fusion solution (in either 0.9% sodium chloride solution or 5% dextrose solution) should be used within 8 hours at ambient temperature (including the one-hour infusion), or for a total of 24 hours (including the one-hour infusion) under the refrigerated conditions.
In addition, chemical and physical stability of the infusion solution has been demonstrated for 24 hours under refrigerated conditions. As both the first diluted solution and the second (final) infusion solution are supersaturated, the solutions may crystallize over time. If crystals and/or particulates appear, the solutions must not be used and should be discarded [see Dosage and Administration (2.5)].
Procedures for proper handling and disposal of antineoplastic drugs should be followed. Several guidelines on this subject have been published [see References (15)]. Any unused product or waste material should be disposed of in accordance with local requirements.
See FDA-Approved Patient Labeling
Patient InformationJEVTANA® (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:
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 works in children.
Who should not receive JEVTANA?
Do not receive JEVTANA if:
What should I tell my doctor before receiving JEVTANA?
Before receiving JEVTANA, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. JEVTANA can interact with many other medicines. Do not take any new medicines without asking your doctor first. Your doctor will tell you if it is safe to take the new medicine with JEVTANA.
How will I receive JEVTANA?
It is important that you take prednisone exactly as prescribed by your doctor. If you forget to take your prednisone, or do not take it on schedule, make sure to tell your doctor or nurse. Before each infusion of JEVTANA, you 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:
Common side effects of JEVTANA include:
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.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about JEVTANA
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
This leaflet summarizes the most important information about JEVTANA. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about JEVTANA that is written for health professionals.
For more inform
