Bendamustine Bendit 100mg

[Product Name] Bendamustine Hydrochloride for Injection

[English Name] Treanda, Levact, Bendamustine

[Specification] 100 mg/vial

[Indications]

In March 2008, the FDA first approved bendamustine hydrochloride for the treatment of Chronic Lymphocytic Leukemia (CLL). In October of the same year, the FDA approved a second indication for the drug: for patients with indolent B-cell Non-Hodgkin Lymphoma (NHL) whose disease has progressed during, or within 6 months of completing, treatment with rituximab (Rituxan) or a rituximab-containing regimen.

[Contraindications]

Contraindicated in patients with a known hypersensitivity to bendamustine hydrochloride or mannitol.

[Drug Interactions]

When co-administered with CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin), the plasma concentration of bendamustine may increase, while the concentrations of its metabolites, M3 and M4, may decrease. When co-administered with CYP1A2 inducers (e.g., omeprazole, smoking), the plasma concentration of bendamustine may decrease, while the concentrations of its metabolites, M3 and M4, may increase.

[Mechanism of Action]

This product is a bifunctional alkylating agent that induces cross-linking of single- and double-stranded DNA via alkylation. This disrupts DNA function and synthesis, and creates cross-links between DNA and proteins, as well as between proteins themselves, thereby exerting an anti-tumor effect.

[Adverse Reactions]

Common adverse reactions associated with bendamustine include nausea, vomiting, diarrhea, fatigue, weakness, rash, pruritus, signs and symptoms of infection (e.g., persistent sore throat, fever, and chills), easy bruising/bleeding, and oral ulcers. Serious adverse reactions may include bone marrow suppression and tumor lysis syndrome. Bendamustine may cause mild or severe allergic reactions; patients may experience allergic symptoms—such as skin rash, facial swelling, or difficulty breathing—during or shortly after administration.

Bendamustine may be harmful to the fetus; therefore, women undergoing treatment must employ appropriate contraceptive measures and discontinue breastfeeding during the course of treatment and for 3 months thereafter.

【Dosage and Administration】

Bendamustine Hydrochloride for Injection is supplied in a strength of 100 mg per vial. The product should be stored at a temperature not exceeding 30°C, protected from light, and reconstituted immediately prior to use.

Reconstitution Procedure: Each 100 mg vial of the drug must first be dissolved in 20 mL of sterile Water for Injection. Shake vigorously until completely dissolved to form a clear, colorless or pale yellow solution; dissolution typically takes no longer than 5 minutes. The resulting concentration after dissolution is 5 mg/mL.

Within 30 minutes of dissolution, withdraw the appropriate volume of the aqueous bendamustine solution as required and transfer it into 500 mL of 0.9% Sodium Chloride Injection or 2.5%/0.45% Glucose/Sodium Chloride Injection, ensuring that the final concentration of bendamustine in the infusion solution falls within the range of 0.2 to 0.6 mg/mL.

The prepared infusion solution may be stored under refrigeration (2–8°C) for up to 24 hours, or at room temperature under natural light for up to 3 hours. When used for the treatment of CLL, Bendamustine is administered in 28-day cycles; typically, a total of 6 treatment cycles are required.

Administration occurs on Days 1 and 2 of each treatment cycle. The recommended dosage is 100 mg/m². The drug is administered via intravenous infusion, with each infusion lasting no less than 30 minutes.

When used for the treatment of NHL, Bendamustine is administered in 21-day cycles; typically, a total of 8 treatment cycles are required. Administration occurs on Days 1 and 2 of each treatment cycle. The recommended dosage is 120 mg/m². Each infusion must last no less than 60 minutes. Bendamustine (Treanda / Levact) is a lyophilized powder for injection classified as a prescription oncological medication. It carries certain toxic side effects and requires reconstitution prior to use. This medication must be administered under the guidance of a physician experienced in its clinical application. Furthermore, as a foreign-sourced prescription drug subject to strict regulatory controls, it imposes specific requirements regarding storage environment and temperature; specifically, it must be stored at a temperature not exceeding 30°C and protected from light. Haidekang does not sell pharmaceuticals; patients are strongly advised to travel abroad personally to seek medical consultation, purchase the medication, and undergo treatment.

Product Specifications

Product Name: Bendamustine Hydrochloride for Injection 100mg (Bendamustine / Bendit)

Generic Name: Bendamustine Hydrochloride for Injection

Composition: Bendamustine Hydrochloride

Dosage Form: A white to off-white, loose, porous mass or powder.

Specification: 100mg

Manufacturer: Natco Pharma

Indications: Indicated for the treatment of indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or following treatment with rituximab or rituximab-containing regimens.

Dosage and Administration: The recommended dosage regimen consists of a 21-day treatment cycle. The medication is administered on Day 1 and Day 2 of each cycle at a dose of 120 mg/m², delivered via intravenous infusion over a period of 60 to 120 minutes, for a maximum of 8 cycles.