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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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Frequently Asked Questions About JEVTANA
and Advanced Prostate Cancer

What is JEVTANA?
JEVTANA® (cabazitaxel) Injection 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.

Find out more about JEVTANA

How does JEVTANA work?
JEVTANA works by making cancer cells unable to divide properly. Every cell in your body contains supporting structures, like a miniature skeleton. JEVTANA makes the “skeleton” in some cancer cells very stiff, so that the cells can no longer grow or divide.

Find out more about JEVTANA

How will I receive JEVTANA?
JEVTANA is a chemotherapy infusion. This means it’s a liquid medicine that is delivered into your body’s bloodstream by an IV. Treatment takes about 1 hour. Generally, people receive JEVTANA every 3 weeks. The amount of JEVTANA and the frequency of your infusions will be determined by your doctor.

JEVTANA infusions may be delivered by an oncology nurse, or someone trained in giving chemotherapy treatments. The oncology nurse is just one part of your multidisciplinary team, which should include your oncologist (a doctor who specializes in fighting cancer), your urologist, your primary care physician, as well as all the other healthcare professionals who may be helpful in coming up with a treatment plan.

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Will I be given any other medication while receiving JEVTANA?
As part of your treatment plan, your doctor will prescribe another medicine called prednisone. Your doctor will tell you how and when to take this medicine. You will need to take this by mouth, every day. It's important that you take the prednisone on the schedule set by your doctor. If you forget to take your medication, or do not take it on schedule, make sure to tell your doctor or nurse.

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.

Your doctor will decide if other medications are necessary. Be sure to tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Find out more about JEVTANA

What should I tell my doctor before beginning treatment with JEVTANA?
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

Tell your doctor about all the medicines you take. This includes 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.

Find out more about JEVTANA

Read Important Safety Information about JEVTANA

What is the most important information about JEVTANA?
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.

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.

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.

Read Important Safety Information about JEVTANA

What are the possible side effects of JEVTANA?
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

Read more about the side effects of JEVTANA

What are some ways to reduce the risk of infection if you have neutropenia?

  • Wash thoroughly. If you’re at a higher risk of infection, make sure to wash your hands often with soap and water. Wash before cooking and eating, and after you use the bathroom, blow your nose, cough, sneeze, or touch pets. You may want to carry hand sanitizer with you at all times
  • Avoid crowds, as well as people who are sick. This includes children who’ve received “live virus” vaccines for diseases such as chickenpox or polio
  • Brush your teeth regularly. Using a soft toothbrush, brush after every meal and before bed. Use alcohol-free mouth rinse. This can help protect your mouth from infection
  • Discuss with your doctor whether or not you should get a flu shot. Vaccines may contain a live virus, which you should not be exposed to
  • Wash vegetables and fruits, and don’t eat undercooked foods. Meat, fish, eggs, and raw vegetables and fruits can carry bacteria that cause infections
  • Take medication. Your doctor may give you a medicine to help raise your white blood cell count and lower your risk of infection. Specifically, your doctor may prescribe a medicine called G-CSF (granulocyte colony-stimulating factor) to help increase your white blood cell count

Read more about addressing certain side effects of JEVTANA

What are some things you can do if you have diarrhea?

Diarrhea is another serious side effect of JEVTANA. It’s a condition in which you have more bowel movements than usual, and stools are loose, soft, or watery. Diarrhea can make some people feel dizzy, cause cramps, raise the body’s temperature, and make the rectal area sore.

Diarrhea can cause dehydration (loss of body fluids or body salts). If not addressed, it can have serious consequences, and can sometimes lead to death. Be sure to report significant vomiting or diarrhea, decreased urinary output, fever, and hematuria (blood in urine) to your oncologist. Tell your doctor if your symptoms get worse or do not get better. You may need to go to the hospital for treatment.

There are several strategies you and your doctor can use to help:

  • Change how you eat. Eat 5 to 6 small meals instead of 3 large ones. Think of your meals as snacks
  • Change what you eat. Try low-fiber foods such as bananas, white rice, white toast, and plain or vanilla yogurt. Eggs (fully cooked to avoid infection), skinless boiled potatoes, skinless poultry or fish, and gelatin are also good choices for an upset stomach
  • Change what you drink. Avoid anything caffeinated—such as coffee, soda, and black tea—as well as anything alcoholic
  • Drink more liquids to replenish what you lose. Drink 8 to 12 cups of clear, non-carbonated,
    room-temperature liquids each day. These liquids can include water, sports drinks, ginger ale, and chicken broth
  • Ask your doctor about medications that can help. There may be options available to you

Read more about addressing certain side effects of JEVTANA

What is advanced prostate cancer?
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. In terms of staging, an advanced prostate cancer is at stage IV.

Find out more about advanced prostate cancer

How is advanced prostate cancer treated?
Prostate cancer treatment varies from person to person. Age, overall health, stage and grade of tumor, and PSA levels all factor into a prostate cancer treatment plan. For a man with advanced prostate cancer, hormone therapy, radiation, and surgery to relieve symptoms may all be considered. Chemotherapy is often used to treat advanced prostate cancer if hormone therapy is no longer working.

Find out more about advanced prostate cancer treatment

What is chemotherapy?
Chemotherapy, or “chemo,” is a systemic treatment, meaning it can fight cancer throughout the body. Chemotherapy may be given orally (through the mouth) or by infusion (using an IV). Chemo may shrink a tumor or stop it from spreading, and chemo can affect cancer at different sites in the body.

Find out more about advanced prostate cancer treatment

Learn more about chemotherapy

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.

See Full Prescribing Information including Boxed WARNING.