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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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Advanced Prostate Cancer Glossary



A

Advanced prostate cancer
A cancer which has widely spread from the prostate to other parts of the body.

Androgen
The main male hormone, such as testosterone.

B

Biopsy
A diagnostic test in which a sample of tissue is removed and examined under a microscope by a pathologist to determine the presence of cancer.

Brachytherapy
A type of radiation therapy in which tiny radioactive “seeds” are implanted directly into or near the cancer tissue.

C

Cancer
A disease caused by the out-of-control growth of the body’s cells, caused by damage to the cells’ DNA.

Chemotherapy
The use of drugs to kill cancer. It can be introduced into the bloodstream by mouth or injection, and circulates throughout the body.

Cryosurgery
Cryosurgery (cryotherapy), a technique which uses very cold gas to freeze and kill prostate cancer cells.

E

External beam radiation therapy
A type of cancer treatment in which high-energy X-rays emitted by an external machine are focused on the diseased organ to kill cancer cells.

G

Gland
An organ that produces a substance such as a hormone, digestive juice, sweat, tears, saliva, semen, or milk.

Gleason system
A way of grading a cancer, or describing how fast a cancer is likely to grow, based on how abnormal the cells look. In the Gleason system, pathologists assign the most common type of cancer cell in your prostate a number between 1 and 5. The higher the number is, the more abnormal the cells are. A second number is then assigned to the second-most common type of cancer cell. The Gleason score is the sum of these two numbers, which will be between 2 and 10.

Grade
A number score assigned to a cancerous biopsy sample that describes how aggressive a cancer is and how fast it is likely to grow and spread.

G–CSF (granulocyte colony-stimulating factor)
A medicine that stimulates the production of neutrophils (a type of white blood cell). G-CSF is a cytokine that belongs to the family of drugs called hematopoietic (blood-forming) agents.

H

Hormone
A substance made by a gland in the body. Hormones control the actions of certain cells and organs.

I

Incontinence
An inability to control urination.

Impotence
Inability to achieve or maintain an erection sufficient for sexual penetration.

Infusion
A method for introducing medicine or other fluids into the bloodstream.

L

Lymph node
Small, bean-shaped group of immune system cells connected by lymphatic vessels. Lymph nodes, or lymph glands, filter lymph (lymphatic fluid), and store lymphocytes (white blood cells). They are located along lymphatic vessels.

M

Metastasis
A process that takes place in advanced cancer, in which cancer spreads from the primary site to other
parts of the body.

O

Oncologist
A doctor who specializes in diagnosing and treating cancer.

P

Pathologist
A doctor who specializes in identifying disease by studying cells and tissues taken from a biopsy under a microscope.

Prognosis
Medical outlook. The likelihood of recurrence, survival, and recovery from a disease.

Prostate
A walnut-shaped organ that surrounds the base of the urethra in men. The prostate is a gland in the male reproductive system that produces a fluid that becomes part of semen.

PSA (prostate-specific antigen) test
A measure of prostate-specific antigen (PSA), a protein produced in the prostate.

R

Radiation therapy (radiotherapy)
The use of X-rays to kill cancer cells and shrink tumors.

Radical prostatectomy
Surgery to treat prostate cancer where the entire prostate gland and some surrounding tissue is removed. When it is likely that the cancer has spread to nearby lymph nodes, they are also removed, along with both seminal vesicles and other surrounding tissues.

Recurrent
Cancer that has returned in a person who seemed to be disease-free after treatment.

S

Seminal vesicles
A pair of glands that lie on the sides of the male reproductive tract. They add a sugar- and protein-rich fluid to semen.

T

Testosterone
A male hormone (androgen) made in the testicles that can trigger the prostate to grow.

Tumor
An abnormal mass created when cells divide too quickly or do not die when they should. A tumor may be benign or cancerous.

U

Urethra
A canal that carries urine from the bladder out of the body and, in men, serves as a passageway for semen.

Urologist
A doctor who specializes in diseases of the urinary system, as well as the male reproductive system.

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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