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U.S. Department of Health and Human Services


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Taxotere (docetaxel) injection concentrate

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


November 2014

Summary View


Alcohol Content
  • Cases of intoxication have been reported with some formulations of docetaxel due to the alcohol content. The alcohol content in a dose of TAXOTERE Injection may affect the central nervous system and should be taken into account for patients in whom alcohol intake should be avoided or minimized. Consideration should be given to the alcohol content in TAXOTERE Injection on the ability to drive or use machines immediately after the infusion. Each administration of TAXOTERE Injection at 100 mg/m2 delivers 2.0 g/m2 of ethanol. For a patient with a BSA of 2.0 m2, this would deliver 4.0 grams of ethanol [see Description (11)]. Other docetaxel products may have a different amount of alcohol.


December 2013

Summary View


Eye Disorders
  • Cystoid macular edema (CME) has been reported in patients treated with TAXOTERE, as well as with other taxanes. Patients with impaired vision should undergo a prompt and complete ophthalmologic examination. If CME is diagnosed, TAXOTERE treatment should be discontinued and appropriate treatment initiated. Alternative non-taxane cancer treatment should be considered.


Postmarketing Experiences
  • Opthalmologic: Cases of cystoid macular edema (CME) have been reported in patients treated with TAXOTERE, as well as with other taxanes
  • Metabolism and nutrition disorders: cases of hyponatremia have been ...


What are the possible side effects of TAXOTERE?

  • Cystoid Macular Edema (CME) is a painless eye disorder that can result in impaired vision.



June 2013

Summary View 


Post-Marketing Experiences
  • Respiratory: dyspnea, acute pulmonary edema, acute respiratory distress syndrome/pneumonitis, interstitial lung disease, interstitial pneumonia, respiratory failure, and pulmonary fibrosis have rarely been reported and may be associated with fatal outcome. Rare cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy.


May 2010

Summary View



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



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


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