Neutropenic deaths have been reported. Obtain frequent blood counts to monitor for neutropenia. Cabazitaxel is contraindicated in patients with neutrophil counts of 1500 cells/mm(3) or less. Severe hypersensitivity can occur and may include generalized rash/erythema, hypotension and bronchospasm. Discontinue cabazitaxel if severe reactions occur and administer appropriate therapy. Cabazitaxel is contraindicated in patients with a history of severe hypersensitivity reactions to cabazitaxel or to drugs formulated with polysorbate 80 .
Cabazitaxel injection is given together with a steroid medicine (eg, prednisone) to treat men with metastatic (cancer that has already spread) prostate cancer. It is used in patients who have already been treated with other medicines that did not work well.
Cabazitaxel belongs to the group of medicines called antineoplastics (cancer medicines). It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor.
This medicine is to be given only by or under the immediate supervision of your doctor.
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of cabazitaxel injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cabazitaxel injection in the elderly. However, elderly patients are more likely to have unwanted side effects, which may require caution in patients receiving cabazitaxel.
|All Trimesters||D||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.|
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.
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 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.
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 is usually not recommended, 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.
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:
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.
This medicine is usually given together with oral prednisone. Your doctor will tell you how much prednisone to take and how often.
You may also receive other medicines to help prevent allergic reactions and nausea from the injection.
Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
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.
Cabazitaxel can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
This medicine may cause serious allergic reactions. Tell your doctor right away if you have a cough, dizziness, trouble breathing, chest or throat tightness, swelling in your face or hands, fever, chills, rash, itching or hives, skin redness, or lightheadedness or faintness while you are receiving this medicine.
Cabazitaxel may cause serious stomach or bowel problems. Call your doctor right away if you have fever, constipation, diarrhea, or stomach pain or tenderness.
Kidney failure may occur with this medicine. Check with your doctor right away if you have confusion, decreased urine output, dizziness, irritability, lethargy, muscle twitching, nausea, rapid weight gain, swelling of the face, ankles, or hands, 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 (eg, St. John's wort) or vitamin supplements.
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:
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:
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.