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U.S. Department of Health and Human Services

Safety

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Taxotere (docetaxel) injection concentrate

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May and April 2010

 

May 2010 Summary View

 

USE IN SPECIAL POPULATIONS

Pediatric Use
  • The overall safety profile of Taxotere in pediatric patients receiving monotherapy or TCF was consistent with the known safety profile in adults.
  • Taxotere has been studied in a total of 289 pediatric patients: 239 in 2 trials with monotherapy and 50 in combination treatment with cisplatin and 5-fluoruracil (TCF).
  • Taxotere Monotherapy Taxotere monotherapy was evaluated in a dose-finding phase 1 trial in 61 pediatric patients (median age 12.5 years, range 1-22 years) with a variety of refractory solid tumors. The recommended dose was 125 mg/m2 as a 1-hour intravenous infusion every 21 days. The primary dose limiting toxicity was neutropenia.
  • The recommended dose for Taxotere monotherapy was evaluated in a phase 2 single-arm trial in 178 pediatric patient (median age 12 years, range 1-26 years) with a variety of recurrent/refractory solid tumors. Efficacy was not established with tumor response rates ranging from one complete response (CR) (0.6%) in a patient with undifferentiated sarcoma to four partial responses (2.2%) seen in one patient each with Ewing Sarcoma, neuroblastoma, osteosarcoma, and squamous cell carcinoma.
  • Taxotere in Combination Taxotere was studied in combination with cisplatin and 5-fluorouracil (TCF) versus cisplatin and 5-fluorouracil (CF) for the induction treatment of nasopharyngeal carcinoma (NPC) in pediatric patients prior to chemoradiation consolidation. Seventy-five patients...
  • Pharmacokinetics: Pharmacokinetic parameters for docetaxel were determined in 2 pediatric solid tumor trials.
    Following docetaxel administration...

 

April 2010 Summary View

 

ADVERSE REACTIONS

Post-marketing Experiences
  • Cutaneous: Scleroderma-like changes usually preceded by peripheral lymphedema
  • Renal: renal failure have been reported, the majority of these cases were associated with concomitant nephrotoxic drugs

DRUG INTERACTIONS

The exposure of docetaxel increased 2.2-fold when it was coadministered with ketoconazole, a potent inhibitor of CYP3A4.  Protease inhibitors, particularly ritonavir, may increase the exposure of docetaxel. Concomitant use of Taxotere and drugs that inhibit CYP3A4 may increase exposure to docetaxel and should be avoided. In patients receiving treatment with Taxotere, close monitoring for toxicity and a Taxotere dose reduction could be considered if systemic administration of a potent CYP3A4 inhibitor cannot be avoided

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