Bendamustine Hydrochloride

BENDAMUSTINE HYDROCHLORIDE- bendamustine hydrochloride injection, solution
Apotex Corp

1 INDICATIONS AND USAGE

1.2 Non-Hodgkin Lymphoma (NHL)

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

2.2 Dosing Instructions for NHL

Recommended Dosage:

The recommended dosage is 120 mg/m2 administered intravenously over 60 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles.

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

Delay bendamustine hydrochloride injection administration in the event of a Grade 4 hematologic toxicity or clinically significant greater or equal to Grade 2 non-hematologic toxicity. Once non-hematologic toxicity has recovered to ≤ Grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) ≥ 1 x 109 /L, platelets ≥ 75 x 109 /L], reinitiate bendamustine hydrochloride injection at the discretion of the treating physician. In addition, consider dose reduction. [see Warnings and Precautions ( 5.1 )]

Dosage 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.

Dosage 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

Bendamustine hydrochloride injection is a hazardous drug. Follow applicable special handling and disposal procedures.1

Bendamustine hydrochloride injection is in a multiple-dose vial. Bendamustine hydrochloride injection is a clear and colorless to yellow solution. Store bendamustine hydrochloride injection at recommended refrigerated storage conditions (2°C to 8°C or 36°F to 46°F). When refrigerated the contents may freeze. Allow the vial to reach room temperature (15°C to 30°C or 59°F to 86°F) prior to use. Observe the contents of the vial for any visible solid or particulate matter and discoloration. Do not use the product if solid or particulate matter is observed after reaching 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 to a 500 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.

The resulting final concentration of bendamustine hydrochloride injection in the infusion bag should be within 0.05 to 0.7 mg/mL. After transferring, thoroughly mix the contents of the infusion bag. The admixture should be a clear and colorless to slightly yellow solution. Use either 0.9% Sodium Chloride Injection, USP, or 2.5% Dextrose/0.45% Sodium Chloride Injection, USP, for dilution, as outlined above. No other diluents have been shown to be compatible.

Table A: Volume (mL) of Bendamustine Hydrochloride Injection required for dilution into 500 mL of 0.9% Sodium Chloride Injection, USP, or 0.45% Sodium Chloride/2.5% Dextrose Injection, USP for a given dose (mg/m2) and Body Surface Area (m2)

Body Surface Area (m2) Volume of Bendamustine Hydrochloride Injection 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.

2.4 Admixture Stability

Bendamustine hydrochloride injection contains no antimicrobial preservative. The admixture should be prepared as close as possible to the time of patient administration.

If diluted with 0.9% Sodium Chloride Injection, USP, or 2.5% Dextrose/0.45% Sodium Chloride Injection, USP, the final admixture is stable for 24 hours when stored refrigerated (2°C to 8°C or 36°F to 46°F) or for 3 hours when stored at room temperature (15°C to 30°C or 59°F to 86°F) and room light. Administration of diluted bendamustine hydrochloride injection must be completed within this period of time.

Bendamustine hydrochloride injection is supplied in a multiple-dose vial. Retain the partially used vial in original package to protect from light and store refrigerated (2°C to 8°C or 36°F to 46°F) if additional dose withdrawal from the same vial is intended.

2.5 Stability of Partially Used Vials (Needle Punched Vials)

Bendamustine hydrochloride injection is supplied as a multiple-dose vial. Although it does not contain any antimicrobial preservative, bendamustine hydrochloride injection is bacteriostatic. The partially used vials are stable for up to 28 days when stored in its original carton under refrigeration (2°C to 8°C or 36°F to 46°F). Each vial is not recommended for more than a total of six (6) dose withdrawals.

After first use, store the partially used vial in original carton at 2°C to 8°C (36°F to 46°F), and then discard after 28 days.

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