Cabazitaxel is used together with prednisone to treat prostate cancer that has spread to other parts of the body (metastatic).

Cabazitaxel is given after other cancer medicines have stopped working.

Cabazitaxel may also be used for purposes not listed in this medication guide.

Cabazitaxel affects your immune system. You may get infections more easily, even serious or fatal infections, especially if you are 65 or older. Call your doctor if you have a fever, muscle pain, cough, diarrhea, or pain or burning when you urinate.

A serious allergic reaction may occur during the injection. Tell your caregivers right away if you have a rash or skin redness, chest tightness or trouble breathing, swelling in your face, or if you feel like you might pass out.

Tell your doctor if you have other symptoms of serious side effects: severe stomach pain, blood in your urine or stools, little or no urinating, chest pain, or shortness of breath.

Cabazitaxel is given as an infusion into a vein. A healthcare provider will give you this injection.

Cabazitaxel must be given slowly, and the infusion can take about 1 hour to complete.

Cabazitaxel is usually given once every 3 weeks. You will be given other medications to prevent certain side effects.

You will most likely take prednisone (a steroid medicine) by mouth every day throughout your cabazitaxel treatment. Do not stop taking prednisone without your doctor's advice, or you could have unpleasant side effects caused by cabazitaxel. Tell your doctor if you miss any doses or you stop taking prednisone for any reason.

Cabazitaxel affects your immune system. You may get infections more easily, even serious or fatal infections, especially if you are 65 or older. Your doctor will need to examine you on a regular basis.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while receiving cabazitaxel, which can lead to a serious electrolyte imbalance.

Your doctor may tell you to check your temperature at home throughout your treatment with cabazitaxel.

Usual Adult Dose for Prostate Cancer:

20 mg/m2 IV over one-hour every three weeks
-Some patients may received a dose of 25 mg/m2 every three weeks

Comments:
-In selected patients, the dose may be increased to 25 mg/m2; primary prophylaxis with G-CSF is recommended in these patients.
-Use in combination with oral prednisone 10 mg once a day.
-Dose is based on calculation of the Body Surface Area (BSA).
-Give premedication regimen at least 30 minutes prior to each administration, including antiemetics prophylaxis as needed.
-Ensure adequate hydration throughout treatment.

Use: In combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen

You should not use cabazitaxel if you are allergic to cabazitaxel, or if you have:

• severe liver problems;

• low white blood cell counts; or

• an allergy to any medicine that contains polysorbate 80.

Tell your doctor if you have ever had:

• radiation treatment;

• liver or kidney disease;

• breathing problems; or

• a severe allergic reaction to any medication.

Although not for use by women, cabazitaxel can cause birth defects in a baby if the father is using this medicine.

Use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose. Tell your doctor at once if a pregnancy occurs during this time.

This medicine may affect fertility (your ability to have children). However, it is important to use birth control to prevent pregnancy because cabazitaxel can harm an unborn baby.

Call your doctor for instructions if you miss an appointment for your cabazitaxel injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe vomiting or diarrhea, fever, or worsening flu-like symptoms.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Cabazitaxel can cause a serious allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives, rash or skin redness; chest tightness or trouble breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Cabazitaxel can cause serious or fatal side effects. Call your doctor at once if you have:

• numbness, burning pain, or tingly feeling in your hands or feet;

• sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;

• stomach pain or tenderness, severe vomiting or diarrhea, ongoing constipation;

• blood in your urine, urinating more often, pain or burning when you urinate;

• low blood cell counts--fever, chills, muscle pain, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

• signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your hands or feet; feeling tired or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of cabazitaxel may include:

• fever, low blood cell counts;

• numbness or tingling;

• nausea, vomiting, stomach pain, loss of appetite;

• constipation, diarrhea;

• weakness, tired feeling;

• blood in your urine;

• back pain, joint pain;

• cough, shortness of breath;

• altered sense of taste; or

• hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect cabazitaxel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.