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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 healthcare provider 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 healthcare provider:
- 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 healthcare provider 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 healthcare provider right away if you have any of these symptoms of infection during treatment with JEVTANA:
- fever. Take your temperature often during treatment with JEVTANA.
- burning on urination
- muscle aches
Also, tell your healthcare provider if you have any diarrhea during the time that your white blood cell count is low. Your healthcare provider 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 healthcare provider should prescribe medicines before each infusion to help prevent severe allergic reactions.
Tell your healthcare provider 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
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 receive 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 healthcare provider will prescribe medicines to prevent or treat vomiting and diarrhea, as needed with JEVTANA.
Tell your healthcare provider 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 healthcare provider if you get any of these symptoms :
- severe stomach-area (abdomen)
- pain constipation fever
- blood in your stool, or changes in the color of your stool
Kidney failure. 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 healthcare provider will check you for this problem and treat you if needed.
Tell your healthcare provider 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
Lung or breathing problems. Lung or breathing problems may happen with JEVTANA and may lead to death. People who have lung disease before receiving JEVTANA may have a higher risk for developing lung or breathing problems with JEVTANA treatment. Your healthcare provider will check you for this problem and treat you if needed.
Tell your healthcare provider right away if you develop any new or worsening symptoms, including: trouble breathing, shortness of breath, chest pain, cough or fever.
What is JEVTANA?
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.
It is not known if JEVTANA is safe and effective in children.
JEVTANA is not for use in females.
Who should not receive JEVTANA Injection?
Do not receive JEVTANA if:
- your white blood cell (neutrophil count) is too low
- you have had a severe allergic reaction to cabazitaxel or other medicines that contain polysorbate 80. Ask your healthcare provider if you are not sure.
- you have severe liver problems
What should I tell my healthcare provider before receiving JEVTANA?
Before receiving JEVTANA, tell your healthcare provider if you:
- had allergic reactions in the past
- have kidney or liver problems
- have lung problems
- are over the age of 65
- have any other medical conditions
- are a female and:
- are pregnant or plan to become pregnant. JEVTANA can harm your unborn baby. Talk to your healthcare provider about the best way for you to prevent pregnancy while you are receiving JEVTANA.
- are breastfeeding or plan to breastfeed. It is not known if JEVTANA passes into your breast milk. You and your healthcare provider should decide if you will take JEVTANA or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements. JEVTANA can interact with many other medicines. Do not take any new medicines without asking your healthcare provider first. Your healthcare provider will tell you if it is safe to take the new medicine with JEVTANA. This Patient Information has been approved by the U.S. Food and Drug Revised: 10/2016 healthcare provider will tell you if it is safe to take the new medicine with JEVTANA.
How will I receive JEVTANA?
- JEVTANA will be given to you by an intravenous (IV) infusion into your vein.
- Your treatment will take about 1 hour.
- JEVTANA is usually given every 3 weeks. Your healthcare provider will decide how often you will receive JEVTANA.
- Your healthcare provider will also prescribe another medicine called prednisone, for you to take by mouth every day during treatment with JEVTANA. Your healthcare provider will tell you how and when to take your prednisone.
It is important that you take prednisone exactly as prescribed by your healthcare provider. If you forget to take your prednisone, or do not take it on schedule, make sure to tell your healthcare provider or nurse. Before each infusion of JEVTANA, your may receive other medicines to prevent or treat side effects.
What are the possible side effects of JEVTANA?
JEVTANA may cause serious side effects including:
- See "What is the most important information I Should know about JEVTANA?"
Common side effects of JEVTANA include:
- Low red blood cell count (anemia). Low red blood cell count is common with JEVTANA, but can sometimes also be serious. Your healthcare provider will regularly check your red blood cell count. Symptoms of anemia include shortness of breath and tiredness.
- Low blood platelet count. Low platelet count is common with JEVTANA, but can sometimes also be serious. Tell your healthcare provider if you have any unusual bruising or bleeding.
- Fever. See "What is the most important information I should know about JEVTANA?"
- blood in your urine. Tell your healthcare provider or nurse if you see blood in your urine.
- back pain
- shortness of breath
- stomach (abdominal) pain
- change in your sense of taste
- joint pain
- hair loss
- decreased appetite
- numbness, tingling, burning or decreased sensation in your hands or feet
Tell your healthcare provider 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 healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088.
General information about the safe and effective use of JEVTANA
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about JEVTANA that is written for health professionals.
What are the ingredients in JEVTANA?
Active ingredient: cabazitaxel
Inactive ingredient: polysorbate 80
Last reviewed on RxList: 3/1/2017
This monograph has been modified to include the generic and brand name in many instances.
Additional Jevtana Information
Jevtana - User Reviews
Jevtana User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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