Docetaxel (Intravenous route)

Pronunciation:

doe-se-TAX-el

Brand Names:

  • Docefrez
  • Taxotere

Dosage Forms:

  • 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 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, have 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 advanced or metastatic (cancer that has spread) breast cancer in patients who have previously received other cancer medicines that did not work well. It is also used together with other medicines (eg, cyclophosphamide, doxorubicin) to treat node-positive breast cancer that can be removed by surgery.

Docetaxel injection is also used to treat advanced or metastatic non-small cell lung cancer (NSCLC) in patients who have previously received platinum-based cancer medicines that did not work well. It is also used together with cisplatin to treat advanced or metastatic NSCLC that cannot be removed by surgery in patients who have not received any cancer treatment for lung cancer.

Docetaxel injection is also used to treat metastatic castration-resistant prostate cancer (prostate cancer that has spread and is resistant to medical or surgical treatments that lower testosterone).

Docetaxel injection is also used together with cisplatin and fluorouracil to treat advanced stomach cancer (eg, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma) in patients who have not received cancer treatment for their advanced cancer.

Docetaxel injection is also used together with cisplatin and fluorouracil as first treatment for advanced squamous cell carcinoma of the head and neck (SCCHN).

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.

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. However, because of docetaxel's alcohol content, it should be used with caution. Recommended doses should not be exceeded and the patient should be carefully monitored during treatment.

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.

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.

  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Varicella Virus Vaccine, Live
  • Zoster 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
  • Amiodarone
  • Atazanavir
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Boceprevir
  • Ceritinib
  • Cholera Vaccine, Live
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Dengue Tetravalent Vaccine, Live
  • Dronedarone
  • Fosnetupitant
  • Hexaminolevulinate
  • Idelalisib
  • Influenza Virus Vaccine, Live
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Nefazodone
  • Nelfinavir
  • Netupitant
  • Poliovirus Vaccine, Live
  • Posaconazole
  • Ritonavir
  • Saquinavir
  • Smallpox Vaccine
  • St John's Wort
  • Telaprevir
  • 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
  • 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 paclitaxel or
  • Asthenia (lack or loss of strength) or
  • Fluid retention (edema) or
  • Kidney disease or
  • Nerve problems (eg, peripheral neuropathy) or
  • Stomach or bowel problems or
  • Thrombocytopenia (low platelet counts) or
  • Vision problems—Use with caution. May make these conditions worse.
  • Allergy to polysorbate 80 or
  • Neutropenia (low white blood cell count)—Should not be used in patients with these conditions.
  • 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.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The injection is usually given every 3 weeks.

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

Your doctor will give you a steroid medicine before each treatment to prevent unwanted effects. 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.

Precautions While Using This Medicine:

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

Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for 3 months after the last dose. If you think you have become pregnant while receiving 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 stomach or bowel problems (eg, enterocolitis, neutropenic colitis), which may be life-threatening. Check with your doctor right away if you have fever, severe stomach pain, vomiting, stomach cramps or tenderness, or watery or bloody diarrhea.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require 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, trouble breathing, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, an irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet.

This medicine may increase your or your child's risk for other cancers, including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), Non-Hodgkin’s Lymphoma (NHL), or kidney cancer. Talk with your doctor if you have concerns about this.

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. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Docetaxel may cause severe lack or loss of strength, which can last a few days up to several weeks. Tell your doctor if you unusual tiredness or weakness.

This medicine contains alcohol and may cause some people to become drowsy, dizzy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

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
Black, tarry stools
bleeding gums
blistering, peeling, or loosening of the skin
blood in the urine or stools
burning, tingling, numbness, or pain in the hands, arms, feet, or legs
chest pain
chills
cough
decrease in the amount of urine
diarrhea
difficulty in swallowing
difficulty moving
dizziness
dry eyes
fainting
fast, slow, or irregular heartbeat
fever
heartburn
hives, itching, skin rash
hoarseness
irritation
joint pain, stiffness, or swelling
lower back or side pain
muscle pain, cramps, or stiffness
noisy, rattling breathing
nosebleeds
pain or burning feeling in the throat
painful or difficult urination
pale skin
pinpoint red spots on the skin
red skin lesions, often with a purple center
red, irritated eyes
redness of the skin
sensation of pins and needles
severe lack or loss of strength
sore throat
sores, ulcers, or white spots on the lips or tongue or inside the mouth
stabbing pain
swelling of the eyelids, face, lips, hands, or feet
tightness in the chest
trouble breathing
troubled breathing at rest
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
vomiting
weight gain
Less common
Bluish color of the skin
blurred vision
burning or itching of the eyes
changes in skin color
chest discomfort
confusion
constipation
discharge, excessive tearing
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
lightheadedness
nausea
pain or discomfort in the arms, jaw, back, or neck
pain, tenderness, or swelling of the foot or leg
rapid, shallow breathing
redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
severe stomach pain
sweating
vomiting of blood or material that looks like coffee grounds
Rare
Dilated neck veins
extreme tiredness or weakness
fast, pounding, or irregular heartbeat or pulse
headache
irregular breathing
nervousness
pounding in the ears
Incidence not known
Agitation
dark urine
decreased awareness or responsiveness
depression
drowsiness
dry mouth
general feeling of tiredness or weakness
hostility
increased thirst
indigestion
light-colored stools
loss of appetite
loss of consciousness
mood or mental changes
muscle spasms (tetany) or twitching seizures
nausea
rapid, shallow breathing
rectal bleeding
seizures
severe abdominal pain, cramping, or burning
severe sleepiness
stomach cramps, pain, or tenderness
stomach pain, continuing
tremor
unusual drowsiness, dullness, or feeling of sluggishness
vomiting of material that looks like coffee grounds, severe and continuing
yellow eyes or skin

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
Absent, missed, or irregular menstrual periods
bad, unusual or unpleasant (after)taste
change in sense of smell
change in taste
discoloration of the fingernails or toenails
dry skin hair loss or thinning of hair
stopping of menstrual bleeding
swelling or inflammation of the mouth
weight loss
Less common
Dry, red, hot, or irritated skin
Incidence not known
Hearing loss
pain and redness of the skin at the place of earlier radiation treatment

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: 9/5/2019

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The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.
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