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Taxotere

Taxotere (docetaxel) is a chemotherapy drug sold by Sanofi-Aventis. It was initiallyoriginally approved by the U.S. Food and Drug Administration in 1996. Since then, the agency approved the drug to treat a variety of cancers. It is one of the most popular drugs used to treat breast cancer.

Taxotere 160mg/8ml Box

Dosage: 20 mg/ 2 ml 80 mg/ 8 ml 160 mg/ 16 ml; Multi-dose vial

Used to Treat: Cancer

Interactions: Cytochrome P450 3A4 (CYP3A4) inducers, inhibitors or substrates

Related Drugs: Abraxane and Taxol

Manufacturer: Sanofi-Aventis US LLC

Black Box Warnings: Toxic deaths; hepatotoxicity, neutropenia, hypersensitivity reactions ) and fluid retention.

Active Ingredient: Docetaxel

FDA Approval Status: Initial approval in 1996

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*Please seek the advice of a medical professional before discontinuing the use of this drug.

About 3 million women in the U.S. are living with breast cancer, according to Breastcancer.org. In 2017, over 300,000 women are expected to be diagnosed with the disease. Oncologists use Taxotere in a vast majority of breast cancer patients. Some sources state that up to 75 percent of these women will receive Taxotere as a form of treatment. According to Sanofi, the drug is the most prescribed in its class.

In studies, Taxotere performed better than other drugs in extending survival of breast cancer patients. However, the drug may also have a distressing side effect for breast cancer survivors: permanent hair loss, also called alopecia. In women, this side effect is particularly disfiguring.

In studies, Taxotere performed better than other drugs in extending survival of breast cancer patients. However, the drug may also have a distressing side effect for breast cancer survivors: permanent hair loss, also called alopecia. In women, this side effect is particularly disfiguring.

In addition to hair loss, Taxotere has also been linked to toxic deaths and other potentially life-threatening side effects. In 2014, the FDA also issued a safety communication about the potential for patients to experience intoxication during or following the administration of Taxotere due to the alcohol content in the drug’s active ingredient docetaxel.

Taxotere and Cancer Growth

Taxotere is indicated to treat various types of cancer, including breast cancer, non-small cell lung cancer (NSCLC), prostate cancer, gastric adenocarcinoma (stomach cancer), and head and neck cancer. Its earliest FDA-approval was for the treatment of NSCLC in 1999. Prostate and breast cancer approvals followed in 2004, with stomach, head and neck cancers obtaining approval for treatment with Taxotere in 2006.

Breast cancer diagram
Diagram showing build up of cells causing a malignant tumor

Cancer is the name given to a collection of related diseases where the body’s cells begin to divide without stopping and spread into surrounding tissues, according to the National Institutes of Health (NIH). This phenomenon can occur most anywhere in the human body as it is made up of trillions of cells.

In a noncancerous framework, the body’s cells grow and divide to form new cells as they become needed. The old or damaged cells then die off so the new cells can take their place. With cancer, this process breaks down, as old or damaged cells remain alive when they should otherwise die, and new cells continue to form when they’re not needed. As these extra cells begin to divide they can form growths called tumors.

Cancerous tumors are called malignant, meaning they can spread into, or invade, nearby tissues. Some cancer cells can also break off and travel through the blood or the lymphatic system (a part of the circulatory system and a vital part of the immune system that protects against disease) forming new tumors distant from the original one.

Spreading of Cancer

When cancer has spread to different areas of the body it is called metastatic cancer.

In patients with breast cancer, Taxotere is indicated to treat those cases which are locally advanced or metastatic after failure of prior chemotherapy. Taxotere is also used as an adjuvant (a substance that aids another or modifies the effect of other agents) treatment in patients with operable node-positive breast cancer (meaning it has been found in the lymph nodes in the armpit area) in combination with doxorubicin and cyclophosphamide.

How Does Taxotere Work?

Like other types of chemotherapy drugs, Taxotere works by stopping cells from dividing and multiplying. Normal, healthy cells stop dividing when they are around similar cells. Cancer cells are damaged and no longer have the ability to stop dividing. This is how cancer continues to spread. Chemotherapy drugs like Taxotere attack the cancer cells’ DNA or RNA so the tumor can no longer copy itself and spread.

Along with another chemo drug called Paclitaxel, Taxotere belongs to a specific class of drug called a taxane. Taxanes are made from plant alkaloids. Specifically, Taxotere is made from the bark of the Pacific Yew tree. It works by inhibiting microtubules within cancer cells. Microtubules are necessary for cell division and replication. When the cell can no longer divide or replicate, it dies.

Pacific Yew Tree
Both Paclitaxel and Taxotere are made from bark that is found on the Pacific Yew tree

Side Effects of Taxotere

In addition to the risk of permanent hair loss, this drug has a number of other side effects associated with its use. Many of these are reversible, though in some cases these complications can result in death.

The following side effects occurred in more than 30 percent of patients:

  • Diarrhea
  • Fatigue and weakness
  • Fluid retention
  • Hair loss
  • Infections
  • Mouth sores
  • Nail changes (nails may discolor or fall off)
  • Nausea
  • Peripheral neuropathy (numbness, tingling in fingers and toes usually associated with nerve damage)
  • Muscle, joint or bone pain*
  • Low platelets*
  • Liver problems*
*Occurs in 10 to 29 percent of patients

Toxic death occurred in about 2 percent (19 out of 965) of metastatic breast cancer patients using Taxotere, according to Warnings and Precautions section of the medication insert. The deaths occurred at a dose of 100 mg/m2. Death occurred in 11.5 percent (7 out of 61) of patients with other tumor types with abnormal liver function.

FDA Black Box Warning on Taxotere

Taxotere includes a black box warning (or boxed warning), the FDA’s most serious type of warning, for several conditions that can result in serious injury or death for patients given the chemotherapy drug.

These conditions include:

Toxic Deaths

The label advises that treatment-related deaths increase with abnormal liver function, at higher doses, and in patients with non-small cell lung cancer (NSCLC) and prior platinum-based therapy (a specific class of cytotoxic chemotherapy drugs derived from the element platinum) recipients receiving Taxotere at 100 mg/m2.

Hepatotoxicity (from hepatic – or liver – toxicity)

This condition implies chemical-driven liver damage. Certain medications, such as Taxotere, when taken in overdoses or sometimes when taken within therapeutic dosing ranges, can injure the liver. The label advises that administering the drug to patients with elevated LFT (or liver function test) levels can increase the risk of severe or life-threatening complications; and further, that LFTs should be obtained before each treatment cycle.

Neutropenia

An abnormally low concentration of neutrophils (a type of white blood cell) in the blood characterizes this condition, causing patients to become more susceptible to bacterial infections that, without immediate medical treatment, can become fatal. The label advises that Taxotere should not be administered in patients with neutrophil counts under 1500 cells per 3 cubic millimeters (mm3) of blood volume. Physicians should obtain frequent blood counts to monitor for this condition in patients being treated with Taxotere.

Hypersensitivity Reactions

These reactions may include a (rash, low blood pressure and potentially life-threatening anaphylaxis (a severe allergic reaction). Severe hypersensitivity has been reported in patients who received dexamethasone premedication, according to the drug’s label. Patients who have severe reactions should immediately stop taking the drug and seek immediate medical attention.)

Fluid Retention

This condition may occur despite dexamethasone (used to treat inflammatory conditions) and may be severe, according to Taxotere’s drug label.

FDA Safety Communication: Chemotherapy Drug Contains Ethanol
On June 20, 2014, the FDA issued a safety announcement warning that the intravenous chemotherapy drug docetaxel (Taxotere) contains ethanol (also known as alcohol), and therefore, may cause patients to experience intoxication or its effects, meaning they may feel drunk during and after treatment. The federal agency required a revision of drug labels for all docetaxel-containing drugs to reflect this warning.

The FDA further advised that health care professionals should consider the alcohol content of docetaxel when prescribing and administering the chemotherapy drug to patients, especially for those individuals for whom alcohol intake should be avoided or minimized and when used along with other medications. The agency advised that the alcohol content in a single dose of docetaxel may affect the central nervous system and therefore, a docetaxel formulation with the lowest possible alcohol content should be used in patients who experience adverse reactions.

Administering the drug at a slower infusion rate was also found to be helpful in resolving symptoms of alcohol intoxication in some patients, according to the FDA. Data reviewed from the FDA Adverse Event Reporting System (FAERS) database, along with medical literature identifying three cases of alcohol intoxication associated with docetaxel, found that one patient did not experience any symptoms of intoxication during drug administration, but did experience symptoms within 24 hours following treatment.

Dosage and Administration of Taxotere

There is no oral pill form of Taxotere. The drug is instead, given intravenously. One day before therapy starts, patients take corticosteroid pills to reduce fluid retention and allergic reactions to the drug. This continues for three days. Depending on a patient’s height, weight, type of cancer and general health, the doctor will determine the dose and schedule of chemotherapy.

Average Dosage in Breast Cancer Patients

60 mg/m2 to 100 mg/m2 intravenously over one hour every three weeks. This recommended dose is specifically for patients with locally advanced breast or metastatic breast cancer whose tumors did not respond to other types of chemotherapy.

For cancer that has spread to the lymph nodes, but is still operable, the dosage increases to 75 mg/m2 administered 1 hour after taking other chemotherapy drugs called doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 courses.

Your doctor may adjust the dose or stop treatment if:

  • The patient develops febrile neutropenia, a condition with a high fever and other signs of infection. This happens when white blood cell counts drop very low because of chemotherapy.
  • The patient develops severe skin reactions.
  • The patient experienced severe nerve damage called peripheral neuropathy. This is usually numbness, weakness or pain in the hands or feet.
  • The patient develops a sore, inflamed mouth and lips that interfere with the ability to talk, eat or sleep.

Doctors will first try to reduce the dose, but if the symptoms worsen or continue at lower doses, the treatment should be discontinued.

Overdose

In case of a possible overdose, patients need to be monitored and given granulocyte-colony stimulating factor (G-CSF). G-CSF is a protein that causes the bone marrow to produce stem cells and white blood cells and release them into the blood stream. These cells will help prevent infection and fever.

Animal Studies

In animal studies, mice died after a dose about 4.5 times a human dose of 100 mg/m2. Male and female rats died at a human dose of 100 mg/m2.

According to the medication insert, two overdoses were reported in patients. Both patients experienced asthma, skin reactions and tingling or prickling of the skin; but they both recovered following appropriate treatment.

Taxotere Drug Interactions and Contraindications

When Taxotere is used along with cytochrome P450 3A4 (CYP3A4) inducers, inhibitors or substrates it may alter the metabolism of the drug’s active ingredient docetaxel (a CYP3A4 substrate). Cytochrome P450 3A4 is an important enzyme in the body, mainly occurring in the liver and the intestine. It metabolizes approximately 50 percent of all marketed drugs in the body, according to the National Institutes of Health (NIH).

Certain inducers, inhibitors or substrates of CYP3A4 inlcude:

  • Antibiotics (clarithromycin, erythromycin and rifampin used to treat tuberculosis)
  • Anti-HIV agents (ritonavir and delavirdine)
  • Antidepressants (fluoxetine and fluvoxamine)
  • Calcium channel blockers (verapamil and diltiazem)
  • Steroids and their modulators (gestodene and mifepristone)
  • Anticonvulsant (anti-seizure) drugs (phenytoin)
  • Antifungal (ketoconazole)
  • Several herbal and dietary substances

In pregnant women, Taxotere can cause harm to the fetus, as shown in animal studies. The drug label advises that women taking Taxotere should avoid becoming pregnant. It is not known if Taxotere is excreted into a nursing mother’s milk, but there is a potential for serious adverse reactions to nursing infants if exposure occurs.

When Taxotere is administered to children, the alcohol content of docetaxel should be considered with dosing. In general, dosing for an elderly patient should be cautious, reflecting the greater frequency of decreased liver, kidney and cardiac function, and the presence of other diseases and/or drug treatments, in this specific population.

Patients with impaired liver function exhibiting unusually high bilirubin levels should not be given Taxotere. Bilirubin is a brownish-yellow substance found in bile that is produced when old red blood cells are broken down in the liver. High levels of the substance can lead to jaundice, which often results in the yellowing of the skin and eyes. The alcohol content of Taxotere should be taken into account when administering the drug to patients with liver impairment.


Kristin Compton is a medical writer with a background in legal studies. She has experience working in law firms as a paralegal and legal writer. She also has worked in journalism and marketing. She’s published numerous articles in a northwest Florida-based newspaper and lifestyle/entertainment magazine, as well as worked as a ghost writer on blog posts published online by a Central Florida law firm in the health law niche. As a patient herself, and an advocate, Kristin is passionate about “being a voice” for others.

Hide Sources

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