However, if you experience any unexpected or worrying side effects after being given jevtana immediately telephone your doctor, or the poisons information centre telephone australia 11 26 or. Cabazitaxel jevtana medical clinical policy bulletins aetna. See full prescribing information for sandostatin lar depot. Cabazitaxel has not been studied in patients with hepatic impairment hi.
Xtandi enzalutamide capsules, for oral use initial u. Severe and sometimes fatal hepatotoxicity has occurred in clinical trials. Side effects of jevtana cabazitaxel injection, warnings. Jevtana cabazitaxel dose, indications, adverse effects. It is given as an infusion into a vein over a period of time. For general information, learn about clinical studies. Cabazitaxel fda orange book approved drug product list.
Cabazitaxel is a cancer medicine that interferes with the growth and spread of cancer cells in the body. It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. This phase i study assessed cabazitaxel safety and pharmacokinetics in patients with hi. Choosing to participate in a study is an important personal decision. For further information call emc accessibility on 0800 198 5000. Effective january 1, 2012 jevtana has been assigned a hcpcs jcode. Docetaxel injection may cause serious side effects including death. Docetaxel fda prescribing information, side effects and uses. Mar 10, 2011 mechanism of action and biological rationale for cabazitaxel. Product information for auspar jevtana cabazitaxel sanofiaventis australia pty ltd pm20100256534 final 9 february 2012.
An increase in new second cancers has happened in people treated with docetaxel injection together with certain other anticancer treatments. Cabazitaxel side effects, dosage, interactions drugs everyday health search. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Download fulltext pdf download fulltext pdf preclinical profile of cabazitaxel article pdf available in drug design, development and therapy 8default. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. See important safety information and full prescribing information, including boxed warning. Docetaxel is a widelyused secondgeneration taxane compound. See full prescribing information for complete boxed warning. See what is the most important information i should know about docetaxel injection. Our jevtana cabazitaxel side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. See full prescribing information for complete boxed. The original leaflet can be viewed using the link above.
These highlights do not include all the information needed and administration instructions. Nov 14, 2019 use cabazitaxel as ordered by your doctor. Highlights of prescribing information these highlights do not include all the information needed to use xtandi safely and effectively. Mechanism of action moa of jevtana cabazitaxel injection. Vumerity diroximel fumarate delayedrelease capsules, for oral use. Phase i dosefinding study of cabazitaxel administered weekly in patients with advanced solid tumours. Stability of cabazitaxel solution after dilution in normal. It works by slowing or stopping the growth of cancer cells in. Dosing and dose modifications for jevtana cabazitaxel. Mechanism of action and biological rationale for cabazitaxel. Listing a study does not mean it has been evaluated by the u. This medicine is taken with a steroid drug like prednisone.
The nlm drug information portal gives users a gateway to selected drug information from the national library of medicine and other key government agencies. Highlights of prescribing information these highlights do. Cabazitaxel is a novel taxane anticancer agent specifically designed to be active both in taxanenaive and taxaneresistant tumours and avoid the decline in response that is often observed with other currently available taxanes. We are an optum company a leading provider of integrated health services. Preclinical profile of cabazitaxel pubmed central pmc.
Cabazitaxel inj jevtana by sanofi aventis belongs to the group of cancerfighting medications known as antineoplastics. Multums drug information does not endorse drugs, diagnose patients or recommend therapy. To evaluate the stability of cabazitaxel diluted in 0. Jevtana is used to treat men with castrationresistant prostate cancer prostate cancer that is resistant to medical or surgical treatments that lower testosterone that has worsened progressed after treatment with other medicines, including docetaxel. Cabazitaxel can cause birth defects in male fetuses. Pdr drug summaries are concise pointofcare prescribing, dosing and administering information to help phsyicans more efficiently and accurately prescribe in their practice pdr s drug summaries are available free of charge and serve as a great resource for us based mds, dos, nps and pas in patient practice. Pdf phase i dosefinding study of cabazitaxel administered. Cabazitaxel reappears on the cancer drugs fund prostate.
Cabazitaxel is a cancer medicine that interferes with the growth and spread of cancer cells in the body cabazitaxel is used together with prednisone to treat prostate cancer that has spread to other parts of the body metastatic cabazitaxel is usually given after other cancer medicines have been tried without success cabazitaxel may also be used for purposes not listed in this. Nov 09, 2018 cabazitaxel is a cancer medicine that interferes with the growth and spread of cancer cells in the body. The first taxane was paclitaxel, a drug isolated from yew tree bark in the 1960s and first approved by the fda in 1992 for treatment of refractory ovarian cancer. Click the orange links and well show you extra information. Skyrizi risankizumabrzaa full prescribing information. Cabazitaxel is approved to be used with prednisone to treat prostate cancer that has metastasized spread to other parts of the body in men whose cancer is castration resistant has not responded to treatments that lower testosterone levels and who have already been treated with chemotherapy that included docetaxel.
Evaluation of safety of cabazitaxel jevtana in patients with metastatic hormone refractory prostate cancer. The commercially available product was prepared according to the manufacturers instructions, and further diluted in ns to obtain concentrations of 0. Take the steroid drug with cabazitaxel as you have been told by your doctor. List of approved drug products containing cabazitaxel in the fda orange book on. Safety and pharmacokinetics of cabazitaxel in patients. Highlights of prescribing information posterior reversible.
Refer to everolimus prescribing information for recommended everolimus dosing information. This product information was approved at the time this auspar was published. Jevtana cabazitaxel injection, for intravenous use initial u. Fda label information for this drug is available at dailymed. Talk with your doctor and family members or friends about deciding to join a study. Monitor hepatic function prior to and during treatment see warnings and precautions 5.
Find patient medical information for cabazitaxel intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Evaluation of safety of cabazitaxel jevtana in patients. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020. For more information, ask your healthcare provider or pharmacist. Patients with advanced, nonhematologic cancer, and normal hepatic function cohort 1. The mtd for cabazitaxel was established as 30 mgm 2 in this study. Jevtana cabazitaxel injection for advanced prostate cancer. See detailed information for jevtana using the cms 1500 form below. Cabazitaxel injection may cause severe or lifethreatening allergic reactions, especially when you receive your first two infusions of cabazitaxel injection. Paclitaxel and docetaxel are semisynthetic derivatives of 10deacetylbaccatiniii,25,26 a natural paclitaxel precursor molecule that can be extracted easily and sustainably from the needles of the european yew tree figure 1. Cabazitaxel intravenous route before using mayo clinic.
Please see full prescribing information patient information, including serious side effects. Highlights of prescribing information these highlights do not include all the information needed to use sandostatin lar depot safely and effectively. A phase 12 dosefinding, safety, and activity study of cabazitaxel in pediatric patients with refractory solid tumors including tumors of the central nervous system. Call your doctor for medical advice about side effects.
This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Highlights of prescribing information these highlights do not include all the information needed to use jevtana safely and effectively. Mar 24, 2020 these are not all the possible side effects of jevtana. In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. If jevtana first diluted solution, or second final dilution for intravenous infusion should come into contact with the skin or mucous, immediately and thoroughly wash with soap and water. Official label printer friendly view all sections close all sections. See full prescribing information for complete preparation. Neutropenia and hypersensitivity see full prescribing information for complete boxed warning. Highlights of prescribing information these highlights. Optumrx specializes in the delivery, clinical management and affordability of prescription medications and consumer health products. Blood and urine tests may be needed to check for unwanted effects.
The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is. General information about the safe and effective use of jevtana. Using this medicine while you are pregnant can harm your unborn baby. Jevtana cabazitaxel injection price in india, by sanofi. Highlights of prescribing information these highlights do not include all the information needed to use ee full prescribing information for jevtana. The text only version may be available in large print, braille or audio cd. Mar 23, 2020 provides accurate and independent information on more than 24,000 prescription drugs, overthecounter medicines and natural products. Cabazitaxel pf induction chemotherapy full text view. The recommended dose of jevtana is based on calculation of the body surface area, and is 20 mgm 2 administered.
Llchighlights of prescribing information these highlights do not include all the information needed to use jevtana safely and effectively. For this medicine, the following should be considered. Jevtana cabazitaxel dosing, indications, interactions. Billingcoding information j9043 1 billable unit is 1mg. Interrupt and then reduce or discontinue stivarga for hepatotoxicity as manifested by elevated liver.
See 17 for patient counseling information and medication. Jevtana cabazitaxel injection, for intravenous use. Jun 23, 2011 cabazitaxel pf induction chemotherapy the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Below is a text only representation of the patient information leaflet. Cabazitaxel injection is given together with a steroid medicine e. Sandostatin lar depot octreotide acetate for injectable suspension, for gluteal intramuscular use initial u. This is not a complete list of side effects and others may occur. Cabazitaxel is designed to kill cancer cells by decreasing their ability to divide. Your doctor will give you medications to prevent an allergic reaction at least 30 minutes before you receive cabazitaxel injection.
Zolinza vorinostat dosing, indications, interactions. Sanofiaventis, the pharmaceutical company that makes taxotere and the newly approved drug, jevtana cabazitaxel yesterday announced that their newly approved treatment for men with metastatic hormonerefractory prostate cancer mhrpc who have been previously treated with a docetaxelbased treatment regimen and failed is finally available for distribution in the united states. Stivarga regorafenib label food and drug administration. All optum trademarks and logos are owned by optum, inc. Multum information has been compiled for use by healthcare practitioners and consumers in the united states and therefore multum does not warrant that uses outside of the united states are appropriate, unless specifically indicated otherwise. A reversephase stabilityindicating liquid chromatographic method was developed and validated before the study. These highlights do not include all the information needed to use jevtana safely and effectively. Women of childbearing potential should not use or handle this medicine. To assess the safety, the maximum tolerated dose mtd and the dose limiting toxicity of cabazitaxel when combined with cisplatin and followup fu induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck scchn. Specifically, it belongs to the group of antineoplastics known as taxanes. Side effects of jevtana cabazitaxel injection, warnings, uses. Hepatotoxicity severe and sometimes fatal hepatotoxicity has occurred in clinical trials see warnings and precautions 5.
953 1165 1418 857 66 884 356 588 18 587 15 1013 885 1394 1441 266 793 1219 1313 111 1204 643 1225 1597 543 124 29 889 384 526 713 898 1233 1444 1157 1065