Rx Item-BENDEKA 100MG MDV 4ML INJ VIAL by Teva Pharma

BENDEKA- bendamustine hydrochloride injection, solution
Teva Pharmaceuticals USA, Inc.
1 INDICATIONS AND USAGE
1.1 Chronic Lymphocytic Leukemia (CLL)

BENDEKA� (bendamustine hydrochloride) injection is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.
1.2 Non-Hodgkin Lymphoma (NHL)

BENDEKA (bendamustine hydrochloride) injection is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Instructions for CLL

Recommended Dosage:

The recommended dose is 100 mg/m2 administered intravenously over 10 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles.

Dose Delays, Dose Modifications and Reinitiation of Therapy for CLL:

BENDEKA (bendamustine hydrochloride) injection administration should be delayed in the event of Grade 4 hematologic toxicity or clinically significant greater than or equal to Grade 2 non-hematologic toxicity. Once non-hematologic toxicity has recovered to less than or equal to Grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) greater than or equal to 1 x 109 /L, platelets greater than or equal to 75 x 109 /L], BENDEKA (bendamustine hydrochloride) injection can be reinitiated at the discretion of the treating physician. In addition, dose reduction may be warranted. [see Warnings and Precautions (5.1) ]

Dose modifications for hematologic toxicity: for Grade 3 or greater toxicity, reduce the dose to 50 mg/m2 on Days 1 and 2 of each cycle; if Grade 3 or greater toxicity recurs, reduce the dose to 25 mg/m2 on Days 1 and 2 of each cycle.

Dose modifications for non-hematologic toxicity: for clinically significant Grade 3 or greater toxicity, reduce the dose to 50 mg/m2 on Days 1 and 2 of each cycle.

Dose re-escalation in subsequent cycles may be considered at the discretion of the treating physician.

BENDEKA 100MG MDV 4ML INJ VIAL by Teva P
NDC No.63459-0348-04 63459-348-04 UPC/GTIN No. 3-63459-34804-9 MPN 34804 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,P

BENDEKA 100MG MDV 4ML INJ VIAL
BENDEKA 100MG MDV 4ML INJ VIAL by Teva Pharma Generic Name: BENDAMUSTINE HCL Description: BENDEKA MF 25MG/ML 4ML CIN: 5215389 NDC: 63459-0348-04 63459-348-04 63459034804 6345934804

Teva Pharmaceuticals USA
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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BENDEKA 100MG MDV 4ML INJ VIAL
BENDEKA 100MG MDV 4ML INJ VIAL by Teva Pharma Generic Name: BENDAMUSTINE HCL Description: BENDEKA MF 25MG/ML 4ML CIN: 5215389 NDC: 63459-0348-04 63459-348-04 63459034804 6345934804