solvent, there is solution containing 10 mg/ml cabazitaxel. The printed package leaflet of the medicinal product must state the name and address of the. See JEVTANA 20 mg/m² recommended dosing and dose modifications (every 3 weeks with prednisone 10 mg daily). 25 mg/m² can be considered in select. Package leaflet: Information for the patient. JEVTANA® 60 mg concentrate and solvent for solution for infusion. cabazitaxel. Read all of this leaflet carefully.
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Jevtana – Patient Information Leaflet (PIL) – (eMC)
To be taken into account if you are in a high risk group such as patients with liver disease, or epilepsy. This can csbazitaxel to death.
You may need to read it again. To view the changes to a medicine you must sign up and log in. The earliest sign of infection may be fever, so if you experience fever, tell your doctor right away. This includes any possible side effects not listed in this leaflet.
Talk to your HCP if you have concerns about fertility. Low white blood cells, which can cause you to get serious infections, and may lead to death.
This information is intended for U. You are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because JEVTANA may alter male fertility.
If this happens, do not drive or use any tools or machines until you feel better. If any of the above applies to you, tell your doctor immediately.
Cabazitaxel (JEVTANA®, Sanofi-Aventis) with PAP | Drug Updates from the FDA | Resources
Below is a text only representation of the Patient Information Leaflet. The approval was based on data from a noninferiority, multicenter, randomized, open-label trial PROSELICA of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen. By reporting side effects you can help provide more information on the safety of this medicine. Reporting of side effects If you get any side effects, talk to your doctor.
Your HCP will check you for this problem and treat you if needed. The concentrate is a clear yellow to brownish yellow oily solution. JEVTANA can cause a leak in the stomach or intestine, intestinal blockage, infection, and bleeding in the stomach or intestine. Richard Pazdur to inform oncologists and professionals in oncology-related fields in a timely manner. Company contact cabazitael Genzyme Therapeutics.
This is common may affect up to 1 in 10 people. Healthcare Professionals I cabwzitaxel a U. Deaths within 30 days of the last study drug dose 5.
Older patients Poor performance status Previous episodes of febrile neutropenia. Also, tell your HCP if you have any diarrhea during the time that your white blood cell count is low.
Ask your doctor to give you information about this other medicine. You may need to go to the hospital for treatment.
What is in this leaflet: These medicines include the following:. People with low blood counts can develop life-threatening infections. Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
The product code s for this leaflet is: The original can be viewed in PDF format using the link above.
Your HCP will regularly check your red blood cell count. Any of these events could cause severe dehydration. You will usually have an infusion once every 3 weeks. The solvent is a clear and colourless solution. Continue typing to refine. One single use clear glass vial, closed with a grey chlorobutyl rubber closure sealed by an aluminium cap with a light green plastic flip-off cover containing 1.
This is very common may affect more than pacckage in 10 people. Symptoms of anemia include shortness of breath and tiredness.
These medicines include the following: It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged. Patients should receive premedication. Overall Survival Tumor Response. Your doctor will pafkage your body surface area in square meters m 2 and will decide the dose you should have.
Like all medicines, this medicine can cause side effects, although not everybody gets them. One single use clear glass vial, closed with a grey chlorobutyl packahe closure sealed by a gold colour aluminium cap with a colourless plastic flip-off cover, containing 4.
Tell your doctor immediately if: