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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.

Learn more

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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JEVTANA Patient Assistance

Ask about your options as soon as possible

JEVTANA Patient AssistanceAn illness like advanced prostate cancer can strain finances. But there are options.
If you have questions about the costs of treatment for advanced prostate cancer, don’t hesitate to ask your healthcare team. They work with people in your situation often, and they may know about special programs to help cover some costs.

You may also be able to speak to a financial counselor in the business office of the hospital about healthcare costs. Make an appointment as soon as possible, or ask a loved one to do it for you. Sharing with a counselor may lead to a better overall financial plan.

PACT+® can offer patient assistance, reimbursement assistance, and more

Help is available.
Sanofi-aventis is dedicated to providing access to sanofi-aventis oncology medications for patients in need. Sanofi-aventis’s PACT+® program may be able to help you afford treatment with JEVTANA® (cabazitaxel) Injection.

The PACT+® program is one of the most comprehensive reimbursement support and patient assistance programs in the industry.

Find out more right away:

You can also contact PACT+® by phone at 1-800-996-6626. Toll-free support is available Monday through Friday, from 9:00 AM to 8:00 PM Eastern Standard Time, for patient and healthcare providers.

In addition, sanofi-aventis provides charitable support to 501(c)3 organizations that offer programs, financial support, and co-pay assistance to patients undergoing treatment for prostate cancer.

Get the facts on PACT+®.
PACT+® is made up of several programs. Here is how each can help patients:

Patient Assistance.
The Patient Assistance Program (PAP) works to provide sanofi-aventis medication free of charge to patients who have no insurance and who meet the program’s eligibility requirements. To qualify, you must meet financial and legal residency criteria, and be under the care of a healthcare provider licensed and authorized to prescribe, dispense, and administer medicines.

Drug Replacement.
If you have insurance but have been denied product coverage on appeal, the Drug Replacement Program may be able to help you. To qualify, you must meet financial criteria, have legal residency status, and be under the care of a healthcare provider licensed and authorized to prescribe, dispense, and administer medicines.

Reimbursement Assistance.
This program helps patients with no insurance or patients who have insurance but have been denied coverage for a sanofi-aventis medication.

Alternative Services.
PACT+® can also work with patients to help them find alternative services and resources, such as:

  • Referrals for co-pay assistance
  • Referrals to other drug assistance programs
  • Prescription savings programs
  • Home care services
  • Nutritional supplements
  • Medical supplies/devices
  • Utilities
  • Cosmetic aids
  • Clothing
  • Transportation
  • Support groups
  • Patient advocacy support
  • Groceries and food banks (such as Meals on Wheels)
  • Cancer advocacy groups
  • Hospice care

Money advice from the American Cancer Society

A prostate cancer diagnosis can mean a shift in finances, which may cause short- and long-term challenges. Read more about this issue, and find resources for patients with prostate cancer and their families.

Visit the American Cancer Society

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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