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Docetaxel (Intravenous route)

Pronunciation:

doe-se-TAX-el

Brand Names:

  • Docefrez
  • Taxotere

Dosage Forms:

  • Solution
  • Powder for Solution

Warnings:

Intravenous route(Solution)

Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based therapy receiving docetaxel at 100 mg/m(2). Docetaxel should generally not be given to patients with bilirubin greater than the ULN, or to patients with AST and/or ALT greater than 1.5 x ULN concomitant with alkaline phosphatase greater than 2.5 x ULN. These patients are at increased risk for developing severe or life-threatening toxicities. Monitor LFTs prior to each treatment cycle. Docetaxel therapy should not be given to patients with neutrophil counts of less than 1500 cells/mm(3); obtain frequent blood counts to monitor for neutropenia. Severe hypersensitivity reactions, including fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Use is contraindicated in patients with a severe hypersensitivity to docetaxel or polysorbate 80. Severe fluid retention may occur .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Mitotic Inhibitor

Uses of This Medicine:

Docetaxel injection is used to treat breast cancer, non-small cell lung cancer, head and neck cancer, gastric (stomach) cancer, and prostate cancer. Docetaxel might be used together with other cancer medicines.

Docetaxel belongs to the group of medicines called antineoplastics (cancer medicines). It interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal cells may also be affected by docetaxel, other unwanted effects will also occur.

This medicine is to be given only by or under the direct supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in the product labeling, docetaxel injection is used in certain patients with the following medical conditions:

  • Bladder cancer.
  • Esophageal cancer (cancer in the esophagus).
  • Ovarian cancer (cancer in the ovary).
  • Small cell lung cancer.

Before Using This Medicine:

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.

Children—

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

Older adults—

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—

Pregnancy CategoryExplanation
All TrimestersDStudies 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.

Breast-feeding—

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.

Other medicines—

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.

  • Rotavirus Vaccine, Live

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 Type 4, Live
  • Adenovirus Vaccine Type 7, Live
  • Aprepitant
  • Atazanavir
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Carbamazepine
  • Clarithromycin
  • Cobicistat
  • Crizotinib
  • Dabrafenib
  • Dronedarone
  • Eslicarbazepine Acetate
  • Fosaprepitant
  • Indinavir
  • Influenza Virus Vaccine, Live
  • Itraconazole
  • Ketoconazole
  • Measles Virus Vaccine, Live
  • Mitotane
  • Mumps Virus Vaccine, Live
  • Nefazodone
  • Nelfinavir
  • Piperaquine
  • Primidone
  • Ritonavir
  • Rubella Virus Vaccine, Live
  • Saquinavir
  • Smallpox Vaccine
  • Telithromycin
  • Thalidomide
  • Typhoid Vaccine
  • Varicella Virus 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

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to polysorbate 80 or
  • Neutropenia (low white blood cells)—Should not be used in patients with these conditions.
  • Asthenia (muscle weakness) or
  • Fluid retention (edema) or
  • Peripheral neuropathy (numbness or tingling in the arms, legs, fingers, or toes) or
  • Thrombocytopenia (low platelet counts) or
  • Vision problems—Use with caution. May make these conditions worse.
  • Infection—May decrease your body's ability to fight infection.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

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.

You will also be given a steroid medicine for a few days to prevent unwanted effects from docetaxel. Carefully follow the instructions about how to take the steroid. If you forget to take the steroid, tell your doctor before you receive the dose.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Docetaxel can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, fever or chills, trouble breathing or swallowing, a fast or irregular heartbeat, or any swelling of your hands, face, mouth, or throat with this medicine.

Docetaxel may cause edema or fluid retention, which means your body is keeping too much water. Check with your doctor right away if you have a rapid weight gain, shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, an irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet.

Serious skin reactions can occur with this medicine. Tell your doctor right away if you have blistering, peeling, or a red skin rash on your arms or legs after receiving this medicine.

Check with your doctor right away if you have burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Tell your doctor right away if you have vision changes, such as blurred vision, difficulty reading, or eye pain with this medicine. These could be symptoms of a serious eye problem called cystoid macular edema.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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
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)
skin rash
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
mood or mental changes
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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 4/4/2014

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