IMPORTANT SAFETY INFORMATION
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 >3x 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
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/m2 (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 versus 20 mg/m2 were leukopenia, neutropenia, and febrile neutropenia.
Please see full prescribing information, including boxed WARNING.