Policycriteria it is the policy of pennsylvania health and wellness that jevtana is medically necessary when the following criteria are met. Lynparza olaparib tablets us prescribing information. Jevtana cabazitaxel injection, for intravenous use initial u. Obtain frequent blood counts to monitor for neutropenia.
Lower dose of cabazitaxel in prostate cancer the asco post. Jevtana is indicated in combination with prednisone for the treatment of patients with hormonerefractory metastatic prostate cancer previously treated with a docetaxelcontaining treatment regimen. Any use of the information is subject, at all times, to ccos terms and conditions. Fda approves lower dose of cabazitaxel for prostate cancer. Dose modifications guidelines for peripheral neuropathy are provided see dosage and administration 2. 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. The european medicines agency has waived the obligation to submit the results of studies with jevtana in all subsets of the paediatric population in the indication of prostate cancer see section. Withhold or discontinue imfinzi to manage adverse reactions as described in table 2. Docetaxel is a widelyused secondgeneration taxane compound. Sanofi has updated the jevtana prescribing information to emphasize the importance of using the. Prednisone plus cabazitaxel or mitoxantrone for metastatic castrationresistant prostate cancer progressing after docetaxel treatment. Food and drug administration approved a lower dose of cabazitaxel 20 mgm 2 every 3 weeks jevtana, sanofiaventis in combination with prednisone for the. April 2014 cabazitaxel injection that may cause an two.
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. Mechanism of action and biological rationale for cabazitaxel. Read the patient information leaflet if available from your pharmacist before you start using cabazitaxel and each time you get a refill. Dosing exceeds single dose limit of jevtana cabazitaxel 25 mgm2. Llchighlights of prescribing information these highlights do not include all the information needed to use jevtana safely and effectively. Jevtana is indicated in combination with prednisone for the treatment of patients with metastatic castrationresistant prostate cancer previously treated with a docetaxelcontaining treatment regimen jevtana dosage and administration dosing information. Important reminder at the end of this policy for important regulatory and legal information. This information is intended for use by health professionals. The number of jevtana treatment cycles that you receive will be determined by your healthcare provider. Lynparza olaparib capsules us prescribing information. In order to monitor the occurrence of neutropenia, frequent blood cell counts should be performed on all patients. These highlights do not include all the information needed to use halaven safely and effectively. The clinicians guide to jevtana jevtana cabazitaxel.
Nightingale is assistant professor in the department of pharmacy practice at the jefferson school of pharmacy, thomas jefferson university, in philadelphia, pa. See full prescribing information for complete boxed warning. Learn about jevtana, a nccn designated category 1 secondline therapy for patients with metastatic castrationresistant prostate cancer mcrpc previously treated with a docetaxelcontaining regimen. Description cabazitaxel jevtana is a microtubule inhibitor. Interactions between jevtana intravenous and selected. The first taxane was paclitaxel, a drug isolated from yew tree. Toxicity in hepatic impairment see full prescribing information for complete boxed. Jevtana is a nccn designated category 1 secondline therapy for mcrpc. Jevtana fda prescribing information, side effects and uses. Jevtana is prescribed in combination with an oral therapy called prednisone. The clinical formulation is supplied in a sterile form for intravenous use only. Please see additional important safety information throughout, and accompanying full.
Fda approved indications jevtana is indicated in combination with prednisone for the treatment of patients with hormone refractory. These highlights do not include all the information needed to use. Perjeta pertuzumab injection, for intravenous use initial u. Jevtana summary of product characteristics smpc by sanofi genzyme. Toxicity in hepatic impairment see full prescribing information for complete boxed warning. Highlights of prescribing information these highlights do not include all the information needed to use yervoy safely and effectively. Product information for auspar jevtana cabazitaxel sanofi aventis australia. Medicinal product subject to restricted medical prescription see annex i. If your partner is pregnant or is planning on becoming pregnant, ensure to use a condom. Jevtana is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castrationresistant prostate cancer previously treated with a docetaxelcontaining treatment regimen. Column 24g 1 mg of jevtana is equal to 1 unit of j9043 and 1 vial 60 mg1. Etailed information for jevtana cabazitaxel injection using the cms 1500 form. It is the policy of health plans affiliated with centene corporation that jevtana is. Highlights of prescribing information yervoy initial.
Jevtana cabazitaxel injection for advanced prostate. It is freely soluble in water, soluble in methanol, and slightly soluble in ethanol. Jevtana cabazitaxel is being used concurrently with other chemotherapy. Ryu is oncology clinical pharmacist in the department of pharmacy at thomas jefferson university hospital in. For information concerning melphalan and prednisone, see manufacturers prescribing information. Please see important safety information on pages 34 and. The european medicines agency has waived the obligation to submit the results of studies with jevtana in all subsets of the paediatric population in the indication of prostate cancer see section 4. Refer todoxorubicin prescribing information for dosing, and dose modifications. Prescribing information jevtana warning neutropenic deaths have been reported. Highlights of prescribing information these highlights do not include all the information needed to use tecentriq safely and effectively. We included the manufacturers prescribing information to supplement. Mar 17, 2020 see full prescribing information for complete boxed warning.
Phase iii data showing improved survival with jevtana. Highlights of prescribing information posterior reversible. Nightingale is assistant professor in the department of pharmacy practice at the jefferson school of pharmacy, thomas jefferson. Jevtana should not be given to patients with neutrophil counts of. Preparation and administration for jevtana cabazitaxel. These highlights do not include all the information needed to use jevtana safely and effectively. See 17 for patient counseling information and fdaapproved patient labeling revised. Left ventricular dysfunction and embryofetal toxicity. Starting and staying on track with jevtana important safety information jevtana may cause serious side effects, including. And patient has castrationresistant metastatic disease. Jevtana is contraindicated in patients with neutrophil counts of.
Highlights of prescribing information these highlights do not include all the information needed to use perjeta safely and effectively. In order to monitor the occurrence of neutropenia, frequent blood cell counts should be performed on all patients receiving jevtana. Low white blood cells, which can cause you to get serious infections, and may lead to death. We included the manufacturers prescribing information to supplement the clinical data.
See important safety information and full prescribing information, including boxed warning. The number of jevtana treatment cycles that you receive. The recommended dose of jevtana is based on calculation of the body surface area bsa, and is 20 mgm 2 administered as a onehour. The recommended dose of jevtana is based on calculation of the body surface area bsa. Primary prophylaxis with gcsf is recommended in patients with highrisk clinical features. Contraindications jevtana should not be used in patients with neutrophil counts of less than or equal to 1,500mm3. Important safety information for jevtana cabazitaxel injection. Highlights of prescribing information these highlights do not include all the information needed to use jevtana safely and effectively. Jevtana summary of product characteristics smpc emc. Highlights of prescribing information yervoy initial u. Patients treated with jevtana may receive prophylactic gcsf as per american society of clinical oncology asco andor current institutional guidelines, to reduce the risk or manage neutropenia complications febrile neutropenia, prolonged neutropenia or neutropenic infection. Jevtana cabazitaxel in combination with prednisone or prednisolone is indicated. Mar 01, 2020 jevtana is indicated in combination with prednisone for the treatment of patients with metastatic castrationresistant prostate cancer previously treated with a docetaxelcontaining treatment regimen. Initial approval criteria coverage is provided in the following conditions.
Jevtana must not be given to patients who have a history of severe hypersensitivity reactions to jevtana or to other drugs formulated with polysorbate 80. Ixempra in combination with capecitabine must not be given to patients with ast or alt 2. Patients treated with jevtana may receive prophylactic gcsf as per american society of clinical oncology asco andor current institutional guidelines, to reduce the risk or manage neutropenia. The intent of the criteria is to ensure that patients follow selection elements established by centene clinical policy for cabazitaxel for injection jevtana. Jevtana may affect your developing baby if you are given jevtana during pregnancy. Please see full prescribing information patient information, including serious side effects. Vials of vinblastine sulfate for injection usp contain 10 mg. Jevtana is expected to be available as a marketed product in the united states this summer. Jevtana cabazitaxel injection is an antineoplastic agent belonging to the taxane class that is for intravenous use. Jevtana cabazitaxel injection for advanced prostate cancer. Cabazitaxel is active in docetaxelsensitive as well as resistant tumours. Jevtana was evaluated in an open label, multicenter phase 12 study conducted in a total of 39 paediatric. Jevtana is a nccn designated category 1 secondline therapy for.
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