Drug Notebook

FDA Alerts

    Treatment-related Mortality
  • Incidence of treatment-related mortality increased in patients with abnormal hepatic function, patients receiving higher doses, and patients with non-small cell lung carcinoma previously treated with platinum-based chemotherapy who received docetaxel monotherapy at a dose of 100 mg/m2. Approximately half of deaths reported in breast cancer patients occurred during the first cycle; most deaths were due to sepsis.
    Hepatic Impairment
  • Docetaxel should not be administered to patients with serum total bilirubin >ULN, or patients with serum AST and/or ALT >1.5 times ULN concurrent with alkaline phosphatase >2.5 times ULN. These patients are at increased risk for grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Increased risk for grade 4 febrile neutropenia, but not toxic death, in patients with isolated elevations of AST or ALT >1.5 times ULN.
  • Obtain and review bilirubin, AST, ALT, and alkaline phosphatase values prior to each cycle.
    Hematologic Monitoring
  • Docetaxel should not be administered to patients with neutrophil counts <1500/mm3.
  • Monitor blood cell counts frequently.
    Hypersensitivity
  • Severe hypersensitivity reactions (hypotension and/or bronchospasm, generalized rash/erythema) reported in patients who received the recommended 3-day dexamethasone premedication. Hypersensitivity reactions requiring discontinuance reported in patients who did not receive dexamethasone premedication. Hypersensitivity reactions resolved following discontinuance of the infusion and appropriate treatment.
  • Do not administer to patients with a history of severe hypersensitivity reactions to docetaxel or polysorbate 80.
    Fluid Retention
  • Severe fluid retention (poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, pronounced abdominal distention, ascites) reported in patients despite receiving the 3-day dexamethasone premedication.
    Experience of Supervising Clinician
  • Administer only under the supervision of qualified clinicians experienced in the use of cytotoxic therapy. Adequate diagnostic and treatment facilities should be readily available to manage complications.

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(doe se TAX el)

What is the most important information I should know about docetaxel?

Do not use this medication without your doctor's consent if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Before being treated with docetaxel, tell your doctor if you have ever been treated with cisplatin (Platinol), or if you have liver disease, congestive heart failure, fluid retention, swelling problems, or if you have ever had an allergic reaction to docetaxel.

Docetaxel can be harmful if it gets on your skin during an IV infusion. If this happens, wash the skin thoroughly with soap and warm water.

Some people receiving a docetaxel injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, warm, or itchy, or if you have chest tightness or trouble breathing during the injection.

Docetaxel can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.

Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection, especially fever.

There are many other drugs that can interact with docetaxel. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

What is docetaxel?

Docetaxel is a cancer medicine that slows the growth and spread of cancer cells in the body.

Docetaxel is used to treat breast cancer, lung cancer, prostate cancer, stomach cancer, and head/neck cancer.

Docetaxel may also be used for other purposes not listed in this medication guide.

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