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 regimen.

JEVTANA Trials Included mCRPC Patients With High-Disease Burden and Rapid Progression after Docetaxel1-4

JEVTANA 20 mg/m2 Dose Was Validated in the PROSELICA Trial3

Large, non-inferiority, multicenter, randomized, open-label study (N=1200)3

1200 patients with mCRPC who previously received docetaxel

Primary Endpoint: Median Overall Survival

Stratification:

ECOG PS: 0, 1 vs 2
Measurable vs nonmeasurable disease

JEVTANA
20 mg/m2

q3wks + prednisone (n=598)

JEVTANA
25 mg/m2

q3wks + prednisone (n=602)

ECOG: Eastern Cooperative Oncology Group

PROSELICA Included Patients With High-Disease Burden (n=1200)3

Disease Burden Presentation in PROSELICA trial: 31% visceral, 94% bone, and 49% lymph nodes

PROSELICA Patients Presented With Rapid Progression After Docetaxel (n=1200)3

86% of patients progressed during or within
6 months of last docetaxel dose. 25% of patients progressed during their last docetaxel infusion, 43% of patients progressed within 3 months since their last dose and 17% from 3-6 months since their last dose

View Summary of Demographics and Patient Characteristics3

JEVTANA 20 mg/m2 +
prednisone (n=598)
JEVTANA 25 mg/m2 +
prednisone (n=602)
Mean age, years (SD)
68.2 (7.2) 68.4 (7.8)
ECOG PS, No. (%)
0,1 539 (90.1) 540 (89.7)
2 59 (9.9) 62 (10.3)
PSA, ng/mL
Median 159.49 170.90
Progression diagnosis criteria, No. (%)
Progression diagnosis criteria, No. (%) 596 (99.7) 599 (94.5)
Increasing PSA 526 (88.0) 518 (86.0)
Progression of
measureable lesion
152 (25.4) 178 (29.6)
Progression of nonmeasureable
lesion (except bone)
66 (11.0) 72 (12.0)
Appearance of new
lesion on bone scan
145 (24.2) 141 (23.4)
Missing 2 (0.3) 3 (0.5)
Disease site (%)
Bone 93.5 94.5
Lymph nodes 49.2 49.7
Lung 15.6 15.9
Liver 15.7 15.0
Patients who experienced progression, No. (%)
During the last docetaxel treatment 153 (25.6) 154 (25.6)
< 3 months since last
docetaxel dose
251 (42) 270 (44.9)
3-6 months after last
docetaxel dose
110 (18.4) 96 (15.9)
>6 months since last
docetaxel dose
69 (11.5) 61 (10.1)
Missing 15 (2.5) 21 (3.5)
Time from last docetaxel dose to progression, months
Median (time) 1.0 1.0
Mean (SD) 2.7 (5.3) 2.3 (4.1)

Cabazitaxel (JEVTANA) is a National Comprehensive Cancer Network® (NCCN®) Designated Category 1 Second-Line Therapy Option for mCRPC patients who previously received docetaxel and has been prescribed to more than 40,000* patients.

*Estimate based on sales & use data in the U.S., 6/2010-8/2017. sanofi-aventis U.S. LLC, A SANOFI COMPANY.

Identify Appropriate Patient Types for JEVTANA

Hear Dr. Pachynski apply trial information to clinical practice and talk about appropriate patient types for JEVTANA.

Russell K. Pachynski, MD
Assistant Professor, Oncology Division
Washington University School of Medicine, in St. Louis, MO.

IMPORTANT SAFETY INFORMATION

WARNING: NEUTROPENIA AND HYPERSENSITIVITY

  • 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/mm3. 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/m2.
  • 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.

CONTRAINDICATIONS

JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500/mm3, patients with a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80, and patients with severe hepatic impairment (total bilirubin >3x upper limit of normal (ULN)).

WARNINGS AND PRECAUTIONS

Bone Marrow Suppression (BMS): BMS manifested as neutropenia, anemia, thrombocytopenia and/or pancytopenia may occur. Neutropenic deaths have been reported. Monitor blood counts frequently to determine if initiation of G-CSF and/or dosage modification is needed. 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. Caution is recommended in patients with hemoglobin < 10 g/dl.

Increased Toxicities in Elderly Patients: Patients ≥65 years of age were more likely to experience fatal outcomes not related to disease progression and certain adverse reactions, including neutropenia and febrile neutropenia. Monitor closely.

Hypersensitivity Reactions: Severe hypersensitivity reactions can occur. Premedicate all patients with antihistamines, corticosteroids and H2 antagonists prior to JEVTANA. Observe patients closely, especially during the first and second infusions. Discontinue JEVTANA immediately if severe hypersensitivity occurs and treat as indicated.

Gastrointestinal (GI) Adverse Reactions: Nausea, vomiting, and severe diarrhea may occur. Death related to diarrhea and electrolyte imbalance occurred in the randomized clinical trials and mortality related to diarrhea has been reported. Intensive measures may be required for severe diarrhea and electrolyte imbalance. Rehydrate and treat with antiemetics and antidiarrheals as needed. If experiencing grade ≥3 diarrhea, dosage should be modified.

GI hemorrhage and perforation, ileus, enterocolitis, neutropenic enterocolitis, including fatal outcome, have been reported. Risk may be increased with neutropenia, age, steroid use, concomitant use of NSAIDs, antiplatelet therapy or anticoagulants, and prior history of pelvic radiotherapy, adhesions, ulceration and GI bleeding. Abdominal pain and tenderness, fever, persistent constipation, diarrhea, with or without neutropenia, may be early manifestations of serious GI toxicity and should be evaluated and treated promptly. JEVTANA treatment delay or discontinuation may be necessary.

Renal Failure: Cases, including those with fatal outcomes, have been reported. Identify cause and manage aggressively.

Urinary Disorders including Cystitis: Cystitis, radiation cystitis, and hematuria, including that requiring hospitalization, has been reported with JEVTANA in patients who previously received pelvic radiation. Cystitis from radiation recall may occur late in treatment with JEVTANA. Monitor patients who previously received pelvic radiation for signs and symptoms of cystitis while on JEVTANA. Interrupt or discontinue JEVTANA in patients experiencing severe hemorrhagic cystitis. Medical and/or surgical supportive treatment may be required to treat severe hemorrhagic cystitis.

Respiratory Disorders: Interstitial pneumonia/pneumonitis, interstitial lung disease and acute respiratory distress syndrome have been reported and may be associated with fatal outcome. Patients with underlying lung disease may be at higher risk for these events. Acute respiratory distress syndrome may occur in the setting of infection. Interrupt JEVTANA if new or worsening pulmonary symptoms develop. Closely monitor, promptly investigate, and appropriately treat patients receiving JEVTANA. Consider discontinuation. The benefit of resuming JEVTANA treatment must be carefully evaluated.

Use in Patients with Hepatic Impairment: JEVTANA dose should be reduced for patients with mild (total bilirubin > 1 to ≤ 1.5 x ULN or AST > 1.5 x ULN) and moderate (total bilirubin > 1.5 to ≤ 3.0 x ULN and any AST) hepatic impairment, based on tolerability data in these patients. Administer JEVTANA 20 mg/m2 for mild hepatic impairment. Administer JEVTANA 15 mg/m2 for moderate hepatic impairment. Monitor closely.

Embryo-Fetal Toxicity: JEVTANA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of JEVTANA.

ADVERSE REACTIONS (ARs)

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.

DRUG INTERACTIONS

Avoid coadministration of JEVTANA with strong CYP3A inhibitors. If patients require coadministration of a strong CYP3A inhibitor, consider a 25% JEVTANA dose reduction.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: The safety and efficacy of JEVTANA have not been established in females. There are no human data on the use of JEVTANA in pregnant women to inform the drug-associated risk.
  • Lactation: The safety and efficacy of JEVTANA have not been established in females. There is no information available on the presence of JEVTANA in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.
  • Females and Males of Reproductive Potential: Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of JEVTANA.

Please see full Prescribing Information, including Boxed WARNING.


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