For U.S. Residents Only
See your advanced prostate cancer treatment - in a different lightJEVTANA 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

Why JEVTANA?

JEVTANA may fight tumors that have become resistant to docetaxel, so it may help you even if docetaxel is no longer working.

Learn more

Questions for Your Healthcare Provider

Ask your healthcare team any questions you have about JEVTANA and your advanced prostate cancer treatment plan. Remember, each man's experience is different. Learn more

IMPORTANT SAFETY INFORMATION FOR
JEVTANA® (CABAZITAXEL) INJECTION

WARNING

JEVTANA may cause serious side effects, including low white blood cells. Low white blood cells can cause you to get serious infections, and may lead to death. The earliest sign of infection may be fever, so tell your healthcare provider right away if you have a fever. People who are 65 years or older may be more likely to have these problems. JEVTANA should not be given to patients with low white blood cell counts. Your healthcare provider:

  • 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 you have enough white blood cells
  • May prescribe a medicine for you to help prevent complications if your white blood cell count is too low

JEVTANA can also cause 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 healthcare provider should prescribe medicines before each infusion to help prevent severe allergic reactions.

  • Symptoms of severe allergic reactions may include rash or itching, skin redness, feeling dizzy or faint, breathing problems, chest or throat tightness, swelling of face. Tell your healthcare provider right away if you have any of these symptoms. Your healthcare provider will stop your JEVTANA treatment right away and treat your allergic reaction.

You should not take JEVTANA if you have had a severe allergic reaction to JEVTANA or other medicines that contain polysorbate 80. Ask your healthcare provider if you are not sure.

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IMPORTANT SAFETY INFORMATION FOR JEVTANA® (CABAZITAXEL) INJECTION

WARNING

JEVTANA may cause serious side effects, including low white blood cells. Low white blood cells can cause you to get serious infections, and may lead to death. The earliest sign of infection may be fever, so tell your healthcare provider right away if you have a fever. People who are 65 years or older may be more likely to have these problems. JEVTANA should not be given to patients with low white blood cell counts. Your healthcare provider:

  • 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 you have enough white blood cells
  • May prescribe a medicine for you to help prevent complications if your white blood cell count is too low

JEVTANA can also cause 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 healthcare provider should prescribe medicines before each infusion to help prevent severe allergic reactions.

  • Symptoms of severe allergic reactions may include rash or itching, skin redness, feeling dizzy or faint, breathing problems, chest or throat tightness, swelling of face. Tell your healthcare provider right away if you have any of these symptoms. Your healthcare provider will stop your JEVTANA treatment right away and treat your allergic reaction.

You should not take JEVTANA if you have had a severe allergic reaction to JEVTANA or other medicines that contain polysorbate 80. Ask your healthcare provider if you are not sure.

Severe stomach and intestine (gastrointestinal) problems. JEVTANA can cause severe stomach and intestine problems, which may lead to death. You may need to go to the hospital for treatment.
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. Your healthcare provider will prescribe medicines to prevent or treat vomiting and diarrhea, as needed with JEVTANA.

Tell your healthcare provider if:

JEVTANA can cause a leak in the stomach or intestine, intestinal blockage, infection, and bleeding in the stomach or intestine. This can lead to death.

Tell your healthcare provider if you have any of these symptoms:

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 healthcare provider will check you for this problem and treat you if needed.

Tell your healthcare provider if you develop these signs or symptoms:

Do not receive JEVTANA if you have severe liver problems.

Before receiving JEVTANA, tell your healthcare provider if you:

Serious side effects of JEVTANA include low white blood cell counts that could lead to serious or life-threatening infections, severe allergic reactions, severe stomach and intestine (gastrointestinal) problems (severe vomiting and diarrhea, a leak in the stomach or intestine, intestinal blockage, infection, and bleeding in the stomach or intestine) that could lead to death and kidney failure.

Common side effects of JEVTANA include:

  • Low white blood cell count
  • Low red blood cell count (anemia). Low red blood cell count is common with JEVTANA, but can sometimes also be serious. Your healthcare provider will regularly check your red blood cell count. Symptoms of anemia include shortness of breath and tiredness.
  • Low blood platelet count. Low platelet count is common with JEVTANA, but can sometimes also be serious. Tell your healthcare provider if you have any unusual bruising or bleeding.
  • Fever
  • tiredness
  • nausea
  • constipation
  • weakness
  • blood in the urine - Tell your healthcare provider or nurse if you see blood in your urine.
  • back pain
  • numbness, tingling, burning or decreased sensation in your hands or feet
    
  • shortness of breath
  • stomach (abdominal) pain
  • change in your sense of taste
  • cough
  • joint pain
  • hair loss
  • decreased appetite

Tell your healthcare provider 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 healthcare provider or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.

Remember, your healthcare provider is the single best source of information regarding your health. Please consult your healthcare provider if you have any questions about your health or your medicine.

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

See Full Prescribing Information including Boxed WARNING.