Docetaxel is a chemotherapy drug that is given as a treatment for many types of cancer. It is commonly known as Taxotere®. It is most commonly used to treat breast, prostate and lung cancer, but may be used for many other types of cancer. This information describes Taxotere, how it is given and some of its possible side effects.
What Taxotere looks like
Taxotere is a yellow/brown liquid which, when diluted, forms a clear solution.
How it is given
Taxotere is given as a drip (infusion) through a fine needle (cannula) inserted into the vein. It can also be given through a central line (a tube inserted into a vein in the chest) or a PICC line (a tube inserted into the crook of your arm). The infusion takes about 60 minutes.
The day before your chemotherapy you will be given steroids to take. These help to reduce some of the side effects and are taken for either one or three days (depending on the type of cancer you are being treated for).
Chemotherapy is usually given as a course of several sessions (or cycles) of treatment over a few months. The length of your treatment and the number of cycles you have will depend on the type of cancer for which you are being treated.
Possible side effects
Each person’s reaction to chemotherapy is different. Some people have very few side effects, while others may experience more. The side effects described in this information will not affect everyone who is given Taxotere, and may be different if you are having more than one chemotherapy drug.
We have outlined the most common side effects and some of the less common ones, so that you can be aware of them if they occur. However, we have not included those that are very rare and therefore extremely unlikely to affect you. If you do notice any effects which you think may be due to the drug but which are not listed in this information, please discuss them with your doctor or chemotherapy nurse.
Lowered resistance to infection
This treatment can reduce the production of white blood cells by the bone marrow, making you more prone to infection. This effect can begin five days after treatment has been given, with your resistance to infection usually reaching its lowest point 7–10 days after chemotherapy. Your blood cells will then increase steadily and will usually have returned to normal levels before your next cycle of chemotherapy is due.
Contact your doctor or the hospital straightaway if:
- Your temperature goes above 38ºC (100.5ºF)
- You suddenly feel unwell (even with a normal temperature).
You will have a blood test before having more chemotherapy to make sure that your cells have recovered. Occasionally, it may be necessary to delay your treatment if the number of blood cells (the blood count) is still low.
Bruising or bleeding
Taxotere can reduce the production of platelets (which help the blood to clot). Let your doctor know if you have any unexplained bruising or bleeding, such as nosebleeds, blood spots or rashes on the skin, and bleeding gums. Your platelet level will be checked before each treatment.
Anaemia (low number of red blood cells)
You may become anaemic while having this treatment. This may make you feel pale, tired and breathless. Let your doctor or nurse know if these symptoms are a problem. If necessary you will be given iron tablets or a blood transfusion
Feeling sick (nausea) and being sick (vomiting)
Your doctor can prescribe very effective anti-sickness (anti-emetic) drugs to prevent or reduce nausea. If the sickness is not controlled, or if it continues, tell your doctor. They can prescribe other anti-sickness drugs which may be more effective. Some anti-sickness drugs may cause constipation. Let your doctor or nurse know if this is a problem.
Sore mouth and ulcers
Your mouth may become sore or dry, or you may notice small ulcers during this treatment. Tell your nurse or doctor if you have any of these problems, as they can give you mouthwashes or medicines to prevent or clear any mouth infection. Using a soft toothbrush may be helpful.
You may notice that your food tastes different. Normal taste will usually come back after the treatment finishes.
This may occur several days after the treatment. Diarrhoea can usually be easily controlled with medicines such as loperamide and codeine. Try to drink as many as 2–3 litres of liquid a day to replace the fluid you are losing. Let your doctor know if diarrhoea is severe or lasts for more than 24 hours.
This usually starts 3–4 weeks after the first course of treatment and is due to the Taxotere. All your hair will probably fall out. You may also have thinning and loss of eyelashes, eyebrows and other body hair. Hair loss is temporary and your hair will start to regrow once the treatment has finished. Scalp cooling is a method of reducing hair loss that may be helpful for some people. You can ask your doctor or nurse if it is available at your hospital.
Taxotere can cause a rash. Your doctors can prescribe medicine to help with this.
Soreness and redness of the palms of the hands and soles of the feet
This is sometimes known as palmar plantar or hand-foot syndrome. This is temporary and will improve when treatment is finished. Your doctor can prescribe medicine to help with this.
Some people can have an allergic reaction to Taxotere while it is being given. Signs of this can include skin rashes and itching, a high temperature, shivering, dizziness, a headache and breathlessness. You will be given steroids to take at home the day before treatment to reduce the chance of this happening. It is important to take the steroids as you have been directed. Let your nurse or doctor know immediately if you have any of these symptoms. If you have an allergic reaction it can be treated quickly.
Tiredness and feeling weak
You may feel very tired. It is important to allow yourself plenty of time to rest.
You may notice that you gain weight and/or that your ankles swell. This decreases slowly once your treatment has finished. The steroid tablets that you are given to take the day before treatment will help reduce the chance of fluid retention. They may also help to reduce the chance of an allergic reaction.
Less common side effects
Numbness or tingling in the hands and feet
This is due to the effect of Taxotere on the nerves and is known as peripheral neuropathy. You may also notice that you have difficulty doing up buttons or picking up small items. Tell your doctor if you notice any of those effects so that they can be monitored. This problem usually improves slowly over a few months after treatment is finished.
Changes in nails
You may notice that your nails begin to crack. There can also be changes in the colour of the nails as well as pain in the nail bed (the base of the nail).
Pain in the joints or muscles
It is important to let your doctor know about this, so that appropriate painkillers can be prescribed.
If you notice any stinging or burning around the vein while the drug is being given, or any leakage of fluid from the cannula site, it is very important that you tell the doctor or nurse immediately. If the area around the injection site becomes red or swollen at any time let your doctor or nurse know.
Risk of blood clots
Cancer can increase your risk of developing a blood clot (thrombosis), and having chemotherapy may increase this risk further. A blood clot may cause symptoms such as pain, redness and swelling in a leg, or breathlessness and chest pain. Blood clots can be very serious so it is important to tell your doctor straightaway if you have any of these symptoms. However, most clots can usually be successfully treated with drugs to thin the blood. Your doctor or nurse can give you more information. If you notice any pain or burning around the vein while the drug is being given, or any leak of fluid from the cannula site, tell your doctor or nurse straightaway.
Some other medicines can be harmful to take when you are having chemotherapy. Let your doctor know about any medications you are taking including any non-prescribed drugs such as complementary therapies and herbal drugs.
Your ability to become pregnant or father a child may be affected by this treatment. It is important to discuss fertility with your doctor before starting treatment.
It’s not advisable to become pregnant or father a child while taking this treatment, as the developing foetus may be harmed. It’s important to use effective contraception while taking these drugs, and for at least a few months afterwards. Again, discuss this with your doctor or nurse.
Additional Information For Healthcare Professionals
ADVERSE REACTIONS SIGNIFICANT
Percentages reported for docetaxel monotherapy; frequency may vary depending on diagnosis, dose, liver function, prior treatment, and premedication. The incidence of adverse events was usually higher in patients with elevated liver function tests.
- Cardiovascular: Fluid retention (13% to 60%; dose dependent)
- Central nervous system: Neurosensory events (20% to 58%; including neuropathy), fever (31% to 35%), neuromotor events (16%)
- Dermatologic: Alopecia (56% to 76%), cutaneous events (20% to 48%), nail disorder (11% to 41%)
- Gastrointestinal: Stomatitis (19% to 53%; severe 1% to 8%), diarrhea (23% to 43%; severe: 5% to 6%), nausea (34% to 42%), vomiting (22% to 23%)
- Hematologic: Neutropenia (84% to 99%; grade 4: 75% to 86%; onset: 4-7 days, nadir: 5-9 days, recovery: 21 days; dose dependent), leukopenia (84% to 99%; grade 4: 32% to 44%), anemia (65% to 94%; dose dependent; grades 3/4: 8% to 9%), thrombocytopenia (8% to 14%; grade 4: 1%; dose dependent), febrile neutropenia (6% to 12%; dose dependent)
- Hepatic: Transaminases increased (4% to 19%)
- Neuromuscular & skeletal:Weakness (53% to 66%;severe 13% to 18%), myalgia (3% to 23%)
- Respiratory: Pulmonary events (41%)
- Miscellaneous: Infection (1% to 34%; dose dependent), hypersensitivity (1% to 21%; with premedication 15%)
1% to 10%:
- Cardiovascular: Left ventricular ejection fraction decreased (prostate cancer: 10%; metastatic breast cancer: 8%), hypotension (3%)
- Dermatologic: Rash/erythema (2%)
- Gastrointestinal: Taste perversion (6%)
- Hepatic: Bilirubin increased (9%), alkaline phosphatase increased (4% to 7%)
- Local: Infusion-site reactions (4%, including hyperpigmentation, inflammation, redness, dryness, phlebitis, extravasation, swelling of the vein)
- Neuromuscular and skeletal: Arthralgia (3% to 9%)
- Ocular: Epiphora associated with canalicular stenosis (=77% with weekly administration; =1% with every-3-week administration)
<1% (Limited to important or life-threatening):
Acute myeloid leukemia (AML), acute respiratory distress syndrome (ARDS), anaphylactic shock, angina, ascites, atrial fibrillation, atrial flutter, bleeding episodes, bronchospasm, cardiac tamponade, chest pain, chest tightness, colitis, conjunctivitis, constipation, cutaneous lupus erythematosus, deep vein thrombosis, dehydration, disseminated intravascular coagulation (DIC), drug fever, duodenal ulcer, dyspnea, dysrhythmia, ECG abnormalities, erythema multiforme, esophagitis, gastrointestinal hemorrhage, gastrointestinal obstruction, gastrointestinal perforation, hand and foot syndrome, hearing loss, heart failure, hepatitis, hypertension, ileus, interstitial pneumonia, ischemic colitis, lacrimal duct obstruction, loss of consciousness (transient), MI, multiorgan failure, myelodysplastic syndrome, neutropenic enterocolitis, ototoxicity, pleural effusion, pruritus, pulmonary edema, pulmonary embolism, pulmonary fibrosis, radiation pneumonitis, radiation recall, renal insufficiency, seizure, sepsis, sinus tachycardia, Stevens-Johnson syndrome, syncope, toxic epidermal necrolysis, tachycardia, thrombophlebitis, unstable angina, visual disturbances (transient)
MECHANISM OF ACTION
Docetaxel promotes the assembly of microtubules from tubulin dimers, and inhibits the depolymerization of tubulin which stabilizes microtubules in the cell. This results in inhibition of DNA, RNA, and protein synthesis. Most activity occurs during the M phase of the cell cycle.
PHARMACODYNAMICS / KINETICS
- Exhibits linear pharmacokinetics at the recommended dosage range
- Distribution: Extensive extravascular distribution and/or tissue binding; Vd: 80-90 L/m2, Vdss: 113 L (mean steady state)
- Protein binding: ~94% to 97%, primarily to alpha1-acid glycoprotein, albumin, and lipoproteins
- Metabolism: Hepatic; oxidation via CYP3A4 to metabolites
- Half-life elimination: Terminal: 11 hours
- Excretion: Faeces (75%, <8% as unchanged drug); urine (6%); ~80% within 48 hours
- Clearance: Total body: Mean: 21 L/hour/m2