Docetaxel (Taxotere)

Generic Name: Docetaxel

Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel has the following structural formula:


TAXOTERE (docetaxel) Structural Formula Illustration

Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14• 3H2O, and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water.

One-vial TAXOTERE (Injection Concentrate)

TAXOTERE (docetaxel) Injection Concentrate is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration.

Each mL contains 20 mg docetaxel (anhydrous) in 0.54 grams polysorbate 80 and 0.395 grams dehydrated alcohol solution.

TAXOTERE is available in single use vials containing 20 mg (1 mL) or 80 mg (4 mL) docetaxel (anhydrous).

TAXOTERE Injection Concentrate requires NO prior dilution with a diluent and is ready to add to the infusion solution.

No health feed found.

Docetaxel interferes with the normal function of microtubule growth. Whereas drugs like colchicine cause the depolymerization of microtubules in vivo, docetaxel arrests their function by having the opposite effect; it hyper-stabilizes their structure. This destroys the cell's ability to use its cytoskeleton in a flexible manner. Specifically, docetaxel binds to the β-subunit of tubulin. Tubulin is the "building block" of mictotubules, and the binding of docetaxel locks these building blocks in place. The resulting microtubule/docetaxel complex does not have the ability to disassemble. This adversely affects cell function because the shortening and lengthening of microtubules (termed dynamic instability) is necessary for their function as a transportation highway for the cell. Chromosomes, for example, rely upon this property of microtubules during mitosis. Further research has indicated that docetaxel induces programmed cell death (apoptosis) in cancer cells by binding to an apoptosis stopping protein called Bcl-2 (B-cell leukemia 2) and thus arresting its function.

Docetaxel is used in the treatment of various cancers, including breast, lung, prostate, gastric, head and neck, and ovarian cancer. Clinical data have shown docetaxel to have cytotoxic activity against breast, colorectal, lung, ovarian, prostate, liver, renal, gastric, and head and neck cancers and melanoma. In hormone-refractory prostate cancer docetaxel improves life expectancy and overall life quality.

The optimal dose scheduling of taxanes remains unconfirmed, but most studies find significant mortality benefit following either a three-week or a one-week administration schedule. While a 2010 article in Current Clinical Pharmacology states, "weekly administration has emerged as the optimal schedule," the official docetaxel package insert recommends administration every three weeks.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

  • Burning, numbness, tingling, or pain in the arms, hands, legs, or feet
  • swelling of the stomach, face, fingers, hands, feet, or lower legs
  • unusual tiredness or weakness
  • weight gain

Less common

  • Black, tarry stools
  • blood in the urine or stools
  • cough or hoarseness (accompanied by fever or chills)
  • difficult or labored breathing
  • difficult or painful urination (accompanied by fever or chills)
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fever or chills
  • hives or skin rash
  • itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  • lower back or side pain (accompanied by fever or chills)
  • noisy, rattling breathing
  • pinpoint red spots on the skin
  • red, scaly, swollen, or peeling areas of the skin (severe)
  • tightness in the chest
  • troubled breathing while at rest
  • unusual bleeding or bruising

Rare

  • Chest pain or discomfort
  • decreased blood pressure
  • fast or irregular heartbeat
  • increased blood pressure

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Congestion
  • diarrhea
  • dryness or soreness of the throat
  • nausea
  • skin rash or redness (mild)
  • sores or ulcers on the lips or tongue or inside the mouth
  • weakness in the arms, hands, legs, or feet

Less common

  • Bloody nose
  • body aches or pain
  • change in the color of the fingernails or toenails
  • dry, red, hot, or irritated skin at the injection site
  • headache
  • hoarseness
  • loosening or loss of the fingernails or toenails, sometimes painful
  • pain in the joints or muscles
  • pain, swelling, or lump under the skin at the injection site
  • runny nose
  • tender, swollen glands in the neck
  • voice changes
  • vomiting

incidence not known

  • Burning, dry, or itching eyes
  • burning upper abdominal or stomach pain
  • confusion
  • difficulty having a bowel movement (stool)
  • discharge from the eyes
  • excessive tearing
  • pain and redness of the skin at the place of earlier radiation treatment
  • rapid breathing
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • sunken eyes
  • tearing of the eyes
  • wrinkled skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

For all indications, toxicities may warrant dosage adjustments [see Dosage Adjustments During Treatment].

Administer in a facility equipped to manage possible complications (e.g. anaphylaxis).

Breast Cancer

  • For locally advanced or metastatic breast cancer after failure of prior chemotherapy, the recommended dose of TAXOTERE is 60 mg/m² to 100 mg/m² administered intravenously over 1 hour every 3 weeks.
  • For the adjuvant treatment of operable node-positive breast cancer, the recommended TAXOTERE dose is 75 mg/m² administered 1 hour after doxorubicin 50 mg/m² and cyclophosphamide 500 mg/m² every 3 weeks for 6 courses. Prophylactic G-CSF may be used to mitigate the risk of hematological toxicities.

Non-Small Cell Lung Cancer

  • For treatment after failure of prior platinum-based chemotherapy, TAXOTERE was evaluated as monotherapy, and the recommended dose is 75 mg/m² administered intravenously over 1 hour every 3 weeks. A dose of 100 mg/m² in patients previously treated with chemotherapy was associated with increased hematologic toxicity, infection, and treatment-related mortality in randomized, controlled trials.
  • For chemotherapy-naïve patients, TAXOTERE was evaluated in combination with cisplatin. The recommended dose of TAXOTERE is 75 mg/m² administered intravenously over 1 hour immediately followed by cisplatin 75 mg/m² over 30-60 minutes every 3 weeks.

Prostate Cancer

  • For hormone-refractory metastatic prostate cancer, the recommended dose of TAXOTERE is 75 mg/m² every 3 weeks as a 1 hour intravenous infusion. Prednisone 5 mg orally twice daily is administered continuously.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Varicella Virus Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adenovirus Vaccine
  • Aprepitant
  • Atazanavir
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Ceritinib
  • Cholera Vaccine, Live
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Dronedarone
  • Fluconazole
  • Fosaprepitant
  • Idelalisib
  • Indinavir
  • Influenza Virus Vaccine, Live
  • Itraconazole
  • Ketoconazole
  • Nefazodone
  • Nelfinavir
  • Pitolisant
  • Poliovirus Vaccine, Live
  • Ritonavir
  • Saquinavir
  • Smallpox Vaccine
  • St John's Wort
  • Telithromycin
  • Thalidomide
  • Typhoid Vaccine
  • Voriconazole
  • Yellow Fever Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cisplatin
  • Dalfopristin
  • Quinupristin
  • Sorafenib

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Medicines used to treat cancer are very strong and can have many unwanted effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

You will receive this medicine in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of docetaxel injection in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of docetaxel injection in the elderly. However, elderly patients are more likely to have unwanted effects and age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving docetaxel injection.

Pregnancy

Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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