Bendalab 100 mg Ingredients and Usage

The active ingredient is Bendamustine Hydrochloride. It is typically supplied as a powder or a concentrated solution that must be reconstituted and diluted before being administered as an intravenous (IV) infusion over 30 to 60 minutes.

Bendalab is clinically indicated for the treatment of adult patients with:

• Chronic Lymphocytic Leukemia (CLL): For first-line treatment or in combination with other agents.
• Indolent B-cell Non-Hodgkin’s Lymphoma (NHL): In cases where the disease has progressed during or after treatment with Rituximab or a Rituximab-containing regimen.

How Does Bendalab Work?

Bendamustine has a unique structure combining an alkylating agent (nitrogen mustard) and a purine analog, giving it a dual mechanism of action:

1. DNA Damage (Alkylating Agent Action): It forms strong covalent bonds (alkyl groups) with the genetic material (DNA and RNA) within the cancer cell nucleus.
2. Cross-Linking: This action causes both intra-strand and inter-strand DNA crosslinks, leading to DNA strand breaks and interference with DNA synthesis.
3. Cell Death: The resulting DNA damage is irreparable, activating multiple pathways that lead to cell cycle arrest and, ultimately, programmed cell death (apoptosis) in the rapidly dividing cancer cells. It is active against both dividing and resting cells.

Bendalab 100 mg Side Effects and Warnings

As a powerful chemotherapy drug, Bendalab causes significant side effects, requiring frequent monitoring, especially of blood counts.

Black Box Warnings and Critical Precautions:

1. Myelosuppression (Low Blood Counts): Bendamustine causes severe myelosuppression, leading to critically low levels of white blood cells (neutropenia, increasing infection risk), red blood cells (anemia), and platelets (thrombocytopenia, increasing bleeding risk). CBC (Complete Blood Count) monitoring is frequent and dose adjustments may be required.
2. Infections: Patients are at high risk of severe infections, including pneumonia, sepsis, and reactivation of viral infections (e.g., Hepatitis B, Herpes Zoster, CMV, and rare cases of Progressive Multifocal Leukoencephalopathy (PML)).
3. Infusion Reactions and Anaphylaxis: Severe allergic and infusion reactions, including fever, chills, rash, and anaphylaxis, can occur, usually within minutes of infusion. Premedication is often required.
4. Tumor Lysis Syndrome (TLS): Rapid breakdown of cancer cells can lead to TLS, causing acute kidney failure and electrolyte imbalance. Hydration and allopurinol may be required.
5. Extravasation Injury: Bendamustine can cause severe tissue damage if it leaks out of the vein at the infusion site. The infusion site must be monitored closely.

Bendalab 100 mg Storage Conditions

Bendalab Injection (powder or solution) requires specific storage and handling:

• Store the unopened vials in a refrigerator at a temperature between 2°C and 8°C (36°F and 46°F). Protect from light.
• Handling: Because it is a cytotoxic agent, it must be prepared and administered by personnel trained in the safe handling of chemotherapy, using protective equipment.
• Administration: The reconstituted and diluted solution must be administered promptly according to the cycle schedule determined by the oncologist.