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Jevtana

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Jevtana

PATIENT INFORMATION

JEVTANA®
(JEV-TA-NA)
(cabazitaxel) Injection

Read this Patient Information before you start receiving JEVTANA and each time before you receive your infusion. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about JEVTANA?

JEVTANA may cause serious side effects including:

1. Low white blood cells. Low white blood cells can cause you to get serious infections, and may lead to death. People who are 65 years or older may be more likely to have these problems. Your doctor:

  • will do blood tests regularly to check your white blood cell counts during your treatment with JEVTANA.
  • may lower your dose of JEVTANA, change how often you receive it, or stop JEVTANA until your doctor decides that you have enough white blood cells.
  • may prescribe a medicine for you called G-CSF, to help prevent complications if your white blood cell count is too low.
    Tell your doctor right away if you have any of these symptoms of infection while receiving JEVTANA:
  • fever. Take your temperature often during treatment with JEVTANA.
  • cough
  • burning on urination
  • muscle aches

Also, tell your doctor if you have any diarrhea during the time that your white blood cell count is low. Your doctor may prescribe treatment for you as needed.

2. Severe allergic reactions. Severe allergic reactions can happen within a few minutes after your infusion of JEVTANA starts, especially during the first and second infusions. Your doctor should prescribe medicines before each infusion to help prevent severe allergic reactions.

Tell your doctor or nurse right away if you have any of these symptoms of a severe allergic reaction during or soon after an infusion of JEVTANA:

  • rash or itching
  • skin redness
  • feeling dizzy or faint
  • breathing problems
  • chest or throat tightness
  • swelling of face

3. Gastrointestinal symptoms. Vomiting and diarrhea can happen when you take JEVTANA. Severe vomiting and diarrhea with JEVTANA can lead to loss of too much body fluid (dehydration), or too much of your body salts (electrolytes). Death has happened from having severe diarrhea and losing too much body fluid or body salts with JEVTANA. Tell your doctor if you have vomiting or diarrhea. Your doctor will prescribe medicines to prevent or treat vomiting and diarrhea, as needed with JEVTANA. Tell your doctor if your symptoms get worse or do not get better. You may need to go to the hospital for treatment.

4. Kidney failure. Kidney failure may happen with JEVTANA, because of severe infection, loss of too much body fluid (dehydration), and other reasons, which may lead to death. Your doctor will check you for this problem and treat you if needed. Tell your doctor if you develop:

  • swelling of your face or body
  • decrease in the amount of urine that your body makes each day.

What is JEVTANA?

JEVTANA is a prescription anti-cancer medicine used with the steroid medicine prednisone. JEVTANA is used to treat people with prostate cancer that has worsened (progressed) after treatment with other anti-cancer medicines, including docetaxel.

It is not known if JEVTANA is safe and works in children.

Who should not receive JEVTANA?

Do not receive JEVTANA if:

  • your white blood cell (neutrophil count) is too low
  • you have had a severe allergic reaction to cabazitaxel or other medicines that contain polysorbate 80. Ask your doctor if you are not sure.

What should I tell my doctor before receiving JEVTANA?

Before receiving JEVTANA, tell your doctor if you:

  • had allergic reactions in the past
  • have kidney or liver problems
  • are over the age of 65
  • have any other medical conditions
  • if you are a female and:
    • are pregnant or plan to become pregnant. JEVTANA can harm your unborn baby. Talk to your doctor about the best way for you to prevent pregnancy while you are receiving JEVTANA.
    • are breastfeeding or plan to breastfeed. It is not known if JEVTANA passes into your breast milk. You and your doctor should decide if you will take JEVTANA or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. JEVTANA can interact with many other medicines. Do not take any new medicines without asking your doctor first. Your doctor will tell you if it is safe to take the new medicine with JEVTANA.

How will I receive JEVTANA?

  • JEVTANA will be given to you by an intravenous (IV) infusion into your vein.
  • Your treatment will take about 1 hour.
  • JEVTANA is usually given every 3 weeks. Your doctor will decide how often you will receive JEVTANA .
  • Your doctor will also prescribe another medicine called prednisone, for you to take by mouth every day during treatment with JEVTANA. Your doctor will tell you how and when to take your prednisone.

It is important that you take prednisone exactly as prescribed by your doctor. If you forget to take your prednisone, or do not take it on schedule, make sure to tell your doctor or nurse. Before each infusion of JEVTANA, you may receive other medicines to prevent or treat side effects.

What are the possible side effects of JEVTANA?

JEVTANA may cause serious side effects including:

  • See “What is the most important information I should know about JEVTANA?”

Common side effects of JEVTANA include:

  • Low red blood cell count (anemia). Your doctor will regularly check your red blood cell count. Symptoms of anemia include shortness of breath and tiredness.
  • Low blood platelet count. Tell your doctor if you have any unusual bruising or bleeding.

  • tiredness
  • nausea
  • constipation
  • weakness
  • blood in the urine. Tell your doctor or nurse if you see blood in your urine.
  • back pain
  • decreased appetite
  • fever
  • shortness of breath
  • stomach (abdominal) pain
  • change in your sense of taste
  • cough
  • joint pain
  • hair loss
  • numbness, tingling, burning or
  • decreased sensation in your
  • hands or feet

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of JEVTANA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about JEVTANA

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

This leaflet summarizes the most important information about JEVTANA. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about JEVTANA that is written for health professionals.

For more information, go to www.sanofi-aventis.us or call 1-800-633-1610.

What are the ingredients in JEVTANA?

Active ingredient: cabazitaxel

Inactive ingredient: polysorbate 80

Last reviewed on RxList: 10/16/2012
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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