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, and in patients with severe
hepatic impairment (total bilirubin > 3 x 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. Primary prophylaxis with G-CSF should be considered 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.
Hypersensitivity Reactions: Severe hypersensitivity reactions can occur. Premedicate all patients with antihistamines,
corticosteroids and H2 antagonists prior to the JEVTANA infusion. Observe patients closely, for
hypersensitivity reactions, 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
anti-emetics and anti-diarrheals 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, anti-platelet
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.
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 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.
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 with caution in patients with mild and moderate
hepatic impairment and closely monitor for safety.
Embryo‐Fetal Toxicity: JEVTANA is not indicated for use in female patients and can cause fetal harm when administered
to a pregnant woman. There are no adequate and well controlled studies in pregnant women using JEVTANA. Females of
childbearing potential should be advised to avoid becoming pregnant during treatment with JEVTANA.
ADVERSE REACTIONS (ARs)
Deaths due to causes other than disease progression within 30 days of last study drug dose were reported in 18 (5%)
JEVTANA-treated patients. The most common fatal ARs were infections (n=5) and renal failure (n=4).
The most common (≥10%) grade 1–4 ARs were anemia, leukopenia, neutropenia, thrombocytopenia, diarrhea,
fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia,
peripheral neuropathy, pyrexia, dyspnea, dysgeusia, cough, arthralgia, and alopecia.
The most common (≥5%) grade 3–4 ARs were neutropenia, leukopenia, anemia, febrile neutropenia, diarrhea, fatigue,
and asthenia.
Please see full prescribing information, including boxed WARNING.
