Rx Item-Jevtana Fdn10Mg/Ml Vial By Aventis Pharma

vial , yellow
Solution is yellow to brownish-yellow

JEVTANA- cabazitaxel
Sanofi-Aventis U.S. LLC

WARNING: NEUTROPENIA AND HYPERSENSITIVITY

Neutropenia: Neutropenic deaths have been reported. In order to monitor the occurrence of neutropenia, frequent blood cell counts should be performed on all patients receiving JEVTANA. JEVTANA is contraindicated in patients with neutrophil counts of ?1,500 cells/mm3 [see Contraindications (4) and Warnings and Precautions (5.1)] .



Severe hypersensitivity: 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 [see Dosage and Administration (2.1), Contraindications (4), and Warnings and Precautions (5.2)].

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 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.

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 [see Warnings and Precautions (5.2)]:

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 [see Warnings and Precautions 5.3)].

JEVTANA injection single-use vial requires two dilutions prior to administration [see Dosage and Administration (2.5)].

RX ITEM-Jevtana Fdn10Mg/Ml Vial By Avent
item No.:RX107363 NDC No.24582411 UPC No.:300245824113 NDC No. 00024-5824-11 0024-5824-11 024582411 0024582411 024-5824-11 UPC/GTIN No. 3-00245-82411-3 MPN 582411

Jevtana Fdn10Mg/Ml Vial By Aventis Pharm
BRAND: JEVTANA NDC: 00024-5824-11,24582411 UPC: 3-00245-82411-3,300245824113 Aventis Pharmaceuticals

CABAZITAXEL INTRAVEN VIAL
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