Prescription medicine
Cabazitaxel Brand names: Jevtana
Cabazitaxel (Jevtana) is a prescription medicine with an FDA approval on record since 2010. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the cabazitaxel FDA label on DailyMed (effective October 7, 2025, Sanofi-Aventis U.S. LLC); the NDA 201023 record on Drugs@FDA; every cabazitaxel label on DailyMed.
Highlights of the record
FDA label of October 7, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
NEUTROPENIA AND HYPERSENSITIVITY WARNING: NEUTROPENIA AND HYPERSENSITIVITY.
See full prescribing information for complete boxed warning. Neutropenic deaths have been reported. Obtain frequent blood counts to monitor for neutropenia. JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm 3 . Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features. Consider primary prophylaxis with G-CSF in all patients receiving a dose of 25 mg/m 2 ( 4 , 5.1 , 5.2 ) Severe hypersensitivity can occur and may include generalized rash/erythema, hypotension and bronchospasm. Discontinue JEVTANA immediately if severe reactions occur and administer appropriate therapy. ( 2.1 , 5.2 ) Contraindicated if history of severe hypersensitivity reactions to cabazitaxel or to drugs formulated with polysorbate 80. ( 4 ) Neutropenia: Neutropenic deaths have been reported. Monitor for neutropenia with frequent blood cell counts. JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm 3 . Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features. Consider primary prophylaxis with G-CSF in all patients receiving a dose of 25 mg/m 2 [see Contraindications (4) and Warnings and Precautions (5.1 , 5.2) ]. […]
Used for
From the label: indications and usageJEVTANA ® 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.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- June 17, 2010 Jevtana Kit, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first June 23, 2022; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 27, 2031 Jevtana Kit injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,469 through July 30, 2026
What is cabazitaxel used for?
From the label: indications and usageJEVTANA ® 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. JEVTANA is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen.
Conditions named in the indications of cabazitaxel's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Jevtana), Sanofi-Aventis U.S. LLC, effective October 7, 2025 (SPL set de3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa), via openFDA; the full label on DailyMed
What does the patient leaflet for cabazitaxel say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about JEVTANA?JEVTANA may cause serious side effects including: Low white blood cell count. Low white blood cell counts are common during treatment with JEVTANA and can cause serious infections that may lead to death. Men who are 65 years or older may be more likely to have these problems. Your healthcare provider: will do blood tests regularly to check your white blood cell counts during your treatment with JEVTANA. may lower your dose of JEVTANA, change how often you receive it, or stop JEVTANA until your healthcare provider decides that you have enough white blood cells. may prescribe a medicine for you called G-CSF to help prevent complications if your white blood cell count is too low. Tell your healthcare provider right away if you have any of these symptoms of infection during treatment with JEVTANA: fever. Take your temperature often during treatment with JEVTANA. cough burning on urination muscle aches Also, tell your healthcare provider if you have any diarrhea during the time that your white blood cell count is low. Your healthcare provider may prescribe treatment for you as needed. Severe allergic reactions. Severe allergic reactions can happen within a few minutes after your infusion of JEVTANA starts, especially during the first and second infusions. Your healthcare provider should prescribe medicines before each infusion to help prevent severe allergic reactions. Tell your healthcare provider or nurse right away if you have any of these symptoms of a severe allergic reaction during or soon after an infusion of JEVTANA: rash or itching feeling dizzy or faint chest or throat tightness skin redness breathing problems swelling of your face Severe stomach and intestine (gastrointestinal) problems. JEVTANA can cause severe vomiting and diarrhea, which may lead to death. […]
Source: FDA drug label (Jevtana), Sanofi-Aventis U.S. LLC, effective October 7, 2025 (SPL set de3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa), via openFDA; the full label on DailyMed
Is there a generic for cabazitaxel (Jevtana)?
The FDA approved the first generic cabazitaxel on June 23, 2022. 5 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 3 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 5 patents for Jevtana Kit injection: the compound patent runs to December 10, 2025 (pediatric exclusivity to June 10, 2026), and the last listed entry to April 27, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2010 earliest approval on file
- 2022 first generic approved
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the cabazitaxel label say about other medicines?
The cabazitaxel label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name cabazitaxel. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atazanavir | drug interactions | Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase plasma concentrations of cabazitaxel. |
| Clarithromycin | drug interactions | Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase plasma concentrations of cabazitaxel. |
| Itraconazole | drug interactions | Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase plasma concentrations of cabazitaxel. |
| Ketoconazole | drug interactions | Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase plasma concentrations of cabazitaxel. |
| Nefazodone | drug interactions | Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase plasma concentrations of cabazitaxel. |
| Nelfinavir | drug interactions | Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase plasma concentrations of cabazitaxel. |
| Ritonavir | drug interactions | Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase plasma concentrations of cabazitaxel. |
| Voriconazole | drug interactions | Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase plasma concentrations of cabazitaxel. |
Source: FDA drug label (Jevtana), Sanofi-Aventis U.S. LLC, effective October 7, 2025 (SPL set de3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa), via openFDA; the full label on DailyMed
What do FAERS reports show for cabazitaxel?
The FDA Adverse Event Reporting System holds 3,469 reports that list cabazitaxel among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 693 are coded as a death and 1,329 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Cabazitaxel side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other