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Jevtana
Overview
What is Jevtana?
JEVTANA (cabazitaxel) injection is an antineoplastic agent belonging to the taxane class that is for intravenous use. It is prepared by semi-synthesis with a precursor extracted from yew needles.
The chemical name of cabazitaxel is (2α,5β,7β,10β,13α)-4-acetoxy-13-({(2R,3S)-3-[(tertbutoxycarbonyl) amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate–propan-2-one (1:1).
Cabazitaxel has the following structural formula:
Cabazitaxel is a white to almost-white powder with a molecular formula of CHNOCHO and a molecular weight of 894.01 (for the acetone solvate) / 835.93 (for the solvent free). It is lipophilic, practically insoluble in water and soluble in alcohol.
JEVTANA (cabazitaxel) injection 60 mg/1.5 mL is a sterile, non-pyrogenic, clear yellow to brownish-yellow viscous solution and is available in single-dose vials containing 60 mg cabazitaxel (anhydrous and solvent free) and 1.56 g polysorbate 80.
Each mL contains 40 mg cabazitaxel (anhydrous) and 1.04 g polysorbate 80.
DILUENT for JEVTANA is a clear, colorless, sterile, and non-pyrogenic solution containing 13% (w/w) ethanol in water for injection, approximately 5.7 mL.
JEVTANA requires two dilutions prior to intravenous infusion. JEVTANA injection should be diluted only with the supplied DILUENT for JEVTANA, followed by dilution in either 0.9% sodium chloride solution or 5% dextrose solution.
What does Jevtana look like?
What are the available doses of Jevtana?
JEVTANA (cabazitaxel) injection is supplied as a kit consisting of the following:
What should I talk to my health care provider before I take Jevtana?
How should I use Jevtana?
JEVTANA is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen.
The recommended dose of JEVTANA is based on calculation of the Body Surface Area (BSA), and is 20 mg/m administered as a one-hour intravenous infusion every three weeks in combination with oral prednisone 10 mg administered daily throughout JEVTANA treatment.
A dose of 25 mg/m can be used in select patients at the discretion of the treating healthcare provider
Premedicate at least 30 minutes prior to each dose of JEVTANA with the following intravenous medications to reduce the risk and/or severity of hypersensitivity :
Antiemetic prophylaxis is recommended and can be given orally or intravenously as needed
JEVTANA injection single-use vial requires dilutions prior to administration .
What interacts with Jevtana?
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What are the warnings of Jevtana?
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What are the precautions of Jevtana?
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What are the side effects of Jevtana?
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What should I look out for while using Jevtana?
JEVTANA is contraindicated in patients with:
What might happen if I take too much Jevtana?
There is no known antidote for JEVTANA overdose. Overdose has resulted from improper preparation Read the entire section carefully before mixing or diluting. Complications of overdose include exacerbation of adverse reactions such as bone marrow suppression and gastrointestinal disorders. Overdose has led to fatal outcome.
In case of overdose, the patient should be kept in a specialized unit where vital signs, chemistry and particular functions can be closely monitored. Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed.
How should I store and handle Jevtana?
JEVTANA is a cytotoxic anticancer drug. Follow applicable special handling and disposable procedures Lactated Ringer’s Injection, USP in VIAFLEX plastic container is available as follows:Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.Lactated Ringer’s Injection, USP in VIAFLEX plastic container is available as follows:Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Cabazitaxel is a microtubule inhibitor. Cabazitaxel binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules, which results in the inhibition of mitotic and interphase cellular functions.
Non-Clinical Toxicology
JEVTANA is contraindicated in patients with:Ceftriaxone – see
Caution is advised when administering Lactated Ringer’s Injection, USP to patients treated with drugs that may increase the risk of sodium and fluid retention, such as corticosteroids.
Caution is advised when administering Lactated Ringer’s Injection, USP to patients treated with drugs for which renal elimination is pH dependent. Due to the alkalinizing action of lactate (formation of bicarbonate), Lactated Ringer’s Injection, USP may interfere with the elimination of such drugs.
Renal clearance of lithium may also be increased. Caution is advised when administering Lactated Ringer’s Injection, USP to patients treated with lithium.
Because of its potassium content, Lactated Ringer’s Injection, USP should be administered with caution in patients treated with agents or products that can cause hyperkalemia or increase risk of hyperkalemia, such as potassium sparing diuretics (amiloride, spironolactone, triamterene), with ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine.
Caution is advised when administering Lactated Ringer’s Injection, USP to patients treated with thiazide diuretics or vitamin D, as these can increase the risk of hypercalcemia.
JEVTANA is contraindicated in patients with neutrophils ≤1,500/mm . Closely monitor patients with hemoglobin <10 g/dL.
Bone marrow suppression manifested as neutropenia, anemia, thrombocytopenia and/or pancytopenia may occur. Neutropenic deaths have been reported.
In a randomized trial (TROPIC) in previously treated patients with metastatic castration-resistant prostate cancer, five patients (1.3%) died from infection (sepsis or septic shock). All had grade 4 neutropenia and one had febrile neutropenia. One additional patient's death was attributed to neutropenia without a documented infection. Twenty-two (6%) patients discontinued JEVTANA treatment due to neutropenia, febrile neutropenia, infection, or sepsis. The most common adverse reaction leading to treatment discontinuation in the JEVTANA group was neutropenia (2%). Grade 3–4 neutropenia has been observed in 82% of patients treated with JEVTANA in the randomized trial.
In a randomized trial (PROSELICA) comparing two doses of JEVTANA in previously treated metastatic castration-resistant prostate cancer, 8 patients (1%) on the 20 mg/m arm and 15 patients (3%) on the 25 mg/m arm died from infection; of these, 4 deaths on the 20 mg/m arm and 8 deaths on the 25 mg/m arm occurred within the first 30 days of treatment.
Fewer patients receiving JEVTANA 20 mg/m were reported to have infectious adverse reactions. Grade 1–4 infections were experienced by 160 patients (28%) on the 20 mg/m arm and 227 patients (38%) on the 25 mg/m arm. Grade 3–4 infections were experienced by 57 patients (10%) on the 20 mg/m arm and 120 patients (20%) on the 25 mg/m arm. Noninferiority for overall survival was demonstrated between these two arms
Based on guidelines for the use of G-CSF and the adverse reactions profile of JEVTANA, primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features (older patients, poor performance status, previous episodes of febrile neutropenia, extensive prior radiation ports, poor nutritional status, or other serious comorbidities) that predispose them to increased complications from prolonged neutropenia. The effectiveness of primary prophylaxis with G-CSF in patients receiving JEVTANA has not been studied. Therapeutic use of G-CSF and secondary prophylaxis should be considered in all patients at increased risk for neutropenia complications.
Monitoring of complete blood counts is essential on a weekly basis during cycle 1 and before each treatment cycle thereafter so that the dose can be adjusted, if needed .
The following serious adverse reactions are discussed in greater detail in another section of the label:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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