s who have a history of severe hypersensitivity reactions to JEVTANA or to other drugs formulated with polysorbate 80 [see Contraindications (4)].
1.INDICATIONS AND USAGE
JEVTANA® is a microtubule inhibitor indicated in combination with prednisone for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen.
2.DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
The individual dosage of JEVTANA is based on calculation of the Body Surface Area (BSA) and is 25 mg/m2 administered as a one-hour intravenous infusion every three weeks in combination with oral prednisone 10 mg administered daily throughout JEVTANA treatment.
Premedication is recommended prior to treatment [see Dosage and Administration (2.3)].
JEVTANA should be administered under the supervision of a qualified physician experienced in the use of antineoplastic medicinal products. Appropriate management of complications is possible only when the adequate diagnostic and treatment facilities are readily available.
JEVTANA Injection single-use vial requires two dilutions prior to administration [see Dosage and Administration (2.5)].
Do not use PVC infusion containers and polyurethane infusions sets for preparation and administration of JEVTANA infusion solution [see Dosage and Administration (2.5)].
Both the JEVTANA Injection and the diluent vials contain an overfill to compensate for liquid loss during preparation.
2.2 Dose Modifications
The JEVTANA dose should be reduced to 20 mg/m2 if patients experience the following adverse reactions.
Table 1: Recommended Dosage Modifications for Adverse Reactions in Patients Treated with JEVTANA Toxicity Dosage Modification
Prolonged grade ≥ 3 neutropenia (greater than 1 week) despite appropriate medication including G-CSF Delay treatment until neutrophil count is
> 1,500 cells/mm3, then reduce dosage of JEVTANA to 20 mg/m2. Use G-CSF for secondary prophylaxis.
Febrile neutropenia Delay treatment until improvement or resolution, and until neutrophil count is
> 1,500 cells/mm3, then reduce dosage of JEVTANA to 20 mg/m2. Use G-CSF for secondary prophylaxis.
Grade ≥ 3 diarrhea or persisting diarrhea despite appropriate medication, fluid and electrolytes replacement Delay treatment until improvement or resolution, then reduce dosage of JEVTANA to 20 mg/m2.
Discontinue JEVTANA treatment if a patient continues to experience any of these reactions at 20 mg/m2.
2.3 Premedication
Premedicate at least 30 minutes prior to each dose of JEVTANA with the following intravenous medications to reduce the risk and/or severity of hypersensitivity:
antihistamine (dexchlorpheniramine 5 mg, or diphenhydramine 25 mg or equivalent antihistamine),
corticosteroid (dexamethasone 8 mg or equivalent steroid),
H2 antagonist (ranitidine 50 mg or equivalent H2 antagonist).
Antiemetic prophylaxis is recommended and can be given orally or intravenously as needed.
2.4 Administration Precautions
JEVTANA is a cytotoxic anticancer drug and caution should be exercised when handling and preparing JEVTANA solutions, taking into account the use of containment devices, personal protective equipment (e.g., gloves), and preparation procedures. Please refer to Handling and Disposal (16.3).
If JEVTANA Injection, first diluted solution, or second (final) dilution for in |
