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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 doctor 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 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 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 doctor 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 doctor right away if you have any of these symptoms. Your doctor 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 doctor if you are not sure.

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Indication

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.

Why JEVTANA?

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

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Questions for Your Doctor

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

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What Is Prostate Cancer?

Cancer and the prostate

What Is Prostate Cancer? What is the prostate?
The prostate is a small, walnut-shaped gland, or organ used to produce a substance. Found at the base of a man's urethra, the prostate adds a nutrient-rich fluid to semen.

The male hormone testosterone is what spurs the prostate to grow, and in older men it is sometimes enlarged. This condition is called benign prostatic hyperplasia, or BPH, and it is not usually a life-threatening problem.

Cancerous cells in the prostate are the result of a series of genetic mutations, or changes in the cells' DNA (their genetic blueprints). These mutated cells may form a solid growth called a tumor, and the tumor may spread from the prostate to other areas of the body, such as the bones, the blood, the lymph nodes, or other organs. A cancer that has spread to other organs is called advanced, or metastatic.

Because the prostate surrounds the urethra and is below the bladder, it is usually examined by a urologist, or doctor who specializes in problems with the urinary system.


Prostate cancer risk

Prostate cancer is relatively common.
Other than skin cancer, prostate cancer is the most common cancer among men in the United States. It's estimated that, in the US, more than 2 million men have had the disease. And 1 in 6 men will be diagnosed with prostate cancer at some point.

The causes of prostate cancer are not known.
But some of the risks associated with it are. Here are the major ones:

  • Genes (family history). Genes are DNA instructions that tell the body how to make the proteins it needs. You get your genes from your parents. Over time, genes can change, or mutate, and certain mutations can make cells grow uncontrollably, leading to cancer. Only 5% to 10% of cancers are thought to have a genetic component that strongly affects risk. But prostate cancer does tend to be more common in men whose close family members have had this condition. If you have prostate cancer, your immediate family members may want to be screened early and regularly
  • Age. More than 65% of all cancers of the prostate are found in men older than 65
  • Race. Prostate cancer develops more often in African-American men than in Caucasian men, and, unfortunately, African-American men are more than twice as likely to die of this disease
  • Geography. For reasons not well understood, prostate cancer rates are higher in North America and Europe, and lower in Asia, Africa, and South America

Symptoms of advanced prostate cancer

Symptoms of advanced prostate cancerAs prostate cancer spreads, it can cause more and more symptoms.
At first, many men with prostate cancer report surprisingly few or even no symptoms. For a long time, they may not know that they have the disease.

But when the cancer spreads outside the prostate and nearby lymph nodes (becomes metastatic), it is usually accompanied by symptoms. These can include:

  • Trouble urinating
  • Blood in the urine
  • Numbness in the feet or legs
  • Loss of bladder or bowel control
  • Back pain

Not everyone with advanced prostate cancer has the same symptoms. Whether or not a particular symptom is present, the cancer itself may still be there.

You should always talk to you doctor about any symptoms that bother you or do not go away.

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 doctor 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 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 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 doctor 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 doctor right away if you have any of these symptoms. Your doctor 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 doctor if you are not sure.

JEVTANA can also cause gastrointestinal symptoms.
Nausea, 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. You may need to go to the hospital for treatment.

Kidney failure may happen with JEVTANA.
Kidney failure may happen because of severe infection, loss of too much body fluid (dehydration), or for 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

Before receiving JEVTANA, tell your doctor if you:

  • had allergic reactions in the past
  • have kidney or liver problems. JEVTANA should not be given to patients with liver problems (hepatic impairment)
  • are age 65 or older as these patients:
    • — may be more likely to experience certain adverse reactions, including low white blood cell count
          with or without fever, tiredness, weakness, fever, dizziness, urinary tract infection and
          dehydration
  • have any other medical conditions
  • if you are female and:
    • — are pregnant or plan to become pregnant as JEVTANA can harm your unborn baby
    • — are breastfeeding or plan to breastfeed

Serious side effects of JEVTANA include low white blood cell counts that could lead to serious or life-threatening infections, severe allergic reactions, gastrointestinal symptoms (nausea, severe vomiting and diarrhea) 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). 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
  • Vomiting
  • Diarrhea
  • Constipation
  • Weakness
    
  • Blood in the 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. You may report side effects to FDA at
1-800-FDA-1088.

Remember, your doctor is the single best source of information regarding your health. Please consult your doctor 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.

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