Description
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 together with prednisone 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.
This product is available in the following dosage forms:
- Solution
Before Using
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. 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.
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.
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.
Drug Interactions
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.
- Abametapir
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Amiodarone
- Aprepitant
- Asciminib
- Atazanavir
- Avacopan
- Bacillus of Calmette and Guerin Vaccine, Live
- Belumosudil
- Berotralstat
- Boceprevir
- Carbamazepine
- Ceftobiprole Medocaril
- Ceritinib
- Cholera Vaccine, Live
- Clarithromycin
- Cobicistat
- Conivaptan
- Crizotinib
- Daridorexant
- Darolutamide
- Dengue Tetravalent Vaccine, Live
- Dronedarone
- Ebola Zaire Vaccine, Live
- Elexacaftor
- Eltrombopag
- Enasidenib
- Enzalutamide
- Fedratinib
- Fexinidazole
- Fosaprepitant
- Fosnetupitant
- Hexaminolevulinate
- Idelalisib
- Influenza Virus Vaccine, Live
- Itraconazole
- Ketoconazole
- Lanreotide
- Lazertinib
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
- Rolapitant
- 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
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 medicine must be given slowly, so the needle will have to remain in place for at least 1 hour. 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
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. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. 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 2 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for 4 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 (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis) can occur with this medicine. Tell your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.
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, including 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.
Talk with your doctor before receiving this medicine if you plan to have children. Some men who receive this medicine have become infertile (unable to have children).
This medicine may cause a serious type of reaction called tumor lysis syndrome (TLS). Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.
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
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 or tightness
- 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
- trouble breathing
- 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
- loss or thinning of the 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.
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