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)

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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What are the possible side effects of docetaxel?

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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How is docetaxel used?
Docetaxel is given as an injection through a needle placed into a vein. You will receive this medicine in a clinic or hospital setting. Docetaxel must be given slowly through an IV and it may take up to an hour to complete your dose. Your doctor may prescribe a steroid medicine for you to take for a few days before your injection. This will help prevent swelling or an allergic reaction to docetaxel. Do not miss any doses of the steroid. Docetaxel must be given slowly through an IV and it may take up to an hour to complete your dose.

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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.

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What happens if I miss a dose?
Call your doctor for instructions if you miss a dose of docetaxel or the steroid medicine.

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What other drugs will affect docetaxel?
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.

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Docetaxel has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryotoxicity and fetotoxicity in rabbits and rats. There are no controlled data in human pregnancy. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus or potential risk for loss of the pregnancy. Women of childbearing potential should be advised to avoid becoming pregnant during therapy. Docetaxel should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Decreased testicular weights were reported in rats when docetaxel was administered in multiple intravenous doses up to 0.3 mg/kg (approximately 1/50th the recommended human dose on a mg/m2 basis). A 10-cycle toxicity study in rats (5 mg/kg) and dogs (0.375 mg/kg) showed testicular atrophy or degeneration. An increased frequency of dosing in rats also produced similar effects at lower dose levels.

There are no data on the excretion of docetaxel into human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, mothers should discontinue nursing prior to administration of docetaxel.

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Who should NOT use this medication?

  • Known hypersensitivity to docetaxel, polysorbate 80, or any other ingredient in the formulation.
  • Baseline neutrophil count <1500/mm3.

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What happens if I overdose?
Seek emergency medical attention if you think you have received too much of this medicine. Overdose symptoms may include fever, chills, body aches, flu symptoms, numbness, burning, pain, or tingly feeling, or white patches or sores inside your mouth or on your lips.

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What should I discuss with my healthcare provider before using docetaxel?
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 or swelling problems; or if you have ever had an allergic reaction to docetaxel. If you have any of these conditions, you may need a dose adjustment or special tests to safely receive docetaxel. FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use docetaxel without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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