The intent of the criteria is to ensure that patients follow selection elements established by centene clinical policy for cabazitaxel for injection jevtana. Perjeta pertuzumab injection, for intravenous use initial u. Lynparza olaparib capsules us prescribing information. In a clinical study, men received a median of 6 treatment cycles of jevtana and 29% 109 out of 371 of men received 10 cycles of jevtana. Preparation and administration for jevtana cabazitaxel. Jevtana should not be given to patients with neutrophil counts of. See 17 for patient counseling information and fdaapproved patient labeling revised. Llchighlights of prescribing information these highlights do not include all the information needed to use jevtana safely and effectively. These highlights do not include all the information needed to use halaven safely and effectively. Learn about jevtana, a nccn designated category 1 secondline therapy for patients with metastatic castrationresistant prostate cancer mcrpc previously treated with a docetaxelcontaining regimen. Jevtana cabazitaxel in combination with prednisone or prednisolone is indicated. 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.
Highlights of prescribing information yervoy initial u. Important reminder at the end of this policy for important regulatory and legal information. Sanofi has updated the jevtana prescribing information to emphasize the importance of using the. Docetaxel is a widelyused secondgeneration taxane compound. Primary prophylaxis with gcsf is recommended in patients with highrisk clinical features. Ryu is oncology clinical pharmacist in the department of pharmacy at thomas jefferson university hospital in. Highlights of prescribing information yervoy initial. Dose modifications guidelines for peripheral neuropathy are provided see dosage and administration 2. Withhold or discontinue imfinzi to manage adverse reactions as described in table 2. Jevtana cabazitaxel is being used concurrently with other chemotherapy.
Jevtana cabazitaxel injection for advanced prostate cancer. Toxicity in hepatic impairment see full prescribing information for complete boxed. Jevtana is prescribed in combination with an oral therapy called prednisone. For information concerning melphalan and prednisone, see manufacturers prescribing information. Interactions between jevtana intravenous and selected. Fda approves lower dose of cabazitaxel for prostate cancer. Jevtana cabazitaxel injection, for intravenous use. It is the policy of health plans affiliated with centene corporation that jevtana is. Please see additional important safety information throughout, and accompanying full.
See 17 for patient counseling information and fdaapproved patient labeling. Product information for auspar jevtana cabazitaxel sanofi aventis australia. Highlights of prescribing information these highlights do not include all the information needed to use tecentriq safely and effectively. Toxicity in hepatic impairment see full prescribing information for complete boxed warning. 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. Dosing exceeds single dose limit of jevtana cabazitaxel 25 mgm2. Jevtana is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castrationresistant prostate cancer previously treated with a docetaxelcontaining. The clinicians guide to jevtana jevtana cabazitaxel. Food and drug administration approved a lower dose of cabazitaxel 20 mgm 2 every 3 weeks jevtana, sanofiaventis in combination with prednisone for the. Low white blood cells, which can cause you to get serious infections, and may lead to death.
Jevtana cabazitaxel injection is an antineoplastic agent belonging to the taxane class that is for intravenous use. 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. 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. 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. These highlights do not include all the information needed to use jevtana safely and effectively. Obtain frequent blood counts to monitor for neutropenia. We included the manufacturers prescribing information to supplement. April 2014 cabazitaxel injection that may cause an two. Refer todoxorubicin prescribing information for dosing, and dose modifications. Important safety information for jevtana cabazitaxel injection. Left ventricular dysfunction and embryofetal toxicity. The number of jevtana treatment cycles that you receive.
Men who are 65 years or older may be more likely to have these problems. Vials of vinblastine sulfate for injection usp contain 10 mg. The recommended dose of jevtana is based on calculation of the body surface area bsa. The number of jevtana treatment cycles that you receive will be determined by your healthcare provider. Please see important safety information on pages 34 and. Description cabazitaxel jevtana is a microtubule inhibitor. In order to monitor the occurrence of neutropenia, frequent blood cell counts should be performed on all patients. Fda approved indications jevtana is indicated in combination with prednisone for the treatment of patients with hormone refractory. This information is intended for use by health professionals.
Starting and staying on track with jevtana important safety information jevtana may cause serious side effects, including. Initial approval criteria coverage is provided in the following conditions. We included the manufacturers prescribing information to supplement the clinical data. Phase iii data showing improved survival with jevtana. Highlights of prescribing information these highlights do not include all the information needed to use yervoy safely and effectively. Jevtana cabazitaxel injection, for intravenous use initial u. Jevtana is indicated in combination with prednisone for the treatment of patients with hormonerefractory metastatic prostate cancer previously treated with a docetaxelcontaining treatment regimen. 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. Jevtana is a nccn designated category 1 secondline therapy for mcrpc. The clinical formulation is supplied in a sterile form for intravenous use only. Jevtana was evaluated in an open label, multicenter phase 12 study conducted in a total of 39 paediatric. Lynparza olaparib tablets us prescribing information. Nightingale is assistant professor in the department of pharmacy practice at the jefferson school of pharmacy, thomas jefferson university, in philadelphia, pa. Highlights of prescribing information posterior reversible.
Jevtana summary of product characteristics smpc emc. Cabazitaxel is active in docetaxelsensitive as well as resistant tumours. And patient has castrationresistant metastatic disease. The first taxane was paclitaxel, a drug isolated from yew tree. 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. Any use of the information is subject, at all times, to ccos terms and conditions.
Prescribing information jevtana warning neutropenic deaths have been reported. Prednisone plus cabazitaxel or mitoxantrone for metastatic castrationresistant prostate cancer progressing after docetaxel treatment. Jevtana summary of product characteristics smpc by sanofi genzyme. 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. Policycriteria it is the policy of pennsylvania health and wellness that jevtana is medically necessary when the following criteria are met. Read the patient information leaflet if available from your pharmacist before you start using cabazitaxel and each time you get a refill. These highlights do not include all the information needed to use. Jevtana cabazitaxel injection for advanced prostate. Highlights of prescribing information these highlights do not include all the information needed to use jevtana safely and effectively. See full prescribing information for complete boxed warning.
If your partner is pregnant or is planning on becoming pregnant, ensure to use a condom. Column 24g 1 mg of jevtana is equal to 1 unit of j9043 and 1 vial 60 mg1. Jevtana is a nccn designated category 1 secondline therapy for. Lower dose of cabazitaxel in prostate cancer the asco post. Highlights of prescribing information these highlights do not include all the information needed to use perjeta safely and effectively. Nightingale is assistant professor in the department of pharmacy practice at the jefferson school of pharmacy, thomas jefferson. Jevtana is contraindicated in patients with neutrophil counts of. Contraindications jevtana should not be used in patients with neutrophil counts of less than or equal to 1,500mm3. Jevtana is expected to be available as a marketed product in the united states this summer. It is freely soluble in water, soluble in methanol, and slightly soluble in ethanol. Etailed information for jevtana cabazitaxel injection using the cms 1500 form. In order to monitor the occurrence of neutropenia, frequent blood cell counts should be performed on all patients receiving jevtana. See important safety information and full prescribing information, including boxed warning. Ixempra in combination with capecitabine must not be given to patients with ast or alt 2.
The recommended dose of jevtana is based on calculation of the body surface area bsa, and is 20 mgm 2 administered as a onehour. Mechanism of action and biological rationale for cabazitaxel. Jevtana fda prescribing information, side effects and uses. Please see full prescribing information patient information, including serious side effects.
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. 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 may affect your developing baby if you are given jevtana during pregnancy. Mar 17, 2020 see full prescribing information for complete boxed warning. Medicinal product subject to restricted medical prescription see annex i. Jevtana cabazitaxel injection prescribing information.