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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docetaxel
(doe se TAX el)

Do not receive "live" vaccines during treatment with docetaxel. Administration of a live vaccine may be dangerous during treatment with docetaxel.

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.

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.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • easy bruising or bleeding, unusual weakness;

  • feeling like you might pass out;

  • fever, chills, body aches, flu symptoms;

  • severe diarrhea;

  • skin changes or bruising where the IV was placed;

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • feeling short of breath, even with mild exertion;

  • swelling of your ankles or feet, weight gain;

  • a red, blistering, peeling skin rash; or

  • numbness, burning, pain, or tingly feeling.

Less serious side effects may include:

  • feeling weak or tired;

  • white patches or sores inside your mouth or on your lips;

  • mild nausea, vomiting, diarrhea, constipation, or loss of appetite;

  • watery eyes;

  • changes in menstrual periods;

  • temporary hair loss; or

  • fingernail or toenail changes.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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