Bendamustine100mg Injection

  • Medicine Name: Bendit
  • API: Bendamustine
  • Strength : 100 mg 
  • Packaging:  20 mL amber single-use vials
  • Manufactured by: Natco Pharma
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Description

Bendamustine Hydrochloride Injection is an alkylating drug indicated for the treatment of adult patients with:

  • Chronic lymphocytic leukemia (CLL): Efficacy relative to first-line therapies other than chlorambucil has not been established.
  • Indolent B-cell non-Hodgkin lymphoma (NHL): This is indicated for cases that have progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Dosage and Side Effects

For CLL:

  • Dosage: 100 mg/m² infused intravenously over 10 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles.

For NHL:

  • Dosage: 120 mg/m² infused intravenously over 10 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles.

The common side effects of Bendamustine are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis.

Warning and Precautions

  • Myelosuppression: Monitor and adjust the dose based on ANC and platelet count recovery.
  • Infections: Be vigilant for signs of infection or reactivation of infections and provide prompt treatment.
  • Progressive multifocal leukoencephalopathy (PML): Watch for neurological, cognitive, or behavioral signs or symptoms suggestive of PML.
  • Anaphylaxis and Infusion Reactions: Severe anaphylactic reactions have occurred, necessitating clinical monitoring and potential discontinuation. Pre-medication may be required for milder reactions.
  • Tumor Lysis Syndrome: Anticipate and use supportive measures in patients at high risk to prevent acute renal failure and death.
  • Skin Reactions: Discontinue treatment for severe skin reactions. Cases of SJS, DRESS, and TEN, some fatal, have been reported.
  • Hepatotoxicity: Monitor liver chemistry tests before and during treatment.
  • Other Malignancies: Be aware of potential pre-malignant and malignant diseases.
  • Extravasation Injury: Take precautions to avoid extravasation, including monitoring the intravenous infusion site during and after administration.
  • Embryo-Fetal Toxicity: Warn females of reproductive potential and males with female partners of the potential risk to a fetus and recommend the use of effective contraception.

FAQ's

What is a bendamustine injection used for?

Bendamustine injection is used to treat chronic lymphocytic leukemia (CLL, cancer of white blood cells) and indolent B-cell non-Hodgkin’s lymphoma (NHL) in patients who have already received other treatments. It interferes with the growth of cancer cells, which are eventually destroyed by the body.

What type of therapy is bendamustine?

Bendamustine is a chemotherapy drug.

Is bendamustine safe to use?

Bendamustine is safe and effective for lymphodepletion before tisagenlecleucel in patients with refractory or relapsed large B-cell lymphomas.

What is the side effect of bendamustine?

Most common side effects include: fatigue, fever, nausea, and vomiting, diarrhea, constipation, loss of appetite, cough, headache, weight loss, difficulty breathing, rash, mouth irritation, low red blood cells (oxygen-carrying cells), low platelets (blood-clotting cells), and decreased number of three different types 

Is bendamustine FDA approved?

The drug Bendamustine was approved in October 2008 by the US FDA.