity
Major
Ketoconazole Class
Azole Antifungal
Trabectedin Class
Alkylating Drug
Management
Close medical supervision required
Data Source
U.S. FDA via OpenFDA

What To Tell Your Doctor or Pharmacist

If you are taking Ketoconazole and your doctor is considering prescribing Trabectedin (or vice versa), make sure to:

  • Inform your doctor and pharmacist of all current medications, including over-the-counter drugs and supplements
  • Ask whether the benefits of combining these medications outweigh the risks for your specific situation
  • Ask what symptoms to watch for that would indicate the interaction is causing problems
  • Ask how frequently you should be monitored while these are co-prescribed
  • Ask whether any dosage adjustments are needed
  • Never stop or change either medication without first consulting your healthcare provider
💊 Ketoconazole(T8 Keto Flush)+💊 Trabectedin(Yondelis)

Severity & Interaction Details

⚠️
major
Use with caution — major interaction
Serious risk of clinically significant harm. Generally avoid; if used, monitor closely.
Severity scale
MinorContra
On record
Yes
Drug A class
Azole Antifungal
Drug B class
Alkylating Drug
Source
FDA drug label - trabectedin

What this means in plain English

7 DRUG INTERACTIONS CYP3A inhibitors: Avoid concomitant strong CYP3A inhibitors ( 7.1 ) CYP3A inducers: Avoid concomitant strong CYP3A inducers ( 7.2 ) 7.1 Effect of Cytochrome CYP3A Inhibitors Coadministration of YONDELIS with ketoconazole, a strong CYP3A inhibitor, increased systemic exposure of trabectedin by 66%. Avoid using strong CYP3A inhibitors (e.g., oral ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, indinavir, lopinavir, ritonavir, boceprevir, nelfinavir, saquinavir, telaprevir, nefazodone, conivaptan) in patients taking YONDELIS. Drug Interactions Effect of Strong CYP3A Inhibitors on Trabectedin Coadministration of multiple doses of ketoconazole (200 mg twice daily for 7.5 days) with a single dose of YONDELIS (0.58 mg/m 2 ) on day 1 increased trabectedin dose-normalized AUC by 66% and C max by 22% compared to a single YONDELIS dose (1.3 mg/m 2 ) given alone.

About Ketoconazole and Trabectedin

Ketoconazole is an Azole Antifungal, while Trabectedin is an Alkylating Drug. You may recognize them by the brand names Ketodan and Yondelis. Ketoconazole is taken by mouth, whereas Trabectedin is given by intravenous (IV) infusion. Ketoconazole additionally carries an FDA boxed warning, the FDA's strongest safety alert.

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Data integrity: Every interaction shown is extracted directly from official U.S. FDA drug labeling via openFDA and the U.S. National Library of Medicine (NIH) — no interactions are invented, inferred, or manually edited. Maintained by CheckDrugInteractions.com. See our methodology or report a correction at support@checkdruginteractions.com.

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine, supplemented with a small number of well-established interactions from curated clinical references. For informational purposes only. Always consult your pharmacist or physician.