17.PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling

Educate patients about the risk of potential hypersensitivity associated with JEVTANA. Confirm patients do not have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80. Instruct patients to immediately report signs of a hypersensitivity reaction.
Explain the importance of routine blood cell counts. Instruct patients to monitor their temperature frequently and immediately report any occurrence of fever to the treating oncologist.
Explain that it is important to take the oral prednisone as prescribed. Instruct patients to report if they were not compliant with oral corticosteroid regimen.
Explain to patients that severe and fatal infections, dehydration, and renal failure have been associated with cabazitaxel exposure. Patients should immediately report fever, significant vomiting or diarrhea, decreased urinary output, and hematuria to the treating oncologist.
Inform patients about the risk of drug interactions and the importance of providing a list of prescription and non-prescription drugs to the treating oncologist [see Drug Interactions (7)].
Inform elderly patients that certain side effects may be more frequent or severe.
Patient Information
JEVTANA® (JEV-TA-NA)
(cabazitaxel)
Injection

Read this Patient Information before you start receiving JEVTANA and each time before you receive your infusion. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know 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. People who are 65 years or older may be more likely to have these problems. 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 your doctor decides that you have enough white blood cells.
may prescribe a medicine for you called G-CSF, to help prevent complications if your white blood cell count is too low.
Tell your doctor right away if you have any of these symptoms of infection while receiving JEVTANA:

fever. Take your temperature often during treatment with JEVTANA.
cough
burning on urination
muscle aches
Also, tell your doctor if you have any diarrhea during the time that your white blood cell count is low. Your doctor may prescribe treatment for you as needed.

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.
Tell your doctor or nurse right away if you have any of these symptoms of a severe allergic reaction during or soon after an infusion of JEVTANA:

rash or itching
skin redness
feeling dizzy or faint
breathing problems
chest or throat tightness
swelling of face
Gastrointestinal symptoms. 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 bod