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Jevtana Kit (cabazitaxel)
Cabazitaxel works by binding to tubulin beta, disrupting microtubule formation and preventing cancer cell division.
Jevtana Kit (cabazitaxel) is a microtubule inhibitor small molecule developed by SANOFI AVENTIS US and currently owned by Accord Hlthcare. It targets tubulin beta and was FDA approved in 2010 for the treatment of metastatic prostate carcinoma. As an off-patent medication, Jevtana Kit is available from multiple generic manufacturers. Key safety considerations include its long half-life of 74.5 hours. Jevtana Kit is a commercial option for patients with metastatic prostate cancer.
At a glance
| Generic name | cabazitaxel |
|---|---|
| Sponsor | Accord Hlthcare |
| Drug class | Microtubule Inhibitor |
| Target | Tubulin beta |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2010 |
| Annual revenue | 300 |
Mechanism of action
Imagine your cells are like a city with roads and buildings. Microtubules are like the roads that help cells divide and grow. Cabazitaxel blocks these roads, making it difficult for cancer cells to divide and grow.
Approved indications
- Metastatic Prostate Carcinoma
Boxed warnings
- WARNING: 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) ] . 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 [see Dosage and Administration (2.1) , Contraindications (4) , and Warnings and Precautions (5.3) ] .
Common side effects
- Prostatic specific antigen increased
- Febrile neutropenia
- Hormone-refractory prostate cancer
- Metastases to bone
- Prostate cancer metastatic
- Osteonecrosis of jaw
- Disease progression
- Haematuria
- Metastases to lymph nodes
- Hydronephrosis
- Neutrophil count decreased
- Anaemia
Drug interactions
- atazanavir
- boceprevir
- carbamazepine
- clarithromycin
- conivaptan
- indinavir
- itraconazole
- ketoconazole
- lopinavir
- mibefradil
- nefazodone
- nelfinavir
Key clinical trials
- Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A) (PHASE1,PHASE2)
- Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer (PHASE2)
- A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors (PHASE2)
- Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC) (PHASE1,PHASE2)
- A Real-world Study of Characteristics, Treatment Patterns, and Clinical Outcomes Among Lutetium-177 Vipivotide Tetraxetan Treated Patients
- Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel (PHASE2)
- Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer (PHASE2)
- Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute) (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 12453712 | 2030-10-27 | Method of Use |
| 10583110 | 2030-10-27 | Method of Use |
| 10716777 | 2030-10-27 | Method of Use |
| 8927592 | 2030-10-27 | Method of Use |
| 7241907 | 2025-12-10 | Compound |
| 8927592*PED | 2031-04-27 | Compound |
| 7241907*PED | 2026-06-10 | Compound |
| 10583110*PED | 2031-04-27 | Compound |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Jevtana Kit CI brief — competitive landscape report
- Jevtana Kit updates RSS · CI watch RSS
- Accord Hlthcare portfolio CI