Taxotere

Docetaxel, sold under the brand name Taxotere, treats cancers of the breast, lung, prostate, stomach, head and neck. It is one of the most popular drugs doctors use to treat breast cancer, and studies show it extends survival and stops tumors from spreading. However, it is also highly toxic and causes a number of side effects.

Taxotere 160mg/8ml Box
Taxotere Facts
  1. Active Ingredient Docetaxel
  2. Used to Treat Cancers of the breast, lung, prostate, stomach, head and neck
  3. Interactions Cytochrome P450 3A4 (CYP3A4) inducers, inhibitors or substrates
  4. Related Drugs Abraxane and Taxol
  5. Manufacturer Sanofi-Aventis US LLC
  6. Black Box Warnings Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions and fluid retention
  7. FDA Approval Status Initial approval in 1996

Taxotere is a chemotherapy drug made by Sanofi-Aventis. It belongs to a drug class called taxanes. Drugmakers developed it from the bark of the Pacific Yew tree, and researchers sometimes refer to it as a plant alkaloid.

The U.S. Food and Drug Administration originally approved the drug in 1996. It treats several types of tumors, including breast, lung, stomach, prostate, and head and neck cancer. Doctors may prescribe the drug alone or with other chemotherapy drugs.

Although the medication is available in a generic version, docetaxel, sales of the brand-name drug are still going strong. It is available in 90 countries and is approved for 11 different indications in five tumor types, according to Sanofi’s 2017 annual report.

Pacific Yew Tree
Taxotere is made from bark of the Pacific Yew tree.

In clinical studies, researchers found Taxotere increased survival and increased the time it took for tumors to progress compared to other drugs, including mitomycin/vinblastine and doxorubicin, according to the drug’s label.

Because the active ingredient, docetaxel, is a strong chemotherapy drug, it also has a long list of side effects. Most of them are typical for drugs in this class, such as nausea, vomiting and temporary alopecia (hair loss).

But some studies have linked the drug to long-term hair loss. Thousands of breast cancer survivors have filed lawsuits against Sanofi that claim the drugmaker did not warn them of the risk of permanent alopecia.

How Does Docetaxel Work?

Cancer cells are dangerous because they are abnormal cells that continue to divide and multiply. Chemotherapy drugs work by stopping cancer cells from dividing. Specifically, Taxotere works by “freezing” microtubules in a cancer cell, according to Sanofi’s 2017 annual report.

Microtubules are building blocks of the cell’s skeleton. During a cell’s growth cycle, microtubules assemble and disassemble. The medication blocks this process and prevents a cell from dividing, and this eventually kills the cell. Each type of cancer cell has its own rate of dividing, and doctors give chemotherapy in cycles to interrupt the cell division cycle.

Diagram showing chemo drugs attacking cancer cells.
Expand
Chemotherapy drugs like Taxotere stop cancer cells from dividing.

What to Expect During Treatment

Health care providers administer Taxotere through an IV for one hour ever three weeks, according to the drug’s label. Depending on the type of cancer, this can continue for several cycles.

Because the medication can cause serious allergic reactions, patients receive oral corticosteroids to minimize swelling, rashes and other reactions during treatment. Doctors may begin corticosteroid therapy a few days before chemotherapy.

The drug’s label cautions that patients should only receive the drug in a facility equipped to manage complications such as anaphylaxis, which may cause difficulty breathing, shock or vomiting. Depending on the severity of side effects, doctors may adjust the dose.

Dosages and Treatment Schedules

Taxotere has several different dosages and strengths specific to the type of cancer it’s treating. Sometimes, doctors may combine the drug with another chemotherapy drug. This is called adjuvant therapy.

The medication comes in single use vials of 20/mg/mL and 80 mg/4 mL. Doctors tailor the dose to each patient.

Dosages and administration per the medication label:
Locally advanced or metastatic breast cancer:
60 mg/m2 to 100 mg/m2 single agent
Breast cancer adjuvant therapy with other chemotherapy drugs:
75 mg/m2 administered 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every three weeks for six cycles
Non-small cell lung cancer after platinum therapy failure:
75 mg/m2 single agent
Non-small cell lung cancer in people who have never had chemotherapy:
75 mg/m2 followed by cisplatin 75 mg/m2 
Castration-resistant prostate cancer:
75 mg/m2 with 5 mg prednisone twice a day continuously
Gastric cancer:
75 mg/m2 followed by cisplatin 75 mg/m2 (both on day one only) followed by fluorouracil 750 mg/m2 per day as a 24-hour IV (days one to five), starting at end of cisplatin infusion
Squamous cell carcinoma of the head and neck:
75 mg/m2 followed by cisplatin 75 mg/m2 IV (day one), followed by fluorouracil 750 mg/m2 per day as a 24-hour IV (days one to five), starting at end of cisplatin infusion; for four cycles
Squamous cell carcinoma of the head and neck:
75 mg/m2 followed by cisplatin 100 mg/m2 IV (day one), followed by fluorouracil 1000 mg/m2 per day as a 24-hour IV (days one to four); for three cycles

Alternative Treatment Schedules

Doctors have experimented with different treatment schedules for docetaxel in order to decrease toxicity and increase effectiveness. But, one of the problems with the drug is that toxicity and efficacy can be difficult to predict, according to Dr. F.K. Engels and colleagues at the Department of Medical Oncology in the Daniel den Hoed Cancer Center in the Netherlands. They published their findings in the British Journal of Cancer.

Researchers tried weekly treatment schedules. While they found acute toxicities were milder, they found cumulative side effects such as fatigue and physical weakness were more prominent. In the end, they concluded Taxotere treatment every three weeks had been the most convenient schedule.

Side Effects and Warnings

The list of common Taxotere side effects is long, and some reactions to the drug are serious. The most common side effects are low white and red blood cell counts. In clinical trials these occurred in more than 30 percent of patients, according to Chemocare.

The drug carries a black box warning for toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions and fluid retention. Even with corticosteroid premedication, there have been reports of severe allergic reactions to the medication.

Alcohol in the drug can affect the central nervous system and cause patients to feel drunk. The medication can harm unborn babies, and women should not get pregnant during treatment.

Common side effects include:
  • Infections
  • Neutropenia (with or without infection and fever)
  • Anemia
  • Hypersensitivity
  • Neuropathy
  • Difficulty breathing
  • Constipation
  • Anorexia
  • Fluid retention
  • Nausea
  • Diarrhea
  • Vomiting
  • Skin reactions
  • Body pain
  • Hair loss

Drug Interactions

Some drugs can affect the way the body processes docetaxel. Severe toxic reactions can occur if docetaxel exposure increases.

In studies, dugs that inhibit an enzyme called CYP3A4 are especially troublesome for Taxotere patients. CYP3A4 helps the body get rid of toxins and processes medications, and if this enzyme is inhibited, a drug can build up in the body and cause reactions.

For example, one study showed ketoconazole, a potent inhibitor of CYP3A4, reduced the body’s ability to clear docetaxel by nearly 50 percent. Protease inhibitors like ritonavir may also cause issues. The medication label recommends avoiding these drugs.

Herbs and Supplements

People who receive chemotherapy drugs often develop nutritional deficiencies and suffer serious side effects. There is little information on how herbs, vitamins and minerals may interact with Taxotere, but the University of Michigan offers the following information on beneficial supplements for patients to replenish nutrients, reduce side effects and make the medicine more effective.

Replenish nutrients:
  • Calcium
  • Lactobacillus GG
  • Magnesium and Potassium
  • N-Acetyl Cysteine
  • Phosphate
  • Spleen Peptide Extract
  • Taurine
Support medicine:
  • Milk Thistle
  • Wheat Grass
  • Melatonin
  • Antioxidants
  • PSK
  • Thymus Extracts
  • Vitamin A, Vitamin C, and N-Acetyl Cysteine
Lessen side effects:
  • Acetyl-L-Carnitine
  • Beta-Carotene
  • Calcium and Magnesium
  • Chamomile
  • Eleuthero
  • Fruit-Flavored Drinks
  • Ginger
  • Glutamine
  • Glutathione
  • Melatonin
  • N-Acetyl Cysteine
  • Probiotics
  • Selenium
  • Spleen Peptide Extract
  • Thymus Extracts
  • Vitamin B6
  • Wheat Grass
  • Zinc

Taxotere Versus Taxol

According to studies, Taxotere showed more benefits to survival than Taxol (paclitaxel), another chemotherapy drug in the same class. Researchers also found docetaxel was more cost effective.

Docetaxel breast cancer patients survived almost three months longer than patients who took paclitaxel, according to Dr. T. Vu and other doctors at the Provincial Systemic Therapy Program in British Columbia, Canada.

“This population-based study corroborated the randomized trial’s conclusion that for patients with metastatic breast cancer, docetaxel provided superior survival compared with paclitaxel,” the study’s authors wrote in Annals of Oncology in March 2008.

Also, compared to weekly therapy with paclitaxel, docetaxel therapy every three weeks was more cost effective for metastatic breast cancer patients. The costs of adverse event management, cancer progression and supportive care were double for paclitaxel patients, according to a study by Spanish researchers publish in Clinical Translational Oncology in October 2010.

Please seek the advice of a medical professional before making health care decisions.

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Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By
Medically Reviewed By
Dr. Don Hill
Dr. Don Hill Internal Medicine & Oncology

9 Cited Research Articles

  1. American Cancer Society. (n.d.). Chemotherapy for Breast Cancer. Retrieved from https://www.cancer.org/cancer/breast-cancer/treatment/chemotherapy-for-breast-cancer.html
  2. Chemocare. (n.d.). Docetaxel. Retrieved from http://chemocare.com/chemotherapy/drug-info/docetaxel.aspx
  3. DailyMed. (2018, October 6). Taxotere. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45e6dce4-92e2-4ad1-bf11-bbcefb753636&audience=consumer#section-7
  4. Engels, F.K. et al. (2005). Potential for improvement of docetaxel-based chemotherapy: a pharmacological review. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2361544/
  5. Frias, C. et al. (2010, October). Cost-effectiveness analyses of docetaxel versus paclitaxel once weekly in patients with metastatic breast cancer in progression following anthracycline chemotherapy, in Spain. Clinical Translational Oncology. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/20947484
  6. Sanofi. (2017). 2017 Annual Report. Retrieved from http://www.annualreports.com/HostedData/AnnualReports/PDF/NYSE_SNY_2017.pdf
  7. Sanofi. (2017, April 28). Sanofi Delivers Robust Q1 2017 Financial Results. Retrieved from https://mediaroom.sanofi.com/en/press-releases/2017/sanofi-delivers-robust-q1-2017-financial-results/
  8. University of Michigan. (n.d.). Docetaxel. Retrieved from https://www.uofmhealth.org/health-library/hn-1360005
  9. Vu, T. et al. (2008, March). Survival outcome and cost-effectiveness with docetaxel and paclitaxel in patients with metastatic breast cancer: a population-based evaluation. Annals of Oncology. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/18006892
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