IMPORTANT SAFETY INFORMATION FOR JEVTANA® (CABAZITAXEL) INJECTION
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.
- 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
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.
Severe stomach and intestine (gastrointestinal) problems. JEVTANA can cause severe stomach
and intestine problems, which may lead to death. You may need to go to the hospital for treatment.
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. Your doctor will prescribe medicines to prevent
or treat vomiting and diarrhea, as needed with JEVTANA.
Tell your doctor if:
- you have vomiting or diarrhea
- your symptoms get worse or do not get better
JEVTANA can cause a leak in the stomach or intestine, intestinal blockage, infection, and bleeding in the stomach or intestine. This can lead to death.
Tell your doctor if you have any of these symptoms:
- severe stomach-area (abdomen) pain
- blood in your stool or changes in the color of your stool
Kidney failure may happen with JEVTANA, because of severe infection, loss of too much body fluid
(dehydration), and 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 these signs or symptoms:
- 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
- — 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, severe
stomach and intestine (gastrointestinal) problems (severe vomiting and diarrhea, a leak in the stomach
or intestine, intestinal blockage, infection, and bleeding in the stomach or intestine) 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
- blood in the urine - Tell your doctor or nurse if you see blood in your urine.
- back pain
- decreased appetite
- shortness of breath
- stomach (abdominal) pain
- change in your sense of taste
- 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
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
For more information, go to www.sanofi.us
or call 1-800-633-1610.
Full Prescribing Information including Boxed WARNING.