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U.S. Department of Health and Human Services

Safety

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Docetaxel Injection Solution for Intravenous Infusion, 10 mg/mL, 20 mg/12mL, 80 mg/8mL, and 160 mg/16mL

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

 

July 2014

Summary View

WARNINGS AND PRECAUTIONS

Hematologic Effects
  • …In gastric cancer patients treated with docetaxel in combination with cisplatin and fluorouracil (TCF), febrile neutropenia and/or neutropenic infection occurred in 12% of patients receiving G-CSF compared to 28% who did not. Patients receiving TCF should be closely monitored during the first and subsequent cycles for febrile neutropenia and neutropenic infection
Eye Disorders
  • Cystoid macular edema (CME) has been reported in patients treated with Docetaxel. Patients with impaired vision should undergo a prompt and comprehensive ophthalmologic examination. If CME is diagnosed, Docetaxel treatment should be discontinued and appropriate treatment initiated. Alternative non-taxane cancer treatment should be considered.
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 Docetaxel 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 Docetaxel Injection on the ability to drive or use machines immediately after the infusion. Each administration of Docetaxel Injection at 100 mg/m2 delivers 1.8 g/m2 of ethanol. For a patient with a BSA of 2.0m2, this would deliver 3.6 grams of ethanol [see Description (11)]. Other docetaxel products may have a different amount of alcohol.

ADVERSE REACTIONS

*Tables 10 and 11 added*

Post-Marketing Experiences
  • Respiratory: …pneumonitis,….interstitial lung disease…. respiratory failure and pulmonary fibrosis…. may be associated with fatal outcome...
  • Metabolism and Nutrition Disorders- Cases of hyponatremia have been reported.

USE IN SPECIFIC POPULATIONS

Pediatric Use

*Entire Section updated*

Geriatric Use

*Sections added for “Gastric Cancer” and “Head and Neck Cancer”

Hepatic Impairment
  • …The alcohol content of Docetaxel Injection should be taken into account when given to patients with hepatic impairment

PATIENT COUNSELING INFORMATION

  • Explain to patients the possible effects of the alcohol content in Docetaxel Injection, including possible effects on the central nervous system. Patients in whom alcohol should be avoided or minimized should consider the alcohol content of Docetaxel Injection. Alcohol could impair their ability to drive or use machines immediately after infusion.

PATIENT INFORMATION

Docetaxel Injection is a prescription anti-cancer medicine used to treat certain people with:

  • …stomach cancer
  • head and neck cancer

-…You should not become pregnant during treatment with Docetaxel Injection. Talk to your doctor about effective birth control while receiving Docetaxel Injection

What are the possible side effects of Docetaxel Injection

  • Vision Problems including blurred vision or loss of vision.
  • Docetaxel Injection contains alcohol. The alcohol content in Docetaxel Injection may impair your ability to drive or use machinery right after receiving Docetaxel Injection. Consider whether you should drive, operate machinery or do other dangerous activities right after you receive Docetaxel Injection treatment. 

 

April 2014

Summary View

ADVERSE REACTIONS

Post Marketing Experience

Respiratory

  • added ..... description of safety events: dyspnea, acute pulmonary edema, acute respiratory distress syndrome/pneumonitis, interstitial lung disease, interstitial pneumonia, respiratory failure, and pulmonary fibrosis