Product image of Irinotecan Bendalis (Irinotecan Hydrochloride Trihydrate) supplied by GNH India

Irinotecan Bendalis

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Bendalis (Irinotecan Hydrochloride Trihydrate)

Irinotecan, the active ingredient in Irinotecan Bendalis, is a topoisomerase I inhibitor presented as a sterile injectable solution for intravenous use. It treats metastatic colorectal cancer in adult patients.
GNH India supplies Irinotecan Bendalis as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Bendalis Gmbh

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Indications & Clinical Uses

  • Irinotecan is a topoisomerase I inhibitor used primarily in the treatment of colorectal cancer.
  • Metastatic colorectal cancer: used in combination regimens to extend survival.
  • Locally advanced colorectal cancer: employed as part of neoadjuvant therapy to reduce tumor burden.
  • Colorectal cancer refractory to other agents: provides an alternative mechanism of action.

How It Works

  • After intravenous administration, irinotecan is converted intracellularly to its active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex and prevents the religation of single‑strand DNA breaks. This inhibition leads to accumulation of DNA damage during replication, ultimately triggering apoptosis of rapidly dividing cancer cells.

Side Effects

Irinotecan may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Diarrhea: may be severe and require supportive care.
  • Nausea and vomiting: often managed with antiemetics.
  • Fatigue: generalized tiredness during treatment.
  • Alopecia: temporary hair loss.
  • Mild liver enzyme elevation.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophils requiring urgent medical attention.
  • Severe colitis or ileitis: life‑threatening intestinal inflammation.
  • Hepatic toxicity: marked elevation of bilirubin or transaminases.
  • Anaphylactic reactions: acute hypersensitivity requiring immediate intervention.
  • Pulmonary toxicity: interstitial pneumonitis or fibrosis.
  • Tumor lysis syndrome: rapid tumor cell breakdown causing metabolic disturbances.

Precautions & Warnings

  • Before initiating therapy, clinicians should evaluate patient‑specific factors and monitor for toxicity.
  • Dose adjustment: renal or hepatic impairment may require modification.
  • Monitoring: regular complete blood counts and liver function tests are recommended.
  • Hydration: maintain adequate fluids to reduce risk of severe diarrhea.
  • Drug interactions: avoid concurrent strong CYP3A4 inhibitors without supervision.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

Irinotecan can interact with several medicines, influencing its efficacy or safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors: may increase SN‑38 exposure and toxicity.
  • UGT1A1*28 homozygosity: heightened risk of severe neutropenia and diarrhea.
  • Concurrent myelosuppressive agents: additive bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • Antiemetics such as ondansetron: may affect metabolism of irinotecan.
  • Warfarin: potential increase in bleeding risk.
  • Proton‑pump inhibitors: may alter gastric pH and affect drug absorption.

Frequently Asked Questions

Irinotecan Bendalis is a chemotherapy product indicated for the treatment of metastatic colorectal cancer in adult patients. It is administered as part of combination regimens to improve survival outcomes and may also be used in neoadjuvant or refractory settings under specialist oncology supervision.

Irinotecan is a pro‑drug that is converted inside cells to the active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I enzyme, preventing the religation of single‑strand DNA breaks during replication. This leads to accumulation of DNA damage, triggering apoptosis of rapidly dividing tumor cells.

The dose of Irinotecan Bendalis is individualized by the prescribing oncologist based on factors such as body surface area, disease stage, prior therapies, and organ function. No fixed regimen is provided here; clinicians determine the appropriate dosing schedule for each patient.

Safety data for Irinotecan Bendalis in pregnancy and lactation are limited. The drug is generally contraindicated during pregnancy unless the potential benefit justifies the risk, and breastfeeding is not recommended because the medication may be excreted in milk and harm the infant.

To place an order, submit an enquiry on the Irinotecan Bendalis product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain if needed) and any required import documentation.

Irinotecan belongs to the topoisomerase I inhibitor class, differing from agents such as topotecan (another topoisomerase I inhibitor) and from DNA‑alkylating drugs like oxaliplatin. Its unique mechanism offers an alternative for patients who have progressed on other regimens, but it also carries a distinct toxicity profile, notably severe diarrhea and neutropenia.

Irinotecan Bendalis must be stored at 2‑8 °C in a refrigerator, protected from light and moisture. The product should not be frozen or shaken. Prior to administration, it should be inspected for particulate matter and prepared under aseptic conditions according to the manufacturer’s instructions.

Irinotecan Bendalis is administered intravenously, typically as an infusion over 30 to 90 minutes depending on the protocol. The infusion is performed by qualified healthcare professionals in a clinical setting, with appropriate monitoring for infusion‑related reactions and supportive care measures.

The most serious adverse events include febrile neutropenia, severe or life‑threatening diarrhea (colitis/ileitis), hepatic toxicity, and rare hypersensitivity reactions. Patients should be monitored closely for signs of infection, persistent gastrointestinal symptoms, and abnormal liver function tests, and managed promptly if they occur.

Irinotecan Bendalis should be avoided in patients with known hypersensitivity to irinotecan or any of its excipients, those with severe bone‑marrow suppression, uncontrolled infections, or significant hepatic impairment. Caution is also advised for individuals with known UGT1A1*28 homozygosity due to increased risk of toxicity.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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