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The only microtubule inhibitor approved in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen.

Difference in Incidence of Adverse Reactions (ARs) with 20 mg/m2 vs 25 mg/m2 in the PROSELICA trial

ARs Occurring ≥ 5% More Commonly in Patients on 25 mg/m2 vs 20 mg/m2

  • Grade 1-4 ARs: leukopenia, neutropenia, thrombocytopenia, febrile neutropenia, decreased appetite, nausea, diarrhea, hematuria and asthenia.
  • Grade 3-4 ARs: leukopenia, neutropenia, and febrile neutropenia.

Infectious ARs in Patients on 20 mg/m2 vs 25 mg/m2

  • Grade 1-4 infections were experienced by 28% (160) of patients receiving 20 mg/m2 vs 38% (227) of patients receiving 25 mg/m2.
  • Grade 3-4 infections were experienced by 10% (57) of patients receiving 20 mg/m2 vs 20% (120) of patients receiving 25 mg/m2.

ARs* ≥5% in the PROSELICA Trial

Grade 1-4
Grade 3-4
JEVTANA
20 mg/m2 +
prednisone
n=580
JEVTANA
25 mg/m2 +
prenisone
n=595
Absolute
Difference
JEVTANA
20 mg/m2 +
prednisone
n=580
JEVTANA
25 mg/m2 +
prenisone
n=595
Absolute
Difference
Adverse Reaction Grade 1–4 Grade 3–4
Diarrhea 31% 40% -9% 1% 4% -3%
Nausea 25% 32% -7% 0.7% 1% -0.3%
Fatigue 25% 27% -2% 3% 4% -1%
Constipation 18% 18% 0 0.3% 0.7% -0.4%
Vomiting 15% 18% -3% 1.2% 1% +0.2%
Asthenia 15% 20% -5% 2% 2% 0%
Hematuria 14% 21% -7% 2% 4% -2%
Decreased appetite 13% 19% -6% 0.7% 1% -0.3%
Back pain 11% 14% -3% 0.9% 1% -0.1%
Bone pain 8% 8% 0 2% 2% 0
Arthralgia 8% 7% +1% 0.5% 0.8% -0.3%
Urinary tract infection 7% 11% -4% 2% 2% 0
Dysgeusia 7% 11% -4% 0 0 0
Peripheral sensory neuropathy 7% 11% -4% 0 0.7% -0.7%
Peripheral edema 7% 9% -2% 0.2% 0.2% 0
Cough 6% 6% 0 0 0 0
Abdominal pain 6% 9% -3% 0.5% 1% -0.5%
Headache 5% 4% +1% 0.2% 0.2% 0
Dyspnea 5% 8% -3% 0.9% 0.7% +0.2%
Stomatitis 5% 5% 0 0 0.3% -0.3%
Pain in extremity 5% 7% -2% 0.2% 0.5% -0.3%
Dysuria 5% 4% +1% 0.3% 0 +0.3%
Pyrexia 5% 6% -1% 0.2% 0.2% 0
Dizziness 4% 5% -1% 0 0 0
Weight decreased 4% 7% -3% 0.2% 0 +0.2%
Neutropenia 3% 11% -8% 2% 10% -8%
Neutropenic infection§ 3% 7% -4% 2% 6% -4%
Alopecia 3% 6.1% -3.1% 0 0 0
Febrile neutropenia 2% 9% -7% 2% 9% -7%
Wrong technique in drug
usage process
0.3% 5% -4.7% 0 0 0

*Grade from NCI CTCAE version 4.03.
Includes urinary tract infection staphylococcal, urinary tract infection bacterial, urinary tract infection fungal, and urosepsis.
Based on adverse event reporting.
§ Includes neutropenic sepsis.

17% of patients on 20 mg/m2 and 20% of patients on 25 mg/m2 discontinued treatment due to ARs.
The most common ARs leading to treatment discontinuation were fatigue and hematuria.

IMPORTANT SAFETY INFORMATION

WARNING: NEUTROPENIA AND HYPERSENSITIVITY

  • 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/mm3. Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features.
  • 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.

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