Jevtana is a prescription cancer medicine that interferes with the growth and spread of cancer cells in the body.

Jevtana is used together with prednisone to treat prostate cancer that is resistant to medical or surgical treatments that lower testosterone and has spread to other parts of the body (metastatic).

Jevtana is usually given when the prostate cancer has worsened (progressed) after being previously treated with other medicines that included docetaxel as part of the treatment.

You should not use Jevtana if you have severe liver disease, low white blood cell counts, or an allergy to any medicine that contains polysorbate 80.

Jevtana 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.

Call your doctor right away if you have symptoms such as: fever, cough, body aches, easy bruising or bleeding, burning when you urinate, decreased urination, swelling in your hands or feet, severe stomach pain, constipation, blood in your urine or stools, or sudden chest pain and shortness of breath.

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, or if you feel like you might pass out.

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

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

Jevtana 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 Jevtana treatment. Do not stop taking prednisone without your doctor's advice, or you could have unpleasant side effects caused by Jevtana. Tell your doctor if you miss any doses or you stop taking prednisone for any reason.

Jevtana 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 Jevtana, which can lead to a serious electrolyte imbalance.

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

Usual Adult Dose for Prostate Cancer:

25 mg/m2 IV over 1 hour every three weeks

Comments:
-Use in combination with prednisone or prednisolone.
-Give premedication regimen at least 30 minutes prior to each administration.
-Give antiemetics prophylactically or as needed.
-Ensure adequate hydration throughout treatment.

Use: Use in combination with prednisone or prednisolone for the treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel containing regimen.

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

• severe liver disease;

• low white blood cell counts; or

• an allergy to any medicine that contains polysorbate 80.

To make sure Jevtana is safe for you, 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 Jevtana 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.

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

Jevtana 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.

Some side effects may be more likely in older adults.

Common Jevtana side effects 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 interact with 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.