BEMUNAT POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 25 MG/VIAL USP [SIN15257P]

Product Info

BEMUNAT POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 25 MG/VIAL USP

[SIN15257P]

1 INDICATIONS AND USAGE

1.1 Chronic Lymphocytic Leukemia (CLL)
Bendamustine hydrochloride for infusion 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's Lymphoma (NHL)
Bendamustine hydrochloride for infusion is indicated for the treatment of patients with indolent B-cell non-Hodgkin's 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 Dosages
The recommended dose is 100 mg/m² administered intravenously over 30 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:

Bendamustine hydrochloride for infusion administration should be delayed in the event of Grade 4 hematologic toxicity or clinically significant ≥ 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), Bendamustine hydrochloride for infusion can be reinitiated at the discretion of the treating physician. In addition, dose reduction may be warranted. [See Warnings and Precautions (5.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]

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.

2.2 Dosing Instructions for NHL

Recommended Dosages
The recommended dose 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. Dose Modifications and Reinitiation of Therapy for NHL:

Bendamustine hydrochloride for infusion administration should be delayed in the event of a Grade 4 hematologic toxicity or clinically significant ≥ 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), Bendamustine hydrochloride for infusion can be reinitiated at the discretion of the treating physician. In addition, dose reduction may be warranted. [See Warnings and Precautions (5.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]

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 Reconstitution/Preparation for Intravenous Administration

Bendamustine hydrochloride for infusion is indicated for intravenous administration.

After reconstitution of the solution according to the instructions, Bendamustine hydrochloride for infusion is administered as a short intravenous infusion over 30 – 60 minutes.

To prepare the ready-to-use solution, the contents of a vial of Bendamustine hydrochloride for infusion are dissolved in water for infusions as follows:

First, dissolve the vial of Bendamustine hydrochloride for infusion containing 25 mg of Bendamustine hydrochloride in 10 ml by shaking.

First, dissolve the vial of Bendamustine hydrochloride for infusion containing 100 mg of Bendamustine hydrochloride in 40 ml by shaking.

As soon as clear solution forms (within 5 minutes), the total Bendamustine hydrochloride for infusion dose is immediately diluted to a final volume of approximately 500 ml with 0.9% sodium chloride solution. If particulate matter is observed, the reconstituted product should not be used.

Apart from isotonic saline solution, Bendamustine hydrochloride for infusion must not be diluted with other base infusion solutions or other infusion solutions.

2.4 Admixture Stability

Store below 30°C in original package.

Protect from light.

Cytotoxic agent – use caution during handling and preparation. Use of gloves and safety glasses is recommended to avoid exposure.

Reconstituted concentrate in the vial
The concentrate should be further processed immediately.

Diluted solution for infusion

The chemical and physical stability of the preparation after reconstitution to form the solution for infusion (water for infusions and isotonic saline solution) was confirmed for 2 hours at 25° C and 2 days at 2–8° C. From a microbiological point of view, the product should be used immediately. If not used immediately, in- use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8° C, unless dilution has taken place in controlled and validated aseptic conditions. If the ready-to-use preparation is not used immediately, the user is responsible for the Storage Period and conditions.

4 CONTRAINDICATIONS

Bendamustine hydrochloride for infusion is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to Bendamustine or mannitol. (See Warnings and Precautions (5.3) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)