infusion solution is not clear or appears to have precipitation, it should be discarded.
Discard any unused portion.
2.6 Administration
The final JEVTANA infusion solution should be administered intravenously as a one-hour infusion at room temperature.
Use an in-line filter of 0.22 micrometer nominal pore size during administration.
The final JEVTANA infusion solution should be used immediately. However, in-use storage time can be longer under specific conditions, i.e. 8 hours under ambient conditions (including the one-hour infusion) or for a total of 24 hours if refrigerated (including the one-hour infusion) [see Dosage and Administration (2.5)].
3.DOSAGE FORMS AND STRENGTHS
JEVTANA (cabazitaxel) Injection 60 mg/1.5 mL is supplied as a kit consisting of the following:
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JEVTANA Injection 60 mg/1.5 mL: contains 60 mg cabazitaxel in 1.5 mL polysorbate 80,
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Diluent for JEVTANA Injection 60 mg/1.5 mL: contains approximately 5.7 mL of 13% (w/w) ethanol in water for injection.
4.CONTRAINDICATIONS
JEVTANA should not be used in patients with neutrophil counts of ≤ 1,500/mm3.
JEVTANA is contraindicated in patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80.
5.WARNINGS AND PRECAUTIONS
5.1 Neutropenia
Five patients experienced fatal infectious adverse events (sepsis or septic shock). All had grade 4 neutropenia and one had febrile neutropenia. One additional patient's death was attributed to neutropenia without a documented infection.
G-CSF may be administered to reduce the risks of neutropenia complications associated with JEVTANA use. Primary prophylaxis with G-CSF should be considered in patients with high-risk clinical features (age > 65 years, poor performance status, previous episodes of febrile neutropenia, extensive prior radiation ports, poor nutritional status, or other serious comorbidities) that predispose them to increased complications from prolonged neutropenia. Therapeutic use of G-CSF and secondary prophylaxis should be considered in all patients considered to be at increased risk for neutropenia complications.
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 [see Dosage and Administration (2.2)].
JEVTANA should not be administered to patients with neutrophils ≤ 1,500/mm3 [see Contraindications (4)].
If a patient experiences febrile neutropenia or prolonged neutropenia (greater than one week) despite appropriate medication (e.g., G-CSF), the dose of JEVTANA should be reduced [see Dosage and Administration (2.2)]. Patients can restart treatment with JEVTANA only when neutrophil counts recover to a level > 1,500/mm3 [see Contraindications (4)].
5.2 Hypersensitivity Reactions
All patients should be premedicated prior to the initiation of the infusion of JEVTANA [see Dosage and Administration (2.3)]. Patients should be observed closely for hypersensitivity reactions, especially during the first and second infusions. Hypersensitivity reactions may occur within a few minutes following the initiation of the infusion of JEVTANA, thus facilities and equipment for the treatment of hypotension and bronchospasm should be available. Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension a
