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

Irinotecán Glenmark

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecán Glenmark (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecán Glenmark, is a topoisomerase I inhibitor presented as an injectable formulation for intravenous use. It is employed in the treatment of metastatic colorectal cancer and other colorectal cancer indications in adult patients and conforms to European Union pharmaceutical standards, being manufactured under strict GMP conditions.

GNH India supplies Irinotecán Glenmark as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Glenmark Arzneimittel Gmbh

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Indications & Clinical Uses

  • Irinotecán Glenmark is a topoisomerase I inhibitor used in colorectal cancer therapy.
  • Metastatic colorectal cancer: improves overall survival when combined with fluoropyrimidine‑based chemotherapy.
  • Colorectal cancer (advanced): provides disease control in patients who have progressed on prior regimens.

How It Works

  • Irinotecan is a pro‑drug that is converted intracellularly to SN‑38, a potent inhibitor of topoisomerase I. By stabilising the enzyme‑DNA cleavable complex, it prevents relegation of single‑strand DNA breaks, leading to accumulation of DNA damage and ultimately cell death in rapidly dividing tumor cells.

Side Effects

Irinotecán Glenmark may cause a range of adverse reactions.

Common Side Effects

  • Nausea and vomiting: frequent gastrointestinal upset.
  • Diarrhea: can be severe and may require antidiarrheal therapy.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Fatigue: persistent tiredness affecting daily activities.
  • Alopecia: hair loss in some patients.
  • Abdominal pain: discomfort in the stomach area.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophil count requiring urgent care.
  • Severe colitis: intense inflammation of the colon that may be life‑threatening.
  • Hepatotoxicity: liver enzyme elevations indicating possible liver injury.
  • Pulmonary toxicity: rare lung inflammation or fibrosis.
  • Anaphylactic reactions: immediate hypersensitivity requiring emergency treatment.
  • Hemorrhagic cystitis: bladder inflammation with bleeding, though uncommon.

Precautions & Warnings

Before initiating therapy, clinicians should assess patient‑specific risk factors and monitor closely.

  • Monitor blood counts: perform regular complete blood count tests to detect neutropenia.
  • Assess liver function: evaluate hepatic enzymes and bilirubin prior to each cycle.
  • Evaluate bowel status: avoid use in patients with recent bowel obstruction or perforation.
  • Use prophylactic antiemetics: administer anti‑nausea medication to reduce vomiting.
  • Adjust dose in hepatic impairment: consider reduced dosing for patients with significant liver dysfunction.
  • Store at controlled room temperature: keep in original packaging, protect from moisture and light.

Avoid Interactions

Irinotecán Glenmark can interact with several medicines; awareness helps prevent adverse outcomes.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): increase SN‑38 exposure.
  • UGT1A1 inhibitors (e.g., atazanavir, indinavir): raise risk of severe neutropenia and diarrhea.
  • Concurrent myelosuppressive agents: amplify bone‑marrow toxicity.
  • High‑dose radiation therapy to the abdomen: may exacerbate gastrointestinal toxicity.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin): may modestly raise drug levels.
  • CYP3A4 inducers (e.g., rifampicin, carbamazepine): could reduce efficacy.
  • Anticoagulants (e.g., warfarin): monitor coagulation parameters due to potential bleeding risk.
  • Antidiarrheal agents (e.g., loperamide): use cautiously as they may mask severe diarrhea.

Frequently Asked Questions

Irinotecán Glenmark contains irinotecan hydrochloride, a topoisomerase I inhibitor used primarily in the treatment of metastatic colorectal cancer and advanced colorectal cancer. It is administered as part of combination chemotherapy regimens to improve survival and disease control in adult patients.

Irinotecan is a pro‑drug that is metabolised inside cancer cells to SN‑38, an active metabolite that binds to topoisomerase I. This binding prevents the enzyme from resealing single‑strand DNA breaks during replication, leading to accumulation of DNA damage and ultimately causing tumor cell death.

The dosing regimen for Irinotecán Glenmark is determined by the prescribing oncologist based on the patient’s weight, performance status, treatment protocol and renal or hepatic function. The prescriber sets the exact dose, schedule and any necessary dose adjustments.

The safety of Irinotecán Glenmark in pregnancy and lactation has not been established. It is classified as contraindicated for use in pregnant or nursing women because it may cause fetal harm or be excreted in breast milk. Women of child‑bearing potential should use effective contraception during treatment.

To request Irinotecán Glenmark, submit an enquiry on the 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 the necessary import documentation.

Irinotecán Glenmark belongs to the topoisomerase I inhibitor class, differing from agents such as oxaliplatin (a platinum compound) or fluoropyrimidines (e.g., 5‑FU). It is often combined with fluoropyrimidines to enhance efficacy. Compared with alternative regimens, irinotecan offers a distinct mechanism of action and a side‑effect profile that includes notable gastrointestinal toxicity.

Irinotecán Glenmark should be stored at controlled room temperature, below 25 °C, in its original packaging to protect from moisture and light. Once reconstituted, the solution must be used according to the manufacturer’s stability guidelines and kept refrigerated if required by the specific preparation instructions.

The product is supplied as an injectable formulation for intravenous infusion. It is administered by a qualified healthcare professional, typically as an infusion over 30‑90 minutes, depending on the treatment protocol and patient tolerance.

The most serious risks include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea or colitis, hepatic toxicity, and rare but severe allergic reactions such as anaphylaxis. Patients should be monitored closely for signs of infection, gastrointestinal distress and liver function abnormalities.

Irinotecán Glenmark is contraindicated in patients with known hypersensitivity to irinotecan or any of its excipients, those with recent bowel obstruction or perforation, and individuals who are pregnant or breastfeeding. Caution is also advised for patients with severe hepatic impairment or existing bone‑marrow suppression.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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