FAQ
JEVTANA is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic
castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing treatment regimen1.
Yes1.
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WARNING: NEUTROPENIA AND HYPERSENSITIVITY Severe hypersensitivity: Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of the JEVTANA infusion and administration of appropriate therapy. Patients should receive premedication. JEVTANA is contraindicated in patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80. |
JEVTANA received initial FDA approval in June 20101.
JEVTANA 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 needles1.
JEVTANA is a microtubule inhibitor. It 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 functions1.
JEVTANA 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) at a concentration of 40 mg/mL1.
Each mL of cabazitaxel solution contains 40 mg cabazitaxel (anhydrous) in polysorbate 80 (433 mg) and citric acid (4 mg). Each vial of JEVTANA is supplied with a diluent containing 13% (w/w) ethanol in water for injection1.
The recommended dose of JEVTANA is based on calculation of Body Surface Area (BSA) and is 20 mg/m2 administered as one-hour intravenous infusion every three weeks in combination with oral prednisone 10 mg administered daily throughout JEVTANA treatment.1
A dose of 25mg/m2 can be used in select patients at the discretion of the treating healthcare provider. Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features.1
Consider primary prophylaxis with G-CSF in all patients receiving a dose of 25 mg/m2.1
Pre-medicate at least 30 minutes prior to each dose of JEVTANA with the following intravenous medications to reduce the risk and/or severity of hypersensitivity1:
- Antihistamine (dexchlorpheniramine 5mg, or diphenhydramine 25 mg or equivalent antihistamine),
- Corticosteroid (dexamethasone 8 mg or equivalent steroid),
- H2antagonist.
Antiemetic prophylaxis is recommended and can be given orally or intravenously as needed1
JEVTANA injection single-dose vial requires two dilutions prior to administration.1
G-CSF=granulocyte-colony stimulating factor
Reduce or discontinue JEVTANA dosing for adverse reactions as described below:
| Toxicity1 | Dose modification1 |
| Prolonged grade ≥3 neutropenia (>1 week) despite appropriate medication including granulocyte-colony stimulating factor (G-CSF) | Delay treatment until neutrophil count is >1,500 cells/mm3, then reduce dosage of JEVTANA by one dose level. Use G-CSF for secondary prophylaxis. |
| Febrile neutropenia or neutropenic infection | Delay treatment until improvement or resolution, and until neutrophil count is >1,500 cells/mm3, then reduce dosage of JEVTANA by one dose level. Use G-CSF for secondary prophylaxis. |
| Grade ≥3 diarrhea or persisting diarrhea despite appropriate medication, fluid and electrolyte replacement | Delay treatment until improvement or resolution, then reduce dosage of JEVTANA by one dose level. |
| Grade 2 peripheral neuropathy | Delay treatment until improvement or resolution, then reduce dosage of JEVTANA by one dose level. |
| Grade ≥3 peripheral neuropathy | Discontinue JEVTANA. |
| Hepatic impairment | Administer JEVTANA at a dose of 20 mg/m2 for patients with mild hepatic impairment and 15 mg/m2 for patients with moderate hepatic impairment. |
Patients at a 20 mg/m2 dose who require dose reduction should decrease dosage of JEVTANA to 15 mg/m2.1
Patients at a 25 mg/m2 dose who require dose reduction should decrease dosage of JEVTANA to 20 mg/m2. One additional dose reduction to 15 mg/m2 may be considered1.
The most common all grades adverse reactions and laboratory abnormalities (≥10%) with JEVTANA 20 mg/m2 or 25 mg/m2 are neutropenia, anemia, diarrhea, nausea, fatigue, asthenia, vomiting, hematuria, constipation, decreased appetite, back pain, and abdominal pain.1
JEVTANA is contraindicated in patients with1:
- Neutrophil counts of ≤1,500/mm3
- History of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80
- Severe hepatic impairment (total bilirubin >3 × ULN)1
JEVTANA injection and Diluent for JEVTANA should be stored at 25°C (77°F); excursions permitted between 15°C–30°C (59°F–86°F). Do not refrigerate1.
JEVTANA is supplied as a kit: NDC0024-5824-11, that contains the following:
- One single-dose vial of JEVTANA: a clear yellow to brownish yellow viscous solution of 60mg/1.5mL in a clear glass vial with a grey rubber closure, aluminum cap, and light green plastic flip-off cap (JEVTANA vial: NDC 0024-5823-15).
- One single-dose vial of Diluent for JEVTANA: a clear colorless solution of 13% (w/w) ethanol in water for injection in a clear glass vial with a grey rubber closure, gold-color aluminum cap, and color less plastic flip-off cap (Diluent via:l NDC0024-5822-01)1.
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Hypersensitivity Reactions
Educate patients about the risk of potential hypersensitivity associated with JEVTANA. Confirm patients do not have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80. Instruct patients to immediately report signs of a hypersensitivity reaction.
Bone Marrow Suppression
Inform patients that JEVTANA decreases blood count such as white blood cells, platelets and red blood cells. Thus, it is important that periodic assessment of their blood count be performed to detect the development of neutropenia, thrombocytopenia, anemia, and/or pancytopenia. Instruct patients to monitor their temperature frequently and immediately report any occurrence of fever to their healthcare provider.
Increased Toxicities in Elderly Patients
Inform elderly patients that certain side effects may be more frequent or severe.
Importance of Prednisone
Explain that it is important to take the oral prednisone as prescribed. Instruct patients to report if they were not compliant with oral corticosteroid regimen.
Infections, Dehydration, Renal Failure
Explain to patients that severe and fatal infections, dehydration, and renal failure have been associated with cabazitaxel exposure. Patients should immediately report fever, significant vomiting or diarrhea, decreased urinary output, and hematuria to their healthcare provider.
Urinary Disorders Including Cystitis
Inform patients that hematuria may occur during treatment with JEVTANA. Inform patients that previously received pelvic radiation that cystitis and radiation cystitis may occur during treatment with JEVTANA. Advise patients to report any occurrence of hematuria, or any signs and symptoms of cystitis or radiation cystitis, to their healthcare provider.
Respiratory Disorders
Explain to patients that severe and fatal interstitial pneumonia/pneumonitis, interstitial lung disease and acute respiratory distress syndrome have occurred with JEVTANA. Instruct patients to immediately report new or worsening pulmonary symptoms to their healthcare provider
Drug Interactions
Inform patients about the risk of drug interactions and the importance of providing a list of prescription and non-prescription drugs to their healthcare provider.
Embryo-Fetal Toxicity
Advise male patients with female partners of reproductive potential to use effective contraception during treatment and
for 4 months after the last dose of JEVTANA. Infertility Advise male patients that JEVTANA may impair fertility.1
Please see full Warnings and Precautions in the prescribing information.
Patients can be directed to the JEVTANA patient website at www.JEVTANA.com for additional information about the medication, including resources and support services.
Ready to start a patient on JEVTANA in your practice?
Hear from Industry Leaders about various topics in our Video Series:
Meet Dr. Stephen Freedland. Steve Freedland, a urologist at Cedars-Sinai Medical Center in Los Angeles, California.
What is JEVTANA’s Mechanism of Action (MOA) and Taxane Chemical Structure
See the data from the CARD Trial
What to know about JEVTANA
See a detailed overview of treatment with JEVTANA
Hear Dr. Slovin share an example of an mCRPC patient who she is currently treating with JEVTANA.
Susan Slovin, MD, PhD
Medical Oncologist
Memorial Sloan Kettering Cancer Center
Ready to start a patient on JEVTANA in your practice?
Hear from Industry Leaders about various topics in our Video Series:
Meet Dr. Stephen Freedland. Steve Freedland, a urologist at Cedars-Sinai Medical Center in Los Angeles, California.
What is JEVTANA’s Mechanism of Action (MOA) and Taxane Chemical Structure
See the data from the CARD Trial
What to know about JEVTANA
See a detailed overview of treatment with JEVTANA
Hear Dr. Slovin share an example of an mCRPC patient who she is currently treating with JEVTANA.
Susan Slovin, MD, PhD
Medical Oncologist
Memorial Sloan Kettering Cancer Center
Important Safety Information
Reference: 1. JEVTANA Prescribing Information. Morristown, NJ. Sanofi.
