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Dear Amy,
Start JEVTANA in mCRPC Patients With High Disease Burden1
NOW AVAILABLE: New Recommended Dose Option of 20 mg/m2
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.
The PROSELICA Trial Presents Results With High Disease
Burden Patients1
The PROSELICA trial was a non-inferiority, multicenter, randomized, open-label study of JEVTANA 20 mg/m2 (n=598) vs JEVTANA 25 mg/m2 (n=602) in patients with mCRPC previously treated with a docetaxel-containing regimen. The primary endpoint was median overall survival (OS).
Patients in the PROSELICA trial presented with high disease burden (n=1200):2
93% Bone Metastases
15% Lung Metastases
49% Metastases to Lymph Nodes
15% Liver Metastases
JEVTANA 20 mg/m2 Delivered Overall Survival Comparable to 25 mg/m2
•  Per intent-to-treat population: 13.4 months (95% CI: 12.2 - 14.9) median overall survival JEVTANA 20 mg/m2 and 14.5 months (95% CI: 13.5 - 15.3) for JEVTANA 25 mg/m2 (HR = 1.024) (97.78% CI: 0.886 - 1.184).1
•  In TROPIC: 15.1 months (95% CI: 14.1-16.3) median overall survival for patients receiving JEVTANA 25 mg/m2 vs 12.7 months (95% CI: 11.6-13.7) with mitoxantrone (P<0.0001). Number of deaths were 234 (62%) with JEVTANA vs 279 (74%) with mitoxantrone.1
•  In TROPIC, the most common (≥5%) grade 1-4 hematologic laboratory abnormalities for JEVTANA 25 mg/m2 + prednisone vs mitoxantrone were anemia (98% vs 82%), leukopenia (96% vs 93%), neutropenia (94% vs 87%), thrombocytopenia (48% vs 43%), febrile neutropenia (7% vs 1%). The most common (≥5%) grade 3-4 hematologic laboratory abnormalities for JEVTANA 25 mg/m2 + prednisone vs mitoxantrone were neutropenia (82% vs 58%), leukopenia (69% vs 42%), anemia (11% vs 5%), and febrile neutropenia (7% vs 1%).1
•  Protocol avoided prophylactic use of G-CSF during cycle 1.2 Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features.1
The Recommended Dosing Options for JEVTANA
For patients with mCRPC previously treated with a docetaxel-containing regimen, the recommended dose of JEVTANA is 20 mg/m2 every 3 weeks + oral prednisone 10 mg daily throughout treatment. 25 mg/m2 can be used in select patients.1
•  Patients at a 20 mg/m2 dose who require dose reduction should decrease dosage of JEVTANA to 15 mg/m2.
•  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 considered.
See complete list of dose modifications for JEVTANA.
Difference in Incidence of Adverse Reactions (ARs)* With JEVTANA 20 mg/m2 vs 25 mg/m2
•  Grade 1-4 ARs occurring ≥5% more commonly in patients on the 25 mg/m2 vs 20 mg/m2 arms were leukopenia, neutropenia, thrombocytopenia, febrile neutropenia, decreased appetite, nausea, diarrhea, hematuria and asthenia.1
•  Grade 3-4 ARs occurring ≥5% more commonly in patients on the 25 mg/m2 vs 20 mg/m2 arms were leukopenia, neutropenia, and febrile neutropenia.1
•  Fewer patients receiving 20 mg/m2 were reported to have infectious ARs.1
 
—  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.
•  17% of patients on 20 mg/m2 and 20% of patients on 25 mg/m2 discontinued due to ARs. The most common ARs leading to treatment discontinuation were fatigue and hematuria.1
We appreciate your time.
To learn more about JEVTANA or to contact your representative, please select below:
ADDITIONAL IMPORTANT SAFETY INFORMATION
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, patients with severe hepatic impairment (total bilirubin >3 x upper limit of normal [ULN]), and in pregnant women (JEVTANA can cause fetal harm and potential loss of pregnancy).
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. Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features. 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 clinical trial 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.
ADVERSE REACTIONS (ARs)
Deaths due to causes other than disease progression within 30 days of last JEVTANA dose were reported in 22 (3.8%) patients in the 20 mg/m2 arm and 32 (5.4%) patients in the 25 mg/m2 arm. The most common fatal ARs were related to infections, and these occurred more commonly with 25 mg/m2 (n=15) vs 20 mg/m 2 (n=8).
The most common 1-4 grade ARs and laboratory abnormalities (≥10%) with JEVTANA 20 mg/m2 or 25 mg/m2 were neutropenia, anemia, leukopenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, and anorexia.
Grade 3-4 ARs occurring ≥5% more commonly with 25 mg/m2 vs 20 mg/m2 were leukopenia, neutropenia, and febrile neutropenia.
Please see accompanying full Prescribing Information, including boxed WARNING.
References: 1. JEVTANA Prescribing Information. Bridgewater NJ: sanofi-aventis U.S. LLC; January 2018. 2. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45(2):228–247
© 2018 sanofi-aventis U.S. LLC. A SANOFI COMPANY
SAUS.CAB.18.01.0224  3/18



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