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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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Prostate Cancer Web Sites

More ways to see treatment in a different light—connect with cancer patients and advocates online.
The Internet offers a great way to quickly find information on advanced prostate cancer and to meet other men fighting this disease. There are many support groups and research organizations to contact, so you are never alone. Here are several of the most prominent advocacy groups:

The American Cancer Society
1-ACS-2345 (1-800-227-2345)
www.cancer.org
A nationwide, community-based, voluntary health organization, the ACS offers the "Man to Man" program for prostate cancer patient education and support.

Association of Oncology Social Work
1-215-599-6093
www.aosw.org
The AOSW is a patient advocacy group that connects patients and their families and caregivers with essential community, state, national, and international resources.

Cancer Care®
1-800-813-HOPE (1-800-813-4673)
www.cancercare.org
CancerCare is a non-profit agency devoted to offering free professional support services to people of all ages, with all types of cancer, at any stage of the disease.

Cancer Hope Network
1-866-212-2454
www.cancerhopenetwork.org
The non-profit organization that provides free and confidential one-on-one support to cancer patients and their families. CHN can find someone for you to talk to who has already gone through what you’re experiencing, for additional support and information.

CancerInformation.com
www.cancerinformation.com
At CancerInfomation.com, you'll find in-depth information on prostate cancer (as well as other cancers), from screening methods and risk factors to descriptions of various stages of the disease and treatment options.

Cancer.net
1-571-483-1780
www.cancer.net
A service of the American Society of Clinical Oncology (ASCO), Cancer.net provides general information about cancer, updates on research and clinical trials, as well as information on side effects, caregiver issues, and the needs of the newly diagnosed.

The Cancer Support Community
1-888-793-WELL (1-888-793-9355)
www.thewellnesscommunity.org
The Cancer Support Community offers free education and emotional support to cancer patients and their families, including stress-reduction techniques, workshops, exercise tips, and social events.

The National Cancer Institute
1-800-4-CANCER (1-800-422-6237)
www.cancer.gov
The National Cancer Institute's Web site provides accurate, up-to-date information about many types of cancer, information about clinical trials, resources for people dealing with cancer, and information for researchers and health professionals.

The PACT+® Reimbursement Program
1-800-996-6626
www.pactplusonline.com
The sanofi-aventis PACT+® Program is a comprehensive program that includes reimbursement and patient assistance services to help lower some of the hurdles to getting access to medication for patients in need.

Partnership for Prescription Assistance
1-888-477-2669
www.pparx.org
The Partnership helps qualifying patients without prescription drug coverage get information about government-supported and private patient assistance programs.

The Prostate Cancer Foundation
1-800-757-CURE (2873)
www.pcf.org
PCF is the leading philanthropic organization funding prostate cancer research and a source of information about prostate cancer and its most recent and effective treatment options.

Us TOO International Prostate Cancer Education and Support Network
1-800-808-7866
www.ustoo.org
Us TOO International is a non-profit, grassroots organization started in 1990 by prostate cancer survivors to offer education and support for men and their families.

ZERO – The Project to End Prostate Cancer
1-888-245-9455
www.zerocancer.org
ZERO provides multiple resources to help patients, family members, caregivers, and partners better handle prostate cancer diagnosis and treatment, including how to address pain and emotional effects.

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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