Bendamustine Hydrochloride 25mg Powder For Concentrate For Solution For Infusion - 26ml

Product Overview

Bendamustine Hydrochloride 25mg Powder For Concentrate For Solution For Infusion is a powerful antineoplastic agent specifically formulated for the treatment of certain hematological malignancies. As a prescription-only medication, it is administered under strict medical supervision to combat various forms of cancer, including chronic lymphocytic leukemia (CLL) and indolent non-Hodgkin's lymphoma (iNHL).

This medication belongs to the class of alkylating agents, which work by interfering with the DNA of cancer cells, thereby inhibiting their growth and proliferation. It is designed to be reconstituted and then diluted for intravenous infusion, ensuring precise delivery and therapeutic effect within a controlled clinical environment.

Product Details

Active Ingredient: Bendamustine Hydrochloride

Strength: 25 mg

Form: Powder for Concentrate for Solution for Infusion

Administration Route: Intravenous Infusion

Package Size: Typically supplied as a single-use vial containing 25mg of bendamustine hydrochloride powder, intended for reconstitution to a specific volume (e.g., 26ml final solution for infusion).

Benefits of Use

• Targeted action against cancer cells in chronic lymphocytic leukemia and indolent non-Hodgkin's lymphoma.
• Effectively damages cancer cell DNA, leading to cell cycle arrest and apoptosis.
• Offers a crucial therapeutic option for patients requiring systemic chemotherapy.

How to Use

Bendamustine Hydrochloride must be prepared and administered by qualified healthcare professionals experienced in the use of antineoplastic agents. The administration process typically involves:

1. The powder in the vial is first reconstituted with a specified amount of sterile water for injection, following aseptic techniques.
2. The reconstituted solution is then further diluted in an appropriate intravenous infusion solution (e.g., 0.9% Sodium Chloride or 5% Dextrose) to achieve the final concentration for infusion.
3. The diluted solution is administered intravenously over a period specified by the prescribing physician, typically 30 to 60 minutes.
4. Dosage and treatment schedule are individualized based on the patient's medical condition, body surface area, and treatment protocol.
5. Regular monitoring of blood counts and organ function is essential throughout the treatment course.

Caution & Warnings

• Myelosuppression: May cause severe bone marrow suppression, leading to leukopenia, thrombocytopenia, and anemia. Frequent blood count monitoring is mandatory.
• Infections: Increased risk of opportunistic and severe infections due to immunosuppression.
• Infusion Reactions: Acute infusion-related reactions, including fever, chills, pruritus, and rash, can occur.
• Skin Reactions: Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported.
• Hepatotoxicity: Liver function should be monitored regularly.
• Tumor Lysis Syndrome: Risk of tumor lysis syndrome, especially in patients with high tumor burden.
• Extravasation: Avoid extravasation as it can lead to tissue damage.
• Embryo-fetal Toxicity: Harmful to a fetus; not recommended for use during pregnancy or breastfeeding. Effective contraception should be used by both male and female patients during and after treatment.
• Administer only under the supervision of a physician experienced in chemotherapy.

Ingredients

Active Ingredient: Bendamustine Hydrochloride

Excipients: Mannitol. Hydrochloric acid (for pH adjustment, if necessary).

Storage Conditions

Store unopened vials refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze.

After reconstitution and dilution, refer to specific product information for stability data, as this may vary and typically requires use within a short period under refrigerated conditions.