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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.

Sign up for the free JEVTANA Connects™ Program

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You'll receive e-mails with suggestions for dealing with certain side effects. And you can join the JEVTANA Patient Matching Program developed by the Cancer Hope Network.

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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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Addressing Certain Side Effects of JEVTANA

Life during chemotherapy treatment

Side Effects of JEVTANAJEVTANA® (cabazitaxel) Injection targets cancer cells, but it can also damage some normal cells.
This can cause side effects. Here are some helpful hints for addressing certain side effects.

You may experience side effects in different ways. Ask your doctors what to do about any side effects that bother you.

If you have advanced prostate cancer and are making new treatment decisions with your doctor, you should weigh the potential side effects of JEVTANA against its ability to fight your cancer.


Important Safety Information for 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.

Before starting JEVTANA, make sure to tell your doctor about any medicines you're taking, including prescription medications, over-the-counter therapies, vitamins, herbal remedies, and supplements.

Addressing serious side effects

Two of the more serious side effects of JEVTANA are low white blood cell count (neutropenia) and diarrhea. Make sure to talk to your healthcare team about any side effects you experience that don't go away or are bothersome.

Working with your healthcare team, there 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. Specifically, your doctor may prescribe an injectible medicine called G-CSF (granulocyte colony-stimulating factor) to help increase your white blood cell count

Call your doctor or nurse right away if you think you have an infection. Be sure you know how to reach your doctor after office hours and on weekends.

Learn more about side effects of JEVTANA, including an increased risk of infection

There are several things your doctor can do to help get your diarrhea under control, including prescribing you medications and adjusting your dose of JEVTANA. Here are a few other strategies you may want to consider:

  • 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

Common side effects

Common side effects of JEVTANA include low white blood cell count, low red blood cell count (anemia), low blood platelet count, 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.

It's important to talk to your doctors and nurses about any side effects you are experiencing. They are your best resource for dealing with certain side effects.

Here are a few ways to address certain common side effects of JEVTANA:

  • Low red blood cell count (anemia). Anemia can make you feel tired, so get plenty of rest. Accept more help from others. Also, talk to your doctors about a well-balanced diet that can help you get the calories and protein you need. The right diet may help you keep your weight up and help your body repair damaged tissue. Your doctor will routinely check your red blood cell count and may recommend treatment if it is too low
  • Low blood platelets, or thrombocytopenia. JEVTANA can cause a drop in the number of blood platelets. Low blood platelets can lead to excessive bleeding, because the blood cannot clot properly. Your doctor may recommend treatment
  • Nausea and vomiting. Stay away from foods with strong tastes and smells. Eat smaller meals of easy-to-digest foods like crackers and toast
  • Constipation. Drink at least 8 cups of water every day. Be more active, or as active as is comfortable for you. Talk to your healthcare team about a high-fiber diet that can help you have more bowel movements
  • Fatigue. Give yourself plenty of time to rest—at least 8 hours of sleep per night—but also make an effort to be active regularly. Try going for short walks every day. You may also want to keep a journal of your energy level
  • Kidney and bladder problems. Drink plenty of fluids, and drink less caffeine
  • Muscle or joint pain. Talk about your pain with your doctors, describing it on a scale from 1 to 10. Mention where it occurs, how long it lasts, and whether anything makes it feel better (an ice pack, a heating pad, etc.). If your doctor gives you medicine for your pain, do not skip any doses
  • Hair loss. If you want to buy a wig or hair piece, try to do so while you still have hair. That way, you can match your hair's color and style easily. Remember that you may feel cooler with less hair, so keep a hat around

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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