Drug Notebook

FDA Alerts

  • Conventional paclitaxel: Anaphylaxis and severe hypersensitivity reactions (dyspnea and hypotension requiring treatment, angioedema, and/or generalized urticaria) reported. Fatal reactions reported despite premedication. Administer premedication (corticosteroids, diphenhydramine, histamine H2-receptor antagonists) to all patients. Do not administer paclitaxel to patients with a history of severe hypersensitivity reactions to the drug.
  • Paclitaxel should not be administered to patients with solid tumors with neutrophil counts <1500/mm3 or to patients with AIDS-related Kaposi’s sarcoma with neutrophil counts <1000/mm3. Monitor blood cell counts frequently.
  • Albumin-bound paclitaxel differs from conventional paclitaxel; do not substitute albumin-bound paclitaxel for conventional paclitaxel or vice versa.
  • 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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paclitaxel
(PAK li TAK sel)

What is paclitaxel?
Paclitaxel is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body. Paclitaxel is used to treat breast cancer, lung cancer, and ovarian cancer. It is also used to treat AIDS-related Kaposi's sarcoma. Paclitaxel may also be used for other purposes not listed in this medication guide.

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What are the possible side effects of paclitaxel?

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

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

  • slow heart rate;

  • seizure (black-out or convulsions);

  • pale skin, easy bruising or bleeding, unusual weakness;

  • fever, chills, body aches, flu symptoms;

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

  • numbness, tingling, or burning pain in your hands or feet;

  • increased blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats); or

  • warmth or redness under your skin.

Less serious side effects may include:

  • pain, swelling, redness, or skin color changes where the medicine was injected;

  • joint or muscle pain;

  • mild nausea, vomiting, diarrhea; or

  • hair loss.

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 paclitaxel given?
Paclitaxel is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 24 hours to complete. Paclitaxel is usually given every 3 weeks. Follow your doctor's instructions. Before your injection, you may be given other medications to help prevent a serious allergic reaction to paclitaxel. Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

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What is the most important information I should know about paclitaxel?
Do not use this medication 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. You should not be given this medication if you are allergic to paclitaxel, or to other medications that contain an ingredient called Cremophor EL (polyoxyethylated castor oil). This includes cyclosporine (Gengraf, Neoral, Sandimmune) and teniposide (Vumon). Before you receive paclitaxel, tell your doctor if you have liver disease, heart disease, or a severely weak immune system.

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What happens if I miss a dose?
Contact your doctor if you miss an appointment for your paclitaxel injection.

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What other drugs will affect paclitaxel?
There are many other medicines that can interact with paclitaxel. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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

Paclitaxel has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of low fertility and fetotoxicity in rats and evidence of maternal, embryo and fetotoxicity in rabbits. 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.

Animal studies have resulted in abortions, decreased corpora lutea, a decrease in implantations and live fetuses, and increased resorptions and embryo-fetal deaths.

There are no data on the excretion of paclitaxel 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 paclitaxel.

Animal studies have revealed that intravenous administration of carbon-14 labeled paclitaxel on days 9 to 10 postpartum, concentrations of radioactivity in milk were higher than in plasma and declined in parallel with the plasma concentrations.

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Who should NOT use this medication?

    Conventional Paclitaxel
  • Known hypersensitivity to paclitaxel, polyoxyl 35 castor oil (Cremophor® EL, polyethoxylated castor oil), or any other ingredient in the formulation.
  • Baseline neutrophil counts <1500/mm3 in patients with solid tumors.
  • Baseline neutrophil counts <1000/mm3 in patients with AIDS-related Kaposi’s sarcoma.
    Albumin-bound Paclitaxel
  • Baseline neutrophil counts <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 numbness or tingling, fever, chills, mouth sores, unusual bleeding or weakness, or any signs of infection.

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What should I discuss with my healthcare provider before receiving paclitaxel?
You should not be given this medication if you are allergic to paclitaxel, or to other medications that contain an ingredient called Cremophor EL (polyoxyethylated castor oil). This includes cyclosporine (Gengraf, Neoral, Sandimmune) and teniposide (Vumon). Before you receive paclitaxel, tell your doctor if you are allergic to any drugs, or if you have: liver disease; heart disease; or a severely weak immune system. If you have any of these conditions, you may need a dose adjustment or special tests to safely receive paclitaxel.

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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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