Bendit 100mg Injection (Bendamustine Injection IP)
Prescription RequiredManufactured By
Natco
Pack Of
1
Salt Composition
Bendamustine Injection IP
Storage
Below 30°C
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Overview
Bendit 100mg Injection contains bendamustine, an alkylating anticancer medicine that creates DNA cross-links and leads to malignant-cell death. It is mainly used in chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL), with its exact role evolving as newer targeted agents become available.
Bendamustine 100mg injection can cause severe myelosuppression, prolonged lymphocyte suppression, infection, infusion reactions, tumor lysis, and serious skin reactions. The 100 mg vial is a preparation strength; patient dosing is calculated in mg/m².
Quick Product Facts
| Field | Publication wording |
|---|---|
| Brand | Bendit 100mg Injection |
| Active molecule | Bendamustine |
| Strength | 100 mg |
| Dosage form | IV infusion |
| Manufacturer / Marketer | Natco |
| Pack / Presentation | 1 vial |
| Storage | Below 30°C |
| Prescription | Required |
| Clinical supervision | Specialist supervision required |
Uses and Indications
- Chronic lymphocytic leukemia (CLL)
- Indolent B-cell non-Hodgkin lymphoma (NHL)
Bendamustine 100mg injection can also be utilized in conjunction with other agents like bendamustine/rituximab combinations for particular lymphoid malignancies. Treatment selection is determined by a number of aspects, including the biology and the type of malignancy, age, underlying illnesses, prior treatments, and newer agents like BTK and BCL2 inhibitors.
How Bendit 100mg Injection Works
Bendit 100mg Injection is known to affect the cancer cells’ DNA by making improper bonds in between and within the DNA strands. The ability of the cells to copy their DNA will therefore be hampered, making them unable to multiply.
Clinical Evidence for Bendit 100mg Injection
CLL pivotal study: Bendamustine injection showed better treatment responses and helped delay disease progression compared with chlorambucil in the pivotal study.
Indolent NHL studies: Studies demonstrated significant patient response to therapy in cases of indolent B-cell NHL refractory to rituximab treatment.
Bendamustine-rituximab: This treatment regimen proved to be a successful alternative for patients with indolent lymphoma.
Side Effects of Bendit 100mg Injection
Bendamustine 100mg injection can produce a number of side effects, and their intensity will depend on the patient. Certain side effects are temporary, but some require immediate attention by a doctor. Therefore, monitoring during treatment is common practice.
Common side effects
- Low white cells
- Anaemia
- Low platelets
- Nausea/vomiting
- Fatigue
- Fever
- Infections
- Rash
Serious side effects
- Severe/prolonged myelosuppression
- Opportunistic infection
- Severe infusion reactions
- Tumour lysis syndrome
- SJS/TEN/DRESS
- Secondary malignancies
Critical Safety Warning
PROLONGED IMMUNOSUPPRESSION: It has been found that Bendamustine 100mg Injection may cause long-lasting reduction of immunity, which may lead to infections and may activate viruses. Any signs of fever, shingles rash, and infections should be discussed immediately with a healthcare provider.
Bendit 100mg Injection Dosage and How To Take It
Important: These are only general references to be used when giving treatments. The physician will prescribe the proper dosage, frequency, interaction with other drugs, adjustment of dosage because of renal or hepatic dysfunction, and management of adverse effects depending on the patient's status.
| Clinical situation | Dose |
|---|---|
| CLL classic label | 100 mg/m² IV on Days 1 and 2, repeated every 28 days for up to 6 cycles |
| Indolent NHL classic label | 120 mg/m² IV on Days 1 and 2, repeated every 21 days for up to 8 cycles |
| Combinations | The dose may be different when bendamustine 100mg is combined with rituximab or other medicines |
| Organ impairment | Severe liver or kidney impairment may limit the use of bendamustine |
Bendit 100mg Injection Missed Dose
If an infusion is missed, contact the hematology department. The cycle may be delayed based on blood counts, infection, organ function, and disease status.
Safety Advice for Bendit 100mg Injection
| Category | Status | Guidance |
|---|---|---|
| Pregnancy | Avoid | Bendit 100mg Injection can harm an unborn baby and should be avoided during pregnancy. |
| Infection | High caution | Bendit 100mg Injection can weaken the immune system, so infections and viral reactivation should be monitored closely. |
| Skin | Urgent review | A severe or worsening rash should be assessed by a doctor promptly. |
| Tumor lysis | Monitor | Patients with a high tumor burden may have a greater risk of tumor lysis syndrome, so monitoring is important. |
| Driving | Caution | Fatigue or dizziness may affect alertness and make driving unsafe. |
Monitoring During Bendit 100mg Injection Treatment
- CBC/lymphocytes
- Renal/liver function
- Infection/viral reactivation
- Tumor lysis markers if high risk
- Infusion reactions
- Skin reactions
Bendit 100mg Injection Fact Box
| Parameter | Verified / publication wording |
|---|---|
| Brand | Bendit 100mg Injection |
| Generic | Bendamustine |
| Strength | 100 mg |
| Form | IV infusion |
| Manufacturer / Marketer | Natco |
| Pack | 1 vial |
| Storage | Below 30°C |
| Prescription | Required |
| Self-treatment | Not appropriate; follow specialist prescription |
| Major safety theme | PROLONGED IMMUNOSUPPRESSION |
Bendit 100mg Injection Drug Interactions
| Drug / Class | Risk | What To Do |
|---|---|---|
| Other myelosuppressive therapy | Additive cytopenias | Regular CBC monitoring is important. |
| Live vaccines | Serious infection risk | Avoid live vaccines during treatment unless the doctor advises otherwise. |
| CYP1A2 modifiers | May alter metabolism | Tell the doctor about all medicines and smoking habits. |
| Rituximab | Intentional deeper immunosuppression | Monitor for infections and hepatitis B reactivation. |
FAQs About Bendit 100mg Injection
Is 100 mg the whole patient dose?
No, the usual dose of bendamustine injection is 100 mg, but that is not the full dose to be given to all patients. It is calculated based on the body surface area in mg/m²; thus, the final dose will either be more or less than 100 mg based on the dosing regimen and health status of the patient.
What types of cancer is the Bendamustine Injection used to treat?
Bendit 100mg Injection is primarily prescribed for the treatment of CLL and some types of indolent B-cell NHLs. It can be administered either as monotherapy or as a component of combination therapy like rituximab, depending upon the type of cancer and therapeutic strategy adopted.
Why are infections a concern with the Bendamustine Injection?
Bendamustine 100mg injection may result in long-term inhibition of the body's lymphocytes, which play a vital role in boosting immunity against various infections. This could make the patient prone to severe infections and reactivation of viruses while taking this medication. It is advised to seek medical attention if the patient experiences any sign of infection.
Can severe skin reactions occur with the Bendit 100mg injection?
Yes. There could be severe skin reactions, such as blisters, peeling skin, or ulcers on the mouth or any other mucous membrane. This condition calls for immediate medical attention since it might be a severe skin reaction.
What is tumor lysis syndrome?
Tumor lysis syndrome is a condition that happens due to rapid breakdown of cancer cells as a result of treatment. The substances inside these cells will be released into the bloodstream and might lead to alterations in electrolyte balance and possible kidney dysfunction.
Can Bendamustine 100mg be delayed for low blood counts?
Yes. Treatment with bendamustine 100mg Injection can be postponed or the dose adjusted if the blood cell count drops excessively low, especially if there is an increased likelihood of developing an infection or bleeding. Blood counts are normally measured before every treatment cycle by the physician.
Can the Bendit 100mg Injection be given at home?
No. Bendit 100mg is administered via an intravenous (IV) infusion by healthcare professionals who are well-versed in providing such care in a medical environment. This ensures that any adverse effects that may arise can be observed.
References
- Current bendamustine prescribing information https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022249s006lbl.pdf
- Knauf WU, et al. Bendamustine vs chlorambucil in CLL https://www.sciencedirect.com/science/article/pii/S1098301512015896
- Rummel MJ, et al. Bendamustine-rituximab studies https://pubmed.ncbi.nlm.nih.gov/23433739/
- Current NCCN CLL/SLL and lymphoma guidelines https://jnccn.org/view/journals/jnccn/24/3/article-p68.xml
- National Cancer Institute. Bendamustine Hydrochloride. NCI Drug Dictionary https://www.cancer.gov/publications/dictionaries/cancer-drug/def/bendamustine-hydrochloride
Marketer Details
Natco
Author Details
Written By:
Nonish Sharma
I am a medical content writer with a strong academic background in life sciences, holding an M.Sc. in Biotechnology... Read More
Reviewed By:
Vaibhav Shakya
Dr. Vaibhav Shakya, MD, is a Medical reviewer and medicine expert at Globans Pharma, with more than 9 years of experienc... Read More
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