Bendeka

BENDEKA- bendamustine hydrochloride injection, solution
Teva Pharmaceuticals USA, Inc.

1 INDICATIONS AND USAGE

1.1 Chronic Lymphocytic Leukemia (CLL)

BENDEKA® 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 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:

Delay BENDEKA administration 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], reinitiate BENDEKA (bendamustine hydrochloride) injection at the discretion of the treating physician. In addition, consider dose reduction. [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.

Consider dose re-escalation in subsequent cycles at the discretion of the treating physician.

2.2 Dosing Instructions for NHL

Recommended Dosage:

The recommended dose is 120 mg/m2 administered intravenously over 10 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles.

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

Delay BENDEKA administration in the event of a 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], reinitiate BENDEKA at the discretion of the treating physician. In addition, consider dose reduction. [see Warnings and Precautions (5.1)]

Dose modifications for hematologic toxicity: for Grade 4 toxicity, reduce the dose to 90 mg/m2 on Days 1 and 2 of each cycle; if Grade 4 toxicity recurs, reduce the dose to 60 mg/m2 on Days 1 and 2 of each cycle.

Dose modifications for non-hematologic toxicity: for Grade 3 or greater toxicity, reduce the dose to 90 mg/m2 on Days 1 and 2 of each cycle; if Grade 3 or greater toxicity recurs, reduce the dose to 60 mg/m2 on Days 1 and 2 of each cycle.

2.3 Preparation for Intravenous Administration

BENDEKA is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

BENDEKA is in a multiple-dose vial. At room temperature, BENDEKA is a clear, and colorless to yellow ready-to-dilute solution. Store BENDEKA at recommended refrigerated storage conditions (2-8°C or 36-46°F). When refrigerated, the contents may partially freeze. Allow the vial to reach room temperature (15-30°C or 59-86°F) prior to use. Do not use the product if particulate matter is observed after achieving room temperature.

Intravenous Infusion

  • Aseptically withdraw the volume needed for the required dose from the 25 mg/mL solution as per Table A below and immediately transfer the solution to a 50 mL infusion bag of one of the following diluents:
    0.9% Sodium Chloride Injection, USP; or
    2.5% Dextrose/0.45% Sodium Chloride Injection, USP; or
    5% Dextrose Injection, USP.

The resulting final concentration of bendamustine hydrochloride in the infusion bag should be within 1.85 mg/mL – 5.6 mg/mL. After transferring, thoroughly mix the contents of the infusion bag. The admixture should be a clear, and colorless to yellow solution.

No other diluents have been shown to be compatible. The 5% Dextrose Injection, USP, offers a sodium-free method of administration for patients with certain medical conditions requiring restricted sodium intake.

Table A: Volume (mL) of BENDEKA required for dilution into 50 mL of 0.9% saline, or 0.45% saline/2.5% dextrose or 5% dextrose for a given dose (mg/m2) and Body Surface Area (m2)
Body Surface Area (m2) Volume of BENDEKA to withdraw (mL)
120 mg/m2 100 mg/m2 90 mg/m2 60 mg/m2 50 mg/m2 25 mg/m2
1 4.8 4 3.6 2.4 2 1
1.1 5.3 4.4 4 2.6 2.2 1.1
1.2 5.8 4.8 4.3 2.9 2.4 1.2
1.3 6.2 5.2 4.7 3.1 2.6 1.3
1.4 6.7 5.6 5 3.4 2.8 1.4
1.5 7.2 6 5.4 3.6 3 1.5
1.6 7.7 6.4 5.8 3.8 3.2 1.6
1.7 8.2 6.8 6.1 4.1 3.4 1.7
1.8 8.6 7.2 6.5 4.3 3.6 1.8
1.9 9.1 7.6 6.8 4.6 3.8 1.9
2 9.6 8 7.2 4.8 4 2
2.1 10.1 8.4 7.6 5 4.2 2.1
2.2 10.6 8.8 7.9 5.3 4.4 2.2
2.3 11 9.2 8.3 5.5 4.6 2.3
2.4 11.5 9.6 8.6 5.8 4.8 2.4
2.5 12 10 9 6 5 2.5
2.6 12.5 10.4 9.4 6.2 5.2 2.6
2.7 13 10.8 9.7 6.5 5.4 2.7
2.8 13.4 11.2 10.1 6.7 5.6 2.8
2.9 13.9 11.6 10.4 7 5.8 2.9
3 14.4 12 10.8 7.2 6 3

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Any unused solution should be discarded according to institutional procedures for antineoplastics.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.