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

Irinotecan Aurobindo

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Aurobindo (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Aurobindo, is a topoisomerase I inhibitor presented as a sterile injectable formulation for intravenous use. It treats metastatic and advanced colorectal cancer in adult patients.

GNH India supplies Irinotecan Aurobindo as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres worldwide.

Manufacturer / TM Owner

Aurobindo Pharma România S.R.L.

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Indications & Clinical Uses

Irinotecan Aurobindo is a chemotherapy agent that targets colorectal cancer pathways.

  • Metastatic colorectal cancer: improves overall survival when used in combination regimens.
  • Advanced colorectal cancer: reduces tumor progression and disease burden.
  • Colorectal adenocarcinoma: contributes to disease control as part of standard first‑line therapy.

How It Works

  • Irinotecan is a prodrug that is enzymatically converted to the active metabolite SN‑38. SN‑38 binds to DNA topoisomerase I, stabilizing the enzyme‑DNA complex and preventing relegation of single‑strand breaks, which leads to accumulation of DNA damage and inhibition of tumor cell replication.

Side Effects

Irinotecan may cause a range of adverse reactions.

Common Side Effects

  • Nausea and vomiting: frequent gastrointestinal upset.
  • Diarrhea: may be severe and require supportive care.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Alopecia: hair loss during treatment.
  • Fatigue: generalized tiredness.
  • Abdominal pain: discomfort in the stomach area.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophil count.
  • Severe diarrhea leading to dehydration.
  • Intestinal perforation: rare but life‑threatening.
  • Allergic reactions: rash, bronchospasm, or anaphylaxis.
  • Hepatotoxicity: elevated liver enzymes.
  • Cardiac toxicity: rare arrhythmias or ischemia.

Precautions & Warnings

Before initiating therapy, several safety considerations are required.

  • Baseline blood counts: assess neutrophil and platelet levels.
  • Liver function: evaluate hepatic enzymes and bilirubin.
  • Renal function: monitor creatinine clearance.
  • Concomitant medications: review for agents that may increase toxicity.
  • Patient education: advise on signs of severe diarrhea and infection.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Irinotecan may interact with other drugs, affecting efficacy or safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce SN‑38 exposure.
  • Anticholinergic agents: can exacerbate constipation and ileus.

Moderate Interactions (Monitor Closely)

  • UGT1A1 inhibitors (e.g., atazanavir): may increase SN‑38 levels.
  • Anticoagulants (e.g., warfarin): heightened bleeding risk.
  • Other myelosuppressive chemotherapy: additive bone‑marrow suppression.
  • Diuretics: risk of electrolyte imbalance with diarrhea.

Frequently Asked Questions

Irinotecan Aurobindo is a chemotherapy medication indicated for the treatment of metastatic and advanced colorectal cancer in adult patients. It is administered intravenously, often as part of combination regimens that include fluoropyrimidines and other agents.

Irinotecan is a prodrug that is converted in the body to the active metabolite SN‑38. SN‑38 inhibits DNA topoisomerase I, preventing the re‑ligation of single‑strand DNA breaks, which leads to DNA damage and ultimately stops tumor cell replication.

The dosing of Irinotecan is individualized by the prescribing oncologist. Factors such as the patient’s body surface area, disease stage, prior therapies, and organ function determine the exact amount and schedule, and these details are not publicly standardized.

Safety of Irinotecan during pregnancy and lactation has not been established. Because of potential fetal toxicity and excretion in breast milk, it is generally avoided unless the therapeutic benefit clearly outweighs the potential risk to the fetus or infant.

To order, submit an enquiry on the Irinotecan Aurobindo product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams, verifies trade or institutional credentials, and then provides pricing, availability, shipping details, and any required import documentation.

Compared with other topoisomerase I inhibitors such as topotecan, Irinotecan has a distinct metabolic activation to SN‑38 and is commonly used in fluorouracil‑based regimens for colorectal cancer. Its efficacy and toxicity profile differ, with Irinotecan often causing more pronounced diarrhea and neutropenia, while topotecan may have a different dosing schedule and side‑effect spectrum.

Irinotecan Aurobindo must be stored at 2‑8 °C, protected from light, and kept in its original packaging. It should not be frozen or shaken. Once reconstituted, the solution should be used promptly according to the manufacturer’s instructions and any remaining product discarded if not used within the recommended time.

The medication is supplied as a sterile powder for intravenous infusion. After reconstitution with the appropriate diluent, it is filtered if required and administered by a qualified healthcare professional over a prescribed infusion period, typically under clinical monitoring for adverse reactions.

The most serious adverse events include severe neutropenia, febrile neutropenia, grade 3‑4 diarrhea that can lead to dehydration, intestinal perforation, and rare life‑threatening allergic reactions. Patients should be closely monitored for signs of infection, persistent diarrhea, abdominal pain, or any hypersensitivity symptoms.

Irinotecan should be avoided in patients with known hypersensitivity to the drug or its excipients, those with uncontrolled infections, significant bone‑marrow suppression, severe hepatic impairment, or pregnant women unless the potential benefit justifies the risk. Clinical judgment is essential to determine suitability.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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